Scientific advice on evaluation of the availability of new scientific information on the safety of PIP breast implants.
Date: 2018-03-28
Institutions: Directorate-General for Health and Food Safety
Subjects: health policy, health risk, medical device, product safety, toxicology

Scientific Committee on Health Environmental and Emerging Risks 

SCHEER 

SCIENTIFIC ADVICE ON 

Evaluation of the availability of new scientific information 
on the safety of PIP breast implants 

The SCHEER adopted this final Scientific Advice 
 on 28 September 2017 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Final Advice 
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ABSTRACT 

Following  a  request  from  the  European  Commission,  the  Scientific  Committee  on  Health, 
Environmental  and  Emerging  Risks  (SCHEER)  hereby  provides  an  inventory  of  new 
information available on the safety of Poly Implant Prothèse (PIP) silicone breast implants to 
evaluate whether an update  of  the  2014  SCENIHR  Opinion  on  the  safety  of  the  PIP  breast 
implants (2014 Opinion) is warranted. 

In  addition  to  conducting  a  literature  review,  a  public  call  for  scientific  information  was 
launched.  The  literature  review  showed  that  new  information  is  available  regarding  the 
possible health effects of PIP breast implants, but this information is rather limited. Also, the 
public  call  for  information  did  not  result  in  the  submission  of  scientific  papers  regarding 
health effects specific to PIP implants, but rather on breast implants in general. Therefore, 
on  the  basis  of  the  new  scientific  information  gathered,  the  SCHEER  concludes  that  an 
update of the 2014 Opinion is not warranted. 

New scientific information was found relating to the early and increased PIP implant rupture 
risk, which suggested that the risk was probably due to the low quality of the implant’s shell 
as  already  reported  in  2014  Opinion.  Based  on  new  data,  the  rupture  rate  of  PIP  silicone 
breast  implants  was  calculated  to  about  23%,  which  is  similar  to  the  25%  -  30%  rupture 
rate indicated in the 2014 Opinion. 

Keywords: PIP breast implants, implant failure, safety evaluation, toxicity, silicone, risk 
assessment 

Scientific Advice to be cited as: 

SCHEER  (Scientific  Committee  on  Health,  Environmental  and  Emerging  Risks), 
Evaluation  of  new  scientific  information  on  the  safety  of  PIP  breast  implants,  28 
September  2017. 

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About the Scientific Committees 

Two 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 new 
or emerging problems that may pose an actual or potential threat.  

These  committees  are  the  Scientific  Committee  on  Consumer  Safety  (SCCS)  and  the 
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The Scientific 
Committees  review  and  evaluate  relevant  scientific  data  and  assess  potential  risks.  Each 
Committee  has  top  independent  scientists  from  all  over  the  world  who  are  committed  to 
working in the public interest.  
In  addition,  the  Commission  relies  upon  the  work  of  other  Union  bodies,  such  as  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). 

SCHEER 

This  Committee,  on  request  of  Commission  services,  provides  Opinions  on  questions 
concerning health,  environmental and  emerging  risks.  The  Committee  addresses  questions 
on:  

- health and environmental risks related to pollutants in the environmental media and other 
biological and physical factors in relation to air quality, water, waste and soils.  
-  complex  or  multidisciplinary  issues  requiring  a  comprehensive  assessment  of  risks  to 
consumer  safety  or  public  health,  for  example  antimicrobial  resistance,  nanotechnologies, 
medical devices and physical hazards such as noise and electromagnetic fields.  

Scientific Committee members 

Roberto  Bertollini,  Teresa  Borges,  Wim  de  Jong,  Pim  de  Voogt,  Raquel  Duarte-Davidson, 
Peter Hoet, Rodica Mariana Ion, Renate Krätke, Demosthenes Panagiotakos, Ana Proykova, 
Theo  Samaras,  Marian  Scott,  Remy  Slama,  Emanuela  Testai,  Theo  Vermeire,  Marco  Vighi, 
Sergej Zacharov 

Contact: 
European Commission 
DG Health and Food Safety 
Directorate C: Public Health, Country Knowledge, Crisis management 
Unit C2 – Country Knowledge and Scientific Committees  
Office: HTC 03/073    L-2920 Luxembourg 
SANTE-C2-SCHEER@ec.europa.eu 

