Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Conditions: Ventral Incisional Hernia
Sponsor: Medtronic - MITG

 
Observational Registry Study for Symbotex™ 
Composite Mesh in Ventral Hernia Repair 
 
 
The SymCHro Study  
 
Protocol #:   
COVSYMB0441 
Version: 
 A -6 MAR 2014 
 
Sponsor 
 
COVIDIEN  
SOFRADIM PRODUCTION  
FRANCE 
 
Authorized representative contracted by Covidien Sofradim 
Production to implement and conduct the study 
 
CLUB HERNIE Association, 70 rue Carves, 92120 
MONTROUGE, France, represented by Jean-François 
GILLION in his capacity as President,  
 
Investigator Coordinator 
Dr Jean Francois Gillion 
Medical institution Hôpital prive d'Antony 
41 av A BRIAND, 92160 ANTONY - France 
 
This observational registry study protocol is the property of the Sponsor and is a confidential document. It is not 
to be copied or distributed to other parties without prior written authorisation from the Sponsor. 
 
116, avenue de Formans 
01600 TREVOUX 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
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Table of content: 
 
 
 
1. 
Study Objectives .......................................................................................................... 4 
1.1 Primary Objective ..................................................................................................... 5 
1.2 Secondary Objectives................................................................................................ 5 
2. 
Study Design and Methodology .................................................................................. 5 
2.1 Definition .................................................................................................................. 5 
2.2 Scope ......................................................................................................................... 5 
2.3 Monitoring procedures .............................................................................................. 7 
3. 
Product Description ..................................................................................................... 7 
4. 
Patient Selection .......................................................................................................... 7 
4.1 Inclusion Criteria ...................................................................................................... 8 
4.2 Exclusion Criteria ..................................................................................................... 8 
5. 
Clinical Assessments ................................................................................................... 8 
5.1 Preoperative data ....................................................................................................... 8 
5.2 Operative data (D0) ................................................................................................... 8 
5.3 Discharge data ........................................................................................................... 9 
5.4 Post-operative course (D1) Follow up ...................................................................... 9 
5.5 Post-operative course (D8) Follow up ...................................................................... 9 
5.6 1 month (D30) Follow up ......................................................................................... 9 
5.7 1 year follow-up ........................................................................................................ 9 
5.8 2 year follow-up ...................................................................................................... 10 
6. 
Statistical Methods .................................................................................................... 10 
7 
Ethical Considerations, Data storage and Confidentiality ......................................... 12 
7.1 Patient Information Notice ...................................................................................... 12 
7.2 Data Storage and Confidentiality ............................................................................ 12 
8 
Safety Assessment ..................................................................................................... 12 
9 
References ................................................................................................................. 13 
10 
Appendix ............................................................................................................... 14 
 
 
 
 
 
 
 
 
 
 
 
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
Protocol number: COVSYMB0441 
 
 
 
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Observational Registry Study for Symbotex™ 
Composite Mesh in Ventral Hernia Repair 
 
Background 
An abdominal wall hernia is an abnormal protrusion of the contents of the abdominal 
cavity or of pre-peritoneal fat through a defect or weakness in the abdominal wall. Repair 
of abdominal wall hernia is one of the most common procedures performed by surgeons.  
 
Until the 1990s, the fascia-duplication and the fascia-adaptation were the “gold standard” 
in ventral hernia repair. Because of this unacceptably high recurrence rates after simple 
reconstruction and the development of new tissue-compatible, prosthetic materials, many 
surgeons share the opinion that an additional strengthening of the frontal abdominal wall 
by implantation of allo- and autoplastic material should be obligatory. According to DEN 
HARTOG et al Cochrane review [1] there is good evidence that mesh repair is superior to 
suture repair in terms of recurrences.  
 
As pointed out by ROBINSON et al [2] ideal mesh has been sought since prosthetic 
materials for hernia repair were first introduced in the 1950s. Authors have generally 
agreed on several properties of this theoretically ideal mesh:  
o be strong enough to withstand physiologic stresses over a long period of time  
o conform to the abdominal wall 
o promote strong host tissue ingrowth, which mimics normal tissue healing 
o resist the formation of bowel adhesions and erosions into visceral structures  
o not induce allergic or adverse foreign body reactions  
o resist infection  
o be non-carcinogenic 
There is little agreement or consensus in the literature as to the ideal approach for this 
difficult problem. In recent years population based studies have provided better data on 
the true failure rates associated with the various herniorrhaphies [3].  
The use of meshes became popular during the 20th century following several studies 
which showed recurrence rates significantly lower than suture repairs (approximately 
10% of recurrence for mesh repairs against 25 to 55% for suture repairs) [4]. 
 
According to a review of the literature pooling recurrence data from 2,559 patients, the 
global recurrence rate varies between 0 and 6% for Parietex™ Composite Mesh at a mean 
follow-up of 26.1 months. 
As described in the literature, the worst recurrence rate following incisional hernia repairs 
using synthetic meshes by laparoscopic and open approach, is 5.9 % [5] and 5.6 %[6] 
respectively. 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
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Within 10 years, the tension repairs were outnumbered by tension-free, mesh-based 
techniques, and these latter hernioplasties now dominate hernia repair in the marketplace 
[7]. Literature demonstrates prosthetic repair as the best solution even though no 
consensus is currently established regarding the ideal technique (choice of mesh, surgical 
technique, and implantation site). Currently, the gold standard for ventral hernia repair 
according to many surgeons [8],[9],[10],[11] is the Rives Stoppa retro-rectus repair. 
However, open intraperitoneal technique (the mesh is placed behind all layers of the 
abdominal wall including the parietal peritoneum [12]) could be an alternative to a 
retromuscular repair [13]. In this technique, where one side of the mesh faces the 
abdominal wall, and the other side is in contact with the viscera, hernia repair requires 
minimizing tissue attachment properties or two-sided (i.e. composite) mesh. 
Parietex composite mesh (first generation) available since 1998 has become one of the 
most effective mesh when an intraperitoneal placement is required [14, 15]. 
 
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft 
tissue where a weakness exists, in procedures involving primary abdominal wall and 
incisional hernia surgeries. 
 
Symbotex™ composite mesh is made out of a three-dimensional monofilament polyester 
textile, which is covered with an absorbable, continuous and hydrophilic film on one of 
its sides. This film is made up of a mix of collagen from porcine origin and glycerol.  
The non-absorbable three-dimensional polyester mesh provides long term reinforcement 
of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue 
attachment to the mesh in case of direct contact with the viscera. 
Symbotex™ Composite Mesh was developed based on the Parietex™ Composite (PCO) 
and Parietex Optimized Composite (PCOX) design and collagen technology for 
minimizing tissue attachment to the mesh in case of direct contact with the viscera. 
 
