Opinion on the safety of surgical meshes used in urogynecological surgery.
Date: 2016-02-12
Institutions: Directorate-General for Health and Consumers
Subjects: disease prevention, health control, medical device, public health, surgery

Scientific Committee on Emerging and Newly Identified Health Risks 

SCENIHR 

Opinion on  

The safety of surgical meshes used in urogynecological 
surgery 

The SCENIHR approved this Opinion on 3 December 2015  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

About the Scientific Committees  

Three  independent  non-food  Scientific  Committees  provide  the  Commission  with  the 
scientific  advice  it  needs  when  preparing  policy  and  proposals  relating  to  consumer 
safety, public health and the environment. The Committees also draw the Commission's 
attention to the new or emerging problems which may pose an actual or potential threat.  

They  are:  the  Scientific  Committee  on  Consumer  Safety  (SCCS),  the  Scientific 
Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on 
Emerging  and  Newly  Identified  Health  Risks  (SCENIHR)  and  are  made  up  of  external 
experts.  

In addition, the Commission relies upon the work of the European Food Safety Authority 
(EFSA),  the  European  Medicines  Agency  (EMA),  the  European  Centre  for  Disease 
prevention and Control (ECDC) and the European Chemicals Agency (ECHA). 

SCENIHR 

This Committee deals with questions related to emerging or newly identified health and 
environmental  risks  and  on  broad,  complex  or  multidisciplinary  issues  requiring  a 
comprehensive  assessment  of  risks  to  consumer  safety  or  public  health  and  related 
issues  not  covered  by  other  Community  risk  assessment  bodies.  Examples  of  potential 
areas  of  activity  include  potential  risks  associated  with  interaction  of  risk  factors, 
synergic  effects,  cumulative  effects,  antimicrobial  resistance,  new  technologies  such  as 
nanotechnologies,  medical  devices  including  those  incorporating  substances  of  animal 
and/or  human  origin,  tissue  engineering,  blood  products,  fertility  reduction,  cancer  of 
endocrine  organs,  physical  hazards  such  as  noise  and  electromagnetic  fields  (from 
mobile  phones,  transmitters  and  electronically  controlled  home  environments)  and 
methodologies for assessing new risks. It may also be invited to address risks related to 
public health determinants and non-transmissible diseases. 

Scientific Committee members 

Michelle  Epstein,  Igor  Emri,  Philippe  Hartemann,  Peter  Hoet,  Norbert  Leitgeb,  Luis 
Martínez Martínez, Ana Proykova, Luigi Rizzo, Eduardo Rodriguez-Farré, Lesley Rushton, 
Konrad Rydzynski, Theodoros Samaras, Emanuela Testai, Theo Vermeire 

Contact: 

European Commission  
DG Health and Food Safety  
Directorate C Public Health  
Unit C2 – Health Information and Scientific Committees 
Office: HTC 03/073 L-2920 Luxembourg  
SANTE-C2-SCENIHR@ec.europa.eu 

© European Union, 2015 
ISSN 1831-4783 
doi:10.2772/63702   
The  Opinions  of  the  Scientific  Committees  present  the  views  of  the  independent 
scientists who are members of the committees. They do not necessarily reflect the views 
of  the  European  Commission.  The  Opinions  are  published  by  the  European  Commission 
in their original language only. 

ISBN 978-92-79-43917-9 
ND-AS-14-005-EN-N 

http://ec.europa.eu/health/scientific_committees/emerging/Opinions/index_en.htm 

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The safety of surgical meshes used in urogynecological surgery 

ACKNOWLEDGMENTS 

Members of the Working Group are acknowledged for their valuable contribution to this 
Opinion. The members of the Working Group are: 

The SCENIHR members: 

Prof.  Philippe  Hartemann  (Chair)  -  Université  de  Lorraine,  Faculté  de  Médecine,  Nancy, 
France. 

em. Prof. Norbert Leitgeb – Graz University of Technology, AT.  

Prof. Luis Martínez Martínez - University of Cantabria, Santander, Spain.  

Prof. Theodoros Samaras (co- Rapporteur) - University of Thessaloniki, Greece.  

External experts: 

Dr. Catherine Brogan - Therapeutic Goods Administration, Australia.  

Prof.  Christopher  Chapple  (Rapporteur)  -  Sheffield  Teaching  Hospitals  NHS  Foundation 
Trust, Sheffield, United Kingdom.  

Prof. Xavier Deffieux - Assistance Publique Hopitaux de Paris (Antoine Beclere  Hospital, 
Clamart), France.  

Dr. Jorge Garcia - Therapeutic Goods Administration, Australia.  

Dr. Alfredo L. Milani - Reinier de Graaf Hospital, the Netherlands.  

The additional contribution of the following experts is gratefully acknowledged: 

Prof. Sheila MacNeil, University of Sheffield, Sheffield, United Kingdom, for the in-depth 
review of the report and for the contribution to the section on 'aging of the material of 
surgical meshes' and its influence on the performance of these medical devices. 

All Declarations of Working Group members and supporting experts are available at the 
following webpage: 

http://ec.europa.eu/health/scientific_committees/emerging/members_wg/index_en.htm  

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The safety of surgical meshes used in urogynecological surgery 

ABSTRACT 

Surgical meshes have been used since the 1950s to repair abdominal hernias and were 
then used in the 1990s for the treatment of male and female stress urinary incontinence  
(SUI),  female  pelvic  organ  prolapse  (POP)  and  colorectal  functional  disorders  (CFD). 
More  recently  the  use of  synthetic  mesh  and biological  materials  has  become  common, 
requiring new surgical insertion tools and tissue fixation anchors.  

The  use  of  meshes  in  surgery  has  been  shown  to  be  associated  with  various  adverse 
complications such as infection, tissue extrusion, separation of vaginal epithelium leading 
to visualisation of the mesh (mesh exposure), mesh shrinkage and adverse side effects 
including  pain  and  sexual  dysfunction.  The  European  Commission  has,  thus,  requested 
the SCENIHR to assess the health risks of meshes used in urogynaecological surgery. 

The  various  options  for  the  treatment  of  pelvic  floor  dysfunctions  were  reviewed  based 
on  the  scientific  literature  and  the  guidelines  from  scientific  societies  and  health 
authorities. Included were both non-surgical and surgical treatment methods.  

Non-biological  surgical  mesh  materials  can  be  divided  into  three  categories:  non-
absorbable  synthetics,  absorbable  synthetics,  and  composites.  Synthetic  meshes  that 
have been used with mono- or multi-filament structure are usually classified according to 
their  mesh  size  as  Types  1,  2,  3  or  4  (Amid  Classification),  where  type  1  is  with  pores 
>75  µm,  type  2  with  pores  <10µm,  type  3  with  micropores  and  type  4  with 
monofilaments  and  submicronic  pores  of  <1µm.  Today,  type  1  polypropylene  mesh  is 
the most commonly used.  

Clinical  outcome  following  mesh  implantation  is  influenced  by  material  properties, 
product  design,  overall  mesh  size,  route  of  implantation,  patient  characteristics, 
associated procedures (e.g. hysterectomy) and the surgeon’s experience. The SCENIHR 
recommends  that  such  aspects  should  be  taken  into  account  when  choosing  an 
appropriate therapy.  

In  assessing  the  risk  associated  with  mesh  application,  it  is  important  to  consider  the 
overall  surface  area  of  material  used,  the  product  design  and  the  properties  of  the 
material used. The available evidence suggests a higher morbidity in treating POP, which 
uses a much larger amount of mesh compared to SUI.  

When assessing synthetic mesh risks, there is a need to clearly distinguish between the 
risks associated with SUI sling surgery and those of POP mesh surgery; sling surgery for 
SUI is associated with lower risks compared to POP mesh surgery.  

The implantation of any mesh for the treatment of POP via the vaginal route should only 
be  considered  in  complex  cases,  in  particular,  after  failed  primary  repair  surgery.  Mesh 
exposure  rates  for  vaginal  POP  surgery  with  mesh  range  from  4  to  19%  (Milani  et  al., 
2013). The use of autologous graft material is not feasible for POP because of the large 
mesh  area  required  and  the  resulting  donor  morbidity.  The  use  of  absorbable  mesh 
inserted  either  via  a  transabdominal  or  transvaginal  route  is  associated  with  a  high 
failure rate. Transvaginal surgery using non-absorbable synthetic mesh for POP involves 
a much greater surface area of mesh and is associated with a higher risk of mesh-related 
morbidity  than  seen  with  transabdominal  insertion  of  mesh.  Sacrocolpopexy  is 
associated with greater surgical morbidity compared to vaginal repair. 

In  sling  surgery,  there  is  evidence  that  absorbable  biological  materials  have  a  high 
failure rate while sling surgery with non-absorbable synthetic mesh was effective with an 
approximately mesh exposure rate of 4% (Brubaker et al., 2011). Autologous slings are 
a more invasive alternative (because of the need to harvest native tissue), but they also 
can be inserted using a minimally invasive approach. The traditional surgical approach of 
colposuspension  is  associated  with  greater  morbidity  compared  to  sling  surgery  with 
mesh.  

However, synthetic sling SUI surgery is an accepted procedure with proven efficacy and 

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The safety of surgical meshes used in urogynecological surgery 

safety  in  the  majority  of  patients  with  moderate  to  severe  SUI,  when  used  by  an 
experienced  and  appropriately  trained  surgeon.  Therefore,  the  SCENIHR  supports 
continuing synthetic sling use for SUI, but emphahsises the importance of appropriately 
trained surgeons and detailed counselling of patients about the associated risk/benefits. 

Based on the available scientific evidence, the SCENIHR recommends 

• 

• 

• 

• 

the  implantation  of  any  mesh  for  the  treatment  of  POP  via  the  vaginal  route 
should  be  only  considered  in  complex  cases  in  particular  after  failed  primary 
repair surgery, 

that  due  to  increased  risks  associated  with  the  use  of  synthetic  mesh  for  POP 
repair  via  a  trans-vaginal  route,  this  option  should  only  be  used  when  other 
surgical procedures have already failed or are expected to fail.  

limiting the amount of mesh for all procedures where possible. However, there is 
a  need  for  further  improvement  in  the  composition  and  design  of  synthetic 
meshes, in particular for POP surgery. 

the  introduction  of  a  certification  system  for  surgeons  based  on  existing 
international guidelines and established in cooperation with the relevant European 
Surgical Associations. 

•  appropriate  patient  selection  and  counselling,  which  is  of  paramount  importance 
for the optimal outcome for all surgical procedures, particularly for the indications 
discussed. This should be based on the results of further clinical evidence, which 
should be collected in a systematic fashion for all of these devices. 

Keywords:  surgical  meshes,  risk  assessment,  Scientific  Committee  on  Emerging  and 
Newly Identified Health Risks 

Opinion to be cited as: 
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), The 
safety of surgical meshes used in urogynecological surgery, 3 December 2015  

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The safety of surgical meshes used in urogynecological surgery 

TABLE OF CONTENTS 

ABSTRACT 

TABLE OF CONTENTS 

1. EXECUTIVE SUMMARY 

2. BACKGROUND 

3. TERMS OF REFERENCE 

4. SCIENTIFIC RATIONALE 

4.1. Introduction 

4.1.1. Indications for the use of surgical meshes 

4.1.2. Regulatory framework 

4.1.3. Methodogy 

4.2. Treatment 

4.2.1. Treatment without using meshes 

4.2.2. Treatment using meshes 

4.2.3. Results of treatment using meshes 

4.2.4. Learning curve and clinical experience 

4.2.5. Mitigating risks through patient selection and counselling 

4.2.6. Patient counselling 

4.2.7. Risk assessment and recommendations by National Associations 

5. OPINION 

5.1. Terms of reference 

5.1.1. Risks associated with the use of mesh in urogenital surgery 

5.1.2. Identification of high risk patient groups 

5.2. Recommendations 

6. MINORITY OPINION 

7. CONSIDERATION OF THE RESPONSES RECEIVED DURING THE CONSULTATION 
PROCESS 

8. ABBREVIATIONS AND GLOSSARY OF TERMS 

9. APPENDIX 

10. LIST OF REFERENCES 

4 
6 
7 
13 
15 
16 
16 
16 
17 
19 
20 
20 
26 
39 
54 
56 
58 
59 
63 
63 
63 
66 
66 
67 

68 
69 
70 
82 

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The safety of surgical meshes used in urogynecological surgery 

1. EXECUTIVE SUMMARY 

Stress  urinary  incontinence  (SUI),  which  means  incontinence  occurring  in  association 
with exercise or rising intra-abdominal pressure, is a common condition in women, with 
its prevalence increasing with age. It occurs as a consequence of either weakness in the 
sphincter muscles within the walls of the urethra or prolapse of the urethra. Pelvic organ 
prolapse  (POP),  which  can  lead  to  prolapse  of  the  urethra,  can  also  lead  to  other 
consequences,  such  as  prolapse  of  the  vagina  itself  (anterior  vaginal  wall  with  bladder 
descent, and posterior vaginal wall with descent of the rectum and/or pouch of Douglas 
causing an enterocele and/or the uterus or vaginal vault prolapse). These conditions can 
be  associated  with  SUI,  overactive  bladder  (OAB),  bladder  outlet  obstruction  (BOO) 
symptoms  and/or  defaecatory  disorders.  SUI  and  POP  are  both  major  causes  for 
reducing the quality of life among the female population. Stress urinary incontinence is 
uncommon in men, for whom the most related health problems are commonly benign or, 
even more often, malignant prostate disease, which may require prostatic surgery. This 
type  of  surgery  may  result  in  incontinence  as  a  direct  consequence  of  damage  to  the 
urethral muscle controlling micturition. 

The  use  of  synthetic  mesh  has  become  popular  in  recent  years  for  the  management  of 
SUI  in  female  and,  more  recently,  in  male  patients.  It  has  also  been  employed  in  the 
management  of  pelvic  organ  prolapse  in  female  patients,  affecting  both  the  lower 
genitourinary and colorectal tract. Review of the current literature and experience from 
clinical practice suggests that the use of surgical mesh in this context is associated with 
both  benefits  and  risks.  However,  only  a  few  randomised  controlled  studies  have  been 
published  until  now.  The  use  of  such  mesh  in  repair  surgery  may  lead  to  various 
complications of poor tissue integration, such as tissue extrusion, exposure of the mesh 
and shrinkage of the mesh. The success of mesh interventions varies depending on the 
type of anatomical defect, its severity, the presence of risk factors, the rationale for the 
use of mesh and the skill and experience of the surgeons.  

In light of the above, the Scientific Committee on Emerging and Newly Identified Health 
Risks (SCENIHR) was requested to provide a scientific Opinion on the safety of surgical 
meshes  used  in  contemporary  pelvic  surgery.  In  the  Opinion,  the  following  issues  have 
been addressed: 

1.  Risks associated with the use of surgical meshes for treating SUI and POP. 

2.  Identification of high-risk patient groups.  

3.  Risk of meshes other than for urogynecological surgery. 

4.  Need for further assessment in this field. 

5.  The scientific rationale for the use of synthetic surgical mesh for the management 

of urinary incontinence, POP and colorectal functional disorders. 

Surgical meshes are produced by manufacturers to treat the above-mentioned disorders 
and, because of their intended medical use, fall under the scope of the medical devices 
Directive  93/42/EEC  (including  Amendment  2007/47/EC).  Among  others,  this  Directive 
contains essential requirements that medical devices must meet.  

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The safety of surgical meshes used in urogynecological surgery 

This  Opinion  reviews  the  options  available  for  the  management  of  SUI  in  female  and 
male  patients,  and  for the  repair  of  POP  affecting  both the  genitourinary  and  colorectal 
systems. The indication for the use of synthetic mesh is to provide additional support to 
the  urethra,  rectum  or  pelvic  organs.  In  many  cases,  it  is  not  possible  to  use  patients’ 
own  tissue  (autologous  tissue)  to  provide  this  support,  due  to  the  lack  of  an  adequate 
amount of tissue. In this context, in previous years, efforts to use materials either from 
human  donors  (allografts)  or  from  animal  sources  (xenografts)  have  failed.  This  has 
added impetus to introduce synthetic mesh into clinical use. 

Before  a  decision  for  surgery  is  made,  it  is  important  to  explore  non-surgical  solutions 
for SUI, POP and colorectal functional disorders (CFD). If non-surgical solutions are not 
feasible or unacceptable to the patient, in a shared decision process the surgeon and the 
patient  should  determine  whether  to  use  a  surgical  approach  with  or  without  mesh. 
Statistical  information  regarding  the  incidence  of  potential  complications  is  inconsistent 
worldwide.  Many  patients  are  still  undergoing  mesh  surgery  as  a  first  option  without 
having  all  the  necessary  information  regarding  the  potential  risks.  Unless  worldwide 
standardisation  of  guidelines  and  statistically  accurate  information  identifying  the 
potential risk in the use of these products is adopted, then true informed consent can not 
and  is  not  being  obtained  from  the  patient.  Information  given  to  practitioners  by  the 
manufacturers  regarding  the  'proven'  safety  of  these  products  and  the  510k  clearance 
loophole needs to be addressed before true informed consent can be made. 

Meshes  are  not  the  first  choice  for  any  indication,  but  are  considered  as  a  primary 
surgical  solution  in  many  cases  of  SUI,  despite  reported  adverse  events.  For  prolapse 
repair,  larger  meshes  than  for  SUI  are  needed  for  vaginal  or  transabdominal 
implantation. In the context of POP, the use of mesh placed by the vaginal route is only 
recommended as a secondary choice after primary surgery with native tissue has failed 
or  it  is  expected  to  fail.  There  is  currently  limited  use  of  mesh  for  CFD,  mainly  in 
specialised centres.  

The  scientific  rationale  for  the  use  of  synthetic  mesh  was  reviewed  based  on 
contemporary literature. Several clinical implementation techniques are available and are 
briefly discussed in this Opinion. A number of adverse events are reported in association 
with the use of synthetic mesh. This has led to the creation of guidelines in recent years 
to  provide  advice  on  issues  that  require  consideration  before  using  synthetic  surgical 
mesh.  The  choice  to  use  synthetic  meshes  may  influence  the  outcome  of  surgery  and 
needs to be discussed in detail with patients before carrying out surgery.  

The following questions raised in the mandate are answered in this Opinion. 

Are specific meshes, in terms of designs and/or materials, considered to be of a 
higher risk? If possible list and describe the risks. 

There are a number of different types of meshes, which include:  

•  Allografts (e.g., cadaveric fascia, dura mater) 

•  Xenografts (e.g., porcine, bovine) 

•  Autografts (e.g., fascia lata, rectus fascia) 

•  Synthetic meshes (partially absorbable or non-absorbable)  

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The safety of surgical meshes used in urogynecological surgery 

In  this  Opinion  the  SCENIHR  focuses  on  the  use  of  synthetic  non-absorbable  meshes. 
These are usually classified in four types (see Table 10). 

The  current  consensus  is  that  synthetic  non-absorbable  meshes  Type  2  (microporous, 
less  than  10  microns,  mono  and  multifilament)  and  Type  4  (sub-micronic  and 
monofilament) are considered not appropriate for use in this clinical context. 

Current evidence suggests:  

−  Type  1  (macroporous,  monofilament)  is  considered  to  be  the  most  appropriate 

synthetic mesh for insertion via the vaginal route.  

−  Type  1  (macroporous,  monofilament)  and  Type  3  (microporous,  multifilament) 

are the most appropriate synthetic meshes for insertion via the abdominal route. 

Currently,  there  is  insufficient  evidence  on  the  performance,  risk  and  efficiency  of 
meshes  of  other  materials.  Clinical  experience  with  polyvinylidene  fluoride  (PVDF)  is 
mainly for hernia repair and at present does not allow any reliable conclusions for use in 
urogynecological surgery. 

In assessing the risks associated with surgical mesh insertion, it is important to consider 
the following: 

•  Overall surface area of material used (which is greater for POP than for SUI); 
•  Product  design  (e.g.,  physical  characteristics  of  the  mesh,  size  of  the  pore  as  a 
predisposing  factor  to  infection  in  particular  with  a  pore  size  of  less  than  75 
microns); 

•  Material  properties  (biocompatibility,  long-term  stability,  flexibility,  elasticity, 
aging, etc.); mesh exposure is only seen with non-absorbable synthetic mesh; 
•  Contrasting  the  options  available,  autologous  tissue  has  a  low  failure  rate  and 
complication  rate,  but  is  associated  with  potential  donor  site  morbidity; 
xenografts and allografts have a high failure rate and low complication rate but a 
higher risk of infection; whilst synthetics have a low failure rate but a higher risk 
of exposure of the material and associated complications. 

•  The  physical  properties  and  durability  of  the  materials,  balanced  with  the 

unwanted consequences of implanting the material on a long-term basis. 

•  A standardised classification system of complication should be used. 

Are certain surgical techniques of higher risk? If possible list and describe the 
risks. 

All synthetic meshes are associated with the risk of mesh exposure as demonstrated by 
numerous  animal  studies.  At  a  two-year  follow  up  of  women  treated  for  SUI  with 
retropubic and transobturator midurethral synthetic slings mesh, the exposure rate was 
4%  (Brubaker  et  al.,  2011).  Mesh  exposure  rates  for  vaginal  POP  surgery  with  mesh 
ranges from 4 to 19% (Milani et al., 2013). 

In  general  terms,  vaginal  surgery  is  associated  with  a  higher  risk  of  mesh-related 
morbidity than abdominal insertion of mesh. However, the abdominal route is associated 
with  specific  increased  risks  related  to  the  surgical  approach,  such  as  bowel  occlusion. 
Furthermore,  the  abdominal  route  requires  general  anaesthesia,  whereas  the  vaginal 
route is also feasible under spinal anaesthesia. 

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The safety of surgical meshes used in urogynecological surgery 

In risk assessment of the use of mesh it is necessary to differentiate between different 
indications such as SUI and POP.  

The  SCENIHR  acknowledges  the  efficacy  and  use  of  implanted  meshes  for  SUI  in  the 
majority of patients with moderate to severe SUI. It considers that the associated risk is 
limited,  but  recognises  the  absence  of  long-term  data.  Most  complications  associated 
with mesh insertion are related to the route of insertion. 

The  SCENIHR  acknowledges  that  vaginally-implanted  mesh  for  POP  is  associated  with 
increased  risks  compared  to  mesh  implantation  for  SUI.  Its  use  should  be  restricted  to 
patients selected according to established evidence based clinical guidelines. 

Are any combinations of the above (designs/materials and surgical techniques) 
of a higher risk? 

Combination of the above mentioned designs/materials and surgical techniques may be 
associated  with  higher  risk.  With  vaginal  insertion  of  non-absorbable  synthetic  mesh  a 
large  surface  area  is  associated  with  a  higher  complication  rate  compared  with 
transabdominal  insertion.  However,  there  are  generic  differences  and  potential 
complications  distinguishing  the  two  surgical  approaches,  and  this  fact  should  also  be 
taken into account in a risk assessment. 

Are  there  specific 
techniques) with the use of meshes in urogynecological surgery? 

limitations  (e.g.  clinical,  designs/materials,  surgical 

There  are  specific  limitations  to  the  use  of  meshes  in  urogynecological  surgery.  The 
following limitations apply: 

•  The  available  evidence  suggests  that  xenograft  and  allograft  materials  are 
associated  with  a  high  failure  rate  (due  to  degradation  of  mechanical  properties 
with  time),  but  are  not  associated  with  such  severe  side  effects  as  synthetic 
meshes.  

•  The risk of severe side effects (e.g. mesh exposure, shrinkage, pain) increases 

with the surface area of synthetic non-absorbable meshes. Material properties will 
influence the outcome (biocompatibility, tissue integration, long-term stability, 
and mechanical responses over time including flexibility, elasticity and resistance 
to deformation). 

•  Patient  characteristics,  such  as  obesity,  will  have  an  influence  on  efficacy  and 

potential complications.  

What  are  the  risks  of  surgical  interventions  using  mesh  compared  to  classic 
surgical interventions? 

When  treating  SUI,  sling  procedures  are  associated  with  more  storage  and  voiding 
symptoms  than  other  repositioning  procedures.  The  use  of  synthetic  non-absorbable 
mesh  is  associated  with  a  risk  of  mesh  exposure.  However,  other  surgical  procedures, 
such  as  colposuspension,  are  associated  with  an  increased  risk  of  long-term 
rectocele/enterocele. 

When  treating  POP  via  the  vaginal  route,  the  use  of  synthetic  non-absorbable  mesh  is 
associated with a risk of mesh exposure and de novo prolapse of the untreated vaginal 
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compartment, as well as the development of de novo SUI. The risk of mesh exposure is 
reduced  when  using  the  transabdominal  route  compared  to  the  transvaginal  route. 
However,  it  should  be  kept  in  mind  that  transabdominal  and  transvaginal  POP  repair 
have distinct indications as discussed in current guidelines. Moreover, there are generic 
differences and different potential complications for these two surgical approaches. 

What factors could affect the outcome of the surgical interventions? 

The factors influencing the surgical outcomes are: 

•  Material properties (biocompatibility, tissue integration, long-term stability, and 

mechanical performance over time which includes flexibility, elasticity, aging  and 
resistance to deformation ) 

•  Product design (e.g. physical characteristics of the mesh, size of the pore as a 

predisposing factor to infection in particular with a pore size less than 75 microns) 

•  Overall mesh size (which is greater for POP than for SUI) 
•  Route of implantation, (e.g., vaginal or transabdominal) 
•  Patient characteristics (e.g., age, obesity, smoking) 
•  Associated procedures (e.g., hysterectomy) 
•  Surgeon’s experience 

The SCENIHR recognises the importance of following established guidelines, the need for 
adequate  training  and  clinical  experience  of  the  surgeon  as  well  as  the  need  to  further 
improve the design of the device, in particular for use in the pelvic floor, which appears 
to  be  a  more  demanding  environment  than  the  abdomen  (where  the  non-degradable 
meshes have a lower complication rate). 

Are  there  patients  groups  (e.g. 
comorbidities) for which the use of meshes would carry a specific risk? 

in  relation  to  age,  weight  or  other 

Yes. The SCENIHR acknowledges the importance of the identification of high-risk patient 
groups. Age and obesity have been shown to be associated with increased risk of mesh 
exposure. This should be investigated further.  

In light of the above, identify risks associated with use(s) of meshes other than 
for urogynecological surgery and advise if further assessment in this field(s) is 
needed. 

The SCENIHR notes there is limited information in the literature on this subject. There is 
a suggestion that morbidity may be associated with colorectal use of meshes. This needs 
to be quantified by further research before any conclusion can be made. 