© European Union, 2017 

ISSN 2467-4559 
doi:10.2875/058745 

ISBN 978-92-79-80129-7 
EW-CA-18-002-EN-N 

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. 

http://ec.europa.eu/health/scientific_committees/policy/index_en.htm 

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ACKNOWLEDGMENTS 

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

The SCHEER members: 

Wim de Jong 
Demosthenes Panagiotakos 
Theodoros Samaras 

All  CVs  and  Declarations  of  SCHEER  members  are  available  at  the  following  webpage:  
http://ec.europa.eu/health/scientific_committees/scheer/members_committee_en 

This Scientific Advice has been subject to a commenting period of ten weeks after its initial 
publication  (from  7  April  until  15  June  2017).  Comments  received  during  this  time  were 
considered by the SCHEER.  

The comments received were considered to be outside the scope of this advice as they were 
providing additional information on possible adverse effects of SBI in general. 

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TABLE OF CONTENTS 

ABSTRACT ............................................................................................................. 2 

ACKNOWLEDGMENTS .............................................................................................. 4 

1 

MANDATE ...................................................................................................... 6 

1.1  BACKGROUND ................................................................................................ 6 

1.2  MEANS OF ACHIEVING THE GOALS .................................................................... 7 

1.3  TERMS OF REFERENCE .................................................................................... 7 

2 

3 

4 

CONCLUSIONS ............................................................................................... 8 

MINORITY OPINION ........................................................................................ 8 

DATA AND METHODOLOGY ............................................................................... 8 

4.1 

Introduction ................................................................................................... 8 

4.2  Methodology .................................................................................................. 9 

5 

ASSESSMENT ............................................................................................... 11 

5.1  Sources of information ................................................................................... 11 

5.1.1  Results from the literature review .................................................................... 11 

5.1.2  Results from the call for information ................................................................ 13 

5.1.3  Information submitted during commenting period .............................................. 13 

5.2  Rupture rate of PIP breast implants ................................................................. 13 

6    REFERENCES .................................................................................................. 15 

ANNEX I: Evaluation of papers identified through literature search ................................ 24 

ANNEX II Evaluation of papers received during the call for information .......................... 25 

ANNEX III Evaluation of papers received during the commenting period ........................ 26 

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1  MANDATE 

1.1  BACKGROUND 

A. The safety of the PIP silicone breast implants 

Over  many  years,  the  PIP  manufacturer  fraudulently  made  use  of  industrial  silicone 
instead of the approved medical grade silicone in many of the  breast implants produced. 
Investigations  were  triggered  by  an  unusually  high  short-term  breast  implant  rupture 
rate. The product was thereafter withdrawn from the EU market. 

Following  this  fraud,  SCHENIR  was  requested  to  provide  two  scientific  Opinions  on  the 
safety  of  the  PIP  silicone  breast  implants.  The  first  one,  a  rapid  scientific  Opinion,  was 
adopted  by  SCENIHR  on  1  February  20121.  This  Opinion  was  updated  by  a  second  one, 
adopted on 12 May 2014.2 

Given  the  importance  of  the  matter,  the  Commission  relevant  services,  DG  GROW  and 
DG  SANTE,  are  committed  to  monitoring  the  publication  of  new  and  valid  scientific 
information  and  facilitating  possible  update  of  the  2014  Opinion  on  the  PIP  silicone 
breast implants in the light of such new scientific data. 

Besides its regular consultation of the National Competent Authorities, DG GROW and DG 
SANTE  recognise  the  need for  a  formal  scientific  evaluation  of  the  current  availability  of 
n e w   a n d   relevant information. 

This  need  is  also  highlighted  in  the  remarks  of  the  European  Ombudsman’s  Decision  in 
case  174/2015/FOR  on  the  Commission's  alleged  failure  to  investigate  conflicts  of 
interests  relating  to  the  adoption  of  a  report  on  the  safety  of  removing  PIP  breast 
implants:  “The  Commission  should  continue  to  evaluate  new  scientific  data  relating  to 
the safety of PIP implants.” 3 

The  investigation  into  the  availability  of  new  scientific  data  that  would  warrant  an 
eventual update of the May 2014 Opinion on the safety of the PIP breast implants should 
take  into  account  all  the  necessary  fields  and  especially  those  covered  by  the  previous 
Opinion,  such  as  the  physiochemical  properties  of  PIP  implants,  their  toxicology,  the 
clinical impact and recommendations. 