In addition, Symbotex ™ Composite has been specifically designed for ease of use for 
example:  
 Green flap for helping to visualization of the fixation area  
 Presence of green marking for orienting and placing the mesh; the green drop- 
shaped marker in the center of the mesh helps the orientation and placement of the 
mesh to the medial line of the body. 
 Mesh transparency for improved anatomy visualization during placement 
 Conformability of textile for position against the abdominal wall. 
 
In order to assess the clinical outcomes following the use of Symbotex™ Composite 
Mesh in primary abdominal wall and incisional hernia repair, this observational registry 
study has been initiated. 
 
1. Study Objectives 
 
The aim of this Observational Registry Study is to assess the short- and long-term clinical 
outcomes following the use of Symbotex™ Composite Mesh in primary and incisional 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
Protocol number: COVSYMB0441 
 
 
 
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abdominal wall hernia surgeries by open or laparoscopic approach, according to the 
Instruction for use (IFU) (Appendix B). 
 
One hundred consecutive, adult patients scheduled for primary and incisional abdominal 
wall hernia surgeries using Symbotex™ Composite Mesh will be reported in the Club 
Hernie online database, with standard data captured of all preoperative, perioperative and 
post-operative data, for patient’s outcomes measurements. 
 
1.1 Primary Objective 
Evaluate the incidence of peri-operative and post-operative complications, with post-
operative evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month 
(D30 follow up), 1Year and 2 Year follow up after primary and incisional abdominal wall 
hernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach 
(such as anticipated device related complications such as pain, recurrence, complications 
related to adhesions, wound complications, other postoperative complications, SAE…). 
 
1.2 Secondary Objectives 
Description and assessment of the use of Symbotex™ Composite Mesh for primary and 
incisional abdominal wall hernia surgeries (surgical techniques, description of dissection, 
mesh handling, ease of use, surgeon’s satisfaction, Quality of life and patient 
satisfaction...). 
 
 
2. Study Design and Methodology 
 
This is an observational multicenter registry Study. 
 
2.1 Definition 
According to MEDDEV 2.12.2 rev 2 for post-market follow up studies,  
Device Registry: An organized system that uses observational study methods to collect 
defined clinical data under normal conditions of use relating to one or more devices to 
evaluate specified outcomes  for a population defined by a particular disease, condition, 
or exposure and that serves predetermined scientific, clinical or policy purpose(s). 
 
2.2 Scope 
One hundred consecutive adult patients scheduled for primary and incisional abdominal 
wall hernia surgeries using Symbotex™ Composite Mesh will be reported in the Club 
Hernie database in real time.  
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
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A working group of hernia surgeons, under the auspices of the Club Hernie Society 
board, have created a French Registry of Abdominal Wall Hernias called Club Hernie. 
The Club Hernie is a non-profit organization created in 2009, currently including 30 
French surgeons’ members, with the aim to improve the healthcare treatments in parietal 
surgery by an assessment of surgical practices, promoting research in abdominal wall 
surgery using an internet database open to surgeon members to monitor their own hernia 
practice and outcomes.  
 
This online database consists of a systematic and consecutive data entry of all patients 
treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with 
standard data captured of all preoperative, perioperative and post-operative data.  
 
Covidien is contracting with Club Hernie to act as a authorized representative to perform 
sponsor’s clinical study-related duties and functions, such as implementation and conduct 
of this observational registry study.  
 
The Club Hernie database will be used for the 100 patient registry from the Club Hernie 
surgeon members using Symbotex™ Composite Mesh. The Club Hernie database is free 
for use by surgeons. Only Hernia Club surgeon members are allowed to get an account 
for the database, protected by identifier and password. The surgeon members having 
signed the Quality Charter are committed to respecting its principles Club Hernie surgeon 
members participating in the study will be surgeon members using Symbotex™ 
Composite Mesh for primary abdominal wall and incisional hernia surgeries according to 
their current therapeutic practice. 
 
The database is required to be completed anonymously. Therefore, it does not contain 
any patient data such as name, date of birth, social security number or address of the 
patient. 
 
One hundred patients will be followed using the online database for registration and 
patient outcome measurements, including pre-operative, operative, discharge, post-
operative course (D1 and D8 follow up), 1 month (D30 follow up), 1Year and 2 Year 
follow up.  The pain nurses will carry out the pain evaluation on the day of surgery (D0) 
and on postoperative day 1 (D1) (by phone call in case of day surgery). Pain on day 8 is 
assessed either during clinical exam or by phone if the patient is already discharged. 
Patients will be given an appointment for a clinical visit on day 30 (D30 follow up). 
The post-operative visit at 1 month (D30 follow up) is the standard of care for patient 
follow up following primary abdominal wall and incisional hernia surgeries. 
 
For long-term follow up, two sets of self-administered QOL questionnaires will be 
administered by phone call at 1 Year and 2 Year follow-up. 
Follow up by phone questionnaires will be performed by a Clinical Research Associate 
mandated by Club Hernie, independent from the operative surgeons 
The Clinical Research Associate will enter into the database answers from the patient- 
based self-assessment questionnaires. 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
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The answers will be registered without any medical adjustment into the database. The 
patients who complain of any trouble will be invited to have a clinical visit at the 
surgeon’s office. The correlation between the patient’s answer and clinical assessment 
and physical examination will then be determined. 
A patient will be considered lost to follow-up after 5 failed attempts of meticulous postal 
reminders and phone calls at various times, therefore minimizing the non-response bias. 
 
 
2.3 Monitoring procedures 
 
No source data verification will be done.  
Quality data control of all data captured into the online database will be performed by 
coherence analysis by Club Hernie authorized representative. 
 
3. Product Description 
 
The product description and Instructions for Use are described in Appendix A & B. 
SymbotexTM Composite Mesh is proposed in three configurations (flat mesh without 
preplaced suture yarns, flat mesh with preplaced suture yarns, and mesh with open skirt 
(flap).  
Symbotex™ Composite Mesh is available in several shapes and sizes. 
 
 
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft 
tissue where a weakness exists, in procedures involving primary abdominal wall and 
incisional hernia surgeries. The non-absorbable three-dimensional Polyethylene 
terephthalate (polyester) mesh provides long term reinforcement of soft tissues. On the 
opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in 
case of direct contact with the viscera. 
 
In addition, Symbotex ™ Composite has been specifically designed for ease of use, for 
example:  
 Presence of green marking for orienting and placing the mesh, the green drop- 
shaped marker in the center of the mesh helps the orientation and placement of the 
mesh to the medial line of the body. 
 Mesh transparency for improved anatomy visualization during placement 
 Conformability of textile for position against the abdominal wall 
 
The Symbotex ™ Composite Mesh will be CE marked and manufactured by the sponsor 
of the study, SOFRADIM PRODUCTION (subsidiary of Covidien).  
4. Patient Selection 
 
The first one hundred consecutive adult patients scheduled for primary and incisional 
abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™ 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
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Composite Mesh (Flat sheet (SYM), Flat Sheet with sutures (SYM-F), with flap (SYM-
OS) by open or laparoscopic approach. Patients’ data will be reported in the Club Hernie 
database in real time.  
 