Recommendations 

•  Ensure that patients are correctly and comprehensively informed on the benefits 

and risks associated with the use of synthetic non-absorbable meshes. 

•  Establish European implant registries. 

•  Establish  scientific  studies  to  assess  the  long-term  (at  least  5  years)  safety  and 

performance of synthetic non-absorbable meshes.  

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The safety of surgical meshes used in urogynecological surgery 

•  Encourage  further  research  into  novel  design  and  materials,  in  particular 
absorbable  meshes,  and  improved  technologies  for  manufacturing  meshes,  such 
as electrospinning.  

•  Encourage  further  research  into  the  application  of  regenerative  medicine 

technology, such as the cellular seeding of graft materials. 

•  Adopt evidence-based Pan European Guidelines.  

•  Develop  training  programmes  for  surgeons in  association  with  European  medical 

associations. 

12 

 
The safety of surgical meshes used in urogynecological surgery 

2. BACKGROUND 

Synthetic surgical meshes are medical devices intended to be implanted to reinforce soft 
tissues to treat their weakness, which includes prolapse of the pelvic floor in women and 
weakness of the urethral sphincter in women and men.  

According  to  the  Council  Directive  93/42/EEC,  medical  devices  shall  only  be  placed  on 
the  market  if  they  meet  the  essential  requirements  laid  down  in  the  Annex  I  of  the 
directive, in particular in relation to the health and safety of patients. 

Surgical  meshes  have  been  used  since  the  1950s  to  repair  abdominal  hernias. 
Implantable meshes have played an important role in the treatment of complex hernias 
and other abdominal wall reconstruction procedures. In the 1990s, gynecologists began 
using  the  same  surgical  mesh  for  surgical  treatment  of  Stress  Urinary  Incontinence 
(SUI). The first procedure was called the “tension-free vaginal tape procedure” and was 
considered  an  alternative  to  the  traditional  surgery  either  using  patients’  own  tissue  or 
forming  a  hitch  of  the  vagina  and  bladder  base  –  a  so-called  colposuspension.  The 
technique  designed  for  the  treatment  of  SUI  involved  a  transabdominal  or  transvaginal 
approach, which subsequently evolved into a purely vaginal approach for the insertion of 
a loose mid-urethral sling procedure. Responding to the  need perceived by the medical 
community,  the  medical  devices  manufacturers  produced  mesh  kits  containing  the  pre-
shaped  mesh  implant(s)  as  well  as  the  accessory  tools  needed  for  their  placement. 
Surgical mesh kits continue to evolve using new materials and new insertion tools, tissue 
fixation anchors and surgical techniques. 

Surgical  mesh  materials  can  be  divided  into  four  categories  (1)  non-absorbable 
synthetic, (2) absorbable synthetic (3) biologic (4) composite. Different types of designs 
are available aimed at better integration in the organism after implantation. 

Pelvic  floor  dysfunction  is  a  major  health  problem  in  women  as  they  age,  as  shown  by 
the  11.4% prevalence  of  symptomatic  pelvic  organ  prolapse  (POP)  in  women  above  45 
years (1 in every eight women) (Slieker-ten Hove et al., 2009), as well as the 11-20% 
(1  in  every  5-10  women)  lifetime  risk  of  undergoing  a  single  operation  for  POP  or  SUI 
bythe  age  of  80  (Olsen  et  al.,  1997,  Wu  et  al.,  2014).  A  large  proportion  of  repeat 
operations  (up  to  1  in  3)  has  been  documented,  as  well  as  the  time  intervals  between 
them, which decrease with each successive procedure. 

SUI  affects  an  estimated  20-40%  of  women.  A  Norwegian  study  (Hannestad  et  al., 
2000)  reported  the  percentage  of  patients  with  SUI  to  be  approximately  50%  with 
incontinence, the remainder with urge (11%) and mixed incontinence (36%). 

The surgical repair of POP proved to be a longstanding challenge with high failure rates 
of  primary  repair.  As  a  consequence,  clinicians  changed  to  the  use  of  substitute 
materials  to  augment  the  native  tissue  reaction  including  the  use  of  developed  mesh 
kits. The rapid and widespread transition from traditional pelvic organ prolapse surgery 
using native tissue, to mesh-augmented prolapse repair aimed to  improve the frequent 
unsatisfactory outcomes. 

POP  is  a  major  health  issue  in  women  of  older  age  and  one  of  the  most  common 
indications  for  gynaecological  surgery.  Generally,  the  lifetime  risk  for  a  woman  of 

13 

 
 
The safety of surgical meshes used in urogynecological surgery 

undergoing surgical treatment for POP is about 7-20%. Despite the fact that POP is one 
of  the  most  common  indications  for  gynaecologic  surgery,  epidemiological  studies  on 
incidence and prevalence are scarce (Slieker-ten-Hove et al., 2009). 

With  the  increasing  life  expectancy  and  the  changing  lifestyle  of  women,  a  further 
increase in the demand for pelvic floor surgery is expected for the future. This is already 
expressed in recent data on the lifetime risk for a woman to undergo a single operation 
for POP or SUI at the age of 80, which has been adjusted upwards from 11% in 1997 to 
20% in 2014 (Wu et al.,2014). A vast group of women seem to prefer surgical correction 
of the vaginal anatomy. 

Surgical meshes were introduced in recent years in the form of sling surgery used for the 
treatment of sphincteric incontinence in men usually following prostatic surgery. 

Meshes  have  also  been  used  for  the  treatment  of  colorectal  prolapse.  However,  in  the 
current Opinion this type of use is not dealt with specifically. 

Current  data  suggest  that  the  use  of  mesh  in  surgery  is  associated  with  benefits  and 
risks, but there are few published randomised controlled trials. The use of mesh in repair 
surgery  may  lead  to  various  complications,  such  as  rejection,  tissue  extrusion,  mesh 
exposure and shrinkage. The rate of success of treatment with mesh implantation varies 
depending on the type of the anatomical defect, its severity, the presence of risk factors 
and  the  mesh  used.  Some  women  reported  significant  side  effects  after  this  type  of 
surgery. Mesh complications in men are less commonly reported and are usually related 
to obstructive voiding. 

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

3. TERMS OF REFERENCE 

In  light  of  the  above  considerations,  the  Scientific  Committee  on  Emerging  and  Newly 
Identified  Health  Risks  was  requested  to  provide  a  scientific  Opinion  on  "The  safety  of 
surgical meshes used in urogynecological surgery". The following items were addressed: 

•  Risks associated with the use of meshes in treating SUI and POP 

-  Are  specific  meshes,  in  terms  of  designs  and/or  materials,  considered  to  be  of  a 

higher risk? If possible list and describe the risks. (Q1) 

-  Are certain surgery techniques of higher risk? If possible list and describe the risks. 

(Q2) 

-  Are any combinations of the above (designs/materials and surgical techniques) of a 

higher risk? (Q3) 

-  Are  there  specific  limitations  (e.g.  clinical,  designs/materials,  surgical  techniques) 

to the use of meshes in urogynecological surgery? (Q4) 

-  What  are  the  risks  of  surgical  interventions  using  mesh  compared  to  classic 

surgical interventions? (Q5) 

-  What factors could affect the outcome of the surgical interventions? (Q6) 

•  Identification of high risk patient groups 

-  Are there patients groups (e.g. in relation to age, weight or other comorbidities) for 

which the use of meshes would carry a specific risk? (Q7) 

•  In  the  light  of  the  above,  list  risks  associated  with  use(s)  of  meshes  other  than  for 
urogynecological  surgery  and  advise  if  further  assessment  in  this  field(s)  is  needed 
(Q8) 

In  its  assessment,  the  SCENIHR  was  invited  to  take  into  account  the  established 
registries in the field. 

15 

 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

4. SCIENTIFIC RATIONALE 

4.1. Introduction 

4.1.1. Indications for the use of surgical meshes 

Various  options  exist  for  the  treatment  of  pelvic  floor  dysfunctions.  Treatment  is 
justified,  if  conservative  strategies,  such  as  ‘watchful  waiting’  or  pelvic-muscle  training 
(see  4.2.2)  are  unsuccessful.  Depending  on  the  type  of  pelvic  floor  dysfunction,  the 
therapeutic approach and the size of mesh implanted may differ. 

The indications and the risk/benefit ratios for the use of urogynecological meshes depend 
on  the  type  of  pelvic  floor  dysfunction.  Currently,  there  are  three  major  indications  for 
which surgical meshes are used: 

•  Male and female Urinary Incontinence (UI) 

• 

Female Pelvic Organ Prolapse (POP) 

•  Colorectal Functional Disorders (CFD) 

Urinary incontinence (UI) 

Female 

About 50% of women with UI report symptoms of stress incontinence, but estimates of 
the prevalence and incidence are limited, because epidemiologic studies use inconsistent 
methods  of  measurement  and  different  populations  (Reynolds et  al.,  2011)  with  regard 
to age and ethnicity. Longitudinal studies assessing the incidence and natural history of 
stress  incontinence  estimate  an  annual  incidence  of  4%  to  10%.  While  remission  does 
occur, data are sparse. Multiple risk factors are associated with developing the symptom 
of stress incontinence. 

Male 

Urinary  incontinence  in  elderly  community-dwelling  men  affects  quality  of  life  and 
increases the risk of institutionalisation (Shamliyan et al., 2009). Pooled prevalence of UI 
increased  with  age  to  between  21%  and  32%  in  men  above  60  years.  Poor  general 
health,  comorbidities,  severe  physical  limitations,  cognitive  impairment,  stroke,  urinary 
tract  infections,  prostate  diseases  and  diabetes  were  associated  with  UI.  Radical 
prostatectomy  or  radiotherapy  for  prostate  cancer  compared  with  watchful  waiting 
increased  UI.  Short-term  prevention  of  UI  with  pelvic  floor  muscle  rehabilitation  after 
prostatectomy was not consistently seen across randomised, controlled trials. 

Pelvic organ prolapse 

Pelvic  organ  prolapse  (POP)  is  a  highly  prevalent  condition  that  effects  up  to  50%  of 
parous  women,  causing  a  variety  of  urinary,  bowel  and  sexual  symptoms  that  may  be 
associated;  however  not  all  of  those  women  are  bothered  by  this  condition.  (Maher  et 
al., 2013). A large cross-sectional study among community-dwelling women between 45 

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The safety of surgical meshes used in urogynecological surgery 

and  85  years  of  age  demonstrated  a  prevalence  rate  of  ‘symptomatic’  POP  of  11.4%. 
However,  only  6.9%  of  women  with  stage  I  and  15.8%  of  those  with  stage  II 
experienced  problems,  e.g.  vaginal  bulge  symptoms.  (Slieker-ten-Hove  et  al.,  2009) 
Some  loss  of  utero-vaginal  support  is  present  in  most  adult  women  and  should  be 
if 
considered  physiological  (Milani,  2012).  Surgery  should  only  be  considered 
symptomatic  POP  is  present  and  when  conservative  measures/therapies  have  failed 
(Dutch Multidisciplinary Guidelines on Prolapse, 2014).  

Colorectal functional disorders 

Internal or external rectal prolapse may be problematic and associated with constipation, 
obstructed  defecation,  faecal  incontinence  and  pain.  Treatment  may  be  conservative 
(such  as  increased  dietary  fibre,  pelvic  physiotherapy)  or  surgical.  For  the  surgical 
therapy  of  internal  rectal  prolapse,  an  open  or  laparoscopic  anterior  rectopexy  is  often 
performed.  Synthetic  mesh  is  used  to  suspend  and  distract  the  prolapsed  part  of  the 
rectum.  Some  patients  who  have  undergone  this  treatment  report  chronic  pain.  (Dutch 
Guidelines, 2014; Dutch Health Care Inspectorate, 2013).  

4.1.2. Regulatory framework 

Surgical mesh as a medical device 

Surgical  meshes  are  produced  by  manufacturers  to  treat  female  SUI,  POP  or  CFD,  and 
hence,  because  of  their  intended  medical  purpose,  fall  under  the  scope  of  the  medical 
devices  directive  93/42/EEC  and  amendment  2007/47/EC  which  contain  the  essential 
requirements  of  medical  devices  (Annex  I),  the  conformity  assessment  procedure  and 
the obligations of manufacturers for placing medical devices on the European market. 

Apart from specific design-related requirements such as on biocompatibility, stability and 
usability,  which  include  protection  from  foreseeable  error,  mistake  and  misuse,  general 
requirements demand that a medical device must: 

•  have an acceptable risk/benefit ratio; 

•  be designed based on state-of-the-art knowledge by observing the principles of 

inherent safety; 

•  achieve the intended performance; 

•  must not compromise the clinical condition and safety of the patients during the entire 

product lifetime as defined by the manufacturer; 

•  must not be adversely affected by transport and storage; 

•  have risks from unintended side-effects limited to an acceptable level when weighed 

against the device’s benefits; 

•  be accompanied by all information required to use the device safely; and 

•  have been proven safe and effective by clinical evidence.  

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The safety of surgical meshes used in urogynecological surgery 

There is a large variety of surgical meshes with quite different performance 
characteristics related to: 

•  material (synthetic or biologic);  
•  shape; 
•  dimensions; 
•  filaments; 
•  pore size; 
•  thickness; 
•  knitting patterns; 
•  aging; 
•  extrusion/exposure; 
•  biocompatibility; 
• 

instantaneous mechanical properties, such as  
-  elasticity,  
stiffness, and 
- 
-  bursting strength 

•  Time-dependent mechanical properties, such as 

creep,  
- 
relaxation, 
- 
shrinkage, 
- 
-  degradation  

In addition, mesh performance may critically depend on the directionality of the imposed 
mechanical load and/or how it was placed and fixed into the surrounding tissue.  

At the time of writing, there are no specific product standards on national, European or 
international  levels.  The  available  national  standard  in  France  (AFNOR  NF  S94-801)  is 
restricted  to  requirements  of  preclinical  and  clinical  testing  of  vaginal  reinforcement 
implants  for  SUI  and/or  POP  that  requires  that  both  preclinical  and  clinical  studies  be 
carried  out  before  introducing  any  new  implantable  mesh,  as  well  as  post-marketing 
surveillance. There are only a few general aspects related to product design covered by 
existing  standards  such  as  on  biocompatibility  (EN  10993-1  to  EN  10993-20)  or  on 
bursting  properties  (EN  13938-1,  EN  13938-2),  however,  a  device-specific  standard 
containing  specific  requirements  on  the  device  is  still  lacking,  in  particular  with 
quantitative  requirements,  such  as  site-specific  mechanical  properties,  material  aging 
and degradation, inflammatory response to the implanted materials (as demonstrated in 
animals), and minimisation of mesh extrusion. 

The  conformity  assessment  procedure  for  CE  labelling  offers  the  manufacturer  a  choice 
among  several  modules,  which  depend  on  the  intrinsic  risks  of  a  medical  device  for  its 
intended use under normal conditions.  

To  account  for  the  different  hazard  potential  of  the  large  diversity  of  medical  devices, 
manufacturers  must  classify  their  devices  into  one  of  the  four  risk  classes  I,  IIa,  IIb  or 
III, based on the device’s intrinsic risks. This is done by applying 18 classification rules 
as set out in Annex IX of the MDD 93/42/EEC and explained in guidance documents such 
as MEDDEV 2.4/1. 

The  European  Union’s  New  Approach  regulatory  policy  was  adopted  in  1986  and 
implemented  for  medical  devices  by  the  related  Directives,  among  others.  It  offers 
manufacturers  the  possibility  to  replace  third-party  testing,  even  of  critical  devices,  by 

18 

 
The safety of surgical meshes used in urogynecological surgery 

their  own  self-responsible  conformity  assessments  based  on  the  condition  that  their 
quality management systems have been certified by a third party.  

Because synthetic surgical meshes are less active than biological materials, implantable, 
and intended for long-term use, they belong to conformity class IIb (otherwise class III). 
according  to  rule  8  of  the  MDD  when  lacking  supporting  pharmaceutical  coating.  This 
means that surgical meshes must either a) pass a third-party EC type examination by a 
European Notified Body (according to MDD Annex III) and requires the manufacturer to 
implement  a  quality  management  system  (according  to  either  MDD  Annex  IV,  V  or  VI) 
that is also certified by a European Notified Body, or, alternatively, b) manufacturers can 
choose to implement a full Quality Management System (QMS), which must be certified 
by a Notified Body.  

In  case  a  medical  device  compromises  the  health  and/or  safety  of  patients  or  other 
persons  in  spite  of  its  correct  installation,  maintenance  and  use,  adequate  measures 
need  to  be  taken  by  manufacturers,  Member  States  and  the  Commission  to  remedy 
existing non-compliances. 

With  regard  to  the  involved  procedures  for  all  medical  devices,  conformity  with  the 
essential  requirements  must  be  based  on  a  convincing  clinical  evaluation  of  available 
clinical  data.  In  addition,  manufacturers  must  implement  a  risk  management  process, 
which  includes  a  post-market  surveillance  procedure  with  active  and  continuous 
feedback  data  acquisition,  monitoring  and  risk  assessment.  Post-market  surveillance 
must include both monitoring of complaints and adverse events, in addition to a regular 
review  and  updates  to  the  body  of  clinical  evidence  for  the  performance  of  the  device. 
The  results  of  this  regular  surveillance  must  be  assessed  for  potential  subsequent 
application  of  routine  risk  reduction  activities  (e.g.  improved  instructions  for  use)  and 
additional  risk  reduction  activities  (e.g.  design  changes,  physicians’  education  and 
training). Evidence of this process is essential to ensure that the risk-to-benefit ratio for 
the device can be justified by a manufacturer. 

Furthermore,  any  malfunction,  deterioration  in  the  characteristics  and/or  performance, 
inadequacy in the labelling or instructions for use of a medical device that might lead or 
might  have  led  to  a  serious  deterioration  of  a  patient’s  state  of  health  or  to  his/her 
death, must be reported to the competent authorities.  

Therefore, with regard to these obligations, sufficient clinical data should be available for 
surgical  meshes  to  allow  adequate  risk  assessment  and  identification  of  problems  with 
their design and/or their use. 

4.1.3. Methodogy 

The contemporary guidelines are based on clinical evidence derived from the conclusions 
of RCTs. An exception to this rule is related to the evidence base on the materials used 
for mesh implantation.  

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The safety of surgical meshes used in urogynecological surgery 

4.2. Treatment 

Before  resorting  to  surgery,  it  is  important  to  consider  non-surgical  solutions  for  SUI, 
POP and CFD with the patient.  

If non-surgical options are not feasible, then the surgeon must decide whether to use a 
surgical  approach  with  or  without  mesh,  although  currently,  meshes  are  considered  a 
primary  surgical  solution  in  many  cases  of  stress  incontinence.  All  surgical  approaches 
have  risks  and  despite  reported  adverse  events,  mesh  use  still  plays  a  primary  role  in 
surgery for SUI. Larger surface area meshes are needed for vaginal and transabdominal 
implantation for prolapse repair. For POP, the use of meshes is usually considered as a 
second  choice  after  failed  primary  surgery.  There  is  a  limited  use  of  mesh  for  CFD  in 
specialist centres. 

4.2.1. Treatment without using meshes 

Stress urinary incontinence (SUI) 

o 

Female 

Non-surgical treatment 

Guidelines from EAU (European Association of Urology), NICE / RCOG (United Kingdom), 
CNGOF  (College  National  des  Gynécologues  et  Obstétriciens  Français)  and  AFU 
(Association  Française  d’Urologie)  (France),  ACOG  (American  College  of  Obstetricians 
and Gynecologist) and ACP (American College of Physicians) (USA) recommend first-line 
treatment  with  pelvic  floor  muscle  training  (PFMT)  in  women  with  SUI  (Qaseem  et  al., 
2014; Fritel et al., 2010; Smith et al., 2013; NICE, 2013; Lucas et al., 2013). Pelvic floor 
muscle  training  should  be  as  intensive  as  possible.  Weight  loss  is  recommended  for 
obese women with SUI (grade: strong recommendation; moderate quality evidence).  

No  treatment:  Spontaneous  resolution  of  symptoms:  After  2-15  years  follow-up,  2-
30%  of  women  with  stress  incontinence  at  any  time  appear  to  undergo  spontaneous 
resolution  of  symptoms  (Dolan  et  al.,  2003;  Heidler  et  al.,  2007;  Lifford  et  al.,  2008; 
Jahanlu  et  al.,  2008;  Reynolds  et  al.,  2011;  Fritel  et  al.,  2012).  However,  a  reliable 
spontaneous resolution rate cannot be determined because population (age, menopausal 
status, etc.), follow-up duration and diagnostic criteria (cure or just improvement) differ 
considerably between published studies. 

Pads:  These  are  routinely  used  by  women  and,  to  a  lesser  extent,  by  men  with 
incontinence (Brazzelli et al., 2002). 

Weight  loss:  Randomised  clinical  trials  show  that  in  overweight  and  obese  women, 
weight loss (>5%) is associated with a decrease in the prevalence of SUI symptoms and 
in stress-incontinence episodes (Subak et al., 2009; Wing et al., 2010). 

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The safety of surgical meshes used in urogynecological surgery 

Medication: Meta-analyses showed that medication with duloxetine is associated with a 
significant  decrease  in  incontinence  episode  frequency  when  compared  to  placebo 
(Latthe et al., 2008; Li et al., 2013). 

Local estrogens: A meta-analysis showed that in post-menopausal women, there was 
some  evidence  that  estrogens  used  locally  (vaginal  creams  or  pessaries)  may  improve 
incontinence  (global  urinary  incontinence).  However,  according  to  the  authors’ 
conclusions,  there  was  little  evidence  from  the  trials  on  the  period  after  oestrogen 
treatment  had  finished  and  no  information  about  the  long-term  effects  of  this  therapy 
was given. Conversely, systemic hormone replacement therapy using conjugated equine 
oestrogen  may  worsen  incontinence.  Moeover,  there  were  too  few  data  to  reliably 
address  other  aspects  of  oestrogen  therapy,  such  as  oestrogen  type  and  dose,  and  no 
direct  evidence  comparing  routes  of  administration.  The  risk  of  endometrial  and  breast 
cancer after long-term use of systemic oestrogen suggests that treatment should be for 
limited periods, especially in those women with an intact uterus. (Cody et al., 2012). 

Pessaries - Intravaginal devices: RCTs showed that the use of intravaginal devices / 
pessaries  is  associated  with  a  decrease  in  incontinence  episode  frequency  when 
compared to no treatment (Ziv et al., 2008; Cornu et al., 2013). 

Urethral inserts - Urethral devices: The efficiency of urethral inserts has been poorly 
investigated. They are rarely used. 

Physiotherapy:  Numerous  techniques  of  physiotherapy  have  been  reported  and 
evaluated in the field of SUI. The main technique utilised is pelvic floor muscle training 
(PFMT). 

A recent review of PFMT in a Cochrane meta-analysis showed that in women presenting 
with SUI, PFMT was associated with higher cure rates (56% vs 6%, RR 8.3, 95%CI 3.6-
19.0)  when  compared  to  no  treatment  (Dumoulin  et  al.,  2014).  No  serious  adverse 
events have been reported. 

In addition to PFMT, adjunct physical therapies include:  

−  Biofeedback (BF) 

−  Electrostimulation 

−  Magnetic therapy 

−  Weighted vaginal cones 

−  Bladder training. 

Surgical treatment without mesh 

Surgical approaches comprise: 

o 

Female 

Colposuspension:  Retropubic  urethropexy:  For  this  approach,  several  techniques  are 
applied such as the Burch and Marshall Marchetti Krantz (MMK) techniques. 

21 

 
 
The safety of surgical meshes used in urogynecological surgery 

The  Burch procedure  is  carried  out  via  the abdominal  route  (open  or  laparoscopic).  For 
an  open  technique,  a  Pfannenstiel  incision  is  performed.  Post-operative  pain  in  the 
Pfannenstiel scar has often been reported. 

Open  retropubic  colposuspension  is  the  most  widely  evaluated  surgical  technique  for 
SUI.  Open  retropubic  colposuspension  is  associated  with  high  rates  of  objective  and 
subjective  cure  rates,  especially  in  the  long-term  (Lapitan  et  al.,  2012).  After  5  years, 
approximately  70%  of  women  were  still  symptom-free  or  no  longer  complained  of 
incontinence. 

Laparoscopic  colposuspension  is  associated  with  similar  cure  rates  for  SUI  when 
compared to open colposuspension, but with a lower risk of complications and a shorter 
hospital stay (Dean et al., 2009).  

Needle  suspension:  Several  techniques  using  needle  suspension  such  as  Stamey,  Raz, 
Pereyra and Gittes procedures have been described, but currently are rarely used.  

Pubovaginal slings: Autologous fascial slings: This procedure is usually performed via an 
abdominal  route.  The  autologous  sling  is  made  of  a  strip  of  tissue  from  the  abdominal 
rectus fascia or fascia lata.  

Autologous  fascial  slings  are  associated  with  similar  cure  rates  for  female  SUI  when 
compared  to  open  colposuspension,  but  with  a  higher  risk  of  post-operative 
complications (bladder outlet obstruction, need for self-catheterisation, etc.) (Rehman et 
al., 2011; Albo et al., 2007). 

Urethral balloon: This technique is not recommended as a first-line surgical treatment 
for SUI (EAU, 2014 Lucas et al., 2013; Fritel et al., 2010; Hermieu et al., 2010). 

Urethral  injections:  Injections  of  bulking  agents  seem  to  be  associated  with  lower  cure 
rates  for  SUI  when  compared  to  colposuspension  or  autologous  slings  (Pickard  et  al., 
2003). 

Stem  cell  periurethral  injections  -  Cell  therapy:  There  is  insufficient  data  concerning 
periurethral  stem  cell  injections  (autologous  myoblasts,  muscle  derived  stem  cells, 
autologous  fibroblasts)  that  are  supposed  to  treat  intrinsic  sphincteric  deficiency  (Aref-
Abid et al., 2013). 

Artificial urinary sphincter (AUS): The artificial urinary sphincter (AUS) in women has not 
yet  been  widely  used  nor  evaluated  in  RCTs.  This  technique  is  not  recommended  as  a 
first-line  surgical  treatment  for  SUI  (EAU,  2014;  Lucas et  al.,  2013;  Fritel  et  al.,  2010; 
Hermieu et al., 2010). 

o 

Male 

Urethral  injections:  No  existing  evidence  indicates  that  bulking  agents  cure  post-
prostatectomy  incontinence.  There  is  weak  evidence  that  bulking  agents  can  offer 
temporary  improvement  in  quality  of  life  in  men  with  post-prostatectomy  incontinence 
(EAU, 2014). 