B. Possible association between breast implants in general and anaplastic large 
cell lymphoma 

Anaplastic  large  cell  lymphoma  (ALCL)  is  a  very  rare  type  of  lymphoma.  ALCL  is  not  a 
cancer  of  the  breast  tissue  and  the  prognosis  of  the  disease  is  generally  favourable.  A 
possible association between breast implants and ALCL is under scrutiny in the European 
Union and at international level by regulators and scientists. 
According  to  an  estimation4  of  the  US-Food  Drug  Administration,  in  2011  there  were 
between  100-250  known  cases  of  ALCL  in  women  with  breast  implants  out  of  an 

1 http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf 
2 http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf 
3 http://www.ombudsman.europa.eu/cases/decision.faces/en/61195/html.bookmark 
4 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm 

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estimated  number  of  5  to  10  million  women  who  have  received  breast  implants 
worldwide. 

The information  to date suggests that women with  breast implants may have a very  low 
but increased risk of developing ALCL, while the rarity of the disease makes it difficult to 
establish  a  definite  causal  relationship  (Center  for  Devices  and  Radiological  Health 
U.S. Food and Drug Administration).5 

Given  that  this  suspected  association  between  breast  implants  and  ALCL  appears  to  be 
an  emerging  risk,  the  SCHEER  should  determine  whether  there  is  enough  scientific 
information  available  to  allow  for  a  full  risk  assessment  of  the  matter.  The  existence  of 
information  on  a  specific  association  with  PIP  silicone  breast  implants  should  also  be 
investigated. 

1.2  MEANS OF ACHIEVING THE GOALS 

In  order  to  make  a  thorough  collection  of  all  the  data  on  the  two  aforementioned  issues, 
two actions were considered: 

1) Holding a public call for data open to all stakeholders, and holding it open long enough 
to ensure that  any information pertaining to the two topics may be submitted. 

2) Conducting  a  review  of  the  published  scientific  literature  and  of  any  other  source  of 
relevant data  available on the two topics. 

The  relevant  scientific  information  should  be  retained  and should serve as the basis for 
the  SCHEER  to  reply  to  the  questions  described  in  the  terms  of  reference.  Any  rejection 
of  acquired  information  should be justified. The Committee will decide if  both topics may 
be  addressed by one call for data and one scientific literature review at the same time or 
if  separate processes need to be organised. 

1.3  TERMS OF REFERENCE 

Following  the  assessment  of  the  availability  of  the  scientific  information  the  SCHEER 
should: 

1) Indicate whether there is sufficient new scientific information to warrant  an update  of 
the May 2014 Opinion on the safety of the PIP breast implants 

2) Provide  a  formal  Advice  on  the  state  of  scientific  knowledge  regarding  a  possible 
connection  between breast implants and anaplastic large cell lymphoma 

5 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm  

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2  CONCLUSIONS 

Following  the  request  received  from  the  European  Commission,  the  Scientific  Committee 
on  Health,  Environmental  and  Emerging  Risks  (SCHEER)  performed  a  literature  review 
and  launched  a  call  for  information  to  gather  new  scientific  information  related  to  the 
safety  of  the  PIP  breast  implants,  which  became  available  after  the  publication  of  the 
Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants - Update of 
the Opinion of February 20126  (2014 Opinion). 

Based  on  the  analysis  of  the  literature  review,  it  is  concluded  that  insufficient  new 
information  is  available  to  warrant  an  update  of  the  2014  Opinion.  New  scientific 
information was found relating to the early and increased PIP implant rupture risk, which 
suggested  that  the  risk  was  probably  due  to  the  low  quality  of  the  implant’s  shell  as 
already  reported  in  2014  Opinion.  The  calculation  of  the  rupture  rate  based  on  PIP 
explants indicates a rupture rate of PIP breast implants of approximately 23%, similar to 
the 25% - 30% rupture rate presented in the 2014 Opinion. 