4.1 Inclusion Criteria 
- All patients regardless of gender ≥ 18 years of age presenting with ventral hernias. 
- Patients will be informed by surgeon with a written information notice of the nature of 
the observational registry study. 
 
4.2 Exclusion Criteria 
No exclusion criteria outside the product IFU (Appendix B) 
 
5. Clinical Assessments 
 
Patients will be followed using the online database for registration and patient outcome 
measurements, including pre-operative, operative and discharge data, post-operative 
course (D1 and D8 follow up), 1 month (D30 follow up), 1Year and 2 Year follow up.  
 
The study patients will be evaluated and the data will be recorded at time of consultation 
at the following time points. 
 
5.1 Preoperative data 
 
- 
Demographic data  (age , gender, ASA score, BMI, patient’s occupation)  
- 
Relevant prior medical/surgical history (previous surgical procedure including  
- 
Hernia antecedents and abdominal surgical history) and comorbidities 
- 
Hernia symptoms, disorders, region, discomfort and frequency 
 
5.2 Operative data (D0) 
 
- 
Date of surgery 
- 
Surgical technique approach 
- 
Defect size, Hernia type and location 
- 
Mesh size and type (SYM, SYMF; SYMOS) 
- 
Amount of Overlap 
- 
Type of fixation  
- 
Operative time (from incision to closure, skin to skin), ,  
- 
Mesh positioning and time  

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
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- 
Peri-operative events (including SAEs) 
- 
Surgeon satisfaction (Mesh handling, mesh manipulability, ease of use) 
- 
Pain assessment measured with VAS* score (The pain nurse will carry out the 
pain evaluation) 
* VAS: The postoperative pain is assessed using a 0–10 Visual Analogue Scale. 
Worst pain experienced over the last 24 hours. 
 
5.3 Discharge data 
 
- 
Date of discharge 
- 
Length of Hospital stay (number of nights in the institution after the surgery) 
- 
Post-operative complications (including SAEs) 
 
5.4 Post-operative course (D1) Follow up 
 
- 
Pain assessment measured with VAS score (The pain nurse will carry out the 
pain evaluation, either during systematic clinical visit  or by phone call in case 
of day surgery  
 
5.5 Post-operative course (D8) Follow up  
 
Pain assessment measured with VAS score, either during systematic clinical visit or 
by phone call when a patient is already discharged.  
 
5.6 1 month (D30) Follow up 
 
- 
Pain assessment measured with VAS* score  
- 
* Mid pain for VAS score between 0 and 3; Moderate pain for VAS score > 3 
and > 6 ; Severe pain for VAS scores > 6.  
- 
Post-operative complications (including SAEs) 
- 
Quality of Life « QoL » Questionnaire (Appendix C)  
 
5.7 1 year follow-up 
 
- 
QoL and patient satisfaction Questionnaire (Appendix C)  

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
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- 
Post-operative complications (including SAEs) 
- 
Pain assessment measured with VAS score*  
Follow-up at 1 year: All patients will be contacted by phone in order to complete a self-
assessment questionnaire.  
*The patients who complained of any trouble will be invited to have a clinical visit at the 
surgeon’s office. Post-operative complications and VAS score will be recorded. 
 
5.8 2 year follow-up 
 
- 
QoL and patient satisfaction Questionnaire (Appendix C)  
- 
Post-operative complications (including SAEs) 
- 
Pain assessment measured with VAS score*  
Follow-up at 2 year: All patients will be contacted by phone in order to complete a self-
assessment questionnaire.  
*Patients who complain of any trouble will be invited to have a clinical visit at the 
surgeon’s office. Post-operative complications and VAS score will be recorded.  
6. Statistical Methods 
 
6.1 Sample Size Calculation 
 
As described in the literature, the worst recurrence rate following incisional hernia repairs 
using synthetic mesh by laparoscopic and open approach, is 5.9 % [5] and 5.6 %[6] 
respectively. 
Assuming a 95% confidence interval, a recurrence rate of 5.9 % with a +/- 5% precision, 
N=86 patients are needed for the Evaluable Population. Anticipating a 15% lost to follow 
up at 24 months, we plan to recruit a minimum of 100 patients for this observational 
registry as the Evaluable Population. Patients that are lost to follow-up or that withdraw 
consent will not be replaced.  
 
 
6.2 Statistical Analysis Plan Summary 
 
General Considerations 
 
Statistical analysis will consist of descriptive analysis. A statistical analysis plan will be 
developed by Club Hernie. 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
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- 
Qualitative variables will be described by their absolute and relative (%) frequencies 
of each class or value, and by two-tailed 95% confidence intervals. 
- 
Quantitative variables will be described by their mean, standard deviation (SD), 
extreme values (minimum and maximum values), and number of missing data and by 
two-tailed 95% confidence intervals. 
 
Statistical Analysis Plan Summary 
 
The analysis will be performed for primary and secondary endpoints, all data will be 
analyzed, according to the methods previously described in the general considerations 
section.  
 
1) Descriptive Analysis of  patients registration and outcomes measurement  
 
2) Baseline and Demographic Data Analysis 
 
3) Operative Data Analysis 
 
4) Primary endpoints measured within 1month, 1 Year and 2 Year follow-up 
a. Peri-operative complications 
b. Post-operative complications such as anticipated device related 
complications as pain, recurrence, complications related to adhesions, 
wound complications, other postoperative complications, SAEs… 
c. All complications 
 
5) Secondary endpoints analysis during the whole follow-up 
 
a. Surgical technique and mesh fixation 
b. Operative time descriptive analysis 
c. Ease of use / mesh manipulability assessment by surgeons 
d. Length of hospital stay analysis 
e. Quality of life and patient satisfaction  analysis  
f. Surgeon satisfaction 
 
Statistical Analysis Schedule 
 
Interim analyses and one final analysis will be performed on the follow-up data in its 
entirity. 
One final clinical study report will be issued. 
 
 
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
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7 Ethical Considerations, Data storage and Confidentiality  
 
This study is an observational study; therefore the ISO 14155 Standard is not 
applicable. 
This Observational Registry Study will be conducted according to applicable French 
regulation. No specific examinations or lab tests are to be performed above and beyond 
those usually undertaken by the surgeon, and no additional visits are required for study 
purposes. 
The study will be registered on the www.clinicaltrials.gov and the study results will be 
posted on this website. 
 
7.1 Patient Information Notice 
A written information notice will be given by the surgeon to inform the patient about the 
nature of the study.  
 
The physician will provide the patient with the information sheet during the pre-operative 
visit. This form will contain information concerning the nature and purpose of the 
Study.  
 