Synthetic mesh or sling: Fixed slings are positioned under the bulbar urethra and fixed 
by a retropubic or transobturator approach. The tension is adjusted during surgery and 
cannot be readjusted post-operatively. Fixed  male slings appear to  be less  effective for 
men  with  severe  incontinence,  previous  radiotherapy,  or  previous  urethral  stricture 

22 

 
The safety of surgical meshes used in urogynecological surgery 

surgery.  Possible  adverse  events  include  voiding  dysfunction,  device  extrusion  and 
chronic pain (EAU, 2014). 

Adjustable  male  mesh  slings  allow  for  adjusting  the  tension  post-operatively.  The 
evidence is restricted to small case series with short follow-up. There is no evidence that 
adjustability  of  the  male  sling  offers  additional  benefit  over  other  types  of  sling  (EAU, 
2014). 

Artificial  urinary  sphincter  (AUS):  Although  the  AUS  is  considered  to  be  the  standard 
treatment for men with SUI, the quantity and level of evidence for effectiveness is low. 
There  have  been  no  well-designed  prospective  RCTs.  Non-randomised  cohort  studies 
suggest  that  primary  AUS  implantation  is  effective  for  resolving  or  improving  SUI  in 
men,  but  may  be  less  effective  for  men  who  have  had  pelvic  radiotherapy.  There  is  no 
evidence that tandem cuff placement and insertion of the device through a single incision 
is superior to standard implantation (EAU, 2014). 

Pelvic Organ Prolapse (POP) 

Non-surgical treatment 

No  treatment:  Without  treatment,  spontaneous  regression  of  symptoms  and/or 
anatomical  status  in  women  with  POP  is  common,  but  a  large  prospective  cohort  study 
concluded  that  a  small  proportion  of  women  with  symptomatic  POP  had  progression 
within 5 years (Miedel et al., 2011; Bradley et al., 2007). 

Taking  no  treatment  but  following  lifestyle  advice  may  also  have  some  effect.  Obesity 
may be a risk factor for POP and for POP recurrence following surgery, as well as other 
factors  that  increase  intra-abdominal  pressure  (chronic  heavy  lifting,  repetitive  cough 
efforts, dyschezia/obstructive defecation syndrome). The prevalence of POP seems to be 
increased in women who report carrying out heavy lifting. 

Being  overweight  or  obese  is  associated  with  progression  of  POP.  Weight  loss  does  not 
appear to be significantly associated with the regression of POP, suggesting that damage 
to the pelvic floor related to weight gain might be irreversible.  

Pessaries:  Using 
intravaginal  devices  offer  an  effective  and  patient-reported 
satisfactory treatment. However, side effects exist such as vaginal (anaerobic) discharge 
or sequestration. Regular review is required and the discontinuation rate is very high at 
long-term follow-up (Bugge et al., 2013). 

Physiotherapy:  Pelvic  floor  muscle  training  should  be  the  first  line  treatment  for  POP 
with or without pessary use, but the training needs proper instruction and close follow-
up to be effective. PFMT is associated with a reduction in symptoms associated with POP 
and  decrease  in  ICS  (International  Continence  Society)  POP-Q  (POP  Quantification 
system)  stage  1/2  prolapse,  although  the  clinical  relevance  of  this  improvement  is  not 
yet established. (Hagen et al., 2014). 

Medication:  Whilst  local  oestrogen  therapy  can  provide  good  symptomatic  benefit, 
there is no evidence that it corrects the anatomical changes of POP. A recent Cochrane 
review  concluded  that  there  was  limited  evidence  from  randomised  controlled  trials 
regarding  the  use  of  oestrogens  for  the  prevention  and  management  of  POP  (Ismail  et 
al., 2010). 

23 

 
 
The safety of surgical meshes used in urogynecological surgery 

Surgical treatment without mesh 

Cystocele  repair:  This  procedure  is  done  by  the  vaginal  route  (anterior  colporrhaphy 
and  vaginal,  paravaginal  repair).  Anterior  colporrhaphy  is  performed  by  an  anterior 
vaginal  wall  incision  in  the  midline,  and  dissection  to  separate  the  vaginal  epithelium 
from  the  underlying  muscularis.  This  tissue  is  plicated  in  the  midline  using  absorbable 
sutures. Recurrence rates are high, particularly using anatomic outcome criteria (i.e. POP 
stage  2  or  higher).  However  when  contemporary  ‘functional’  outcome  measures  are 
used,  that  is  (1)  absence  of  bulge  symptoms,  (2)  prolapse  descent  at  or  within  the 
hymen,  (3)  absence  of  re-operation  for  POP,  the  success  rate  of  this  treatment  at  one 
year is reported at 88% (Chmielewski et al., 2011) This stresses the importance of the 
selection  of  clinically  relevant  outcome  measurements.  It  is  advisable  to  primarily  use 
those that are important from a patient’s perspective (Toozs et al., 2012). 

The  objective  of  paravaginal  repair  by  the  vaginal  route  is  to  re-attach  the  detached 
lateral  vaginal  fascia  to  its  ‘normal’  points  of  insertion  on  the  lateral  sidewall.  There  is 
very limited data about this technique (Maher et al., 2013). 

Rectocele  repair:  The  technique  of  rectocele  repair  (posterior  colporrhaphy  and  site 
specific posterior repair) by the vaginal route consists of the correction of defects in the 
rectovaginal  fascia  separating  rectum  and  vaginal  mucosa  (Maher  et  al.,  2013).  A 
midline incision is performed on the posterior wall of the vaginal mucosa. The vagina is 
dissected  from  the  rectum  in  the  midline.  In  posterior  colporraphy,  the  recto-vaginal 
fascia  is  approximated  in  the  midline  either  with  continuous  or  interrupted  absorbable 
sutures. 

Apical  repair:  The  treatment  of  uterine  prolapse  or  vaginal  apical  prolapse  depends  on 
the patient’s characteristics (previous hysterectomy, concomitant hysterectomy) and the 
surgeon’s 
of 
hysterectomy+colpopexy  or  hysteropexy  or  colpopexy  (Maher  et  al.,  Cochrane  2013). 
The ‘pexy’ (suspension) may be performed using a sacrospinous or utero-sacral ligament 
suspension. 

uterine/apical 

treatment 

prolapse 

consists 

policy. 

The 

of 

Results associated with sacrospinous or uterosacral ligaments seem comparable (Barber 
et al., 2014). 

Colpocleisis:  Obliterative  procedures  such  as  colpocleisis 
(LeFort  colpocleisis, 
colpohysterectomy,  colpectomy)  are  offered  to  women  with  POP  who  no  longer  wish  to 
preserve  vaginal  coital  function.  The  technique  consists  of  vaginal  closure  +/- 
colpectomy or colpo-hysterectomy. Colpocleisis is associated with high success rates, low 
rates of recurrence and low rates of complications, especially after the age of 80 (Sung 
et al., 2006; Fitzgerald et al., 2008; Mueller et al., 2014; Vij et al., 2014; Zebede et al., 
2014). 

Cystocele  repair:  Abdominal  paravaginal  repair  via  the  abdominal  route  is  performed 
through  a  Pfannenstiel  incision  (laparotomy)  or  laparoscopically.  After  entering  the 
paravesical space and/or prepubic space, tears avulsing the pubocervical fascia from the 
arcus tendineus pelvic fascia (ATFP) are repaired by re-anchoring the detached anterior 
vaginal  suspensory  hammock  to  the  pelvic  girdle  with  interrupted  non-absorbable  or 
absorbable sutures (Reid et al., 2011). 

Isolated  abdominal  hysterectomy:  Isolated  abdominal  hysterectomy  has  not  been 
evaluated for the treatment of uterine/pelvic organ prolapse. 

24 

 
The safety of surgical meshes used in urogynecological surgery 

Uterine  suspension  with  anterior  fixation  or  posterior  uterine  suspension  using  non-
absorbable sutures has been widely reported by laparotomy or laparoscopy (Smith et al., 
1977). The use of strips of skin (Poulhés et al., 1971) or fascia lata (Ridley et al., 1976) 
for uterine and bladder suspension has also been described. 

Abdominal sacral hysteropexy/colpopexy: This procedure for uterine/vault prolapse uses 
mesh  to  secure  the  vagina  up  to  the  sacrum  and  is  associated  with  a  low  complication 
rate  (i.e.,  de  novo  dyspareunia  and  vaginal  mesh  exposure)  because  the  vagina  is  not 
opened  (Roovers,  2004;  Maher  et  al.,  2004).  However,  during  7  years  of  follow-up 
(Nygaard  et  al.,  2013),  abdominal  sacrocolpopexy  failure  rates  increased.  Urethropexy 
prevented  SUI  longer  than  no  urethropexy.  Abdominal  sacrocolpopexy  effectiveness 
should be balanced with long-term risks of mesh or suture erosion. In this study, mesh 
erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5%. 

Abdominal  uterosacral  ligament  suspension:  The  technique  (colpopexy)  consists  of 
suspending  the  vaginal  apex  (mainly  following  concomitant  hysterectomy)  to  the 
uterosacral  ligaments,  using  non-absorbable  or  absorbable  sutures,  laparoscopically 
(Ostrzenski  et  al.,  1996;  Filmar  et  al.,  2014)  or  by  laparotomy  (Cunjian  et  al.,  2012; 
Lowenstein et al., 2009; Crigler et al., 2012). However, Jeon et al. (2008) have shown 
that  abdominal  uterosacral  ligament  colpopexy  (with  concomitant  hysterectomy)  was 
associated  with  an  increased  risk  of  recurrence  (6.2  times  higher)  when  compared  to 
abdominal sacral colpopexy with mesh and hysterectomy. 

Anterior  abdominal  rectopexy:  Some  authors  reported  anterior  rectopexy  for  rectocele 
repair without mesh for the treatment of rectocele (Pironi et al., 2012). 

Pelvic cul-de-sac (Douglas pouch) closure: This technique has not been evaluated for the 
treatment of uterine/pelvic organ prolapse as an isolated technique. 

Colorectal Functional Disorders (CFD) 

In  the  following,  the  various  treatment  options  will  only  be  briefly  mentioned,  as  CFD 
only  marginally  falls  within  the  scope  of  this  Opinion  and  most  approaches  have  been 
described in previous chapters. 

No treatment - Spontaneous resolution of symptoms  

−  Weight loss 

−  Medication 

−  Pessaries 

−  Physiotherapy 

−  Pads - Plugs 

Surgical techniques without mesh 

−  Artificial anal sphincter 

−  Abdominal route 

−  Vaginal route 

−  Perineal route 

25 

 
 
The safety of surgical meshes used in urogynecological surgery 

−  Trans-anal surgery. 

4.2.2. Treatment using meshes 

The aim of using meshes 

The  rationale  behind  the  use  of  synthetic  meshes  in  urogynecological  surgery  was  to 
increase  the  durability  of  surgical  results,  particularly  with  regard  to  the  recurrence  of 
pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI), and to reduce re-
operation  rates  of  POP.  Recurrence  rates  for  using  native  tissues  for  these  repairs  is 
about 20-30% within 10 years of follow-up (Olsen et al., 1997; Denman et al., 2008). 

For the vaginal repair of POP, synthetic materials have been used since the start of this 
millennium  (absorbable  mesh:  polyglactin;  Weber  et  al.,  2001).  In  2004,  the  wide 
spread introduction of non-absorbable synthetic meshes started, particularly distributed 
in so-called ‘mesh kits’ (synthetic polypropylene). It is unclear whether the use of these 
synthetic  meshes/mesh  kits  has  actually  significantly  reduced  the  rate  of  prolapse 
recurrence  and/or  re-operations  for  POP  in  the  longer  term.  There  are  no  scientific 
studies on long-term follow-up (e.g., 10 years) with randomised trials that compared the 
use  of  these  mesh  kits  with  native  tissue  repair.  These  data  are  urgently  needed  to 
quantify  the  risk/benefit  ratio  of  these  treatments/biomaterials  for  pelvic  floor 
reconstructive  surgery.  However,  authorities  have  been  critical  about  the  efficiency  of 
synthetic meshes in their reports. 

Introduction 

Biological  grafts  are  alternatives  to  synthetic  mesh.  Autologous  fascia  is  the  most 
commonly  used  material  with  over  100  years  of  experience  and  good  efficacy  for  the 
treatment of SUI. The main drawback, however, is the need to harvest the graft from a 
donor  site  (fascia  lata  from  the  thigh,  or  rectus  fascia  from  the  abdominal  wall),  and 
potential  morbidity  (e.g.  wound  infection,  scar,  nerve  injury,  hernia)  (Birch  and  Fynes, 
2002a).  Additionally,  there  is  a  limitation  on  how  much  graft  can  be  harvested.  This 
precludes its use in POP, which is associated with relatively large fascial defects. These 
problems can be avoided by using grafts derived from cadavers or, alternatively, animal- 
derived collagen matrices (e.g., porcine dermis, porcine small intestine, bovine dermis). 
However,  these  materials  require  extensive  processing  (decellularisation,  sterilisation 
and  cross-linking  processes)  to  resist  degradation  (Freytes  et  al.,  2006).  While 
decellularisation renders materials non-immunogenic, both sterilisation (mandatory) and 
decellularisation  may  critically  degrade  their  biomechanical  properties.  Cross-linking  to 
improve  strength  of  biomaterials  can  provoke  a  persistent  inflammatory  response 
associated  with  excessive  fibrosis  (Vangsness  et  al.,  2003).  Furthermore,  there  is  the 
risk of viral or prion transmission (Birch and Fynes, 2002a). Although clinical studies are 
limited,  clinical  experience  indicates  that  all  of  these  natural  materials  appear  to  be 
associated  with  graft  failure  in  the  medium-term  due  to  the  body’s  encapsulation  and 
subsequent degradation of the materials with limited remodelling.  

There are many factors that influence the response to biomaterials, which can be divided 
into 3 broad categories: 

26 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

• 

• 

• 

(1) Chemistry and manufacturing influences on physical properties (e.g. their 
mechanical properties (stiffness and strength, porosity and degradability). 

(2) Nature of the patient’s immune response to the implanted biomaterials.  

(3) Surgical- and patient-specific factors (e.g. individual anatomy, co-
morbidities).  

Currently, there are several hypotheses describing implant failure: (a) mechanical failure 
of  the  material  (i.e.,  the  materials  do  not  have  the  appropriate  mechanical  properties), 
(b) enzymatic degradation resulting in mechanical failure of the material and (c) chronic 
inflammation leading to fibrosis and extrusion of the material through the host tissues. 

Literature search on biomaterials 

A literature search limited to the years 1990 to 2013 was performed using the MEDLINE 
database for studies investigating the in vivo response to biomaterials used routinely in 
pelvic  floor  surgery  and  clinical  trials  (Gigliobianco  et  al.,  2014).  The  following  search 
terms  were  used:  ‘pelvis’,  ‘pelvic  floor’,  ‘vagina’,  ‘in  vivo’,  ‘in  vitro’,  ‘biocompatibility’, 
‘prolapse’,  ‘incontinence’,  ‘biomaterial’,  ‘sling’,  ‘mesh’,  ‘polypropylene’,  ‘autografts’, 
‘allografts’  and  ‘xenografts’.  Abstracts  were  screened  for  relevance  by  two  persons 
before  full  articles  were  retrieved.  Papers  were  included  if  they  described  changes  in 
physical  or  biomechanical  properties  of  materials  after  implantation  in  animals  or 
humans  or  the  histological  features  of  the  host  response  to  the  implanted  material. 
Implantation sites were restricted to subcutaneous, intravaginal or abdominal muscles. 

In examining the literature on meshes, the SCENIHR searched MEDLINE for articles from 
1990  to  2013  containing  clinical  and  animal  studies  of  pelvic  floor  repair  materials  and 
found  10  studies  on  autologous  materials,  11  on  allograft  materials,  23  on  xenografts 
and 30 on polypropylene meshes. These articles form the basis of the review included in 
the Opinion and are summarised in Appendices I-IV. 

Autologous materials 

Introduction 

Autologous grafts harvested from the rectus fascia and fascia lata have long been used 
in  SUI  surgery.  A  major  advantage  of  autografts  over  synthetic  materials  is  that 
extrusion is almost unheard of (Golomb et al., 2001) and the overall long-term outcomes 
with  autografts  are  largely  excellent  with  reported  rates  of  cure  generally  over  90% 
(Morgan et al., 2000; Latini et al., 2004). Possible disadvantages of autografts are that 
the connective tissues  of patients with SUI may be inherently weak which pre-disposes 
them  to  failure,  and  for  POP  surgery  it  is  necessary  to  harvest  adequate  amounts  of 
tissue. 

Biomechanical properties 

In all four studies, there was agreement that the mechanical properties did not change 
significantly over 12 to 16 weeks duration (Choe et al., 2001; Kim et al., 2001; Dora et 
al., 2004; Hilger et al., 2006). 

27 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

Host response 

Eleven reported studies suggest that when autologous fascia is implanted, there may be 
a  minimal  to  moderate  inflammatory  response,  a  moderate  degree  of  collagen 
production and a suggestion that grafts undergo a degree of remodelling over the long-
term  (Dora  et  al.,  2004;  Hilger  et  al.,  2006;  Choe  et  al.,  2001;  Kim  et  al.,  2001; 
Fitzgerald et al., 2000; Jeong et al., 2000; Carneiro et al., 2005; Krambeck et al., 2006; 
Woodruff et al., 2008; Pinna et al., 2011; Almeida et al., 2007). 

Allografts 

Introduction 

Allografts  used  in  pelvic  floor  reconstruction  usually  consist  of  fascia.  The  donors  are 
screened  for  infectious  diseases  before  the  grafts  undergo  cleaning,  freeze-drying  and 
gamma irradiation to eradicate any infectious or immunogenic material. A concern with 
these  grafts  is  that  the  donors  are  often  elderly  with  age-related  connective  tissue 
weakening  (Moalli,  2006),  and  in  addition,  processing  techniques  such  as  freeze-drying 
and solvent dehydration may reduce tensile strength (Lemer et al., 1999).  

Cadaveric grafts are advantageous in that they avoid donor site complications. In terms 
of efficacy, results are mixed. Some have shown cadaveric fascia have similar subjective 
cure  rates  compared  with  autologous  fascia  at  around  90%  at  2  years  (McBride  et  al., 
2005).  However,  upon  urodynamic  testing,  42%  of  cadaveric  graft  patients  had  SUI, 
whereas no patients with autologous grafts had SUI (Howden et al., 2006). Five studies 
show disparate results (Hilger et al., 2006; Kim et al., 2001; Walter et al., 2003; Spiess 
et al., 2004; Rice et al., 2004) 

Biomechanical properties 

The  available  studies  show  disparate  results  with  respect  to  the  changes  in  mechanical 
properties  of  allografts  following  implantation  which  may  be  attributable  to  the 
heterogeneity  in  the  type  of  allografts  used,  the  animals  studied,  the  sites  of 
implantation and the assessment at different time points. 

Host response 

There have been many studies in which allografts have been implanted into animals and 
humans. The time since implantation ranged from 2 days up to 65 weeks (Hilger et al, 
2006;  Krambeck  et  al.,  2006;  Woodruff  et  al.,  2008;  Rice  et  al.,  2010;  Sclafani  et  al., 
2000;  Yildirim  et  al.,  2005;  Vandevord  et  al.,  2010;  Kolb  et  al.,  2012).  Five  of  these 
report good integration into the abdominal wall (Scalfani et al., 2000; Kolb et al., 2012; 
Richters  et  al.,  2008)  and  rectus  muscle  (Rice  et  al.,  2010;  Yildirim  et  al.,  2005)  in 
different  animal  models.    However  others  (Hilger  et  al.,  2006;  Krambeck  et  al.,  2006; 
VandeVord et al., 2010) have found relatively poor cell infiltration and fragmentation of 
the  scaffolds.  Overall  there  was  a  degree  of  agreement  that  allograft  induces  an  acute 
inflammatory  response  around  the  grafts  (Hilger  et  al.,  2006;  Krambeck  et  al.,  2006; 
Rice  et  al.,  2010;  Sclafani  et  al.,  2000;  Yildirim  et  al.,  2005;  Vandevord  et  al.,  2010; 
Kolb et al., 2012; Richters et al., 2008). 

28 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

Xenografts 

Introduction 

Grafts from animals, mainly porcine and bovine, have been used in pelvic floor surgery. 
These  materials  undergo  extensive  processing  after  harvesting  to  de-cellularise  and 
render  them  non-immunogenic.  Additionally,  FDA  regulations  on  animal  source  and 
vaccination  status  must  be  complied  with  (Amrute  and  Badlani,  2009).  Porcine  dermis 
may  be  artificially  cross-linked  using  hexamethylene-di-isocyanate  to  make  it  more 
resistant  to  enzymatic  digestion  (Winters,  2006).  Clinical  studies  showed  lower 
continence rates for porcine dermis (approx. 80%) and increased re-operation compared 
to  synthetic  tape  or  autologous  fascia  (Lucas  M,  2004).  Porcine  small  intestine 
submucosa (SIS) has cure rates from 79 to 93% at 2 and 4 year follow-up, respectively 
(Jones et al., 2005; Rutner et al., 2003). However, one study raised concerns that SIS 
may not be strictly acellular and may contain porcine DNA (Zheng et al., 2005), which, if 
present, would lead to an aggressive immune response and destruction of the implant.  

Biomechanical properties 

Non-cross-linked porcine dermal collagen matrix rapidly degrades (within 3 months) and 
loses most of its mechanical integrity within this period. By contrast, cross-linked porcine 
dermal  collagen  matrix  is  more  resistant  to  degradation  and  maintains  its  mechanical 
properties for at least 3 months, whereas SIS appears to increase in strength for as long 
as 2 years after implantation. It is well known that the degree of cross-linking affects the 
inflammatory  response  to  materials  –  a  little  is  fine,  but  too  much  leads  to  an  M1 
macrophage response. 

The  issue  of  how  cross-linking  affects  natural  collagenous  biomaterials  has  been 
addressed  in  various  studies.  Studies  on  non-cross-linked  materials  show  moderate 
remodelling,  but  often  very  rapid  degradation.  In  contrast,  cross-linked  xenografts  are 
associated  with  relatively  little  cell  infiltration,  more  remodelling  and  in  some  cases, 
encapsulation of implants. (Cole et al., 2003; Badylak et al., 2001) 

Host response 

There  have  been  an  extensive  number  of  studies  looking  at  the  extent  of  the 
inflammatory response of the host to xenografts, for example Hilger et al. and Pierce et 
al. found minimal neovascularisation and collagen ingrowth in porcine dermal xenografts 
(Hilger et al., 2006; Pierce et al., 2009b). In contrast, non-cross-linked SIS leads to high 
collagen  ingrowth  with  a  moderate  degree  of  remodeling  and  orientation  and  high 
neovascularisation (Almeida et al., 2007; Rice et al., 2010; VandeVord et al., 2010; Liu 
et al., 2011; Konstantinovic et al., 2005; Zhang et al., 2003; Ko et al., 2006; Badylak et 
al.,  2002;  Poulose  et  al.,  2005;  Rauth  et  al.,  2007).  On  the  other  hand,  many  studies 
agree  in  reporting  a  very  rapid  degradation  of  the  SIS  which  is  replaced  by  the  host 
tissue [Liu et al., 2011; Zhang et al., 2003; Badylak et al., 2001; Badylak et al., 2002; 
Thiel et al., 2005; Daly et al., 2012; Suckow et al., 2012). Only two studies reported an 
tissue  penetration  without 
absence  of  host 
neovascularisation  for  SIS  implanted  in  rats  (MacLeod  et  al.,  2005)  and  rabbits 
(Krambeck et al., 2006). In humans, Cole et al. performed revision surgery on a patient 
who  had  developed  a  bladder  outlet  obstruction  after  SIS  implantation  and  found  that 
the implant had been encapsulated (Cole et al., 2003). Nevertheless, other investigators, 
at 12 and 48 months, respectively, found that the SIS was replaced by native tissue in 

infiltration  and 

fibroblast 

fibrotic 

29 

 
The safety of surgical meshes used in urogynecological surgery 

humans  (Wiedmann  et  al.,  2004;  Deprest  et  al.,  2010).    In  summary,  most  studies 
suggest that the degree of cross-linkage affects the rate of degradation and the degree 
of the inflammatory response of the host. Cross-linked collagenous matrices induce little 
cell infiltration, hence there is limited collagen remodeling and graft degradation. In non-
cross-linked  xenografts,  cell  infiltration  was  greater  with  a  faster  degradation  rate  and 
collagen production.  

Polypropylene 

Introduction 

There is a range of synthetic polypropylene meshes, which are summarised in Table 10. 
They are classified as Amid Classification Types 1, 2, 3 or 4 according to their pore size, 
where  1  is  macroporous  (>75  µm),  2  is  less  than  10  µm,  3  is  microporous,  and  4  is 
nanoporous (<1µm). Thus, a wide range of synthetic materials has been investigated for 
use  in  the  treatment  of  SUI.  These  materials offer  several  advantages  including lack  of 
transmission  of  infectious  diseases  and  easy  availability,  as  well  as  sustainable  tensile 
strength  due  to  their  potential  non-degradable  nature  (Gomelsky  and  Dmochowski, 
2007).  Mesh  materials  have  been  classified  into  4  groups  based  on  their  porosity 
(monofilament  or 
(microporous  or  macroporous)  and 
multifilament)  (Amid  et  al.,  1997),  although  a  modified  classification  has  recently  been 
suggested (Klinge and Klosterhalfen, 2012) based on the following: (1) large pores, (2) 
small  pores,  (3)  additional  features,  (4)  no  pores,  (5)  3D  structure  and  (6)  biological 
origin. 

filamentous  structure 

The  initial  clinical  experience  with  mid-type  II  (microporous/multifilament  fibres,  e.g. 
expanded  PTFE),  and  III  (macroporous  and  microporous/multifilament  fibres,  e.g., 
Mersilene)  meshes  was  largely  negative  with excision  rates  of  up  to  30%  for  expanded 
PTFE  (Weinberger  and  Ostergard,  1996)  and  extrusion  rates  of  17%  for  Mersilene 
(polyester) (Young et al., 2001). 