The  call  for  information  did  not  result  in  the  submission  of  any  scientific  data  and/or 
information  regarding  health  effects  specific  to  PIP  breast  implants.  A  lot  of  information 
was  submitted  concerning  breast  implants  in  general  but  not  focusing  specifically  on  PIP 
breast  implants.  This  information  was  considered  not  relevant  for  the  evaluation  of  the 
availability of new scientific data on  the safety of PIP breast implants. 

In  conclusion,  the new  scientific  information  gathered, both  via  the  call  for  information 
and  via  the  literature  review,  was  considered  insufficient  and  an  update  of  the  2014 
Opinion is therefore unwarranted. 

3  MINORITY OPINION 

None 

4  DATA AND METHODOLOGY 

4.1  Introduction 

This  document  provides  an  inventory  of  the  information  on  the  safety  of  PIP  silicone 
breast  implants  which  became  available  after  the  publication  of  2014  Opinion,  to 
evaluate whether an update of the 2014 Opinion is warranted. 

This Scientific Advice answers question one of the ‘Terms of Reference’ of the mandate. 

The  state  of  scientific  knowledge  regarding  a  possible  connection  between  breast 
implants and anaplastic large cell lymphoma is presented in a separate document. 

6 http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf 

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4.2  Methodology 

New  scientific  information  on  the  possible  adverse  effects  of  PIP  breast  implants  was 
obtained by two independent methods: a literature search and an open call for information. 
All  submitted  information  was  considered  but  conclusions  were  based  exclusively  on  peer-
reviewed scientific papers. 

The  literature  search  was  conducted  to  retrieve  scientific  literature  available  on  PIP  breast 
implants. The major search terms, PIP and breast implants were used in combination  with 
additional  terms  listed  below.  Papers  were  selected  based  on  the  search  terms  using 
PubMed  and  Find-eR (a tool for searching  multiple  library  resources  in  one  interface  which 
includes  the  European  Commission  Library  collections,  plus  millions  of  online  full-text 
journal  articles  and  eBooks).  The  publication  period  of  the  scientific  papers  covered  was 
from January 2012 to August 2016. 
Literature search using PubMed resulted in 366 entries. Table 1 below shows the key words 
used  and  number  of  papers  obtained.  Duplicate  articles  were  obtained  because  the  search 
included more key words. 

Table 1- Results from PubMed 

Key words including MeSH terms (PubMed)7

No of 
hits 

59 

("Phys  Perspect"[Journal]  OR  "pip"[All  Fields])  AND  (("silicones"[MeSH  Terms]  OR 
"silicones"[All  Fields]  OR  "silicone"[All  Fields])  AND  ("breast  implants"[MeSH  Terms]  OR 
("breast"[All Fields] AND "implants"[All Fields]) OR "breast implants"[All Fields]))] 

(Poly[All Fields] AND Implant[All Fields] AND Prothese[All Fields]) AND implants[All Fields] 

51 

"PIP"  (All  Fields)  AND  ("breast  implants"[MeSH  Terms]  OR  ("breast"[All  Fields]  AND 
"implants"[All  Fields])  OR  "breast  implants"[All  Fields]))  AND  ("infection"[MeSH  Terms] 
OR "infection"[All Fields]) 

(PIP) breast implant AND cancer 

(PIP) AND breast implants AND infection 

(PIP) AND breast implants AND inflammation 

(PIP) AND breast implants AND rupture 

(PIP) AND breast implants AND risk assessment 

(PIP) AND leakage AND breast implants 

(PIP) AND breast implants AND safety of implants 

(PIP) AND breast implants AND silicone gel 

13 

81 

13 

12 

36 

11 

8 

38 

44 

Table 2 below shows the key words used and number of papers obtained using Find-eR, 
a  tool  for  searching  multiple  library  resources  in  one  interface.  It  includes  the  European 

7  MeSH  (Medical  Subject  Headings)  is  the  NLM  controlled  vocabulary  thesaurus  used  for  indexing  articles  for 
PubMed 

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Commission  Library  collections,  plus  online  full-text  journal  articles  and  eBooks. 
Duplicate articles were obtained because the search included more key words.  Literature 
search using FIND-eR resulted in 72 entries. 