7.2 Data Storage and Confidentiality 
Only Hernia Club surgeon members are allowed to get an account for the database, 
protected by identifier and password. 
The database is completed anonymous. Therefore, it does not contain any patient data 
such as name, date of birth, social security number or address of the patient.  
 
8 Safety Assessment 
 
Adverse Event/ Complications 
.   
Symbotex™ Composite mesh is currently marketed within US and this observational 
registry study will be initiated as soon as marketed in EU. Therefore any device related 
complications noted in this study will be reported to Covidien. 
Study reported device-related events will be reviewed periodically to assess for any 
potential trends 
 
 
 
 
 
 
 
 
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
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9 References   
 
1.  Den Hartog D., et al., Open surgical procedures for incisional hernias. Cochrane 
Database Syst Rev. 2008 Jul 16;(3):CD006438.  
2.  Robinson, Clarke, Schoen, Walsh; Major mesh-related complications following hernia 
repair: events reported to the Food and Drug Administration Surg Endosc. 2005 
Dec;19(12):1556-60 
3.  Arth, K. and M. Rosen, Repair of ventral abdominal wall hernias. ACS surgery; 
principles and practice, 2010: p. 1-20. 
4. Rutkow, I., Demographic and socioeconomic aspects of hernia repair in the United States 
in 2003. Surg Clin North Am, 2003. 83: p. 1045-51. 
5. Palanivelu C., et al., Laparoscopic repair of suprapubic incisional hernias: suturing and 
intraperitoneal composite mesh onlay -A retrospective study; Hernia. 2008 
Jun;12(3):251-6  
6. Ammaturo C, et al., Outcomes of the open mesh repair of large incisional hernias using 
an intraperitoneal composite mesh: our experience with 100 cases Updates Surg. 2010 
Aug;62(1):55-61. And  
Ammaturo C, et al.,  Surgical treatment of large incisional hernias with an 
intraperitoneal Parietex Composite mesh: our preliminary experience on 26 
cases.Hernia. 2004 Aug;8(3):242- 
7. De Los Monteros, E., Reconstruction of the abdominal wall for incisional hernia. Am J   
Surg, 2006. 191: p. 173-7. 
8. Berry, M.F., et al., Repair of large complex recurrent incisional hernias with 
retromuscular mesh and panniculectomy. The American Journal of Surgery, 2007. 
194(2): p. 199-204. 
9. Iqbal, C., et al., Long-Term Outcome of 254 Complex Incisional Hernia Repairs Using 
the Modified Rives-Stoppa Technique. World Journal of Surgery, 2007. 31(12): p. 2398-
2404. 
10.Martín-Duce, A., et al., Modifications to Rives technique for midline incisional hernia 
repair. Hernia, 2001. 5(2): p. 70-2. 
11.Langer, C., et al., Prognosis factors in incisional hernia surgery: 25 years of experience. 
Hernia, 2005. 9: p. 16–21. 
12.Muysoms, F., et al., EuraHS: the development of an international online platform for    
registration and outcome measurement of ventral abdominal wall hernia repair. Hernia, 
2012. 16(3): p. 239-250. 
13.Berrevoet, F., et al., Open intraperitoneal versus retromuscular mesh repair for umbilical 
hernias less than 3cm diameter. The American Journal of Surgery, 2011. 201(1): p. 85-
90. 
14.Balique, J.G., et al.,Traitement des éventrations avec le renfort Parietex Composite : 
résultats à long-terme d’une étude prospective multicentrique. Annales de Chirurgie, 
2004. 129(1-4). 
15.Balique, J., et al., Intraperitoneal treatment of incisional and umbilical hernias using an 
innovative composite mesh: four-year results of a prospective multicenter clinical trial. 
Hernia, 2005. 9: p. 98-74. 
 
 
 
 
 

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10 Appendix 
 
10.1 Appendix A: Product description 
10.2 Appendix B: Instruction for use 
10.3 Appendix C: Quality of Life and patient satisfaction Questionnaire  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
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Appendix A 
 
Product description 
 
The proposed SymbotexTM Composite Mesh configurations are summarized in the 
table below:  
 
Proposed SymbotexTM Composite Mesh 
 
Flat sheet (SYM) 
Flat Sheet with sutures (SYM-F) 
With flap (SYM-OS) 
Photos  
 
 
 
Description 
Symbotex™ composite mesh is 
made out of a three-dimensional 
monofilament polyester textile, 
which is covered with an 
absorbable, continuous and 
hydrophilic film on one of its 
sides. This film is made up of 
collagen from porcine origin 
and glycerol. The collagen film 
is essentially degraded in less 
than 1 month. 
 
A dyed monofilament polyester 
(D&C Green No. 6) marking is 
positioned on the center of the 
textile, on the opposite side of 
the film, and helps center and 
orient the mesh. 
Symbotex™ composite mesh is 
made out of a three-dimensional 
monofilament polyester textile, 
which is covered with an 
absorbable, continuous and 
hydrophilic film on one of its 
sides. This film is made up of a 
mix of collagen from porcine 
origin and glycerol. The collagen 
film is essentially degraded in 
less than 1 month. 
Non-absorbable pre-placed 
sutures are tied to the three-
dimensional mesh. 
A dyed monofilament polyester 
(D&C Green No. 6) marking is 
positioned on the center of the 
textile, on the opposite side of the 
film, and helps center and orient 
the mesh. 
Symbotex™ composite 
mesh is made out of a three-
dimensional monofilament 
polyester textile, which is 
covered with an absorbable, 
continuous and hydrophilic 
film on one of its sides. This 
film is made up of collagen 
from porcine origin and 
glycerol. The collagen film 
is essentially degraded in 
less than 1 month. 
 
A dyed (D&C Green No. 6) 
bi-dimensional 
monofilament polyester 
textile flap is attached to the 
three-dimensional 
reinforcement and helps 
place and fix the mesh. 
Shape, 
Reorder and 
Sizes 
Rectangular:  
SYM1510 (15x10cm) 
SYM2015 (20x15cm) 
SYM2520 (25x20cm) 
SYM3020 (30x20cm) 
SYM3728 (37x28cm)   
SYM4232 (42x32cm) 
 
Elliptical :  
SYM1710E (17x10cm) 
SYM2012E (20x12cm) 
SYM2515E (25x15cm) 
SYM3420E (34x20cm)  
SYM4024E (40x24cm) 
 
 
Circular :  
SYM9 (9cm diameter)  
SYM12 (12cm diameter) 
SYM15 (15cm diameter) 
Rectangular:  
SYM1510F (15x10cm) 
SYM2015F (20x15cm) 
SYM2520F (25x20cm) 
SYM3020F (30x20cm) 
SYM3728F (37x28cm)   
SYM4232F (42x32cm) 
 