A greater pore size  is  considered advantageous, as it allows the admittance of immune 
cells and greater collagen ingrowth into the construct (Birch and Fynes, 2002b). This is 
expected  to  reduce  the  risk  of  mesh  infection  and  accelerate  and  enhance  host  tissue 
integration.  Monofilament  meshes  are  thought  to  reduce  the  risk  of  infection  in 
comparison  to  multifilament  meshes.  The  theoretical  concern  with  the  latter  is  that 
bacteria  may  colonise  the  sub  10 μm  spaces  between  fibres,  which  are  inaccessible  for 
the  larger  host  immune  cells  (9-20  μm)  (Winters  et  al.,  2006).  Today,  an  Amid-type  1 
polypropylene  mesh  that  is  macroporous  and  monofilament  is  most  commonly  used 
(Slack et al., 2006). 

Polypropylene maintains its strength after implantation for up to 24 weeks (Spiess et al., 
2004;  Zorn  et  al.,  2007;  Bazi  et  al.,  2007).  However,  there  is  evidence  that  stiffness 
increases  over  time.  (Melman  et  al.,  2011;  Mangera  et  al.,  2012).  There  is  some 
evidence that meshes with greater stiffness cause the surrounding tissue to weaken; so-
called ‘stress shielding’ (Feola et al., 2013). This may be compared to the effect of metal 
implants on the surrounding bone after orthopaedic surgery and could lead to thinning of 
the surrounding vaginal tissues and predispose extrusion. 

Biomechanical properties 

Seven  studies  investigated  the  mechanical  properties  of  polypropylene  meshes  with 
implantation  times  ranging  from  two  weeks  up  to  two  years  in  animal  models.  Animal 
30 

 
The safety of surgical meshes used in urogynecological surgery 

models  used  were  rat  abdominal  wall  (Spiess  et  al.,  2004;  Zorn  et  al.,  2007),  pig  pre-
peritoneal  implantation  (Boukerrou  et  al.,  2007),  rat  rectus  fascia  (Bazi  et  al.,  2007), 
mini-pig  hernia  repair  (Melman  et  al.,  2011)  and  ewe  abdominal  and  vaginal  walls 
(Manodoro et al., 2013). 

Melman  et  al.,  (2011)  tested  Bard®Mesh,  a  knitted  monofilament  mesh  made  of  High 
Molecular  Weight  Polypropylene  (HMWPP)  and  Ultrapro®,  a  knitted  macroporous 
composite  mesh  made  of  Low  Molecular  Weight  Polypropylene  (LMWPP)  and 
polyglecaprone (Table 10). They were implanted in a mini-pig hernia repair model for up 
to 5 months. HMWPP decreased from 59.3 N maximal load at failure at 1 month to 36.0 
N at 5 months, while LWPP mesh decreased from 61.5 to 37.8 N at 5 months (Melman et 
al.,  2011).  Long-term  studies  were  carried  out  by  Zorn  et  al.  (2007),  where  TVT  and 
SPARC were compared to SIS in a rat abdominal wall defect for up to 12 months. Both 
TVT and SPARC are macroporous meshes made of polypropylene monofilaments. SPARC 
did not change its mechanical properties after 12 months of implantation (maximum load 
mass at baseline 4.44 N, at 12 months 4.88 N). By contrast the maximum load for TVT 
decreased from 7.64 N to 5.13 N for TVT and for SIS decreased from 3.94 N to 1.71 N 
(Zorn  et  al.,  2007).  Bazi  et  al.,also  showed  how  similar  the  mechanical  properties  of 
Gynecare TVT and Advantage® are. Both are macroporous polypropylene monofilament 
meshes  compared  to  other  meshes  such  as  IVS  Tunneller,  multifilament  polypropylene 
mesh  and  SPARC.  The  lowest,  at  25.2  N,  was  TVT  and  the  highest,  at  34.9  N,  was 
Advantage®, with no difference between them 24 weeks after implantation in rat rectus 
fascia  (Bazi  et  al.,  2007).  Other  studies  agree  with  these  parameters,  where  TVT 
complied with the highest break load (7.26 N), compared with 3.83 N for fascia lata up 
to  12  weeks  after  implantation  in  rat  abdominal  wall  (Spiess  et  al.,  2004),  and 
polypropylene  was  apparently  less  stiff  than  other  synthetic  materials  used  for  meshes 
(0.23 N/ mm compared with Nylon, 6.83 N/mm) (Dietz et al., 2003). 

Figure 1: Relative degradation of mechanical strength of synthetic meshes with 
implantation time (note overlapping in black and green lines) 

]

%

[
d
a
o

l

100

80

60

40

20

0

HMWP
LWPP
SPR-mac
TVT-mac
SIS-mic
TVT-pp
Adv-pp

0

3

6

9

12

15

18

21

24

time [month]

A recent study compared two sizes of meshes implanted in two different sites in a sheep 
model. Gynemesh was cut into two sizes (50x50 mm and 35x35 mm) and implanted in 

31 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

20  adult  ewes  on  the  abdominal  and  vaginal  walls  for  60  and  90  days.  After  90  days, 
grafts of both dimensions implanted on the vaginal wall were stiffer than those implanted 
on the abdominal wall (Manodoro et al., 2013). 

Physical characteristics of the mesh, such as monofilament or multifilament, porosity and 
polymer molecular weight, hugely affect the mechanical performance of the implants in 
vivo.  Figure  1  shows  that  except  for  polypropylene  meshes,  the  degradation  of 
mechanical strength can be dramatic for most meshes. 

Host response 

Twenty-one  papers  addressed  the  host  response  to  polypropylene  meshes,  which  were 
assessed in rat abdominal wall (Klinge  et al., 2002; Zheng et al., 2004; Konstantinovic 
et al., 2005; Thiel et al., 2005; Spelzini et al., 2007; Zorn et al., 2007), rat rectus fascia 
(Yildirim  et  al.,  2005;  Bogusiewicz  et  al.,  2006;  Bazi  et  al.,  2007),  rabbit  bladder  neck 
(Rabah  et  al.,  2004),  rabbit  abdominal  wall  (Pascual  et  al.,  2012),  rabbit  rectus  fascia 
(Krambeck  et  al.,  2006),  rabbit  vagina  (Huffaker  et  al.,  2008;  Pierce  et  al.,  2009b), 
mini-pig  hernia,  (Melman  et  al.,  2011),  pig  peritoneum  (Boulanger  et  al.,  2006; 
Boukerrou  et  al.,  2007),  ewe  vagina  (de  Tayrac  et  al.,  2007;  Manodoro  et  al.,  2013), 
ewe  abdominal  wall  (Manodoro  et  al.,  2013)  models  and  in  a  few  clinical  studies 
(Falconer  et  al.,  2001;  Wang  et  al.,  2004;  Woodruff  et  al.,  2008;  Elmer  et  al.,  2009). 
Studies  focused  on  acute  inflammatory  responses  to  the  most  commonly  used,  non-
degradable  meshes,  as  described  in  Table  10.  A  few  investigators  studied  the  acute 
inflammatory response occurring from the day of implantation up to 30 days (Klinge et 
al., 2002; Zheng et al., 2004; Konstantinovic et al., 2005; Thiel et al., 2005; de Tayrac 
et  al.,  2007;  Spelzini  et  al.,  2007;  Pascual  et  al.,  2012).  Other  studies  addressed  the 
immediate  response  at  1-3  months  post  implantation  (Rabah  et  al.,  2004;  Bogusiewicz 
et  al.,  2006;  Boulanger  et  al.,  2006;  Krambeck  et  al.,  2006;  Boukerrou  et  al.,  2007; 
Huffaker et al., 2008; Manodoro et al., 2013) and long-term responses (>3 months) in 
which  fibrosis  and  chronic  inflammation  are  seen  (Falconer  et  al.,  2001;  Wang  et  al., 
2004;  Bazi  et  al.,  2007;  Zorn  et  al.,  2007;  Woodruff  et  al.,  2008;  Elmer  et  al.,  2009; 
Pierce et al., 2009b; Melman et al., 2011). 

A recent study by Manodoro et al., (2013) showed that 90 days after implantation, 30% 
of  Gynemesh  grafts  (50x50  mm)  implanted  in  ewes  caused  vaginal  extrusion    and 
exposure and 60% of the smaller Gynemesh meshes (35x35 mm) had a reduced surface 
(i.e., contraction) (Manodoro et al., 2013). 

Falconer et al., showed that biopsies stained with Masson’s Trichrome following Prolene 
and  Mersilene  meshes  induced  a  higher  inflammatory  response  in  Mersilene  compared 
with Prolene, which only triggered a small inflammatory reaction (Falconer et al., 2001).  

In  a  long-term  study,  Pierce  et  al.,  (2009b)  compared  biological  and  synthetic  grafts 
implanted in rabbits and found that polypropylene caused a milder inflammatory reaction 
compared with a more long-term model with better host tissue incorporation compared 
to  natural  grafts.  Furthermore,  Bazi  et  al.,(2007)  evaluated  biopsies  for  inflammatory 
infiltrates, fibrosis, mast cells, muscular infiltration and collagen filling of the mesh on an 
arbitrary scale described as low, moderate or extensive in H&E, periodic acid-Schiff and 
toluidine blue-stained tissue. This study concluded that all of the investigated materials 
(Advantage,  IVS,  SPARC  and  TVT)  induced  inflammation  and  collagen  production,  with 
SPARC  having  the  mildest  response  while  TVT  was  associated  with  the  highest  adverse 
responses  (Bazi  et  al.,  2007).  In  another  study,  Elmer  et  al.,  reported  an  increase  in 
32 

 
The safety of surgical meshes used in urogynecological surgery 

macrophages  and  mast  cells  and  a  mild,  but  persistent  foreign  body  response  to 
polypropylene  meshes  (Elmer  et  al.,  2009)  which  was  consistent  with  other  reports  in 
which  polypropylene  meshes  were 
leukocytes, 
inflammatory  infiltrates  and  collagen  production  (Pascual  et  al.,  2012;  Pierce  et  al., 
2009b; Woodruff et al., 2008; Bazi et al., 2007; Bogusiewicz et al., 2006; Yildirim et al., 
2005). 

invaded  with  macrophages  and 

In  summary,  polypropylene  meshes  provoke  pronounced  inflammation,  leading  to  a 
massive  cell  infiltration  into  the  scaffold  and  ultimately  induce  collagen  production 
(Govier  et  al.,  2004;  Rabah  et  al.,  2004;  Wang  et  al.,  2004;  Bogusiewicz  et  al.,  2006; 
Bazi et al.,  2007; Maia de Almeida et al., 2007; Huffaker et al., 2008; Woodruff et al., 
2008; Elmer et al., 2009; Pierce et al., 2009a). 

Polyvinylidene fluoride 

Polyvinylidene fluoride (PVDF) is another material with potential favourable properties for 
hernia  repair  (Klink  et  al.,  2011).  However,  the  studies  available  so  far  (Berger  and 
Bientzle,  2009;  Noé  et  al.,  2013;  Noé  et  al.¸2014)  do  not  provide  sufficient  clinical 
evidence  on  the  urogynecological  use  of  meshes  made  of  this  material,  in  particular 
concerning long-term performance. Although this may be a promising technology (Klinge 
et  al.  2015,  Joukhadar  et  al.,  2015;  Sindhwani  et  al.,  2015),  the  introduction  of  new 
materials  and  techniques  should  follow  the  recommendations  of  IUGA  (Slack  et  al., 
2012). 

Post implantation changes and clinical outcomes 

Biomechanics 

In  general,  when  biological  materials  fail  it  is  due  to  enzymatic  degradation  post 
implantation, leading to a loss of mechanical support and weakening of the repair which 
is  particularly  evident  with  non-cross-linked  xenogenic  matrices.  Chemical  cross-linking 
appears to prevent degradation and improve mechanical outcomes. However, there is a 
lack  of  clinical  evidence  on  the  correlation  between  these  mechanical  outcomes  and 
patient outcomes. Autologous grafts are the most successful biological material used in 
contemporary practice and the reviewed studies support long-term mechanical integrity. 
Nevertheless,  there  are  several  important  limitations  related  to  harvesting  from  the 
donor site, though the use of cadaveric tissues avoids these limitations. However, quality 
depends  on  the  age  and  co-morbidities  of  the  donor  and  this  may  explain  diverse 
mechanical properties of the grafts and is consistent with clinical studies showing poorer 
cure rates for cadaveric compared with autologous grafts.  

Studies  on  long-term  stability  (24  months  following  implantation)  showed  that 
polypropylene  meshes  maintained  their  morphology  and  strength  (Spiess  et  al.,  2004; 
Zorn  et  al.,  2007;  Bazi  et  al.,  2007)  but  were  associated  with  increasing  stiffness 
(Melman  et  al.,  2011;  Mangera  et  al.,  2012).  Although  this  is  consistent  with  durable 
cure rates particularly in SUI surgery, there is still doubt regarding the efficacy of trans-
vaginal  POP  repair,  compared  with  native  tissue  repair.  The  major  issue  with 
polypropylene meshes are the associated serious complications, in particular, vaginal or 
urinary  tract  exposure  (up  to  10-14%)  and  because  of  the  greater  stiffness,  the 
surrounding  tissue  weakens,  which  is  termed  stress  shielding  (Feola  et  al.,  2013).  This 
adverse effect can be compared to the effect of metal implants on the surrounding bone 

33 

 
The safety of surgical meshes used in urogynecological surgery 

after  orthopaedic  surgery  (Mahon  et  al.,  2012)  and  may  lead  to  thinning  of  the 
surrounding vaginal tissues predisposing to extrusion. 

Host response 

Implanted  biomaterials  may  generate  foreign  body  responses  with  some  materials 
inducing  an  M1  macrophage  response  as  a  part  of  constructive  remodelling  which 
appears  with  some  biological  matrices,  such  as  SIS.  With  materials  which  the  body 
cannot  remodel  or  integrate  such  as  polypropylene  meshes,  the  response  is  an 
aggressive M2 macrophage response (Remes and Williams, 1992; Wolf et al., 2014). 

Constant  inflammation  in  some  patients  in  response  to  some  non-degradable  materials 
may occur which leads to an up-regulation of degradative enzymes that do not degrade 
the  material,  but  may  damage  the  surrounding  extracellular  matrix  and  contribute  to 
tissue  thinning  and  mesh  exposure.  Moreover,  perpetuation  of  the  inflammatory 
response  may  cause  activated  fibroblasts  to  produce  excessive  disorganised  collagen 
around the implant (i.e., fibrosis) which then encapsulates the material. A small amount 
of  fibrosis  is  arguably  advantageous  for  the  repair  in  SUI,  providing  a  stable  back  stop 
allowing urethral compression. However, excessive fibrosis may lead to mesh contraction 
resulting  in  increased  pull  on  adjacent  tissues  leading  to  complications  such  as  voiding 
dysfunction,  pain  and  painful  intercourse.  In  POP,  this  excessive  fibrotic  response  may 
lead to mesh exposure, which presents a major reconstructive surgical challenge, often 
necessitating repeat procedures with no guarantee of symptom resolution. Nevertheless, 
because the vast majority of patients do well with mesh, some degree of fibrosis may be 
helpful, whereas excessive fibrosis is detrimental. 

Implantation  of  autologous  fascia,  in  general,  integrates  well  within  host  tissues  and  is 
associated  with  minimal  inflammation  when  compared  to  polypropylene  meshes  with  a 
degree of graft remodelling in human studies (Konstantinovic et al., 2005; Rabah et al., 
2004).  Notably,  these  human  studies  reported  reoperative  cases  of  clinical  failure. 
Therefore,  it  is  difficult  to  speculate  whether  successful  outcomes  result  in  fully 
integrated and remodelled graft. Non-cross-linked xenografts are associated with clinical 
failure due to rapid degradation. The degradation, in any case, is presumably faster than 
the time it would take strong tissues to regenerate if no graft were done (Jeong et al., 
2000;  Hilger  et  al.,  2006;  Maia  de  Almeida  et  al.,  2007).  Cross-linked  grafts  avoid  this 
problem, but similar to synthetic mesh, they are associated with constant inflammation 
because  the  body  is  unable  to  integrate  and  remodel  them  and  this  ultimately  leads  to 
graft  encapsulation.  Taken  together,  these  data  suggest  that  there  is  a  need  for  a 
balance  between  degradation  and  replacement  by  new  host  tissues  with  xenografts, 
which SIS appears to fulfil.  

The  immune  response  to  a  foreign  material  may  be  complex,  dynamic  and  patient-
specific. Polypropylene meshes provoke minimal adverse reaction when implanted in the 
abdominal wall for hernia repair, but are associated with complications in the pelvic floor 
which  suggests  a  site-specific  host  response  to  biomechanical  exposure  (Patel  et  al., 
2012), which was confirmed in ewes (Manodoro et al., 2013) and emphasises the need 
for relevant animal models and long-term studies (Deprest and Feola, 2013). 

Synthetic  material  such  as  polypropylene  includes  additives  such  as  softeners  like 
Bisphenyl-A  (BPA),  which  may  leak  into  tissue  and  cause  adverse  health  effects 
(SCENIHR,  Safety  of  the  use  of  bisphenol  A  in  medical  devices,  2015),  but  since 
quantitative  data  on  exposure  are  lacking,  it  is  not  possible  to  do  a  risk  assessment. 
34 

 
The safety of surgical meshes used in urogynecological surgery 

However, data on polypropylene implants for abdominal hernia repair suggest that there 
is no safety concern with regards to BPA (e.g. Henniford et al. 2000). 
Implantation techniques for SUI 

o 

Female patients 

Implantation techniques of mid-urethral slings (MUS) 

Retropubic (RP) approach (bottom-to-top and top-to-bottom) 

MUS  are  placed  by  the  vaginal  route  through  the  retropubic  space  using  a  specific 
device/needle  and/or  exteriorised  through  the  abdominal  skin  using  two  millimetre 
incisions. Two techniques, bottom-to-top and top-to-bottom are used and are associated 
with  complications  such  as  bladder  injury  (6%),  retropubic  haematoma  (<1%),  iliac 
vessel injury (<1%), bowel injury  (<1%), bladder outlet obstruction (BOO) (10%) that 
may require re-intervention for sling section (1%), vaginal sling exposure (1%), failure 
at  short-term  follow-up  (10%)  and  recurrence  at  long-term  follow-up  (10%)  (Ogah, 
2009; Schimpf et al., 2014). 

Trans-obturator (TO) approach (out/in and in/out) 

MUS  are  placed  by  the  vaginal  route  through  the  obturator  foramen  (obturator  and 
adductor muscles) using a helicoidal specific device/needle and exteriorised through the 
groin  area  skin  using  two  millimetre  incisions.  Two  techniques,  the  inside-outside  and 
the  outside-inside,  are  used  and  are  associated  with  complications  such  as 
groin/hip/thigh  pain  (10%),  urethral  or  bladder  injury  (1%),  vaginal  injury  (1%), 
obturator  haematoma  (<1%)  and    bladder  outlet  obstruction  (BOO)  (10%)  that  may 
require  reintervention  for  sling  section  (1%),  vaginal  sling  exposure  (1%),  failure  at 
short-term follow-up (10%) and recurrence at long-term follow-up (10%) (Ogah, 2009; 
Schimpf et al., 2014) 

Prepubic approach 

MUS  are  placed  by  the  vaginal  route  through  a  subcutaneous  perineal  route.  This 
approach  was  less  investigated,  but  seems  to  be  associated  with  lower  cure  rates 
(Daher, 2013; Long, 2013; Fritel et al., 2010). 

Single incision slings (SIS) 

The  risk  of  iliac  vessel  /  bowel  injury  associated  with  the  RP  approach  and  the  high 
prevalence of groin pain associated with the TO approach have led to the development of 
a new generation of MUS: the ‘mini-slings’ in which a single incision is made. The sling is 
significantly shorter in  length compared with ‘classical’ RP or TO slings. However, there 
are  no  data  regarding  the  actual  length  of the  implanted  sling  compared  with  standard 
(‘classical’) RP and TO MUS procedures. The SIS is placed by the vaginal route, following 
a RP or a TO approach, but the sling is not trans-cutaneously exteriorised (the insertion 
stops short of the obturator membrane). The huge differences in the fixation mechanism 
of these SIS may influence outcomes (cure and complications rates). This less invasive 
technique is supposed to decrease complication rates, but the shorter length of the sling 
may  be  associated  with  lower  cure  rates,  especially  at  long-term  follow-up.  Some  SIS 
are  partially  ‘adjustable’  (per-operative  adjustment),  which  makes  it  possible  to  adjust 
the tension of the fixing system. 

35 

 
The safety of surgical meshes used in urogynecological surgery 

An updated systematic review and meta-analysis of randomised controlled trials (RCTs) 
was  recently  performed  comparing  single-incision  mini-slings  (SIMS)  versus  standard 
mid-urethral  slings  (SMUS)  in  the  surgical  management  of  female  stress  urinary 
incontinence (SUI) (Mostafa et al., 2014). 

A  literature  search  was  performed  for  all  RCTs  and  quasi-RCTs  comparing  SIMS  with 
either  transobturator  tension-free  vaginal  tape  (TO-TVT)  or  retropubic  tension-free 
vaginal  tape  (RP-TVT).  The  literature  search  had  no  language  restrictions  and  was  last 
updated  on  May  2,  2013.  The  primary  outcomes  were  patient-reported  and  objective 
cure rates at 12 to 36 months follow-up. Secondary outcomes included operative data; 
peri-  and  post-operative  complications  and  repeat  continence  surgery.  Data  were 
analysed using RevMan software. Meta-analyses of TVT-Secur vs. SMUS were presented 
separately as the former was recently withdrawn from clinical practice. 

A  total  of  26  RCTs  (n=3308  women)  were  included.  After  excluding  RCTs  evaluating 
TVT-Secur, there was no evidence of significant differences between SIMS and SMUS in 
patient-reported  cure  rates  (risk  ratio  [RR]:  0.94;  95%  confidence  interval  [CI],  0.88–
1.00)  and  objective  cure  rates  (RR:  0.98;  95%  CI,  0.94–1.01)  at  a  mean  follow-up  of 
18.6 months. These results were derived by comparing SIMS versus TO-TVT and RP-TVT 
separately.  SIMS  had  significantly  lower  post-operative  pain  scores  (weighted  means 
difference  [WMD]:  −2.94;  95%  CI,  −4.16  to  −1.73)  and  earlier  return  to  normal 
activities  and  to  work  (WMD:  −5.08;  95%  CI,  −9.59  to  −0.56  and  WMD:  −7.20;  95% 
CI,  −12.43  to  −1.98,  respectively).  SIMS  had  a  non-significant  trend  towards  higher 
rates of repeat continence surgery (RR: 2.00; 95% CI, 0.93–4.31). 

This  meta-analysis  showed  that,  excluding  TVT-Secur,  there  was  no  evidence  of 
significant  differences  in  patient-reported  and  objective  cure  between  currently  used 
SIMS  and  SMUS  at  midterm  follow-up  while  associated  with  more  favourable  recovery 
time.  Results  should  be  interpreted  with  caution  due  to  the  heterogeneity  of  the  trials 
included. 

Other MUS procedures 

− 

Intermediate length slings 

In  an  effort  to  maintain  efficacy  while  reducing  some  side  effects,  manufacturers 
developed  hybrid  procedures  using  shorter  slings  (12  cm),  that  are  placed  using  a 
classical  TO  placement  technique  (Waltregny  et  al.,  2012;  de  Leval  et  al.,  2011). 
However,  RCTs  with  larger  sample  sizes  and  long-term  follow-up  are  required  before 
drawing conclusions. 

−  Adjustable MUS (post-operative adjustment) 

No RCT has assessed adjustable MUS. 

o 

Male patients 

Implantation techniques of slings 

Although  numerous  treatment  options  for  male  SUI  exist,  including  penile  clamps, 
transurethral  bulking  agents,  or  catheters  (condom  or  indwelling),  the  most  commonly 
utilised surgical therapies performed include placement of a male sling or AUS. 

36 

 
The safety of surgical meshes used in urogynecological surgery 

Since its  initial introduction, the male sling has become  increasingly utilised  in  cases of 
low-to-moderate volume (1–3 pads/day) incontinence. Although several variations of the 
male  sling  are  currently  available,  the  three  subtypes  with  the  most  reported  series 
available  include  the  bone  anchor  sling  (BAS),  retro-urethral  transobturator  sling  (RTS) 
and the adjustable retropubic sling (ARS). 

Bone-anchored slings result in compression to the bulbar urethra through placement of a 
synthetic  or  organic  mesh,  which  is  secured  to  the  inferior  pubic  ramus  using  six 
titanium screws. Sutures are subsequently secured to the screws and mesh material and 
tightened  to  result  in  appropriate  tensioning.  Following  initial  reports  of  degradation  of 
organic materials, synthetic mesh has become the most commonly utilised material with 
the BAS (Dikranian et al., 2004). 

A  second  category  of  available  male  slings  includes  the  RTS.  In  contrast  to  the  BAS, 
which  utilises  anchored  sutures,  the  RTS  is  self-anchored  with  bilateral  polypropylene 
mesh  arms  placed  in  a  transobturator  fashion.  The  sling  portion  is  secured  at  the 
proximal  bulbar  urethra  with  continence  achieved  through  subsequent  elevation  of  the 
urethra. 

Several  studies  examined  pre-operative  characteristics,  surgical  techniques  and  post-
operative  management  principles  that  have  been  associated  with  improved  outcomes 
with  RTS  placement  (Soljanik  et  al.,  2012;  Render  et  al.,  2009;  Elzevier  and  Cornel, 
2010). Predictive pre-operative characteristics of worsened outcomes include weakened 
residual  sphincter  function,  incomplete  sphincter  closure  and  lack  of  elongation  of  the 
coaptive  sphincter  zone.  Intraoperative  and  post-operative  factors  associated  with 
improved  outcomes  include  tunnelling  of  the  sling  arms  into  subcutaneous  tissues  to 
improve  fixation,  placing  five  or  more  stitches,  using  non-absorbable  stitches  and 
minimising post-operative activity to reduce dislodgement. 

Similar  to  RTS,  ARS  are  surgically  placed  at  the  proximal  bulbar  urethra,  with  traction 
sutures  placed  retropubically.  The  sutures  are  then  tensioned  at  the  level  of  the  rectus 
fascia utilising either a ‘veritensor’ device or silicone columns and washers to provide an 
appropriate level of urethral compression. 

A  fourth  category  of  sling,  which  was  recently  introduced,  is  the  quadratic  sling.  The 
sling consists of a broad-based mesh material placed over the bulbar urethra similar to 
the  BAS.  It  is  then  self-secured  with  four  mesh  arms,  which  are  placed  in  both  a 
transobturator  (two  arms)  and  prepubic  (two  arms)  manner.  The  limbs  may  then  be 
further secured to create additional points of fixation as needed.  