Table 2- Results from FIND-eR 

Key words 

No of hits 

PIP AND Silicone Breast Implants 

PIP AND Breast implants 

PIP AND silicone implants 

PIP and implants 

PIP AND Cancer 

(PIP) AND Inflammation 

PIP AND Rupture 

PIP AND breast implants 

PIP and Anaplastic Large Cell Lymphoma 

6 

9 

7 

13 

5 

0 

3 

5 

2 

(PIP) AND breast implants AND risk assessment  3 

(PIP) AND safety of implants 

Breast implants AND safety of implants 

(PIP) AND silicone gel 

5 

12 

2 

In addition, a call for information was launched by the European Commission to invite all 
interested  parties  to  submit  scientific  information  regarding  the  safety  of  PIP  breast 
implants.  The  call  for  information  was  published  on  14  June  2016  and  closed  on  4 
September  2016.  For  on-going  studies  and  research  that  were  not  completed  by  the 
deadline, the call remained open until 20 November 2016. 

Among  of  all  information  received,  the  SCHEER  considered  only  peer-reviewed  papers 
focusing specifically on the safety of PIP breast implants. 

5  ASSESSMENT 

5.1  Sources of information 

5.1.1  Results from the literature review 

99  papers  were  obtained  from  PubMed  and  10  publications  from  Find-eR.  A  table  was 
prepared  to  facilitate  the  evaluation  of  the  new  scientific  information  collected  (both  via 
the literature review and via call for information), containing the following categories: 

Identification number 

 
  Title 
  Authors 

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  Name of the journal 
  Year of publication 
  Peer review or not 
  Concerning  PIP:  this  tag  means  that  the  paper  contains  data  and  results  on 

clinical studies specifically regarding PIP implants 

  Mentioning  PIP:  this  tag  means  that  the  paper  cites  PIP  breast  implants  but  not 

related to the safety assessment of the PIP breast implants 

  Type of study design: case report, non-human experimental study, observational 

study, clinical trial, randomized clinical trial, other=not a clinical study 

  Sample size: number of patients included 
  Comments made by the evaluators 

A compilation of the papers used for the evaluation is presented in Table 3. 

Only  papers  published  in  peer-reviewed  journals  describing  data  and  results  on  clinical 
studies  specifically  regarding  PIP  implants  were  considered.  Commentaries,  editorials, 
and discussions on silicone breast  implants (SBI)  in general or on the PIP breast implant 
fraud case were not considered for further evaluation. 

The  Pubmed  s e a r c h   resulted  in  99  papers.  After  the  removal  of  8  duplicate 
publications  retrieved via Pubmed,  a total of  91  papers  were  included  in  the  compilation 
of papers to be evaluated. 

The  search  using  the  Find-eR  tool  resulted  in  an  additional  10  papers  which  were  not 
duplicates  of  those  retrieved  via  Pubmed.  The  papers  obtained  consisted  mainly  of  book 
chapters  dealing  with  various  aspects  of  silicone  breast  implants  and  one  EU  report  on 
Notified  Bodies.  One  paper  described  an  assessment  of  Notified  Bodies  in  the  EU.  These 
papers,  although  included  in  the  list  of  papers  to  be  evaluated,  did  not  provide 
information  relating to  PIP  implants specifically  but  to various  aspects  of SBI  in  general. 
As  book  chapters  and  the  Notified  Body  report  are  usually  not  peer  reviewed,  this 
information was not considered for further evaluation. 

Table 3. Papers evaluated as presented in Annex 1. 

Papers dealing with rupture evaluation 

Papers of reviews SBI and/or PIP fraud 

39 

14 

Papers dealing with comments/news on PIP fraud  20 

Papers dealing with other subjects 

27 

The evaluation of each paper is presented in Annex 1. 