Elliptical :  
SYM1710EF (17x10cm) 
SYM2012EF (20x12cm) 
SYM2515EF (25x15cm) 
SYM3420EF (34x20cm)  
SYM4024EF (40x24cm) 
 
 
Circular :  
SYM9F (9cm diameter)  
SYM12F (12cm diameter) 
SYM15F (15cm diameter) 
Circular :  
SYM8OS (8cm) 
 
Rectangular:  
SYM1510OS (15x10cm) 
SYM2015OS (20x15cm) 
SYM2520OS (25x20cm) 
SYM3020OS (30x20cm) 
 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
Page 16 of 19 
APPENDIX B 
Instruction for Use      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STORAGE
Recommended storage conditions: room temperature.
Do not use the device past the last day of the labeled month of expiration.
Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if the integrity of the 
packaging appears compromised.
TRACEABILITY
A traceability label is attached to every device package which identiﬁes the type and lot number of the device. This label should be aﬃxed to the patient’s 
permanent medical record to clearly identify the device which was implanted.
FR
Renfort Composite
AVANT D’UTILISER CE PRODUIT, LIRE ATTENTIVEMENT LES INFORMATIONS CI-DESSOUS.
IMPORTANT !
Cette notice est destinée à faciliter l’utilisation de ce produit. Elle ne constitue pas une référence en matière de techniques chirurgicales. Ce dispositif a été 
conçu, testé et fabriqué pour un usage chez un seul patient. Sa réutilisation ou son retraitement peut provoquer un dysfonctionnement et des blessures 
chez le patient. Son retraitement et/ou sa restérilisation peuvent entrainer un risque de contamination et d’infection du patient. Ne pas réutiliser, retraiter 
ou restériliser ce dispositif.
DESCRIPTION
Le renfort Symbotex™ composite est constitué d’un textile tridimensionnel en polyester monoﬁlament recouvert sur une face, par un ﬁlm hydrophile, 
continu et résorbable à base de collagène d’origine porcine et de glycérol. Le ﬁlm de collagène est essentiellement résorbé en moins d’un mois. 
Un rabat textile bidimensionnel en polyester monoﬁlament de couleur verte (D&C Green No. 6) est ﬁxé sur le renfort tridimensionnel et aide à placer et 
ﬁxer le renfort.
INDICATIONS
Le renfort Symbotex™ composite est utilisé pour le renforcement des tissus mous de la paroi abdominale en présence d’une faiblesse, dans les procédures 
chirurgicales impliquant les hernies primaires de la paroi abdominale et les hernies incisionnelles. 
Le renfort en polyester tridimensionnel non résorbable permet le renforcement à long terme des tissus mous. Sur la face opposée, le ﬁlm hydrophile 
résorbable réduit les phénomènes d’adhérence pouvant survenir entre la prothèse et les tissus en cas de contact direct avec les viscères.
CONTRE INDICATIONS
t$PNNFMFSFOGPSU4ZNCPUFYDPNQPTJUFOFTBMMPOHFSBQBTBWFDMBDSPJTTBODFTPOVUJMJTBUJPOOFTUQBTBQQSPQSJée chez les patients en période de 
croissance.
t5PVUNBUériau étranger est susceptible de provoquer ou de prolonger une infection en présence d’une contamination bactérienne et, de ce fait, l’utilisation 
du renfort Symbotex™ composite peut ne pas convenir en cas d’intervention en site infecté ou contaminé. De plus, ce produit doit être utilisé en sachant que 
l’infection peut nécessiter le retrait du dispositif.
COMPLICATIONS EVENTUELLES
Les éventuelles complications associées à l’utilisation du renfort Symbotex™ composite sont celles classiquement associées à l’implantation d’un renfort 
chirurgical: sérome, hématome, récidive, adhérence, formation de ﬁstules, infection, inﬂammation, douleur chronique, et/ou réactions allergiques aux 
constituants du produit.
L’état de l’art des renforts utilisés conformément à l’indication, établie que les évènements suivants peuvent se produire : dommages aux organes (tels 
que dommages aux intestins et aux viscères), hernies de trocart, occlusion intestinale et rétention urinaire (qui peut se produire lors de l’utilisation 
d’anesthésiques).
AVERTISSEMENTS
1. Pour prévenir toute blessure, une attention particulière est requise lors de la ﬁxation du dispositif en présence de nerfs ou de vaisseaux.
2. Aﬁn de préserver l’élasticité et la porosité du renfort, il est recommandé de ne pas le tendre exagérément au moment de la pose. La tension doit être 
modérée et équivalente dans toutes les directions pour ﬁxer le renfort aﬁn de tenir compte de la rétraction de plaie lors de la cicatrisation.
3. Le renfort doit être utilisé tel que livré sans découpe ultérieure. 
4. L’eﬃcacité et la sécurité relatives à l’utilisation de ce dispositif chez la femme enceinte n’ont pas été établies. Pour les femmes en âge de mener une 
grossesse, le chirurgien doit être attentif au fait que le dispositif ne s’allongera pas de manière signiﬁcative lors de la croissance survenant lors de la 
grossesse.
5. Le dispositif est livré sous emballage stérile. Vériﬁer l’intégrité de l’emballage avant toute utilisation. Ne pas utiliser le dispositif si l’emballage est ouvert 
ou endommagé.
6. Le dispositif se présente sous double emballage stérile. Il est recommandé de n’ouvrir le dernier emballage qu’au moment de la mise en place du renfort 
et de manipuler celui-ci à l’aide de gants et d’instruments non souillés.
7. Le renfort Symbotex™ composite a été conçu pour être utilisé uniquement par voie ouverte.
PRECAUTIONS D’EMPLOI
Les utilisateurs doivent être familiers des procédures et techniques chirurgicales impliquant l’utilisation de renforts chirurgicaux avant d’utiliser le dispositif. 
Ce dispositif est réservé aux praticiens spécialistes qui l’utilisent sous leur seule responsabilité.
1    VUE SCHéMATIQUE
A) RABAT TEXTILE BIDIMENSIONNEL POLYESTER VERT
B) TEXTILE TRIDIMENSIONNEL POLYESTER MONOFILAMENT
C) FILM À BASE DE COLLAGÈNE ET DE GLYCÉROL
INTERVENTIONS  MISE EN PLACE
1. Avant toute manipulation, le renfort Symbotex™ composite doit être hydraté dans son emballage d’origine par immersion complète, quelques secondes 
dans une solution physiologique stérile aﬁn de restituer au renfort sa conformabilité et sa souplesse.
2. Au moment de la mise en place, il est indispensable de repérer parfaitement la face du ﬁlm de la face poreuse du textile, de façon à correctement 
l’orienter : la face poreuse du textile contre la paroi pour une intégration tissulaire / la face du ﬁlm en regard des structures pour lesquelles on souhaite 