The  hypothesised  mechanism  for  improved  continence  with  the  various  sling  designs 
varies  and  is  not  thoroughly  understood.  Bone-anchored  slings  likely  achieve  direct 
compression  of  the  bulbar  urethra  with  subsequent  increases  in  outflow  resistance.  In 
contrast, the mechanism for the RTS is based on the hypothesis that mild/moderate SUI 
results from compromise of periurethral supporting structures (Rehder and Gozzi, 2007). 
Through  proximal  placement  of  the  mesh  material,  the  dynamics  of  the  bulbar  urethra 
are modified to result in functional extension of the membranous and angulation of the 
bulbar urethra. The mechanisms for improved SUI with the ARS and quadratic sling are 
currently  unknown  and  may  result  from  a  combination  of  urethral  compression  and 
angulation. 

37 

 
The safety of surgical meshes used in urogynecological surgery 

Implantation techniques for POP 

Abdominal meshes (AM) (open and laparoscopic/robot) 

The  standard  treatment  for  genital  prolapse  via  the  abdominal  route  is  sacral 
hysteropexy or colpopexy, in which a mesh is attached to the anterior common vertebral 
ligament, in order to correct the anterior (cystocele) and apical (uterus or vaginal apex) 
and/or posterior (rectocele, enterocele) compartments. Either a prosthetic macroporous 
monofilament  polypropylene  mesh  or  a  polyester  mesh  can  be  used.  Various  mesh 
fixation  techniques  have  been  described  using  non-absorbable  sutures  or  anchor 
fixation/tacker/staplers. Following identification of the right ureter, the left iliac vein and 
the iliac vessel junction, the peritoneum above the sacral promontory is incised medially 
to the right ureter and laterally to the sigmoid colon. The bladder is dissected from the 
upper half of the anterior vaginal wall. Concerning the apical compartment: (a) when the 
uterus  is  left  in  the  pelvis,  the  anterior  mesh  is  attached  to  the  anterior  part  of  the 
uterine  isthmus  (the  junction  between  the  cervix  and  the  anterior  part  of  the  uterine 
isthmus)and the mesh is passed laterally in the right broad ligament (or bilaterally); (b) 
when a concomitant hysterectomy is performed, a subtotal hysterectomy is usually done 
(in  order  to  avoid  an  opening  of  the  vagina)  and  the  anterior  mesh  is  attached  to  the 
conserved cervix; (c) in patients presenting with previous total hysterectomy, the mesh 
is attached directly to the vaginal wall. For the posterior mesh placement, a rectovaginal 
dissection is performed down to the level of the levator ani muscles and a mesh is placed 
and  sutured  to  the  levator  ani  muscles  (or  to  the  posterior  vaginal  wall)  using  a  non-
absorbable  suture  along  the  full  length  of  the  posterior  vaginal  wall.  Two  different 
promontory fixation techniques are available: prosthesis fixation to the promontory using 
a suture (non absorbable) or titanium tackers. A complete closure of the peritoneum is 
finally performed. 

The risks associated with sacral colpopexy are the following: vaginal mesh exposure (2-
5%),  de  novo  constipation  /  obstructive  defecatory  syndrome  (10%),  per-operative 
bladder  (1%)  or  bowel  (0.1%)  injury,  de  novo  dyspareunia  (1-3%),  pelvic  abscess  (< 
1%),  spondilodiscitis  (<0.1%)  and  visceral  (bladder,  rectum)  mesh  exposure  (<  0.1%) 
(Maher et al., 2013). 

Sacral  hysteropexy  or  colpopexy  may  be  performed  by  laparotomy  or  by  laparoscopy. 
Laparoscopic  sacrocolpopexy  is  as  efficient  as  open  abdominal  sacrocolpopexy,  with  a 
reduced rate of intraoperative bleeding, hospitalisation, and wound complications (Tyson 
et al., 2013; Freeman et al., 2013). Thus, the laparoscopic approach is recommended for 
sacral  colpopexy.  It  is  recommended  not  to  use  silicone-coated  polyester,  porcine 
dermis, fascia lata and polytetrafluoroethylene meshes. 

The  risk  of  vaginal  mesh  exposure  is  significantly  increased  in  cases  of  sacrocolpopexy 
associated with concomitant total hysterectomy (8.6%), in comparison to 2.2% in those 
with  previous  hysterectomy  (Costantini  et  al.,  2005;  Zucchi  et  al.,  2010).  Thus,  if 
hysterectomy is required, it is recommended to perform a subtotal hysterectomy. 

Even if the prevalence of complications/reintervention seems to be lower following sacral 
colpopexy  when  compared  to  vaginal  mesh  surgery  (Maher  et  al.,  2011),  serious 
complications  have  been  described  at  short-  and  long-term  follow-up  after  sacral 
colpopexy (Nygaard et al., 2013; Arsene et al., 2014) 

38 

 
The safety of surgical meshes used in urogynecological surgery 

Robotic  and  laparoscopic  sacral  colpopexy  had  similar  operative  times,  short-term 
anatomic  cure  rates,  perioperative  complications  and  length  of  hospital  stay  (Anger  et 
al., 2014).  

4.2.3. Results of treatment using meshes 

Mesh surgery for SUI 

o 

Female patients 

Comparative data (RCT): MUS procedures vs other treatments 

Stress  urinary  incontinence  (SUI)  is  a  common,  burdensome  and  costly  condition  for 
women and has  a negative  impact on their quality of  life. Non-surgical measures such 
as  pelvic  floor  muscle  training  (PFMT)  are  useful  treatment  options  in  alleviating 
symptoms, although many women proceed with surgery if these are not successful. 

A  recent  RCT  has  shown  that  for  women  with  moderate  to  severe  SUI,  an  initial  MUS 
procedure  (without  previous  physiotherapy),  as  compared  with  initial  physiotherapy, 
results  in  higher  objective  and  subjective  cure  and  global  improvement  rates  at  12 
months  follow-up.  So,  women  with  moderate  to  severe  SUI  should  be  carefully 
counselled  on  these  treatment  options  and  their  respective  expected  effectiveness 
(Labrie et al., 2013) 

MUS procedures vs Burch colposuspension and Marshall Marchetti Krantz 

Following  the  Pivotal  study  which  contrasted  colposuspension  and  the  synthetic  MUS  
procedure (TVT) (Ward and Hilton, 2002), several meta-analyses evaluated the efficacy, 
complications and reintervention rates of MUS compared to colposuspension (Schimpf et 
al., 2014; Novara et al., 2010; Ogah et al., 2011) and have shown that MUS procedures 
were associated with comparable or significantly higher overall and objective cure rates 
when compared to Burch colposuspension and with shorter operative time and less post-
operative  de  novo  BOO  or  OAB  (overactive  bladder)  symptoms,  although  they  were 
associated with an increased risk of bladder injury. 

Finally, RP MUS and TP MUS are associated with similar patient-reported cure of SUI at 
12 months follow-up and MUS are associated with lower rates of de novo BOO and OAB 
symptoms. 

MUS procedures vs ‘traditional’ suburethral slings (pubovaginal autologous fascia rectus 
slings) 

Several meta-analyses showed that traditional slings have similar success rates to MUS 
procedures,  but  they  are  associated  with  longer  operation  duration  and  higher  rates  of 
adverse events (de novo BOO and OAB symptoms) (Schimpf et al., 2014; Rehman et al., 
2011; Novara et al., 2010; Ogah et al., 2011). 

Finally, MUS are associated with similar results when compared to ‘traditional’ slings, but 
with  shorter  operative  duration  and  lower  rates  of  adverse  events  (LE1),  at  12-months 
follow-up. 

39 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

Comparative data (RCT): MUS (RP, TO, SIS) vs MUS (RP, TO, SIS) 

Comparative data (RCT) concerning MUS: RP vs TO 

Several  meta-analyses  showed  that  RP  MUS  procedures  are  associated  with  higher 
objective  cure  rates  when  compared  to  TO  MUS,  but  similar  subjective  cure  rates 
(Schimpf  et  al.,  2014;  Novara  et  al.,  2010;  Ogah  et  al.,  2011).  Furthermore,  the  RP 
approach  is  associated  with  an  increased  risk  of  bladder  injury  and  haematoma  and 
increased operation duration. 

Finally, TO MUS and RP MUS are associated with similar patient-reported cure of SUI at 
12  months follow-up  (LE1).  The  RP  approach  is  associated  with  higher  rates  of  bladder 
injury (LE1) and the TO approach is associated with higher rates of groin pain (LE1) at 
12 months follow-up. 

Comparative data (RCT) concerning RP MUS: bottom-to-top vs top-to-bottom 

A meta-analysis showed that a RP bottom-to-top (vagina to skin = bottom up) route is 
associated  with  higher  cure  rates  and  lower  BOO  symptoms  and  a  decreased  risk  of 
bladder  injury  and  blood  loss  when  compared  to  a  RP  top-to-bottom  (skin  to  vagina  = 
top down) route (Schimpf et al., 2014; Ogah et al., 2011). 

Finally, a RP bottom-to-top (vagina to skin = bottom up) approach is superior to RP top-
to-bottom (skin to vagina = top down) approach (LE1). 

Comparative data (RCT) concerning TO MUS: in-out vs out-in 

Meta-analysis  showed  similar  outcomes  (cure  rates  and  complications  rates)  for  the  in-
out  TO  technique  and  the  out-in  TO  technique  (Schimpf  et  al.,  2014;  Novara  et  al., 
2010). 

Finally, TO in/out and TO out/in MUS are associated with similar patient-reported cure of 
SUI at 12 months follow-up (LE1). 

Comparative data (RCT) concerning MUS: SIS/SIMS/SFSIS vs other MUS techniques 

Most  data  concerned  the  TVT-Secur  procedure  that  has  already  been  withdrawn  from 
clinical use, since this technique was associated with lower cure rates when compared to 
the standard (classical) MUS procedure (Schimpf et al., 2014; Nambiar et al., 2014). 

A  recent  meta-analysis  concluded  that,  excluding  TVT-Secur,  there  was  no  evidence  of 
significant  differences  in  patient  reported  and  objective  and  subjective  cure  rates 
between MUS and SIS at 18 months follow-up and SIS were associated with lower pain 
scores  post-operatively  (Mostafa  et  al.,  2014).  Furthermore,  a  more  recent  well-
conducted  RCT  also  showed  that,  at  short-term  follow-up  (12  months),  Mini-Arc  (a 
SIS/SIMS  MUS)  was  not  inferior  with  respect  to  cure  and  superior  with  respect  to  pain 
and  recovery,  when  compared  to  Monarc  (a  standard  TO  out-in  MUS)  (Schellart  et  al., 
2014).  

Finally, excluding TVT-Secur, SIS/SIMS/SFSIS and classic full-length MUS are associated 
with  similar  patient-reported  cure  of  SUI  at  18  months  follow-up  (LE1)  and 
SIS/SIMS/SFSIS are associated with lower post-operative pain scores. 

Long-term outcomes are lacking concerning SIS/SIMS/SFSIS. 

40 

 
The safety of surgical meshes used in urogynecological surgery 

Patient stratification 

Recurrence of SUI 

Here, women who have previously undergone anti-incontinence surgery are discussed. 

Most RCTs concerning colposuspension or MUS included naive patients (no previous anti-
incontinence surgery) and women presenting with a recurrence of SUI. 

No  published  RCT  compared  RP  MUS  and  colposuspension  in  women  presenting  with 
recurrent  SUI.  Meta-analysis  concluded  that  there  was  no  evidence  in  objective  and 
subjective symptoms between RP and TO MUS (LE 3) (Agur et al., 2013). 

Mixed urinary incontinence (MUI) 

No  RCT  compared  colposuspension,  autologous  slings  and  MUS  in  a  mixed  urinary 
incontinence  population.  Moreover,  ‘mixed  urinary  incontinence’  definitions  are  very 
different between RCTs. The proportion of women presenting with MUI in published RCT 
varied from 8 to 93% depending on the definition (Brubaker et al., 2009). 

Older women 

There  is  little  evidence  that  increasing  age  is  an  independent  risk  factor  for  failure  or 
recurrence following MUS procedures (both for RP and TO approach) (Rechberger et al., 
2010; Barber et al., 2008; Richter et al., 2008; Groutz et al., 2011) (LE3). 

Although there is no consensus concerning the definition of an ‘old’ woman, a RCT was 
conducted  in  a  group  of  ‘old’  women  (>  70  years  old)  and  showed  that  a  MUS  RP 
procedure  was  associated  with  better  quality  of  life  and  lower  incontinence  symptoms 
when compared to no treatment (LE2) (Campeau et al., 2007). 

No  RCT  compared  colposuspension  or  autologous  slings  and  a  MUS  procedure  in  ‘older’ 
women.  

Finally, there is no evidence that any surgical procedure is associated with better results 
in older women when compared to another procedure. 

Adverse events 

In a two-year follow-up study, which prospectively evaluated TO and RP MUS, a total of 
383  adverse  events  were  observed  among  253  of  the  597  patients  (42%).  The  safety 
committee considered that adverse events (20%) were considered serious and occurred 
in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the 
RP  group. Neurological  adverse  effects  were more  common  in  the  TO  group  than  in  RP 
group  (32  events  vs  20  events  respectively).  23  (4%)  women  experienced  mesh 
complications including delayed presentations in both groups. (Brubaker et al., 2011)  

Guidelines on surgical treatment for women with SUI 

Guidelines from EAU (European Association of Urology), NICE / RCOG (United Kingdom), 
CNGOF (College National des Gynecologues et Obstétriciens Français) & AFU (Association 
Française  d’Urologie)  (France),  AWMF  (Arbeitsgemeinschaft  der  Wissenschaftlichen 
Medizinischen  Fachgesellschaften)  (Germany,  Austria,  Switzerland),  ACOG  (American 
College  of  Obstetricians  and  Gynecologist)  and  ACP  (American  College  of  Physicians) 
first-line  treatment  with  MUS  (RP  or  TO)  (grade:  strong 
(USA)  recommend 

41 

 
The safety of surgical meshes used in urogynecological surgery 

recommendation / Grade A; high quality evidence / LE 1) (Qaseem et al., 2014; Fritel et 
al., 2010; Smith et al., 2013; Lucas et al., 2013; Reisenauer et al., 2013). Second-line 
surgical  therapies  (open  or  laparoscopic  colposuspension  or  autologous  fascial  slings) 
should be offered, if MUS cannot be considered (Grade C). 

Conclusions 

The amount of synthetic mesh used for the treatment of SUI is far less compared to the 
use of such mesh in POP repair. 

There is robust evidence (LE1) to support the use of MUS from over 2,000 publications, 
making  this  treatment  the  most  extensively  reviewed  and  evaluated  procedure  for 
female  SUI  now  in  use.  These  scientific  publications  studied  all  types  of  patients, 
including those with co-morbidities such as prolapse, obesity and other types of bladder 
dysfunction.  It  is,  however,  acknowledged  that  any  operation  can  cause  complications. 
For  MUS  these  include  bleeding,  damage  to  the  bladder  and  bowel,  voiding  difficulty, 
tape  exposure  and  pelvic  pain;  all  of  these  may  require  repeated  surgery,  but  this  is 
uncommon.  Nevertheless,  the  results  of  a  large  multi-centre  trial  have  confirmed 
excellent and equivalent outcomes between a retropubic and a transobturator sling and a 
low rate of complications to be expected after treatment with MUS. (Richter et al., 2010) 
Treatment success  decreased  over  5  years  for retropubic  and  transobturator  slings  and 
did  not  meet  the  prespecified  criteria  for  equivalence  with  retropubic  demonstrating  a 
slight  benefit.  However,  satisfaction  with  both  types  of  slings  remained  high.  Women 
undergoing  a  transobturator  sling  procedure  reported  more  sustained  improvement  in 
urinary symptoms and sexual function. New mesh extrusions occurred in both types over 
time,  although  at  a  similar  rate.  (Kenton  et  al.,  2015).  Additionally,  long-term 
effectiveness  of  up  to  80%  has  been  demonstrated  in  studies  including  one  that  has 
followed up a small group of patients for 17 years (Nilsson et al., 2013). 

o 

Male patients 

Review of surgery results 

Clinical outcomes 

Multiple  series  are  currently  available  reporting  outcomes  of  the  various  male  sling 
techniques.  However,  given  the  nature  of  the  studies  performed  and  methodology  for 
reporting,  outcomes  should  be  interpreted  with  caution.  There  is  currently  no  accepted 
standard  method  for  reporting  pre-  and  post-operative  degrees  of  incontinence  or  any 
consistent  method  for  defining  success  with  treatment.  The  majority  of  studies  have 
poorly  or  undefined  inclusion/exclusion  criteria  with  significant  heterogeneity  of  the 
patient  population  including  inconsistent  inclusion  of  patients  with  varied  etiologies  for 
SUI  or  prior  radiation  therapy.  These  factors,  among  others,  limit  the  ability  to  draw 
comparisons between studies and techniques.  

A comprehensive review on the results of male sling and AUS surgery was performed by 
Trost and Elliott (2012). As the bone anchor sling (BAS) has been available and utilised 
for  a  longer  period  of  time  than  other  slings,  more  studies  are  currently  available  for 
review  with  longer  mean/median  follow-up  periods.  For  the  purposes  of  that  review, 
studies  were  included  if  they  were  published  within  the  past  10  years  and  examined 
synthetic  sling  placement  only,  as  organic  sling  material  is  no  longer  commonly 
employed. 

42 

 
The safety of surgical meshes used in urogynecological surgery 

Overall  results  of  the  BAS  demonstrated  cure  rates  ranging  from  37–67%  with 
improvement  noted  in  an  additional  10–40%.  The  wide  range  of  results  is  likely 
secondary to the surgical method and the definitions for continence utilised and may also 
be  due  to  a  migration  of  case  complexity.  More  recent  reports  have  included  an 
increased  number  of  patients  with  prior  radiation  therapy  and  those  with  more  severe 
pre-operative incontinence. Several studies have noted significance in the association of 
pre-operative continence and post-operative success rates with conflicting reports on the 
impact  of  radiation  on  overall  success.  Complications  commonly  reported  include 
infection  (2–15%),  extrusion  (0–3%),  de  novo  urgency/overactivity  (0–14%),  pain  (0–
73%) (which typically resolves within 4 months), and sling removal (0–13%) (Trost and 
Elliott, 2012).  

Results  from  placement  of  the  RTS  have  similarly  demonstrated  resolution  or 
improvement  in  males  with  mild-to-moderate  SUI  in  9–62%  and  16–46%  of  patients, 
respectively. With the notable exception of Cornel et al., (2010), who reported a success 
rate of 9% and failure rate of 46% among 35 patients, other studies report higher cure 
rates  of  52–74%  with  improvements  noted  in  an  additional  16–27%.  Complications 
reported with the RTS include temporary urinary retention <2 weeks (0–24%), urethral 
injury (0–3%), pain (0–34%), need for sling removal (0–4%) and dysuria (0–14%). 

It  is  notable  that  four  studies  examining  RTS  were  prospectively  designed,  with  three 
accruing over 110 patients (Rehder et al., 2010; Cornel et al., 2010; Cornu et al., 2011; 
Bauer  et  al.,  2011).  As  with  the  BAS  groups,  improved  outcomes  were  noted  among 
patients  with  decreased  pre-operative  incontinence,  with  a  trend  towards  increased 
failures noted among patients with pre-operative radiation therapy (Cornu et al., 2011). 

Two studies of interest investigated the role for RTS as a salvage technique in cases of 
recurrent  incontinence  following  prior  anti-incontinence  surgery.  Christine  and  Knoll 
(2010) reviewed 19 patients with recurrent incontinence undergoing RTS following prior 
AUS  placement.  Patients  had  self-reported  pre-operative  pad  usage  of  2–5 ppd. 
Following RTS placement, 15/19 (79%) reported requiring 0 ppd (pads per day), with the 
remaining  4/19  (21%)  describing  improvement.  Approximately  half  of  the  patients  did 
not require reactivation of the sphincter. Similarly, Soljanik et al. (2010) reported on 29 
patients  undergoing  RTS  following  a  previously  failed  sling  procedure  with  a  pre-
operative  mean  pad  requirement  of  4.3 ppd.  At  17  months  follow-up,  results 
demonstrated resolution of incontinence in 10/29 (35%) with improvement noted in an 
additional  16/29  (55%).  These  studies  highlight  the  potential  role  for  male  sling 
placement  as  a  potential  adjunctive/salvage  treatment;  however,  further  validation  is 
required prior to its consideration as a routine salvage measure.  

A  third  category  of  currently  available  slings  includes  the  ARS.  Results  of  initial  and 
longer-term  follow-up  demonstrate  success  rates  of  13–100%  with  larger  series 
reporting rates of 54–79%. Patients required adjustments in 10–100% of cases, many of 
which  required  repeated  anaesthesia.  Complication  rates  were  significantly  higher 
compared  to  other  sling  categories  with  infections  (5–7%),  extrusion    (3–13%), 
explantation (2–35%), bladder perforation (5–29%), retention (35%) and perineal pain 
(4–38%) being the most commonly reported (Trost and Elliott, 2012). 

Adverse events 

The  adverse  events  of  implanting  a  male  sling  are  summarised  as  follows  (Trost  and 
Elliott, 2012): 

43 

 
The safety of surgical meshes used in urogynecological surgery 

Complications  resulting  from  male  sling  implantation  may  be  categorised  as  occurring 
intra-operatively, early post-operatively (<90 days) or late post-operatively (>90 days). 
Intra-operative  complications  may  include  urethral  injury  occurring  at  the  time  of 
urethral  dissection  or  passage  of  a  trocar  for  male  sling  placement.  If  a  small  injury  is 
recognised,  placement  of  the  male  sling  may  continue  at  a  separate  site  to  prevent 
subsequent  extrusions.  A  large  urethral  injury  should  be  repaired  primarily  with  the 
procedure  aborted  and  a  catheter  placed.  Bladder  injuries  occurring  during  trocar 
passage  may  be  managed  with  repassing  of  the  trocar  and  subsequent  catheterisation 
for  a  period  of  several  days  post-operatively.  Given  the  relative  incidence  of  bladder 
injury  with  retropubic  sling  placements,  patients  undergoing  these  procedures  should 
undergo intraoperative cystoscopy to rule out bladder perforation. 

Early  post-operative  complications  include  urinary  retention,  infection  and/or  extrusion, 
perineal  pain  and  de  novo  detrusor  overactivity.  Urinary  retention  typically  occurs 
secondary to post-operative edema and resolves spontaneously in the majority of cases. 
Persistent retention lasting >8 weeks may indicate inappropriate sizing of the sphincter 
cuff,  overtensioning  of  the  sling,  or  sling  malposition.  Retention  is  typically  managed 
with in-and-out catheterisation with suprapubic tube placement required in rare cases. 

Infections  of  the  sling  material  may  be  secondary  to  unrecognised  urethral  extrusion 
versus  intraoperative  contamination.  Pre-operative  patient  factors  including  repeated 
device placements, prior extrusions and radiation therapy all predispose patients towards 
a  higher  rate  of  post-operative  infections.  The  most  commonly  isolated  organisms  for 
infection include S. aureus, S. epidermidis, Enterococcus, Methicillin resistant S. aureus 
and  gram-negative  bacilli  (Magera  and  Elliott,  2008).  Infections  occurring  beyond  90 
days  may  be  related  to  the  hematogenous  spread  of  bacteria  at  the  time  of  additional 
procedures. 

Urethral  extrusions  occurring  early  in  the  post-operative  period  are  likely  secondary  to 
unrecognised  urethral  injury  occurring  at  the  time  of  surgical  implantation.  Device 
extrusions  require  explantation,  even  in  the  absence  of  infection,  with  possible  repeat 
sling placement performed several months later pending sufficient recovery and absence 
of urethral stricture development. 

Post-operative  perineal  pain  is  common  with  male  sling  placement,  with  some  authors 
noting  pain  in  100%  of  male  sling  patients  for  periods  up  to  4  months.  Patients  may 
additionally  develop  de  novo  detrusor  overactivity,  which  may  be  managed  with 
anticholinergic therapy as indicated. 

Patient stratification 

According  to  Trost  and  Elliott  (2012),  deciding  which  procedure  to  perform  in  males 
presenting with SUI is based on several factors, which are discussed hereafter. 

Most  commonly,  male  slings  are  offered  in  cases  of  lower-volume  incontinence  (1–3 
ppd),  or  in  the  setting  of  complicating  patient  factors  including  inability  to  function  the 
AUS pump. 

There is currently no universally accepted standard by which patients are stratified into 
receiving  a  male  sling  versus  AUS.  Similarly,  there  are  no  currently  accepted  objective 
measures by which men are formally  evaluated for SUI. Evaluating clinicians may elect 
to stratify patients based on subjective reporting of pad usage, objectively obtained 24-

44 

 
The safety of surgical meshes used in urogynecological surgery 

hour  pad  weights,  or  by  the  degree  of  SUI  visualised  on  examination.  This  lack  of 
consensus  on  the  clinical  evaluation  of  males  with  SUI  is  mirrored  in  the  available 
published literature, which similarly lacks an accepted method of standard reporting. 

Additionally,  there  are  currently  no  publications  that  directly  compare  results  for  the 
various  treatments  of  male  SUI  and  as  such,  it  is  not  possible  to  directly  compare 
reported outcomes between studies. Based on the reported literature available, it is not 
possible to definitively identify one sling procedure as superior to another. 

In general, available data on the various male slings have shown a reduction in overall 
efficacy  in  patients  with  pre-surgical,  higher  volume  incontinence, and  therefore  AUS  is 
typically  chosen  in  these  cases.  Alternatively,  male  slings  may  be  preferred  in  cases  of 
diminished  hand  and/or  cognitive  ability,  regardless  of  degree  of  incontinence  as  this 
may avoid potentially serious complications of urinary retention and its sequelae. Given 
the  lack  of  data  and  guidelines,  the  decision  as  to  whether  to  perform  a  male  sling 
versus  AUS  depends  on  several  factors  including  patient  preference,  surgeon  comfort 
and experience with the available  procedures, and knowledge of the currently available 
outcomes and complications of each procedure. 

Conclusions 

Several  therapies  are  currently  available  for  the  treatment  of  low-to-moderate  volume 
incontinence including the AUS and several variations of male slings (BAS, RTS, ARS and 
quadratic  sling).  Patients  with  large-volume  incontinence  are  best  managed  with  AUS 
when  found  to  be  an  appropriate  surgical  candidate.  Complications  of  sling/AUS 
placement  include  temporary  retention,  perineal  pain,  infections,  extrusions,  de  novo 
urinary symptoms and device malfunction. 