The reviews and studies evaluated did not consistently indicate that PIP implants induced 
more  harm  to  patients  compared  to  other  SBI  brands  (Moliter  et  al.  2015,  Wazir  et  al., 
2015).  Therefore,  the  additional  risk  of  PIP  breast  implants  may  be  limited  to  the  high 
rupture  rate  which  is  probably  due  to  a  low  quality  of  the  PIP  breast  implant  shell. 
Indeed,  most  studies  indicate  a  higher  rupture  rate  of  PIP  breast  implants  when 
compared  to  other  SBI  brands.  In  one  study  the  prevalence  of  PIP  breast  implant 
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ruptures was comparable to other SBI brands, but with an increase in ruptures over time 
(Leckenby et al., 2016). Also early adverse events were not different between PIP breast 
implants and two other SBI brands (Mentor(®) and Allergan(®) (Fenoll et al., 2015). 

In  conclusion,  the  literature  review  showed  that  new  information  is  available  regarding 
the possible health effects of PIP breast implants, but this information is rather limited. 

5.1.2  Results from the call for information 

Five  stakeholders  submitted  information  regarding  possible  health  effects  of  PIP  breast 
implants, accounting for a total of 87 papers. However, only 12 papers are related to PIP 
breast implants, 6 of which were also included in the literature review mentioned above. 
The evaluation of the papers provided via the call for information is presented in Annex 
II. None of these 12 papers contained scientific information related to the health impacts 
of  PIP  breast  implants  on  patients.  For  example,  the  submitted  papers  discussed  the 
analytical  chemistry  of  the  PIP  silicones  or  shell  and  some  papers  discussed  the  rupture 
rate  of  PIP  breast  implants.  Most  of  the  other  papers  discuss  SBI  in  general  or  are 
comments/editorials  in  journals  not  containing  scientific  information  on  the  health 
aspects of PIP breast implants. 

5.1.3  Information submitted during commenting period  

A  commenting  period  on  the  scientific  Advices  was  published  on  the  website  of  the 
Scientific  Committees  from  April  7th  until  June  15th,  2017.  Two  organisations  and  one 
individual  (providing  in  total  10  documents)  submitted  comments  and  provided  input 
supposed to be related to the topic of the scientific advice, i.e. the toxicity of PIP silicone 
breast  implants.  Each  contribution  was  carefully  considered  by  the  SCHEER  and 
submitted  papers  were  evaluated  (see  Annex  III).  In  general  the  information  did  not 
specifically  discuss  the  toxicity  of  PIP  implants.  The  SCHEER  concluded  that  the 
comments  were  outside  the  scope  of  this  advice  as  they  were  providing  additional 
information on possible adverse effects of SBI in general.  

5.2  Rupture rate of PIP breast implants 

The probability of rupture for PIP breast implants reported in the 2014 Opinion is around 
25-30%  at  10  years  after  implantation.  In  order  to  estimate  the  current  PIP  breast 
implant  rupture  rate,  a  calculation  was  made  based  on  the  papers  obtained  in  the 
literature  review  and  also  published  studies  already  considered  in  the  2014  Opinion 
(Table  4).  The  rupture  rate  was  determined  based  on  data  for  4641  implants  and  3461 
patients  (Table  4).  This  re-analysis  resulted  in  a  rupture  rate  of  about  23%  (95% 
confidence interval 17.5% to 27.9%), which is in the same range as the rupture rate of 
25%-30% presented in the 2014 Opinion. 

Some studies show that the mean time from PIP implantation to rupture diagnosis and/or 
explanation  was  relatively  short  and  generally  less  than  10  years.  This  may  reflect  the 
consequences  of  the  PIP  breast  implant  fraud  case,  which  prompted  regulatory  bodies 
and  the  plastic  surgery  society  to  advise  that  PIP  implants  be  removed  as  a  preventive 

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measure rather than only when necessitated by the appearance of clinical symptoms. 

Moreover,  Swarts  et  al.,  2013  showed  a  highly  variable  shell  thickness  in  ruptured  PIP 
implants  including  shell  regions  below  the  minimum  thickness  specified  by  the 
manufacturer. 

Table 4. References on rupture rate 

Author 

Number

of 
patients

Rupture 

rate
PIP 

implants (%)a

Billner et al. 2015 

(S
BI  explants) 
64 (115) 

23.48 

Moschetta et al. 2014 

21 (40) 

Mennie et al. 2015 

192 (384) 

Schott et al. 2014 

72 (108) 

Oulharj et al. 2014 

455 (828) 

Quaba et al. 2013b

338 (676) 

50 

21 

23 

7.73 

21.3 

time 

Implant 
at 
explantation  or  rupture 
diagnosis 
(mean 
number  of  years  and 
range) 
8.4 (n.a.)c

≥ 7 (n.a.) 