limiter les adhérences tissulaires.
3. Le rabat textile vert présent sur la face textile facilite le positionnement et la ﬁxation du renfort.
4. Après avoir positionné le renfort, il faut s’assurer qu’aucun tissu n’est inséré entre le renfort et la paroi abdominale.
5. Le renfort doit déborder de 2 à 5 cm les berges du ou des oriﬁce(s). La technique de ﬁxation du renfort (sutures ou agrafes) est laissée au choix du 
praticien. Les moyens de ﬁxation doivent être placés sur le rabat vert aussi près que possible du pourtour du renfort.
NOTE : une attention particulière doit être apportée aﬁn de ne pas ﬁxer sur le ﬁlm.
MODE DE STERILISATION
Dispositif stérile à usage unique. Stérilisé par irradiation gamma .Ne pas restériliser.
CONSERVATION
Conditions de stockage recommandées : température ambiante.
Ne pas utiliser le dispositif au-delà du dernier jour du mois d’expiration ﬁgurant sur l’étiquette.
A réception du dispositif, s’assurer que le conditionnement n’a été ni ouvert ni endommagé et conserve intègre son scellage. Ne pas utiliser le dispositif si 
l’emballage présente un défaut d’intégrité pouvant compromettre la stérilité.
TRACABILITE
Une étiquette de traçabilité identiﬁant le type et le numéro de lot du dispositif est jointe à chaque emballage de dispositif. Cette étiquette est destinée à être 
collée sur le dossier médical permanent du patient aﬁn de clairement identiﬁer le dispositif implanté.
Marquage CE initial: 2014
Symbotex™ 
Composite Mesh 
(99)7500074
1074068
A
B C
EN
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for 
single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this 
device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
Symbotex™ composite mesh is made out of a three-dimensional monoﬁlament polyester textile, which is covered with an absorbable, continuous and 
hydrophilic ﬁlm on one of its sides. This ﬁlm is made up of a mix of collagen from porcine origin and glycerol. The collagen ﬁlm is essentially degraded in 
less than 1 month.
A dyed (D&C Green No. 6) bi-dimensional monoﬁlament polyester textile ﬂap is attached to the three-dimensional reinforcement and helps place and ﬁx 
the mesh.
INDICATIONS
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary 
abdominal wall and incisional hernia surgeries.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic 
ﬁlm minimizes tissue attachment to the mesh in case of direct contact with the viscera.
CONTRAINDICATIONS
t"T4ZNCPUFYDPNQPTJUFNFTIXJMMOPUTUSFUDIUPBDDPNNPEBUFHSPXUIJUTVTFJTOPUBQQSPQSJBUFJOQBUJFOUTJOBQFSJPEPGHSPXUI
t"OZGPSFJHONBUFSJBMNBZQPUFOUJBUFPSQSPMPOHJOGFDUJPOJOUIFQSFTFODFPGCBDUFSJBMDPOUBNJOBUJPOBOEBTTVDIUIFVTFPG4ZNCPUFYDPNQPTJUFNFTI
is not appropriate in an infected or contaminated site. Furthermore, this product should be used with the understanding that infection may require removal 
of the device.
POSSIBLE COMPLICATIONS
The possible complications associated with the use of Symbotex™ composite mesh are those typically associated with surgically implantable mesh: seroma, 
hematoma, recurrence, adhesions, ﬁstula formation, infection, inﬂammation, chronic pain, and/or allergic reactions to the components of the product.
Potential events associated with state of the art mesh with similar indication may include: organ injury (including bowel and visceral injury), trocar-site 
herniation, bowel obstruction and urinary retention (related with the use of anesthetics).
WARNINGS 
1. To avoid injury, exercise caution if ﬁxating the device in the presence of nerves or vessels.
2. In order to maintain the elasticity and the porosity of the reinforcement, it is recommended that the mesh should not be overly stretched when it is 
being put in place. A moderate and equal tension should be applied in all directions for ﬁxation in order to account for wound shrinkage during the healing 
process.
3. The mesh should be used in the form in which it is provided without being cut.
4. The eﬀectiveness and safety related to the use of this device in pregnant women have not been established. For women planning future pregnancies, the 
surgeon should be aware that this product will not stretch signiﬁcantly as the patient grows.
5. The device is provided in a sterile packaging. The packaging is to be checked for any damage before use. Do not use the mesh if the packaging is opened 
or damaged.
6. The device is provided in a double sterile packaging. It is recommended to open the last packaging only for the placement of the mesh and to handle the 
latter using clean gloves and instruments.
7. Symbotex™ composite mesh is designed to be used in open approach only.
PRECAUTIONS
Users should be familiar with surgical procedures and techniques involving the use of surgical mesh before employing this device.
This device should only be used by experienced practitioners who do so under their own responsibility.
1   SCHEMATIC VIEW
A) BI-DIMENSIONAL MONOFILAMENT POLYESTER GREEN FLAP
B) THREE-DIMENSIONAL MONOFILAMENT POLYESTER TEXTILE
C) FILM MADE OF COLLAGEN AND GLYCEROL
OPERATING STEPS  POSITIONING 
1. Symbotex™ composite mesh should be hydrated in its original blister before being handled. This is carried out by immersing it completely in a sterile 
saline solution for several seconds to ensure its conformability and ﬂexibility.
2. When putting it in place, it is essential to identify the ﬁlm side from the porous textile side in order to situate the device correctly: the porous textile side is 
placed against the wall for tissue integration while the ﬁlm side is facing the structures on which the tissue attachment is to be limited.
3. The green ﬂap attached to the textile side helps place and ﬁx the mesh.
4. After placement of the mesh, ensure that no tissue is trapped between the mesh and the abdominal wall.
5. The edge of the reinforcement should extend 2 to 5 cm over the edge of the defect(s) on all sides. The technique used to anchor the mesh (suture or 
staples) is left up to the practitioner. Place ﬁxation means in the green ﬂap as close as possible to the mesh periphery.
NOTE: Careful attention should be paid not to ﬁxate on the ﬁlm.
STERILIZATION TECHNIQUE
Sterile single-use device. Sterilized by gamma radiation. Do not re-sterilize.