Mesh surgery for POP 

Results  are  presented  regarding  outcome  including  adverse  results  related  to  mesh 
placement  (vaginal  mesh  exposure;  bladder/rectal  mesh  exposure;  mesh  infection  and 
mesh  shrinkage  =  mesh  contraction)  and  adverse  effects  which  are  not  related  to  this 
procedure (dyspareunia; hispareunia; haematoma; bladder/rectal injury; abscess).  

Comparative data (RCT): TVM implantation vs. vaginal POP surgery using native 
tissues 

Recently  a  (Dutch)  review  (Milani  et  al.,  2013)  was  published  on  10  randomised 
controlled trials comparing outcomes of synthetic mesh and native tissue surgery for the 
vaginal  repair  of  POP.  Anatomical  and  functional  outcomes  were  reported  as  well  as 
post-operative  and  de  novo  dyspareunia.  These  data  demonstrated  superior  anatomic 
outcomes  (POP  stage  <II)  for  the  anterior  vaginal  compartment  and  could  not 
demonstrate  a  significant  difference  in  de  novo  or  post-operative  dyspareunia,  when 
comparing synthetic mesh implantation and POP repair using native tissues (see Figures 
2-4). 

Figure  2  shows  the  results  of  a  meta-analysis  of  RCTs  that  compare  strict  anatomic 
outcomes  (POP-Q  stage  <II)  for  the  anterior  vaginal  compartment  between  mesh 
implantation  and  the  use  of  native  tissue.  The  Odds  ratio  for  anatomic  success  in  the 
anterior compartment was 6.31 (95% CI 4.62-8.63) 

45 

 
The safety of surgical meshes used in urogynecological surgery 

Figure 2: Anatomic success (POP stage < II) in the anterior vaginal compartment (with 
permission from Milani et al, 2013) 

Figures 3 and 4 show the results of meta-analysis of RCTs that compare post-operative 
and  de  novo  dyspareunia  between  mesh  implantation  and  native  tissue  repair  at  12 
months  follow-up.  No  significant  difference  in  post-operative  dyspareunia  (total  of  295 
patients) or de novo dyspareunia could be demonstrated. 

Figure 3: Post-operative dyspareunia (with permission from Milani et al, 2013) 

Figure 4: De novo dyspareunia (with permission from Milani et al, 2013) 

46 

 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

The  optimal  surgical  repair  of  POP  is  not  yet  known.  Recently,  the  international 
urogynecological organisations (IUGA and ICS) emphasised the importance of the use of 
clinically  relevant  outcome  measures.  From  a  patient  perspective,  subjective  outcome 
measures,  that  is,  the  elimination  of  bothersome  symptoms,  prevail  above  objective 

(anatomical) outcomes (Toozs‐Hobson et al., 2012). Hereunder, (Tables 1-3) the results 

of a recent systematic review and meta-analysis are shown for the comparison of these 
various clinically relevant outcomes between the use of native tissues or synthetic mesh 
implantation for the repair of POP. Table 1 shows the results for the repair of the anterior 
vaginal compartment, Table 2 for the posterior vaginal compartment and Table 3 shows 
results  of  cases  where  more  than  one  vaginal  compartment  was  involved  in  the  repair 
(Dutch Guideline, 2014). 

From left to right in the following table, the outcome measure is defined, the cases and 
denominator  are  shown,  and  the  calculated  relative  risk  with  95%  confidence  intervals 
and the interpretation is given. 

Table 1: Anterior colporrhaphy (native tissue repair) versus mesh implantation (TVM) for 
the surgical repair of anterior compartment prolapse. 

Outcome measure 

Surgery n/N 

RR (95% CI) 

Conclusion 

AC 

TVM 

Number of women with 
recurrent prolapse symptoms 
(bulge)  

90/271 

53/284 

1.77 (1.32-2.37) 

98/349 

62/363 

1.64 (1.24-2.16) 

Subjective 
recurrence higher 
in case of use of 
native tissue 

No research 
available 

Satisfaction of patients 

(PGI-I) 

Quality of life after operation (P-
QOL of PFDI-20) mean/N 

Number of women with 
anatomical prolapse recurrence 
regardless which compartment 

7.5/42 

6.2/43 

MD 0.22 (-0.21, 0.65) 

No difference 

45/37 

34/37 

MD 11.0 (-3.36, 25.36) 

6/20 

1/20 

6.00 (0.79-45.42) 

No difference 

Number of women with an 
anatomical recurrence of the 
anterior vaginal compartment 

200/410 

59/424 

3.39 (2.62-4.38) 

220/478 

69/498 

3.23 (2.55-4.10)  

149/272 

43/277 

3.83 (2.34-6.26) 

51/138 

16/147 

3.41 (2.05-5.68) 

147/296 

43/302 

3.59 (2.38-5.40) 

47 

Objective 
recurrence 
higher in case of 
use of native 
tissue 

 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Outcome measure 

Surgery n/N 

RR (95% CI) 

Conclusion 

281/719 

99/736 

2.82 (2.19-3.62) 

Number of women with de novo 
prolapse of the middle vaginal 
compartment 

Number of women with de novo 
prolapse of the posterior 
vaginal compartment 

Number of women with re-
operation for prolapse 

Number of women with de novo 
dyspareunia  

Sexual functioning score (PISQ-
12) mean/N 

2/15 

13/26 

OR: 0.15 (0.03-0.82) 

No research 
available 

Less de novo 
prolapse when 
using native 
tissue 

14/459 

6/471 

2.18 (0.93-5.10) 

No difference 

9/213 

15/216 

0.61 (0.28-1.32) 

No difference 

35.1/189 

35/200 

MD 0.10 (-0.17, 0.37) 

No difference 

33/37 

37/34 

MD -1.00 (-3.16, 1.16) 

226 

237 

MD 0.08 (-0.18, 0.35) 

Number of women with  

3/324 

41/320 

0.58 (0.36-0.94) 

de novo stress incontinence 

27/344 

42/340 

0.62 (0.40-0.98) 

Less de novo SUI 
using native tissue 

No research 
available 

Number of women with de novo 
urgency, detrusor over activity 
or over active bladder 

Number of women with 
subsequent urinary 
incontinence surgery 

Number of women with mesh 
exposure 

Number of women requiring 
surgery because of mesh 
exposure 

Number of women with post-
operative complications 

Costs 

15/368 

12/380 

1.29 (0.63-2.63) 

No difference 

0/547 

64/563 

0.07 (0.03-0.18) 

0/460 

31/471 

0.09 (0.03-0.29) 

Native tissue 
protects against 
mesh exposure 

Native tissue 
protects against 
mesh exposure 

No research 
available 

No research 
available 

MD = mean difference; OR = odds ratio; RR = Relative Risk; TVM = transvaginal mesh; AC = anterior 
colporrhaphy 

Table 2: Posterior colporrhaphy (native tissue repair) versus mesh implantation (TVM) 
for the surgical repair of posterior compartment prolapse. 

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Outcome measure 

Surgery n/N 

RR (95% CI) 

Conclusion 

PC 

TVM 

Number of women with recurrent 
POP symptoms (bulge)  

7/24 

6/26 

1.26 (0.49-3.23)1 

No difference 

Satisfaction of patients 
(PGI-I) – much better 

Quality of life after operation (P-
QOL of PFDI-20) mean/N 

Number of women with 
anatomical recurrent prolapse 
regardless of which compartment 

Number of women de novo 
prolapse of the anterior vaginal 
compartment 

Number of women with de novo 
prolapse of the middle vaginal 
compartment 

Number of women with 
anatomical recurrence of the 
posterior vaginal 

Number of women requiring a 
subsequent  operation for 
prolapse 

Number of women with de novo 
dyspareunia 

Sexual function score (PISQ-12) 

Number of women with de novo 
stress incontinence  

Number of women with de novo 
urgency, detrusor over activity or 
over active bladder 

Number of women with 
subsequent incontinence surgery 

15/22 

17/28 

0.99 (0.64-1.53)1 

No difference 

14/25 

18/30 

0.93 (0.59-1.47)1 

No difference 

Not published 
separately  

4/24 

16/30 

0.31 (0.12-0.81)1 

Significantly less 
when treated with 
native tissue 

0/24 

0/30 

No difference 

9/25 

1/30 

10.80 (1.47-79.53)1 

Significantly more 
after using native 
tissue 

Not reported 

Not separately 
reported 

Not reported 

1/25 

2/28 

0.56 (0.05-5.81)1 

No difference 

Not reported 

No difference 

Number of women with mesh 
exposure 

0/25 

5/32 

1 

No exposure after 
use of native tissue 

49 

 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Outcome measure 

Surgery n/N 

RR (95% CI) 

Conclusion 

Number of women with surgery 
because of mesh exposure  

Number of women with post-
operative complications 

Costs  

No exposure after 
use of native tissue 

Not reported 

No research 
available 

PC =posterior colporrhaphy; RR = Relative Risk; TVM = transvaginal mesh;  

1 only one study: Withagen et al., 2011 

50 

 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Table 3: Vaginal surgical repair of multiple compartments using native tissues versus 
mesh implantation. 

Result 

Surgery n/N 

RR (95% CI) 

Conclusion 

AC+PC 

TVM 

Number of women with recurrent 
prolapse symptoms (bulge) 

29/173 

24/167 

1.17 (0.71-1.92) 

Subjective 
recurrence higher 
using native tissue 

Satisfaction of patients  
(PGI-I) – much better 

Quality of life after operation (P-
QOL or PFDI-20) mean/N 

Number of women with recurrent 
anatomical prolapse regardless of 
which vaginal compartment 

Number of women with de novo 
prolapse of the anterior vaginal 
compartment 

Number of women with de novo 
prolapse of the middle vaginal 
compartment 

85/121 

76/114 

1.03 (0.87-1.23) 

No difference 

123/249 

85/256 

1.49 (1.20-1.84) 

7/33 

16/30 

0.40 (0.19-0.83) 

No difference 

Objective 
recurrence higher 
using native tissue 

Significantly lower 
using native tissue 

0/39 

2/56 

0.28 (0.01-5.78) 

No difference 

Number of women with anatomical 
recurrence of the posterior vaginal 
compartment 

3/26 

13/32 

0.28 (0.09-0.89) 

Significantly lower 
using native tissue 

Number of women who are 
operated for prolapse 

Number of women with de novo 
dyspareunia 

Sexual function score 
(PISQ-12) mean/N 

Number of women with de novo 
stress incontinence 

Number of women with de novo 
urgency, detrusor over activity or 
over active bladder 

7/189 

4/194 

1.62 (0.54-4.85) 

No difference  

19/103 

14/110 

1.45 (0.77-2.74) 

No difference 

33-35/61 

34 / 64 

0.72 (-1.41–2.86) 

No difference 

27/144 

37/142 

0.72 (0.46-1.12) 

No difference 

Not investigated 

Number of women with mesh 
exposure 

0/249 

39/256 

0.01 (0.00-0.21) 

Mesh increases risk 
for exposure 

51 

 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Result 

Surgery n/N 

RR (95% CI) 

Conclusion 

Number of women needing surgery 
because of mesh exposure 

0/189 

18/194 

0.08 (0.02-0.42) 

Mesh is risk full for 
exposure 

Number of women with post-
operative complications 

Costs 

No research 
available 

No research 
available 

AC = anterior colporrhaphy, PC = posterior colporrhaphy; RR = Relative Risk; TVM = transvaginal mesh 

Conclusion 

For  the  anterior  vaginal  compartment,  there  is  convincing  evidence  that  the  use  of  a 
synthetic mesh to repair a prolapsed anterior vaginal wall is subjectively and objectively 
superior  to  a  native  tissue  repair.  There  is,  however,  no  difference  in  health-related 
quality  of  life  between  mesh  and  native  tissue  repair.  The  rate  of  de  novo  POP  of  the 
untreated  vaginal  compartment  is  significantly  higher  when  synthetic  mesh  is  used. 
There  is  no  evidence  for  a  difference  in  the  need  for  subsequent  operations  for  POP  or 
the  occurrence  of  de  novo  dyspareunia  or  sexual  function.  The  use  of  mesh  results  in 
higher  rates  of  reported  SUI,  although  this  was  not  reflected  in  a  higher  rate  for  SUI 
surgery. Mesh exposure is reported frequently. 

For the posterior vaginal compartment, there is moderate evidence that the use of mesh 
results  in  higher  rates  of  objective  cure  and  de  novo  POP  of  the  anterior  vaginal 
compartment, but no differences in subjective cure or de novo SUI. Mesh exposures are 
reported frequently. 

For  the  treatment  of  more  than  one  vaginal  compartment,  the  meta-analysis  showed 
that the use of mesh resulted in higher rates of subjective and objective ‘cure’, but also 
in  significantly  higher  rates  of  de  novo  POP  of  the  untreated  vaginal  compartments. 
There  were  no  differences  in  patient  satisfaction;  health-related  quality  of  life, 
subsequent operations for POP, de novo dyspareunia, sexual function scores or de novo 
SUI. Mesh exposures, however, were frequently reported. 

The follow-ups of selected papers for that meta-analysis were mainly short (12 months) 
and sometimes medium-term (36 months). Long-term results (5-10 years) of RCTs are 
not yet published and, thus, are yet unavailable for analysis. 

Adverse events 

−  Mesh exposure 

Mesh  exposure  is  the  condition  whereby  synthetic  mesh  is  displayed/exposed  (usually 
visualised  through  separated  vaginal  epithelium)  (Haylen  et  al.,  2012)  and  is  the  most 
frequently  reported  complication  with  rates  ranging  from  4-19%.  These  exposures  can 
cause pain during sexual intercourse, cause blood loss or foul vaginal discharge, but can 
also be asymptomatic. The risk of exposure increases with tobacco use (OR 3.1; 95% CI 

52 

 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

1.1-8.7),  decreased  clinical  experience  of  the  surgeon  (OR:  2.0;  95%  CI  1.2-3.4)  and 
with the use of a ‘total’ (that is anterior and posterior) mesh (OR: 3.0; 95% CI 1.2-7.0) 
(Withagen et al., 2011). 

−  Dyspareunia 

Pain  during  sexual  intercourse  is  frequently  reported  by  women  suffering  from  pelvic 
organ  prolapse  and  usually  diminishes  after  surgical  repair  of  the  prolapsed  vaginal 
compartments.  In  a  systematic  review  of  54 studies  on 4566  patients, the  dyspareunia 
rate  after  a  vaginal  mesh  procedure  was  reported  to  be  8.9%  (range;  0-67%;  95%  CI 
8.0-10.0)(Abed  et  al.,  2011).  Randomised  trials  comparing  vaginal  mesh  versus  native 
tissue repair surgery however did not demonstrate a difference in de novo dyspareunia, 
nor in post-operative dyspareunia (Milani et al., 2013; Dietz and Maher 2013). The most 
important  risk  factor  for  post-operative  dyspareunia  was  pre-operative  dyspareunia. 
(Withagen et al., 2011). 

−  Pain 

Pain  is  a  complication  that  can  occur  after  any  surgical  repair  of  vaginal  prolapse.  Pain 
caused  by  shrinkage  of  vaginal  tissue  caused  by  an  excessive  inflammatory  reaction 
against  the  polypropylene  mesh,  which  acts  as  a  foreign  body,  is  of  a  different  nature 
and can be serious and difficult to treat. Pain in the lower abdomen or pubic region 12 
months  after  a  mesh  augmented  prolapse  repair  is  reported  by  between  3-10%  of 
patients.  Randomised  studies  however  could  not  demonstrate  a  difference  between  a 
mesh-augmented  and  a  conventional  native  tissue  repair  of  POP.  (Milani  et  al.,  2013; 
Withagen et al., 2011) 

−  Other complications 

Other complications that can occur after vaginal mesh surgery are haemorrhage, bowel 
and or rectal injury, urinary infection and post-operative retention. These complications 
also occur after native tissue surgery. 

Guidelines on surgical treatment for women with PO 

The objective of this paragraph is to describe the main recommendations concerning POP 
surgery in Europe and the USA. The reported recommendations have been elaborated by 
international  (IUGA,  EAU)  or  national  scientific  societies  in  the  UK,  Netherlands  and 
France. 

List of existing recommendations: 

- IUGA roundtable (2011): Davila et al., 2012; Slack et al., 2012; Winters et al., 2012; 

Miller et al., 2012. 

- Dutch guidelines on mesh surgery in POP surgery and MUS (2012, updated in 2014). 

- French guidelines on mesh placement in POP surgery (2011 and 2013). 

-  The  UK's  National  Institute  for  Health  and  Clinical  Excellence  (NICE)  has  issued  full 
guidance to the NHS in England, Wales, Scotland and Northern Ireland. 

-  NICE  was  notified  of  various  procedures  for  the  treatment  of  POP.  NICE  asked  the 
Review  Body  for  Interventional  Procedures  to  undertake  a  systematic  review  of  these 
53 

 
The safety of surgical meshes used in urogynecological surgery 

procedures.  The  Interventional  Procedures  Advisory  Committee  (IPAC)  considered  the 
systematic  review  and  has  also  produced  guidance  on: infracoccygeal  sacropexy  using 
mesh  for  vaginal  vault  prolapse  repair, sacrocolpopexy  using  mesh  for  vaginal  vault 
prolapse  repair, sacrocolpopexy  using  mesh  for  uterine  prolapse  repair  and insertion  of 
uterine  suspension  sling  (including  sacrohysteropexy)  using  mesh  for  uterine  prolapse 
repair. 

-  Uterine  prolapse  occurs  when  the  womb  (uterus)  slips  down  from  its  normal  position 
into the vagina. Infracoccygeal sacropexy is an operation that involves the insertion of a 
piece of material (mesh) with the aim of holding the womb in place. 

- Risks and possible problems: Mesh extrusion requiring further treatment occurred in 4 
out of 35 women who had infracoccygeal sacropexy alone and in 6 out of 44 women who 
had the procedure done together with a hysterectomy. As well as looking at this study, 
NICE also asked expert advisers for their views. These advisers are clinical specialists in 
this  field  of  medicine.  The  advisers  said  that  problems  may  include  mesh  extrusion, 
infections, damage to the bladder, bowel or rectum and painful sexual intercourse. The 
advisers also said that there may be fewer complications with newer types of mesh. For 
more  information  about  prolapse  of  the  womb,  a  good  place  to  find  out  more  may  be 
NHS Choices (www.nhs.uk). Your local patient advice and liaison service (usually known 
as PALS) may also be able to give you further information and support.  

Mesh surgery for CFD 

It has already been mentioned above that CFD do not fall exactly within the scope of this 
Opinion and are only mentioned here because the Dutch Health Inspectorate reported a 
considerable number of patients with complaints who had undergone a ventral rectopexy 
for rectal prolapse (Dutch Health Care Inspectorate, 2013). 

4.2.4. Learning curve and clinical experience 

Mid-urethral sling surgery 

The  surgical  duration  of  TVT  surgery  is  shortened  after  the  operator  has  performed  15 
operations (LE 4) (Ito et al., 2011). 

Higher  rates  of  complications  mainly  occur  in  the  first  4  months  of  training  (LE  4) 
(Maguire et al., 2013). 

During  the  learning  phase  (50  first  MUS  procedures),  the  complication  rates  (bladder 
injuries, urinary retention and de novo bladder outlet obstruction symptoms) are higher 
(Lebret et al., 2001). 

Concerning  the  effect  of  a  learning  curve  on  the  success  rates  (objective  and/or 
subjective  cure  rates),  the  published  data  remain  controversial.  Cetinel  et  al.,(2004) 
observed  comparable  outcomes  (subjective  cure  rates)  2  years  after  MUS  procedure, 
irrespective  of  surgeon  ‘experience’  (<  20  MUS  procedures  vs  >  20  MUS  procedures). 
Koops  et  al,  (2006)  reported  that,  at  2  years  follow-up,  the  outcomes  (objective  and 
subjective  cure  rates)  observed  following  20  MUS  procedures  were  better  than  those 

54 

 
 
 
The safety of surgical meshes used in urogynecological surgery 

observed during the 10 first procedures (LE 4). However, at 5 years follow-up, another 
study observed that subjective cure rates were not related to the surgical volume of the 
surgeon  who  performed  the  procedures  (<  50  procedures  vs  >  50  procedures)  (LE  4) 
(Holmgren et al., 2005). 

Finally,  the  learning  curve  for  MUS  surgery  is  probably  variable  (from  one  trainee  to 
another)  and  may  be  longer  than  expected  (learning  curves  should  be  individualised). 
Numerous  confounding  variables  exist,  such  as  the  trainee’s  prior  experience,  the 
difficulty  of  procedures  and  the  level/quality  of  the  supervision  by  a  ‘senior  surgeon’ 
(Khan et al., 2014). 

Pelvic organ prolapse surgery with meshes 

o 

Laparoscopic sacral colpopexy 

A laparoscopic sacral colpopexy (LSC) requires the attaining of laparoscopic suturing and 
knot  tying  skills.  Claerhout  et  al.,  (2009)  observed  that  LSC  operative  duration 
decreased  rapidly  during  the  first  30  procedures  and  reached  a  steady  state  after  90 
cases. However, complication rates remained unchanged throughout this learning curve 
series.  Using  a  cumulative  sum  approach,  they  hypothesised  that  adequate  learning 
occurred after 60 cases (LE 4) (Claerhout, 2009). Akladios et al., (2010) also observed 
that LSC operation duration decreased after 25 procedures. The complication rates were 
also  low  throughout  this  series  and  were  not  affected  by  the  learning  curve.  However, 
this  study  analysed  the  learning  curve  of  a  senior  urogynecologic  surgeon  who 
commenced this technique, and not the learning curve of a trainee. 

Kantartzis  et  al.,  (2013)  analysed  the  learning  curves  of  the  first  180  LSC  done  by  4 
attending  urogynecologists  and  observed  that  there  was no  significant  difference  in  the 
rate of overall complications regardless of the number of prior procedures performed (LE 
4). 

Mustafa  et  al.,  (2012)  observed  that  LSC  operative  time  decreased  considerably 
following the first 15 cases (LE 4). 

However,  since  complication  rates  associated  with  LSC  are  low,  the  published  series 
cannot  assess  the  effect  of  under-experience  since  the  number  of  cases  is  few  in  each 
series.  Furthermore,  the  complication  rates  are  probably  limited  because  of  the 
supervision by a ‘senior surgeon’ during this learning curve. 

Prior  training  in  laparoscopic  suturing  coincided  with  a  short  learning  process  for  the 
phases requiring suturing (Claerhout et al., 2014). The most time-consuming step is the 
dissection  of  the  vault,  for  which  it  took  the  trainee  31  procedures  to  achieve  an 
operation time comparable to that of the teacher (Claerhout et al., 2014). 

The  learning  curve  for  robot-assisted  sacrocolpopexy  (RASC)  may  be  shorter  than  the 
learning  curve  for  LSC  but  there  is  no  precise  data  concerning  this  point  (Serati et  al., 
2014). 

o 

Mesh placed by vaginal route 

Bafghi  et  al.,  (2009)  observed  that  operation  duration  decreased  and  then  remained 
stable after 18 procedures. 

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The safety of surgical meshes used in urogynecological surgery 

Concerning the  prevalence  of vaginal  mesh  exposure,  Guillibert  et  al., (2009) observed 
that  women  treated  by  vaginal  estrogens  and  those  operated  by  the  most  experienced 
surgeon  had  less  exposure.  However,  following  multivariate  analysis,  the  only 
independent risk factors of exposure were the kind of prosthesis, age less than 60 years 
and concomitant hysterectomy (Guillibert et al., 2009). 

Achtari et al., (2005) showed that the prevalence of mesh exposure was associated with 
surgeon experience. 

Withagen et al., (2011) demonstrated that every ten years of clinical experience reduced 
the  risk  for  mesh  exposure  in  transvaginal  mesh  surgery  by  50%:  clinical  and  surgical 
experience  was inversely related to the risk of exposure (OR 0.5, 95% CI 0.3– 0.8 per 
decade). 

Impact of treatment centre and medical specialty 

Concerning  mesh  use  in  POP  surgery,  Rogo-Gupta  et  al.,  (2012)  showed  that 
intermediate-volume (OR 1.53; 95% CI 1.44-1.62) and high-volume (OR 2.74; 95% CI 
2.58-2.92) surgeons are more likely to use mesh than low-volume surgeons. Compared 
with  women  who  underwent  operations  performed  by  gynecologists,  those  treated  by 
urologists are more than three times more likely to undergo mesh-augmented prolapse 
repair (OR 3.36; 95% CI 3.09-3.66). 

Conclusion 

There is a learning curve for MUS procedures and for POP surgery procedures, especially 
concerning  operation  duration,  and  the  evidence  would  suggest  only  experienced 
surgeons (such as > 20 cases performed under supervision of an experienced surgeon) 
should perform this kind of surgery unsupervised. 

4.2.5. Mitigating risks through patient selection and counselling 

Patient selection 

In  the  case  of  urogynaecological  mesh  devices,  there  is  at  present  very  little  robust 
evidence available to inform patient selection when used either for POP or SUI.  

When  considering  surgery  for  SUI  in  female  patients,  the  evidence  stated  in  the  2014 
guidelines of the EAU (EAU, 2014) should be taken into account. 

Ideally  the  increasing  literature  on  complications  (and  by  deduction,  on  successful 
outcomes for patients) will in the future support a meta-analysis of patient selection for 
avoiding poor outcomes. 

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Table 4: Evidence summary to be considered when selecting female patients with SUI for 
surgery. 

Men  can  also  develop  SUI  following  prostatic  surgery  and  have  been  treated  with 
synthetic slings. The evidence summary of the 2014 EAU guidelines (EAU, 2014) in this 
case is shown in Table 5. 

Table 5: Evidence summary to be considered when selecting male patients with SUI for 
surgery. 

A  useful  consensus  statement  published  in  the  International  Urogynaecology  Journal 
(Davila  et  al.,  2012)  relates  to  the  management  of  POP.  This  highlights  the  following 
patient  groups  for  which  caution  should  be  exercised  regarding  transvaginal  mesh 
implants: 

−  Primary prolapse cases.  

−  Patients younger than 50.  

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The safety of surgical meshes used in urogynecological surgery 

−  Lesser  grades  of  prolapse  (POP-Q  ordinal  grade  2  or  less).  Patients  with  mild  to 
moderate POP quantification; asymptomatic prolapses do not necessarily require 
surgical  management.  The  decision  to  operate  should  be  based  upon 
symptomatic problems from the prolapse defined by the patient.2 

−  Posterior compartment prolapse without significant apical descent.  