8.7 (6-15) 

5.1 (1-11) 

n.a. 

7.8 (1-13) 

Berry et al. 2012b

453 

24.85 (range 15.9 – 33.8) 

n.a. (6-11) 

Berry et al. 2013 (update)b

460 

30.55 (range 22.7 – 38.4) 

n.a. (6-11) 

Tropet et al. 2013 

217 (434) 

Aktouf et al. 2012b

99 (192) 

8.7 

11.9 

4.6 (n.a.) 

n.a. 

Leckenby et al. 2016 

455 (905) 

14.25 

7.8 (0.12-16.8) 

De Lorenzi et al. 2015 

360 (443) 

18.5 

Scotto   di   Santolo   et  
al.  2014 

64 

Maijers et al. 2014 

107 (214) 

Khan 2013 

65 

Chummun et al. 2013b

39 (78) 

Maijers et al. 2012b

(224) 

36 

21 

27.7 

21.8 

24 

4.8 (n.a.) 

8 (6-14) 

10 (n.a.) 

7.2 (2-12) 

7 (n.a.) 

10 (n.a.) 

a) 

Indicated  is  the  rupture  rate  as  determined  in  explanted  PIP  breast  implants.  If  the  number  of 
explants was not provided in the paper the percentage indicates patients with the diagnosis of implant 
rupture. 

b)  Studies on rupture rate of PIP implants included in 2014 Opinion on PIP breast implants. 
c)  n.a. not available 

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Molitor  M,  Meš'ták  O,  Popelka  P,  Vítová  L,  Matejovská  J,  Kalinová  L,  Hromádková  V, 
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Moschetta  M,  Telegrafo  M,  Cornacchia  I,  Vincenti  L,  Ranieri  V,  Cirili  A,  Rella  L,  Stabile 
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O'Dowd  A.  (2012)  Around  1000  women  with  private  sector  PIP  implants  seek  NHS  help. 
BMJ 344:e972. doi: 10.1136/bmj.e972. PMID: 22315301 

O'Dowd  A.  (2012)  UK  launches  inquiry  into  safety  of  PIP  breast  implants.  BMJ  344:e11. 
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O'Dowd  A.  (2011)  UK  recommends  PIP  breast  implants  should  not  be  removed.  BMJ 
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O'Dowd  A.  (2012)  Women  have  had  "harrowing"  experiences  over  PIP  implants  scandal. 
BMJ 345:e4560. doi: 10.1136/bmj.e4560. PMID: 22761250 

O'Neill  JK,  Rigby  H,  Kenealy  JM.  (2008)  Leakage  and  osmotic  shifts  in  PIP  Hydrogel 
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Oulharj  S,  Pauchot  J,  Tropet  YJ.  (2014)  PIP  breast  implant  removal:  a  study  of  828 
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Torjesen  I.  (2012)  NHS  should  replace  PIP  implants  even  when  privately  fitted.  BMJ 
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Yildirimer  L,  Seifalian  AM,  Butler  PE.  (2013)  Surface  and  mechanical  analysis  of 
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Zambacos  GJ,  Molnar  C,  Mandrekas  AD.  (2013)  Silicone  lymphadenopathy  after  breast 
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Zuckerman D, Booker N, Nagda S. (2012) Public health implications of differences in 
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ANNEX I: Evaluation of papers identified through literature search 

In  this  Annex  are  listed  the  papers  identified  through  literature  review,  using  Pub-Med 
and Find-eR and the evaluation made by the SCHEER. 

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ANNEX II Evaluation of papers received during the call for information 

In  this  Annex  are  listed  the  papers  received  via  call  information  which  was  published  on 
the 14th  of June 2016 and closed on September 4th  2016 and the evaluation made by the 
SCHEER. 

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ANNEX  III  Evaluation  of  papers  received  during  the  commenting  period  

In  this  Annex  are  listed  the  papers  during  the  commenting  period  which  was  opened 
from April 7th until June 15th, 2017 

25 

Evaluation of the literature received during the commenting period.doc