© 2013 Covidien.
         Sofradim Production, 116, avenue du Formans-01600 Trévoux-France.
www.covidien.com
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands 
are trademarks of a Covidien company, ™* brands are trademarks of their respective owner. 
Made in France. 2014/02 - 3
Single use
0459
Caution, consult
accompanying
documents
Do not 
resterilize
Do not use if package is opened or damaged. / Ne pas utiliser en cas d’endommagement ou d’ouverture de l’emballage.

6. Symbotex™ composite mesh can be trimmed to the desired size without impairment to the minimizing tissue attachment properties of the ﬁlm.
NOTE: The green textile marking should not be cut. It may no longer be centered and could lose its functions if the mesh is 
trimmed.
STERILIZATION TECHNIQUE
Sterile single-use device. Sterilized by gamma radiation. Do not re-sterilize.
STORAGE
Recommended storage conditions: room temperature.
Do not use the device past the last day of the labeled month of expiration.
Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if theintegrity of the 
packaging appears compromised.
TRACEABILITY
A traceability label is attached to every device package which identiﬁes the type and lot number of the device. This label should be aﬃxed to the patient’s 
permanent medical record to clearly identify the device which was implanted.
FR
Renfort Composite
AVANT D’UTILISER CE PRODUIT, LIRE ATTENTIVEMENT LES INFORMATIONS CI-DESSOUS.
IMPORTANT !
Cette notice est destinée à faciliter l’utilisation de ce produit. Elle ne constitue pas une référence en matière de techniques chirurgicales. Ce dispositif a été 
conçu, testé et fabriqué pour un usage chez un seul patient. Sa réutilisation ou son retraitement peut provoquer un dysfonctionnement et des blessures 
chez le patient. Son retraitement et/ou sa restérilisation peuvent entrainer un risque de contamination et d’infection du patient. Ne pas réutiliser, retraiter 
ou restériliser ce dispositif.
DESCRIPTION
Le renfort Symbotex™ composite est constitué d’un textile tridimensionnel en polyester monoﬁlament recouvert sur une face, par un ﬁlm hydrophile, 
continu et résorbable à base de collagène d’origine porcine et de glycérol. Le ﬁlm de collagène est essentiellement résorbé en moins d’un mois. 
Un marquage en polyester monoﬁlament de couleur verte (D&C Green No. 6) est placé au centre du textile, sur la face opposée du ﬁlm, et aide à centrer et 
à orienter le renfort.
INDICATIONS
Le renfort Symbotex™ composite est utilisé pour le renforcement des tissus mous de la paroi abdominale en présence d’une faiblesse, dans les procédures 
chirurgicales impliquant les hernies primaires de la paroi abdominale et les hernies incisionnelles. 
Le renfort en polyester tridimensionnel non résorbable permet le renforcement à long terme des tissus mous. Sur la face opposée, le ﬁlm hydrophile 
résorbable réduit les phénomènes d’adhérence pouvant survenir entre la prothèse et les tissus en cas de contact direct avec les viscères.
CONTRE INDICATIONS
t$PNNFMFSFOGPSU4ZNCPUFYDPNQPTJUFOFTBMMPOHFSBQBTBWFDMBDSPJTTBODFTPOVUJMJTBUJPOOFTUQBTBQQSPQSJée chez les patients en période de 
croissance.
t5PVUNBUériau étranger est susceptible de provoquer ou de prolonger une infection en présence d’une contamination bactérienne et, de ce fait, l’utilisation 
du renfort Symbotex™ composite peut ne pas convenir en cas d’intervention en site infecté ou contaminé. De plus, ce produit doit être utilisé en sachant que 
l’infection peut nécessiter le retrait du dispositif.
COMPLICATIONS EVENTUELLES
 Les éventuelles complications associées à l’utilisation du renfort Symbotex™ composite sont celles classiquement associées à l’implantation d’un renfort 
chirurgical: sérome, hématome, récidive, adhérence, formation de ﬁstules, infection, inﬂammation, douleur chronique et réactions allergiques aux 
constituants du produit.
L’état de l’art des renforts utilisés conformément à l’indication, établie que les évènements suivants peuvent se produire : dommages aux organes (tels 
que dommages aux intestins et aux viscères), hernies de trocart, occlusion intestinale et rétention urinaire (qui peut se produire lors de l’utilisation 
d’anesthésiques).
AVERTISSEMENTS
1. Pour prévenir toute blessure, une attention particulière est requise lors de la ﬁxation du dispositif en présence de nerfs ou de vaisseaux.
2. Aﬁn de préserver l’élasticité et la porosité du renfort, il est recommandé de ne pas le tendre exagérément au moment de la pose. La tension doit être 
modérée et équivalente dans toutes les directions pour ﬁxer le renfort aﬁn de tenir compte de la rétraction de plaie lors de la cicatrisation.
3. Une attention particulière doit être apportée pour ne pas découper le marquage vert. En cas de découpe du renfort, il se peut que le marquage ne soit 
plus centré et ne conserve pas ses fonctionnalités.
4. L’eﬃcacité et la sécurité relatives à l’utilisation de ce dispositif chez la femme enceinte n’ont pas été établies. Pour les femmes en âge de mener une 
grossesse, le chirurgien doit être attentif au fait que le dispositif ne s’allongera pas de manière signiﬁcative lors de la croissance survenant lors de la 
grossesse.
5. Le dispositif est livré sous emballage stérile. Vériﬁer l’intégrité de l’emballage avant toute utilisation. Ne pas utiliser le dispositif si l’emballage est ouvert 
ou endommagé.
6. Le dispositif se présente sous double emballage stérile. Il est recommandé de n’ouvrir le dernier emballage qu’au moment de la mise en place du renfort 
et de manipuler celui-ci à l’aide de gants et d’instruments non souillés.
PRECAUTIONS D’EMPLOI
Les utilisateurs doivent être familiers des procédures et techniques chirurgicales impliquant l’utilisation de renforts chirurgicaux avant d’utiliser le dispositif. 
Ce dispositif est réservé aux praticiens spécialistes qui l’utilisent sous leur seule responsabilité.
1   VUE SCHÉMATIQUE
A) MARQUAGE VERT EN TEXTILE POLYESTER
B) TEXTILE TRIDIMENSIONNEL POLYESTER MONOFILAMENT
C) FILM À BASE DE COLLAGÈNE ET DE GLYCÉROL
INTERVENTIONS  MISE EN PLACE
1. Avant toute manipulation, le renfort Symbotex™ composite doit être hydraté dans son emballage d’origine par immersion complète, quelques secondes 
dans une solution physiologique stérile aﬁn de restituer au renfort sa conformabilité et sa souplesse.
2. Au moment de la mise en place, il est indispensable de repérer parfaitement la face du ﬁlm de la face poreuse du textile, de façon à correctement 
l’orienter : la face poreuse du textile contre la paroi pour une intégration tissulaire / la face du ﬁlm en regard des structures pour lesquelles on souhaite 
limiter les adhérences tissulaires.
3. Le marquage vert est placé contre la paroi abdominale. Il devrait être visible à travers le renfort composite. La partie circulaire du marquage sera centré 
sur l’oriﬁce, la partie triangulaire devra être alignée par rapport à la ligne médiale du corps.
4. Dans le cas d’une utilisation par voie laparoscopique, le renfort Symbotex™ composite doit être roulé après hydratation, face ﬁlm orientée vers l’intérieur, 
de façon à protéger le ﬁlm lors du passage dans le trocart. 
5. Le renfort doit déborder d’au moins 5 cm les berges du ou des oriﬁce(s). La technique de ﬁxation du renfort (sutures ou agrafes) est laissée au choix du 
praticien. Il est recommandé de ﬁxer le renfort à une distance d’environ 1 cm du bord du renfort.
6. Le renfort Symbotex™ composite peut être découpé à la taille désirée, sans perte de la propriété de minimisation des adhérences du ﬁlm.
NOTE : Le marquage vert ne devra pas être découpé. En cas de découpe du renfort, il se peut que le marquage ne soit plus 
centré et ne conserve pas ses fonctionnalités.
MODE DE STERILISATION
Dispositif stérile à usage unique. Stérilisé par irradiation gamma. Ne pas restériliser.
Symbotex™ 
Composite Mesh
(99)7500072
1074070
A
B
C
EN
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for 
single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this 
device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
Symbotex™ composite mesh is made out of a three-dimensional monoﬁlament polyester textile, which is covered with an absorbable, continuous and 
hydrophilic ﬁlm on one of its sides. This ﬁlm is made up of a mix of collagen from porcine origin and glycerol. The collagen ﬁlm is essentially degraded in 
less than 1 month.
A dyed monoﬁlament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the ﬁlm, and helps center and 
orient the mesh.
INDICATIONS
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary 
abdominal wall and incisional hernia surgeries.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic 
ﬁlm minimizes tissue attachment to the mesh in case of direct contact with the viscera.
CONTRAINDICATIONS
t"T4ZNCPUFYDPNQPTJUFNFTIXJMMOPUTUSFUDIUPBDDPNNPEBUFHSPXUIJUTVTFJTOPUBQQSPQSJBUFJOQBUJFOUTJOBQFSJPEPGHSPXUI
t"OZGPSFJHONBUFSJBMNBZQPUFOUJBUFPSQSPMPOHJOGFDUJPOJOUIFQSFTFODFPGCBDUFSJBMDPOUBNJOBUJPOBOEBTTVDIUIFVTFPG4ZNCPUFYDPNQPTJUFNFTI
is not appropriate in an infected or contaminated site.  Furthermore, this product should be used with the understanding that infection may require removal 
of the device.
POSSIBLE COMPLICATIONS
The possible complications associated with the use of Symbotex™ composite mesh are those typically associated with surgically implantable mesh: seroma, 
hematoma, recurrence, adhesions, ﬁstula formation, infection, inﬂammation, chronic pain, and/or allergic reactions to the components of the product.
Potential events associated with state of the art mesh with similar indication may include: organ injury (including bowel and visceral injury), trocar-site 
herniation, bowel obstruction and urinary retention (related with the use of anesthetics).
WARNINGS 
1. To avoid injury, exercise caution if ﬁxating the device in the presence of nerves or vessels.
2. In order to maintain the elasticity and the porosity of the reinforcement, it is recommended that the mesh should not be overly stretched when it is 
being put in place. A moderate and equal tension should be applied in all directions for ﬁxation in order to account for wound shrinkage during the healing 
process.
3. Particular attention should be paid not to cut the green marking. It may no longer be centered and lose its functions if the mesh is trimmed.
4. The eﬀectiveness and safety related to the use of this device in pregnant women have not been established. For women planning future pregnancies, the 
surgeon should be aware that this product will not stretch signiﬁcantly as the patient grows.
5. The device is provided in a sterile packaging. The packaging is to be checked for any damage before use. Do not use the mesh if the packaging is opened 
or damaged.
6. The device is provided in a double sterile packaging. It is recommended to open the last packaging only for the placement of the mesh and to handle the 
latter using clean gloves and instruments.
PRECAUTIONS
Users should be familiar with surgical procedures and techniques involving the use of surgical mesh before employing this device.
This device should only be used by experienced practitioners who do so under their own responsibility.
1   SCHEMATIC VIEW
A) GREEN COLORED POLYESTER MARKING
B) THREE-DIMENSIONAL MONOFILAMENT POLYESTER TEXTILE
C) FILM MADE OF COLLAGEN AND GLYCEROL
OPERATING STEPS  POSITIONING
1. Symbotex™ composite mesh should be hydrated in its original blister before being handled. This is carried out by immersing it completely in a sterile 
saline solution for several seconds to ensure its conformability and ﬂexibility.
2. When putting it in place, it is essential to perfectly diﬀerentiate the ﬁlm side from the porous textile side in order to situate the device correctly: the porous 
textile side is placed against the wall for tissue integration while the ﬁlm side is facing the structures on which the tissular attachment is to be limited.
3. The green marking is then placed against the abdominal wall. It should be visible through the composite mesh. The circular portion of the marking 
should be centered on the defect, while the triangular portion shall indicate the orientation of the mesh in order to correctly align it to the medial line of 
the body.
4. Should it be used in a laparoscopic approach, Symbotex™ composite mesh is to be rolled after hydration, with the ﬁlm facing inside. The ﬁlm is then 
protected when inserted in the trocar.
5. The edge of the reinforcement should be at least 5 cm over the edges of the defect(s). The technique used to anchor the mesh (suture or staples) is left up 
to the practitioner. It is suggested to ﬁxate the mesh at a distance approximately 1cm from the edge of the mesh.