−  Patients with chronic pelvic pain.  

−  Postmenopausal patients who are unable to use vaginal oestrogen therapy since 

this will be first line therapy for extrusion.  

However, other factors may also increase the likelihood of complications associated with 
urogynaecological mesh implantation. These include: 

•  Surgeon’s lack of clinical and surgical experience (Withagen et al., 2011) 

•  Patient factors including: 

o  Lower BMI (Sirls et al., 2013) 

o 

o 

Increased BMI 

Increased age (Kokanali et al., 2014) 

o  Previous  surgical  history,  especially  previous  vaginal  surgery  for  POP  or 

SUI 

o  Comorbidities  which  are  risk  factors  for  impaired  tissue  healing,  such  as 

diabetes mellitus, smoking and steroid use 

o  Concurrent procedures including vaginal hysterectomy (Araco et al., 2009; 

Akyol et al., 2014) 

o  Grade of prolapse. 

4.2.6. Patient counselling 

The  informed  consent  process  should  be  a  wide-ranging  discussion  with  the  patient 
regarding her specific situation. This discussion should cover issues such as: 

•  The  patient  should  be  informed  that  limited  robust  data  is  available  on  the 
efficacy and safety of many of the transvaginal mesh products available for POP 
and that particularly long-term follow-up is currently not available which makes a 
balanced  estimate  of  the  risk/benefit  ratio  difficult.  There  is  considerably  more 
robust  evidence  on  the  safety  and  efficacy  of  polypropylene  mesh  use  for  SUI 
(RANZCOG, 2013; Nillsson et al., 2013). 

•  Potential  benefits  and  complications  of  prolapse  surgery  in  general  versus  the 
status  quo  or  using  conservative  treatments  (e.g.,  pelvic  floor  exercises  or 
vaginal pessary). 

•  Potential  benefits  and  complications  of  transvaginal  mesh  specifically  when 

considered appropriate (Table 1 - Table 3). 

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The safety of surgical meshes used in urogynecological surgery 

•  Alternatives  to  surgical  management,  including  non-surgical  options  such  as 
pelvic floor muscle training (Hagen et al., 2014) and vaginal support pessaries.  

•  Other alternative surgical treatments such as conventional native tissue repair, as 
well  as  abdominal  sacrocolpopexy  (open  or  laparoscopic)  in  appropriate  and 
certain anatomical and functional circumstances. Sacrocolpopexy is not a general 
alternative  for  vaginal  mesh  implantation.  It  depends  on  the  anatomic  and 
functional indications and has its own risk/benefit ratio, which in some instances 
can  be  more  serious  and  needs  to  be  discussed  in  the  shared  decision  process 
with the patient. 

•  Complications  of  transvaginal  mesh  including  mesh  exposure/extrusion,  vaginal 
scarring/stricture,  fistula  formation,  dyspareunia,  urinary  problems,  infection, 
perforation and/or pelvic pain, which may require additional intervention and may 
not be completely resolved even with mesh removal.  

•  Pain and or dyspareunia caused by prolapse surgery with or without mesh should 
be  discussed  based  on  the  available  scientific  evidence  and  not  on  authority-
based Opinions. 

•  Provision of written documentation, including device labelling when available. 

If  a  mesh  procedure  is  considered,  patients  should  be  informed  of  the  following 
additional issues (Health Canada, 2014): 

•  Through  what  route  the  mesh  will  be  placed  (abdominal,  transvaginal, 

transperineal). 

•  That a mesh is considered a permanent implant; removal of mesh or correction of 

mesh-related complications may involve subsequent surgeries. 

•  That complete removal of mesh may not be possible and additional surgeries may 

not fully correct some complications. 

•  Patients  should  be  encouraged  to  ask  their  doctor  questions  about  why  he/she 
thinks  that  mesh  implantation  is  particularly  beneficial  for  her  and  what  the 
evidence  or  level  of  experience  of  the  doctor  is  who  is  supposed  to  perform  the 
procedure,  as  well  as  what  particular  risks  are  involved  in  the  proposed 
procedure. 

4.2.7. Risk assessment and recommendations by National Associations 

In 2007 and 2009 (December), the French National Authority for Health (Haute Autorité 
de  Santé  (HAS))  published  information  for  the  public  and  health  professionals, 
concerning  the  assessment  of  meshes  used  for  the  treatment  of  SUI  or  POP,  including 
the  following:  1)  the  use  of  polypropylene  slings  for  SUI  surgery  was  approved;  2)  the 
use of polypropylene or polyester meshes for POP surgery by abdominal route was also 
approved;  only  macroporous  meshes  with  pore  size  >  10mm  and  low  grammage  of  < 
150  g/m2  should  be  used);  3)  the  use  of  polypropylene  meshes  for  POP  surgery  by 

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The safety of surgical meshes used in urogynecological surgery 

vaginal route was not recommended; (lack of conclusive data concerning side effects and 
actual efficacy compared to autologous techniques). 

In  October  2014,  the  Medicines  and  Healthcare  products  Regulatory  Agency  (MHRA), 
which  is  the  competent  authority  in  the  UK,  published  an  assessement  of  the  evidence 
on  the  benefits  and  risks  of  vaginal  mesh  implants.  This  document  states  that  the 
number  of  reports  of  serious  and  debilitating  problems  following  surgical  treatment  for 
stress  urinary  incontinence  (SUI)  or  pelvic  organ  prolapse  (POP)  using  vaginal  mesh 
implants  is  low  compared  to  the  overall  use of  these  implants.  However,  there  is  some 
evidence  of  under-reporting  to  MHRA,  which  raises  some  concern  about  the  actual 
number  of  problems.  In  its  report,  the  MHRA  concludes  that  the  overall  benefit 
outweighs  the  relatively  low  rate  of  complications  for  the  use  of  vaginal  mesh  implants 
for  SUI.  In  the  case  of  POP  treatment  using  meshes,  the  MHRA  acknowledges  that 
outcomes  are  more  varied,  reflecting  the  various  procedures  currently  used.  On  the 
whole:  “MHRA’s  current  position  is  that,  for  the  majority  of  women,  the  use  of  vaginal 
mesh implants is safe and effective. However, as with all surgery, there is an element of 
risk to the individual patient” (MHRA, 2014). 

In the USA in October 2008, the US Food and Drug Administration (FDA) issued a Public 
Health  Notification  (FDA,  2008)  regarding  vaginal  mesh,  providing  advice  for  surgeon 
training  and  informed  consent  for  patients.  Serious  complications  requiring  further 
surgery  were  described  as  “rare”.  However,  from  2008  to  2010  there  was  a  fivefold 
increase  in  adverse  event  reports  to  the  FDA  in  relation  to  the  use  of  vaginal  mesh  to 
treat  POP.  In  response  to  the  rise  in  reporting,  and  following  an  FDA  internal  review, 
including a systematic literature review, a second Safety Update was issued in July 2011 
(FDA, 2011). This update states that: 1) “serious adverse events are NOT rare, contrary 
to what was stated in the 2008 PHN”; and 2) “transvaginally-placed mesh in POP repair 
does NOT conclusively improve clinical outcomes over traditional non-mesh repair”. The 
update  made  a  distinction  between  the  risks  associated  with  abdominal  implantation  of 
surgical  mesh  for  pelvic  floor  repair  and  vaginal  implantation,  concluding  also  that: 
“There  does  appear  to  be  an  anatomic  benefit  to  anterior  repair  with  mesh 
augmentation.  This  anatomic  benefit  may  not  result  in  superior  symptomatic  outcomes 
or  lower  rates  of  repeat  surgery  for  recurrent  prolapse  compared  to  traditional  POP 
repair without mesh”.  

FDA committee consultation and further regulatory action were announced by the 2011 
publication, and since then the FDA has increased the required post-market surveillance 
of  these  devices.  Manufacturers  of  urogynaecological  mesh  devices  have  also  been 
required  to  undertake  mandatory  post-market  studies  to  provide  comparative  data 
between  mesh  kits  and  conventional  surgery.  In  April  2014,  the  FDA  issued  two 
proposals  to  address  the  risks  associated  with  surgical  mesh  for  transvaginal  repair  of 
POP.  If  finalised,  the  orders  would  reclassify  surgical  mesh  for  transvaginal  POP 
according  to  FDA’s  scheme  from  a  moderate-risk  device  (class  II)  to  a  high-risk  device 
(class III) and require manufacturers to submit a premarket approval (PMA) application 
for the agency to evaluate safety and effectiveness. 

As noted by the RANZCOG publication, the FDA conclusions have sparked further debate 
within  the  medical  and  patient  community.  In  response  to  these  publications  and 
regulatory changes, use of urogynaecological mesh in the USA has declined by 40–60% 
(Daly  et  al.,  2014).  In  addition,  a  number  of  manufacturers  have  withdrawn  their 
meshes from the USA market. 

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The safety of surgical meshes used in urogynecological surgery 

Health Canada has issued a Health Advisory on 4 February 2010 (Health Canada, 2010), 
which  was  revised  In  March  2013.  (Health  Canada,  2013,  Appendix  O)  This  advisory 
provides  a  general  statement  regarding  the  potential  risks  associated  with  the  use  of 
surgical mesh in the repair of POP/SUI. The Advisory notes the increased Canadian and 
international  reports  of  surgical  complications  associated  with  urogynaecological  mesh 
use and requests the reporting of any adverse event associated with this type of device. 

In  May  2014,  Health  Canada  released  two  health  notices  (Health  Canada,  2014).  The 
first  was  a  safety  information  update  to  hospitals  containing  recommendations  for 
surgical mesh for POP procedures and SUI procedures. These recommendations included 
statements  regarding  the  potential  for  higher  rates  of  complications  in  transvaginal 
placement of mesh compared to abdominally placed mesh or native tissue repair. Other 
recommendations  discussed  the  importance  of  surgeon  training.  A  second  information 
notice  was  released  informing  patients  of  the  potential  risk  of  complications  associated 
with  transvaginal  implantation  of  surgical  mesh  devices  for  the  treatment  of  POP  and 
SUI.  The  latest  statement  includes  the  following  comment,  “The  use  of  transvaginal 
mesh  devices  for  POP  and  SUI  repair  has  been  associated  with  reports  of  acute  or 
chronic  pain,  pain  during  sexual  intercourse,  mesh  extrusion  and  shrinkage,  infection, 
urinary  problems,  organ  or  blood  vessel  perforation,  nerve  damage,  bleeding,  vaginal 
tightness  and/or  shortening,  and  recurrent  POP  and  SUI.  Additional  surgery  may  be 
required  and  may  not  fully  correct  some  complications.  Health  Canada  is  reviewing 
labelling  related  to  these  products  to  determine  if  it  provides  appropriate  safety 
information. Additional safety information in the labelling will be requested, as needed.” 

In  Australia,  from  2008,  the  Therapeutic  Goods  Administration  (TGA)  has  been  closely 
monitoring  urogynaecological  meshes  and  has  continued  to  publish  information  for  the 
public  and  health  professionals.  A  review  of  urogynaecological  meshes  was  undertaken 
by TGA in 2010. Following this review, a detailed analysis was undertaken in 2013 of the 
available  published  literature,  the  information  supplied  with  each  device  and  associated 
training  materials  provided  by  sponsors  and  manufacturers.  The  Urogynaecological 
Devices  Working  Group  (established  under  the  Advisory  Committee  on  the  Safety  of 
Medical Devices) provided expert advice to the TGA on this review. 

As part of the review, the TGA undertook a literature search of materials published since 
2009. The overall quality of the literature was found to be poor. As a consequence, there 
was an absence of evidence to support the overall effectiveness of these surgical meshes 
as  a  class  of  products.  However,  the  literature  did  identify  the  already  known  adverse 
outcomes associated with their use. 

The  TGA  review  identified  inadequate  training/experience  for  surgeons  doing  the 
implantations  as  a  factor  in  increasing  the  risk  of  complications.  Certain  patients, 
including those who smoked or were obese, were found to be at higher risk of adverse 
events and repeated procedures. 

As a result of that review, which has raised a number of concerns, the TGA is currently 
reassessing  the  clinical  evidence  for  each  individual  mesh  implant  to  determine  if  they 
comply  with  the  Essential  Principles,  which  set  out  the  requirements  for  safety  and 
performance  necessary  for  inclusion  on  the  Australian  Register  of  Therapeutic  Goods 
(ARTG). 

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Where  individual  meshes  are  found  to  be  noncompliant,  regulatory  action,  such  as 
cancellation  or  suspension  of  particular  devices  from  the  Australian  Register  of 
Therapeutic Goods (ARTG), will be pursued. 

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5. OPINION 

5.1. Terms of reference 

5.1.1. Risks associated with the use of mesh in urogenital surgery 

Are specific meshes, in terms of designs and/or materials, considered to be of a 
higher risk? If possible list and describe the risks. (Q1) 

There are a number of different types of meshes, which include:  

•  Allografts (e.g., cadaveric fascia, dura mater) 

•  Xenografts (e.g., porcine, bovine) 

•  Autografts (e.g., fascia lata, rectus fascia) 

•  Synthetic meshes (partially absorbable or non-absorbable )  

In  this  Opinion,  the  SCENIHR  focuses  on  the  use  of  synthetic  non-absorbable  meshes. 
These are usually classified in four types (see Table 10). 

The  current  consensus  is  that  synthetic  non-absorbable  meshes  Type  2  (microporous, 
less  than  10  microns,  mono  and  multifilament)  and  Type  4  (sub-micronic  and 
monofilament) are considered not appropriate for use in this clinical context. 

Current evidence suggests:  

−  Type 1 (macroporous, monofilament) polypropylene is considered to be the most 

appropriate synthetic mesh for insertion via the vaginal route.  

−  Type  1  (macroporous,  monofilament)  and  Type  3  (microporous,  multifilament) 

are the most appropriate synthetic meshes for insertion via the abdominal route. 

Currently,  there  is  insufficient  evidence  on  the  performance,  risk  and  efficiency  of 
meshes  of  other  materials.  Clinical  experience  with  polyvinylidene  fluoride  (PVDF)  is 
mainly for hernia repair and at present does not allow any reliable conclusions for use in 
urogynecological surgery. 

In assessing the risks associated with surgical mesh insertion, it is important to consider 
the following: 

•  Overall surface area of material used (which is greater for POP than for SUI) 

•  Product  design  (e.g.  physical  characteristics  of  the  mesh,  size  of  the  pore  as  a 
predisposing  factor  to  infection,  in  particular  with  a  pore  size  of  less  than  75 
microns) 

•  Material  properties  (biocompatibility,  long-term  stability,  flexibility,  elasticity, 
aging, etc.); mesh exposure is only seen with non-absorbable synthetic mesh 

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The safety of surgical meshes used in urogynecological surgery 

•  The  physical  properties  and  durability  of  the  materials,  balanced  with  the 

unwanted consequences of implanting the material on a long-term basis.  

Are  certain  surgery  techniques  of  higher  risk?  If  possible  list  and  describe  the 
risks. (Q2) 

All synthetic meshes are associated with the risk of mesh exposure as demonstrated by 
numerous  animal  studies.  At  a  two-year  follow  up  of  women  treated  for  SUI  with 
retropubic and transobturator midurethral synthetic slings, the mesh exposure rate was 
4%  (Brubaker  et  al.,  2011).  Mesh  exposure  rates  for  vaginal  POP  surgery  with  mesh 
ranges from 4 to 19% (Milani et al., 2013). 

In  general  terms,  vaginal  surgery  is  associated  with  a  higher  risk  of  mesh-related 
morbidity than abdominal insertion of mesh. However, the abdominal route is associated 
with  specific  increased  risks  related  to  the  surgical  approach,  such  as  bowel  occlusion. 
Furthermore,  the  abdominal  route  requires  general  anaesthesia,  whereas  the  vaginal 
route is feasible also under spinal anaesthesia. 

In risk assessment of the use of mesh, it is necessary to differentiate between different 
indications such as SUI and POP.  

The  SCENIHR  acknowledges  the  efficacy  and  use  of  implanted  meshes  for  SUI  in  the 
majority of patients with moderate to severe SUI. It considers that the associated risk is 
limited,  but  recognises  the  absence  of  long-term  data.  Most  complications  associated 
with mesh insertion are related to the route of insertion. 

The  SCENIHR  acknowledges  that  vaginally  implanted  mesh  for  POP  is  associated  with 
increased  risks  compared  to  mesh  implantation  for  SUI.  Its  use  should  be  restricted  to 
patients selected according to established evidence based clinical guidelines. 

Are any combinations of the above (designs/materials and surgical techniques) 
of a higher risk? (Q3) 

Combination of the above-mentioned designs/materials and surgical techniques may be 
associated  with  higher  risk.  With  vaginal  insertion  of  non-absorbable  synthetic  mesh  a 
large  surface  area  is  associated  with  a  higher  complication  rate  compared  with 
transabdominal  insertion.  However,  there  are  generic  differences  and  potential 
complications  distinguishing  the  two  surgical  approaches,  and  this  fact  should  also  be 
taken into account in a risk assessment.  

Are  there  specific 
techniques) to the use of meshes in urogynecological surgery? (Q4) 

limitations  (e.g.  clinical,  designs/materials,  surgical 

There  are  specific  limitations  to  the  use  of  meshes  in  urogynecological  surgery.  The 
following limitations apply: 

•  The available evidence suggests that the use of xenograft and allograft materials 
are associated with a high failure rate (due to degradation of mechanical properties 
with time) but are not associated with such severe side effects as synthetic meshes.  

•  The  risk  of  severe  side  effects  (e.g.  mesh  exposure,  shrinkage,  pain)  increases 
with the surface area of synthetic non-absorbable meshes.  

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The safety of surgical meshes used in urogynecological surgery 

•  Material properties will influence the outcome (biocompatibility, tissue integration, 
long-term  stability,  and  mechanical  responses  over  time  including  flexibility, 
elasticity and resistance to deformation). 

•  Patient  characteristics,  such  as  obesity,  will  have  an  influence  on  efficacy  and 
potential complications. 

What  are  the  risks  of  surgical  interventions  using  mesh  compared  to  classic 
surgical interventions? (Q5) 

When  treating  SUI,  sling  procedures  are  associated  with  more  storage  and  voiding 
symptoms  than  other  repositioning  procedures.  The  use  of  synthetic  non-absorbable 
mesh  is  associated  with  a  risk  of  mesh  exposure.  However,  other  surgical  procedures, 
such  as  colposuspension,  are  associated  with  an  increased  risk  of  long-term 
rectocele/enterocele. 

When  treating  POP  via  the  vaginal  route,  the  use  of  synthetic  non-absorbable  mesh  is 
associated with a risk of mesh exposure and de novo prolapse of the untreated vaginal 
compartment, as well as the development of de novo SUI. The risk of mesh exposure is 
reduced  when  using  the  transabdominal  route  compared  to  the  transvaginal  route., 
However,  it  should  be  keept  in  mind  that  transabdominal  and  tranvaginal  POP  repair 
have distinct indications as discussed in current guidelines. Moreover, there are generic 
differences and different potential complications for these two surgical approaches. 

What factors could affect the outcome of the surgical interventions? (Q6) 

The factors influencing the surgical outcomes are: 

•  Material properties (biocompatibility, tissue integration, long-term stability, and 

mechanical performance over time which includes flexibility, elasticity, aging and 
resistance to deformation ) 

•  Product design (e.g. physical characteristics of the mesh, size of the pore as a 

predisposing factor to infection in particular with a pore size less than 75 microns) 

•  Overall mesh size (which is greater for POP than for SUI) 
•  Route of implantation, (e.g., vaginal or transabdominal) 
•  Patient characteristics (e.g., age, obesity, smoking) 
•  Associated procedures (e.g., hysterectomy) 
•  Surgeon’s experience  

The SCENIHR recognises the importance of following established guidelines, the need for 
adequate training and clinical experience of the surgeon as well as the need to further 
improve the design of the device, in particular for use in the pelvic floor, which appears 
to be a more demanding environment than the abdomen (where the non-degradable 
meshes have a lower complication rate). 

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5.1.2. Identification of high risk patient groups 

Are  there  patients  groups  (e.g. 
comorbidities) for which the use of meshes would carry a specific risk? (Q7) 

in  relation  to  age,  weight  or  other 

Yes. The SCENIHR acknowledges the importance of the identification of high-risk patient 
groups. Age and obesity have been shown to be associated with increased risk of mesh 
exposure. This should be investigated further.  

In the light of the above, identify risks associated with use(s) of meshes other 
than  for  urogynecological  surgery  and  advise  if  further  assessment  in  this 
field(s) is needed. (Q8) 

The SCENIHR notes there is limited information in the literature on this subject. There is 
a suggestion that morbidity may be associated with colorectal use of meshes. This needs 
to be quantified by further research before any conclusion can be made. 

5.2. Recommendations 

•  Ensure  that  patients  are  correctly  and  comprehensively  informed  relating  to  the 

performance and risks associated with synthetic non-absorbable meshes  

•  Establish European implant registries  

•  Establish  scientific  studies  to  assess  the  long-term  (at  least  5  years)  safety  and 

performance of synthetic non-absorbable meshes  

•  Support  further  research  into  novel  new  materials,  in  particular  absorbable 

meshes  

•  Support 

further  research 

into  the  application  of  regenerative  medicine 

technology, such as the cellular seeding of graft materials 

•  Adopt evidence based Pan-European Guidelines  

•  Develop  training  programs  for  surgeons  in  association  with  European  medical 

associations 

66 

 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

6. MINORITY OPINION 

None. 

67 

 
 
The safety of surgical meshes used in urogynecological surgery 

7. CONSIDERATION OF THE RESPONSES RECEIVED DURING THE 
CONSULTATION PROCESS 

A  public  consultation  on  this  Opinion  was  opened  on  the  website  of  the  Scientific 
Committees from 12 June to 19 July 2015. Information about the public consultation was 
broadly  communicated  to  national  authorities,  international  organisations  and  other 
stakeholders. 

52  organisations  and  individuals  (providing  in  total  178  comments)  participated  in  the 
public consultation providing input to different chapters and subchapters of the Opinion. 
Among  the  organisations  participating  in  the  consultation,  there  were  universities, 
professional associations, institutes of public health, industry representatives and NGOs.  

Comments  received  during  this  time  have  been  considered  carefully  by  the  SCENIHR. 
Where appropriate, the text of the relevant sections of the opinion has been modified or 
explanations have been added to take account of relevant comments. The literature has 
been  accordingly  updated  with  relevant  publications.  The  scientific  rationale  and  the 
opinion section were clarified and strengthened. In the cases where the SCENIHR, after 
consideration and discussion of the comments, has decided to maintain its initial views, 
the  opinion  (or  the  section  concerned)  has  remained  unchanged.  The  text  of  the 
comments received and the response provided by the SCENIHR is available at: 
http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/sce
nihr_consultation_27_en.htm  

68 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

8. ABBREVIATIONS AND GLOSSARY OF TERMS 

Amid Classification: The classification of materials used for Hernia repair based on their 
pore  size,  as  reported  in:  Amid  PK.  Classification  of  biomaterials  and  their  related 
complications in abdominal wall hernia surgery. Hernia. 1997. 1:15-21 

BOO: bladder outlet obstruction 

EAU: European association of urology 

ICS: international continence society 

MUS: mid-urethral slings 

OAB: overactive bladder 

POP: pelvic organ prolapse 

ppd: pads per day 

RCT: randomised controlled trial 

RP: retropubic 

SIMS: single-incision mini-sling 

SIS: single-incision sling 

SMUS: standard mid-urethral sling 

SUI: stress urinary incontinence 

TO: transobturator 

TOT: transobturator tape 

TVT: tension-free vaginal tape 

69 

 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

9. APPENDIX 

Table 6: Studies on host response to autologous fascia. 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

Autologous rectus fascia 
implanted in 5 patients 
suffering from SUI. Samples 
obtained, respectively, from 
transvaginal revision after 3, 5, 
8 and 17 weeks and from 
replacement after 4 years.  

(Fitzgerald et 
al., 2000) 

(Jeong et al., 
2000) 

Autologous lata fascia 
implanted in 16 rabbits 
randomised into 4 survival 
groups and examined after 1, 
2, 4 and 8 weeks. Implantation 
into upper eyelids.  

(Choe et al., 
2001) 

Dermis, rectus fascia and 
vaginal mucosa harvested from 
20 women undergoing vagina 
prolapse surgery. 

Tensiometric analysis of 
full strips vs. patch 
suture slings. 
Displacement and 
maximum load 
calculated. 

(Kim et al., 
2001) 

Autologous rectus fascia 
implanted in 20 rats 
randomised into 2 survival 
groups (2 and 4 months). 

No significant decrease 
of the fracture toughness 
calculated by the trouser 
tear test over 4 months. 

No significant decrease 
of biomechanical 
properties after 12 
weeks implantation. 

No significant decrease 
of biomechanical 
properties after 12 
weeks implantation. 

(Dora et al., 
2004) 

(Hilger et al., 
2006) 

(Krambeck et 
al., 2006) 

Autologous rectus fascia 
implanted in 15 rabbits 
randomised into 3 survival 
groups (2, 6 and 12 weeks). 
Implantation on the anterior 
rectus fascia.  

Autologous rectus fascia 
implanted in 20 rabbits 
randomised into 2 survival 
groups (6 and 12 weeks). Half 
implanted on the rectus fascia 
and half on the posterior vagina 
fascia. 

Autologous rectus fascia 
implanted subcutaneously on 
the anterior rectus fascia of 10 
rabbits randomised into 2 
survival groups (6 and 12 
weeks).  

70 

- Moderate and uniform infiltration of 
host fibroblasts and 
neovascularisation after 5 and 8 
weeks implantation. 

- After 4 years implantation, no 
evidence of inflammatory cell infiltrate 
or foreign body reaction and collagen 
remodelling by connective tissue 
organised longitudinally. 

- Low inflammatory cell infiltration. 

- Fibroblast infiltration and collagen 
remodelling. 

- 50% decrease in surface area. 

- Collagen remodeling by moderate 
collagen infiltration but encapsulation 
as well.  

- Minimal inflammatory response. 

- Minimal neovascularisation. 

- Moderate fibrosis.  

- High degree of scar.  

- High degree of inflammatory 
infiltrate. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

(Maia de 
Almeida et 
al., 2007) 

Adult female rats incontinence 
model. Marlex, autologous 
sling, SIS, polypropylene mesh 
and Sham at 30 and 60 days. 

Autologous fascia grafts 
explanted after sling revision 
from 5 women, due to different 
complications, between 2-65 
months after implantation. 

(Woodruff et 
al., 2008) 

(Pinna et al., 
2011) 

Autologous fascia lata 
implanted in 14 rabbits 
randomised into 2 survival 
groups (30 and 60 days). 
Implantation into the right 
voice muscle. 

-  Reduced inflammatory response and 
collagen production around 
autologous grafts, in comparison 
with synthetic materials and 
xenografts.  

- Moderate and uniform infiltration of 
host fibroblasts and little 
neovascularisation. 

- Collagen remodeling by new 
collagen fibres organised 
longitudinally. 

- No evidence of encapsulation or 
gross infection. 

- No significant inflammatory 
reaction. 

- No significant fibrosis or scarring.  

Table 7: Studies on host response to allografts. 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

- Both materials extensively invaded 
by host fibroblasts. 

- Both materials present new 
collagen in-growth. 

(Sclafani et 
al., 2000) 

Human cadaveric dermis 
(AlloDerm®) disk implanted 
subdermally behind a patient’s ear. 
Micronised human cadaveric 
dermis (AlloDerm®) injected 
intradermally and subdermally in 2 
different locations behind a 
patient’s ear. Both implants 
examined 3 and 1 month after 
implantation, respectively.  

(Kim et al., 
2001) 

Human cadaveric fascia implanted 
in 20 rats randomised into 2 
survival groups (2 and 4 months). 

No significant decrease of 
the fracture toughness 
calculated by the trouser 
tear test. 

(Walter et al., 
2003) 

Freeze-dried and gamma-
irradiated human cadaveric lata 
fascia implanted in 18 rabbits and 
excised 12 weeks after 
implantation.  

Significant decrease of 
biomechanical properties 
after 12 weeks 
implantation. 

(Spiess et al., 
2004) 

Human cadaveric fascia lata 
implanted subcutaneously on the 
abdominal wall of 20 rats 
randomised into 2 survival groups 
(6 and 12 weeks). 

No significant decrease of 
tensile strength with time. 

71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

(Yildirim et al., 
2005) 

Human cadaveric lata fascia 
implanted in 20 rabbits 
randomised into 4 survival groups 
(2, 7, 15 and 30 days). 
Implantation subcutaneously on 
the abdominal wall.  

(Krambeck et 
al., 2006) 

Cadaveric fascia lata implanted 
subcutaneously on the anterior 
rectus fascia of 10 rabbits 
randomised into 2 survival groups 
(6 and 12 weeks).  

Human cadaveric dermis and lata 
fascia implanted in 20 rabbits 
randomised into 2 survival groups 
(6 and 12 weeks). Half implanted 
on the rectus fascia and half on 
the posterior vagina fascia. 

Very significant decrease 
of biomechanical 
properties after 12 weeks 
implantation. 

(Hilger et al., 
2006) 

- Acute inflammation by high cell 
infiltration predominantly of 
polymorphous granulocytes.  

- Integration in host tissue by 
moderate fibrotic process and 
muscle infiltration on day 30, with 
persistent inflammatory response. 

- Moderate to high focal fibrosis.  

- Minimal to moderate degree of 
scar.  

- High degree of inflammatory 
infiltrate. 

- 2 missing or fragmented materials 
implanted on the vagina after 12 
weeks. 

- Moderate inflammatory response. 

- Minimal neovascularisation.  

- Minimal collagen ingrowth without 
significant cell infiltration.  

- Moderate levels of encapsulation. 

- High levels of degradation. 

- Peripheries of the grafts invaded by 
fibroblasts but central portions 
remained acellular.  

- Thin fibrous capsule formation. 

- Moderate cell infiltration and 
angiogenesis. 

(Woodruff et 
al., 2008) 

Human cadaveric dermis slings 
explanted after revision from 2 
women, due to different 
complications, between 2-65 
months after implantation. 

Human cadaveric dermis and 
fascia lata implanted in 16 rats, 
respectively and both randomised 
into 4 survival groups (2, 4, 8, 12 
weeks). Implantation around the 
bladder neck, anchored to the 
surrounding tissues.  

Human cadaveric dermis 
(AlloDerm®) implanted in 18 rats 
randomised into 2 survival groups 
(30 and 60 days). Implantation 
subcutaneously on abdominis 
rectus muscle defect. 

(VandeVord et 
al., 2010) 

(Rice et al., 
2010) 

(Kolb et al., 
2012) 

Human cadaveric dermis 
(AlloDerm®) implanted 
subcutaneously in 5 pigs 
randomised into 4 survival groups 
(7, 21, 90 and 180 days). 

Increase of tensile strength 
after 30 days and, again, 
increase of tensile strength 
after 60 days respectively 
to 30 days. 

-  Moderate amounts of collagen 
deposition well organised. 

- Abundant revascularisation. 

- Robust inflammatory response 
after 7 days implantation, which 
achieved maximal level at 21 days, 
with formation of granulomas and 
areas of necrosis noted within the 
graft.  

- Moderate fibroblast infiltration, 
collagen in-growth and 

72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

neovascularisation. 

- Moderate levels of encapsulation.  

Table 8: Studies on host response to xenografts. 

Author 

Sample 

Biomechanical Properties 

Host Response 

Abdominal wall defect 
repaired with SIS in 40 dogs 
randomised into 8 survival 
groups (1, 4, 7 and 10 days; 
and 1, 3, 6 and 24 months). 

(Badylak et 
al., 2001) 

Strength was decreased 
from day 1 to day 10 after 
implantation, followed by a 
progressive increased, until 
double of the original 
strength 24 months after 
implantation.  

- Rapid degradation with subsequent host 
remodeling. 

Abdominal wall defect 
repaired with SIS in 10 dogs 
and 30 rats, both, randomised 
into 4 survival groups (1 
week, 1 month, 3 months, 6 
months and 2 years). 

(Badylak  et 
al., 2002) 

SIS removed from a 42-years-
old female patient 4 months 
after pubovaginal implantation 
of the sling due to severe 
obstruction. 

(Cole et al., 
2003) 

- No shrinkage or expansion of the graft 
site over the 2-year period of the study. 

- 1 week after implantation, abundant 
levels of poly-morphonuclear leukocytes 
diminished to negligible after 1 month.  

- Moderate neovascularisation. 

- By 3 months, graft material was not 
recognisable and was replaced by 
moderately well-organized host tissues 
including collagenous connective tissue, 
adipose tissue and skeletal muscle. 

- Completely intact acellular sling. 

- Well defined fibrous capsule.  

- Chronic inflammatory response. 

(Zhang et 
al., 2003) 

SIS implanted in the 
abdominal wall of rats for up 
to 2 months. 

SIS together with the 
abdominal wall have 
increased strength. 

Levels of Interleukin 2 and 6 were high 
straight after the operation but they 
become normal after 2 months. 

Biopsies taken from the 
implantation site of the SIS 
band under the vaginal 
mucosa from 3 patients 
during re-operation, at a 
mean of 12.7 months, after 
pubourethral sling procedures 
due to recurrent urinary stress 
incontinence.  

(Wiedemann 
and Otto, 
2004) 

Abdominal wall defect 
repaired with SIS in 24 Wistar 
rats randomised into 4 
survival groups (7, 14, 30 and 
90 days). 

(Konstantin
ovic et al., 
2005) 

- Focal residues of SIS implant. 

- No evidence of a specific tissue reaction 
that might point to a foreign body 
reaction. 

- No evidence of any significant 
immunological reaction and in particular 
no evidence of any chronic inflammatory 
reaction.  

Significant increase of 
biomechanical properties 
after 90 days implantation. 

- Moderate acute inflammatory response 
at day 7, decreased to minimal after 90 
days. 

- Moderate neovascularisation. 

73 

 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical Properties 

Host Response 

SIS and cross-linked porcine 
dermis (Permacol®) 
implanted subcutaneously on 
the anterior rectus fascia of 
18 rats each randomised into 
5 survival groups (1, 2, 4, 10 
and 20 weeks). 

(Macleod et 
al., 2005) 

- Abundant collagen deposition well 
organised after 90 days. 

For both grafts: 

-No evidence of acute inflammatory 
response. 

- From moderate chronic inflammation 
after 1 week implantation to minimal 
after 20 weeks. 

- No evidence of eosinophilic infiltration 
and stromal fibroblastic reaction over the 
entire implantation. 

- Moderate fibrosis and vascularity 
around the grafts after 1 week 
implantation to minimal after 20 weeks. 

(Poulose et 
al., 2005) 

12 female pigs were implanted 
with SIS intraperitoneally for 
up to 6 weeks. 

- Cell infiltration 

- Vascularisation 

(Thiel et al., 
2005) 

(Krambeck 
et al., 2006) 

(Ko et al., 
2006) 

(Hilger et 
al., 2006) 

SIS implanted subcutaneously 
on the abdominal wall of 30 
rats randomised into 3 
survival groups (7, 30 and 90 
days). 

SIS and porcine dermis 
implanted subcutaneously on 
the anterior rectus fascia of 
10 rabbits randomised into 2 
survival groups (6 and 12 
weeks).  

Abdominal wall defect 
repaired with 8-layer SIS in 
20 domestic pigs randomised 
into 2 survival groups (1 and 
4 months). 

Porcine dermis implanted in 
20 rabbits randomised into 2 
survival groups (6 and 12 
weeks). Half implanted on the 
rectus fascia and half on the 
posterior vagina fascia. 

- Collagen deposition and remodelling 

- Moderate inflammatory reaction 
increased to severe after 90 days. 

- 86% of the graft replaced by new 
collagen fibres. 

- Porcine dermis presented moderate 
fibrosis which was minimal for SIS. 

- Minimal degree of scar for both grafts 
and high degree of inflammatory 
infiltrate. 

No significant changes of 
biomechanical properties 
after 4 months implantation. 

- Dense fibrous connective tissue 
ingrowth. 

- Minimal to mild mononuclear 
inflammatory cell infiltrate throughout the 
connective tissue. 

Very significant decrease of 
biomechanical properties 
after 12 weeks implantation. 

- 2 missing or fragmented materials 12 
weeks after being implanted on the 
vagina. 

- Moderate to strong inflammatory 
response. 

- Minimal collagen ingrowth without 
significant cell infiltration. 

- Minimal neovascularisation. 

- Prominent infiltration and ingrowth of 
host cells. 

SIS implanted in the 
subcutaneous dorsum of 3 

(Kim et al., 

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical Properties 

Host Response 

2007) 

rats sacrificed after 2 weeks.  

(Rauth et 
al., 2007) 

SIS implanted on the 
peritoneal surface of the 
abdominal wall of 6 pigs 
sacrificed 8 weeks after 
implantation. 

(Woodruff et 
al., 2008) 

Porcine dermis slings 
explanted after revision from 
4 women, due to different 
complications, between 2-65 
months after implantation. 

Abdominal wall defect 
repaired with SIS and cross-
linked porcine dermis 
(Permacol®) in 33 primates 
randomised into 3 survival 
groups (1, 3 and 6 months).  

(Sandor et 
al., 2008) 

(Pierce et 
al., 2009b) 

Cross-linked porcine dermis 
implanted on the abdominal 
wall and posterior vagina of 
18 rabbits sacrificed 9 months 
after implantation.  

11 grafts remained intact 
without significant changes 
of biomechanical properties 
compared to the baseline 
values. They just were 
thicker and tolerated less 
elongation at failure. 7 
grafts were partially 
degraded but thicker again 
and with significant 
decrease of all 
biomechanical properties.  

(VandeVord 
et al., 2010) 

SIS and porcine dermis 
implanted in 16 rats, 
respectively and both 
randomised into 4 survival 
groups (2, 4, 8, 12 weeks). 
Implantation around the 
bladder neck, anchored to the 
surrounding tissues.  

75 

- Few macrophages infiltrated or 
accumulated around the grafts.  

- 80% of contraction from original 
surface area. 

- Moderate neovascularisation. 

- Densely populated by host cells with 
moderate amounts of new disorganised 
collagen deposition.  

- Severe encapsulation. 

- No degradation. 

- No fibroblast infiltration or 
neovascularisation.  

- Considerable contraction after 1 month 
for both materials, but no significant 
change over the next 5 months. 

- Better integration of both materials at 
late stage by scar formation. 

- Inflammatory cell infiltration 3 months 
after implantation for SIS and formation 
of few blood vessels.  

- Acellular porcine dermis over the entire 
course of implantation with substantial 
inflammation surrounding their 
perimeter.  

- Partial resorption for both materials 
after 6 months.  

- Host connective tissue incorporation 
between fibres. 

- Intense foreign body reaction in 
degraded grafts which may be expedited 
in vaginal environment. 

- Thin fibrous capsule formation. 

- Moderate cell infiltration and 
angiogenesis for SIS and minimal for 
porcine dermis. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical Properties 

Host Response 

(Rice et al., 
2010) 

Abdominal wall defect repair 
with SIS (Surgisis®) in 18 
rats randomised into 2 
survival groups (30 and 60 
days).  

Increase of tensile strength 
after 30 days and, again, 
increase of tensile strength 
after 60 days respectively to 
30 days. 

13 patients underwent 
secondary sacrocolpopexy 
because of failure or vaginal 
revision because of a graft 
related complication after the 
initial sacrocolpopexy with 
porcine dermal collagen 
(Pelvicol®) (9) or SIS 
(Surgisis®) (4). 

(Deprest et 
al., 2010) 

Abdominal wall defect 
repaired with SIS and 
acellular porcine dermal 
matrix in 50 Sprague Dawley 
rats randomised into 5 
survival groups (1, 2, 4, 8 and 
12 weeks).  

After initial decrease of 
biomechanical properties at 
week 2, these were 
increased over the next 10 
weeks reaching similar 
values from week 1. 

(Liu et al., 
2011) 

- Moderate amounts of collagen 
deposition well organised. 

- Abundant revascularisation. 

- Pelvicol presented high degradation 
rates associated with no body foreign 
reaction. 

- Pelvicol remnants were integrated into 
collagen rich connective tissue with 
limited neovascularisation (scar host 
tissue). 

- No significant body foreign reaction to 
Surgisis grafts. 

- Surgisis no longer recognisable replaced 
by irregularly organised connective tissue 
and fat tissue.  

- Pronounced inflammatory response 1 to 
4 weeks after implantation for SIS 
compared with porcine dermal, but fell to 
similar negligible values for both after 12 
weeks. 

- Large neovascularisation and collagen 
deposition, which was higher for SIS 
group. 

- SIS implants degraded more quickly 
and were almost totally replaced by 
organised collagenous tissues.  

- Contraction at first weeks leading to 
significant lower surface area in both 
materials.  

Abdominal wall defect 
repaired with porcine dermal 
matrix in 24 Yucatan mini pigs 
randomised into 2 survival 
groups (1 and 6 months).  

Significantly greater 
incorporation strengths after 

- Moderate cell infiltration. 

6 months compared with 1 
month. 

- Moderate extracellular matrix 
deposition. 

- Moderate neovascularisation. 

(Jenkins et 
al., 2011) 

(Kolb et al., 
2012) 

Cross-linked porcine dermis 
(Permacol®) implanted 
subcutaneously in 5 pigs 
randomised into 4 survival 
groups (7, 21, 90 and 180 
days). 

76 

- Partial degradation and from widely to 
mild fibrous encapsulation. 

- Mild inflammatory response decreased 
to minimal from day 7 to day 180 after 
implantation.  

- None to minimal neovascularisation 
after 180 days.  

- Small amount of residual SIS remained 
were surrounded by mild to moderate 
chronic inflammation. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical Properties 

Host Response 

Abdominal wall defect 
repaired with porcine dermis 
in rats randomised into 3 
survival groups (1, 3 and 35 
days). 

(Daly et al., 
2012) 

- Moderate levels of encapsulation. 

- Cell infiltrate into entire grafts by day 
35.  

- Degradation of the scaffold most 
pronounced at the periphery with fibrous 
tissue, angiogenesis and foreign body 
giant cells noted. 

- Grafts surrounded by a dense and 
circumferentially organised connective 
tissue. 

- Mononuclear cells decreased in number 
compared with earlier time points. 

Table 9: Studies on host response to polypropylene meshes. 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

(Falconer et al., 
2001) 

(Klinge et al., 
2002) 

(Wang et al., 
2004) 

16 women were implanted 
with TVT for up to 2 years: 
6 with Mersilene and 10 with 
Prolene. 

heavy weight monofilament 
with small pore size (HWM) 
and low weight with large 
pore size multifilament 
(LWM) on the posterior 
abdominal wall of rats for 7, 
14, 21 and 90 days. 

17 women with sling 
extrusion  and 7 women 
with voiding difficulties 
implanted with TVT and 
SPARC. 

(Rabah et al., 
2004) 

Implantation of Surgipro 
and Cadaveric fascia lata in 
rabbit’s bladder neck for 6 
and 12 weeks.  

(Spiess et al., 
2004) 

TVT and Cadaveric fascia 
lata implanted in rats 
abdominal wall for 6 and 12 
weeks. 

TVT has the greater break 
load and the maximum 
average load compared to 
Cadaveric Fascia Lata. 

(Zheng et al., 
2004) 

Prolene and Pelvicol 
implanted in full thikness 
abdominal wall defects in 
rats for 7, 14, 30 and 90 
days. 

77 

Mersilene induces higher inflammatory 
response than Prolene. Mersilene is easier 
to extract than Prolene.  

HWM: intense inflammation, embedded in 
connective tissue. LWM: less pronounced 
inflammatory response and fibrotic 
capsule, collagen distributed within the 
mesh 

Pronounced fibrosis around the fibres – 
extrusion  and voiding difficulty as a result 

Cadaveric fascia lata group: the implant 
was incorporated in a plate of fibrous 
tissue. 

Polypropylene mesh: inflammation 
localised on the graft. 

Prolene prosthesis show the presence of 
leukocytes in the activated state. 

 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

(Konstantinovic 
et al., 2005) 

(Yildirim et al., 
2005) 

(Thiel et al., 
2005) 

Marlex and non-cross-linked 
Surgisis implanted on the 
anterior abdominal wall of 
rats for 7, 14, 30 and 90 
days. 

Gynecare TVT, SPARC™, 
polypropylene mesh and IVS 
implanted in contact with 
the rats rectus muscle for 
up to 30 days. 

Monofilament Polypropylene 
mesh, silicone mesh, SIS 
and PLA were implanted 
subcutaneously on the 
abdomen of rats for 7, 30 
and 90 days. 

(Bogusiewicz et 
al., 2006) 

Monofilament TVT and 
multifilament IVS were 
implanted in rats rectus 
fascia for 42 days. 

(Boulanger et al., 
2006) 

Vicryl, Vypro, Prolene, 
Prolene Soft and Mersuture 
were implanted in pgs 
peritoneum for 10 weeks. 

(Krambeck et al., 
2006) 

SPARC mesh,human 
cadaveric fascia, porcine 
dermis, SIS and autologous 
fascia were implanted in 
rabbits rectus fascia for 12 
weeks. 

(Boukerrou et al., 
2007) 

Pre-peritoneal implantation 
of Vicryl, Vypro, Prolene, 
Prolene Soft and Mersuture 
mesh for 2 months in pigs. 

(Spelzini et al., 
2007) 

Polypropylene type I mesh 
and Macroporous silk 
construct were implanted in 
rat fascial defects for 7, 14, 
30 and 90 days. 

Marlex: more pronounced inflammatory 
reaction and vascularisation throughout the 
graft that Surgisis 

Surgisis: milder inflammatory reaction. 

Inflammation and fibrosis are decreased in 
large pore meshes. 

Polypropylene induces the mildest 
inflammatory response among the 
samples. 

They induce production of similar amount 
of collagen 

Differences in the arrangement of collagen 
and inflammation intensity 

Vicryl: low level of inflammation and 
completely absorbed. 

Vypro: intense inflammation and strong 
fibrotic response. 

Prolene and Prolene Soft: well integrated, 
weak inflammatory response. 

Mersuture: no good integration. 

Polypropylene mesh has the greatest scar 
formation. 

Polypropylene has the mildest 
inflammatory response. 

Polypropylene meshes induce a moderate 
inflammatory response and not 
architectural degradation. 

Non-absorbable, 
monofilamentous, 
macroporous materials 
(type I) seem more 
resistant, retract less and 
has the best tolerance. 

(Zorn et al., 
2007) 

Rat abdominal wall was 
implanted with SPARC™, 
TVT and SIS for 6 weeks, 9, 

TVT has tensile properties 
similar to SPARC and 
They are superior to 

78 

 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

Host Response 

6, 9 and 12 months. 

Stratasis. 

(Bazi et al., 
2007) 

Rats rectus fascia was 
implanted with Advantage, 
IVS, SPARC and TVT for up 
to 24 weeks. 

They all show similar 
mechanical properties 
after removal. 

They induce different host responses due 
to different porosity. 

(de Tayrac et al., 
2007) 

(Huffaker et al., 
2008) 

(Woodruff et al., 
2008) 

Ewes vaginas were 
implanted with a non-coated 
LW polypropylene mesh 
(Soft Prolene) and a coated 
one (Ugytex) from 1 to 12 
weeks.  

Rabbits vaginas were 
implanted with Pelvitex 
(Collagen-coated) and 
Gynemesh (uncoated 
Polypropylene meshes) for 
up to 12 weeks. 

24 grafts were explanted in 
women undergoing sling 
revision after 2-34 months. 
Grafts were Polypropylene 
meshes, autologous fascia, 
porcine dermis and 
cadaveric dermis. 

(Elmer et al., 
2009) 

PROLIFT® was implanted in 
humans for 1 year. 

(Pierce et al., 
2009b) 

(Melman et al., 
2011) 

(Pascual et al., 
2012) 

(Manodoro et al., 
2013) 

Polypropylene mesh vs. 
Cross-linked porcine dermis 
implanted in rabbits vagina 
and abdomen for 9 months. 

Bard® mesh (HWPP), 
Ultrapro® (LWPP), GORE® 
Infinit mesh (ePTFE) in an 
mini-pigs hernia repair for 1, 
3 and 5 months. 

Surgipro, Optilene, GORE® 
Infinit mesh (ePTFE) were 
implanted in rabbits 
abdominal wall defect for 14 
days. 

Gynemesh in two sizes 
(50x50 mm and 35x35 mm) 
implanted in 20 adult ewes 
for 60 and 90 days, both on 
the abdominal and vaginal 
walls. 

Similar inflammatory response between 
the two materials. 

Both materials induce a mild foreign body 
reaction with minimal fibrosis. 

No evidences of degradation or 
encapsulation, abundant host infiltration. 
Neovascularisation was visible. 

Increase in macrophages and mast cells 
count. 

Mild but persistent foreign body response. 

Polypropylene caused milder inflammatory 
reaction, more long-term, good host tissue 
incorporation. 

Their maximum tensile 
strength decreases for all 
of them. 

Inflammation decreases with time. 

Cell infiltration increases with time. 

LWPP implants might be 
improved by the newly 
formed tissue around it.  

PTFE induces an increased macrophage 
response when compared to 
polypropylene. Increase collagen 
deposition in high porosity meshes. 

30% of the 50x50 meshes caused vaginal 
extrusion  and exposure. 

60% of the 35x35 meshes had reduced 
surface (i.e. contracting after 90 days. 

Implants were contracting 
more when implanted on 
the vaginal wall, 
compared to abdominal 
wall. 

Grafts implanted on the 
vaginal wall are stiffer 
than the ones implanted 

79 

 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Author 

Sample 

Biomechanical 
Properties 

on the abdominal wall, 
after retrieval. 

Host Response 

HWPP – heavy weight polypropylene  

LWPP – lightweight polypropylene (also called soft) / ePTFE – expanded polytetrafluoroethylene /  

PLGA – poly lactide-co-glycolide acid / PLA – poly lactide acid / PGA – poly glycolide acid 

Table 10: Classification of synthetic materials used in pelvic floor reconstruction. 

Type 

Mesh Pore size 

Structure 

Polymer 

Trade name 

Company 

I 

Macroporous 

> 75 µm 

Monofilament 

Polypropylene 

Uretex® 

CR Bard 

Gynecare TVT 

Ethicon, 
Johnson&Johnson 

Bard® Mesh 

Bard/Davol 

SPARCTM 

In-FastTM 

MonarcTM 

American 
Systems 

American 
Systems 

American 
Systems 

Medical 

Medical 

Medical 

Lynx® 

Boston Scientific 

Advantage® 

Boston Scientific 

obtryx® 

Boston Scientific 

Optilene® 

B. Braun 

ArisTM 

Mentor Corp 

PerigeeTM 

American 
Systems 

Medical 

Parietene 

Covidien 

Intepro® 

American 
Systems 

Medical 

Gynecare 
Prolift® 

Ethicon, 
Johnson&Johnson 

SurgiproTM 

Covidien 

Prolene® 

Ethicon, 

80 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

Type 

Mesh Pore size 

Structure 

Polymer 

Trade name 

Company 

Johnson&Johnson 

Prolene® Soft 

Ethicon, 
Johnson&Johnson 

Gynemesh PS 

Ethicon, 
Johnson&Johnson 

Atrium 

Atrium Medical 

Marlex® 

CR Bard 

Multifilament 

of 
Copolymer 
glycolide 
(90%) 
and lactide (10%) 

Vicryl® 

Ethicon, 
Johnson&Johnson 

Vypro® 

Ethicon, 
Johnson&Johnson 

Polypropylene  and 
Polyglecaprone 

UltraPro® 

Ethicon, 
Johnson&Johnson 

Poly Glycolic Acid 

Dexon® 

Davis and Geck 

Multifilament 

Expanded PTFF 

GoreTex® 

W.L Gore 

Poly 
Terephtalate 

Ethylene 

Mersuture 

Ethicon, 
Johnson&Johnson 

Multifilament 

PTFE 

Teflon® 

C.R. Bard 

Poly 
Terephtalate 

Ethylene 

Mersilene® 

Ethicon, 
Johnson&Johnson 

Polypropylene 

IVS TunnellerTM  Tyco Healthcare 

Woven polyester 

Protegen 

Boston Scientific 

II 

III 

Macroporous 

< 10 µm 

Macroporous 
with microporous 
components 

< 10 µm 

IV 

Nanoporous 

< 1 µm 

Multifilament 

Silicon-Coated 
Polyester 

Intemesh® 

American 
Systems 

Medical 

Dura 
substitute 

Mater 

PRECLUDE® 
MVP® 
substitute 

Dura 

W.L. Gore 

PTFE, 

Expanded 
pericardial 
membrane 
substitute 

PRECLUDE® 
Pericardial 
Membrane 

W.L. Gore 

81 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The safety of surgical meshes used in urogynecological surgery 

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