© 2013 Covidien.
         Sofradim Production, 116, avenue du Formans-01600 Trévoux-France.
www.covidien.com
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands 
are trademarks of a Covidien company, ™* brands are trademarks of their respective owner. 
Made in France. 2014/02 - 2
Single use
0459
Caution, consult
accompanying
documents
Do not 
resterilize
Do not use if package is opened or damaged. / Ne pas utiliser en cas d’endommagement ou d’ouverture de l’emballage.
CONSERVATION
Conditions de stockage recommandées : température ambiante.
Ne pas utiliser le dispositif au-delà du dernier jour du mois d’expiration ﬁgurant sur l’étiquette.
A réception du dispositif, s’assurer que le conditionnement n’a été ni ouvert ni endommagé et conserve intègre son scellage. Ne pas utiliser le dispositif si 
l’emballage présente un défaut d’intégrité pouvant compromettre la stérilité.
TRACABILITE
Une étiquette de traçabilité identiﬁant le type et le numéro de lot du dispositif est jointe à chaque emballage de dispositif. Cette étiquette est destinée à être 
collée sur le dossier médical permanent du patient aﬁn de clairement identiﬁer le dispositif implanté.
Marquage CE initial: 2014

6. The edge of the reinforcement should be at least 5 cm over the edges of the defect(s). The technique used to anchor the mesh (suture or staples) is left up 
to the practitioner. It is suggested to ﬁxate the mesh at a distance of approximately 1cm from the edge of the mesh.
7. Symbotex™ composite mesh can be trimmed to the desired size without impairment to the minimizing tissue attachment properties of the ﬁlm.
NOTE: The green textile marking should not be cut. It may no longer be centered and could lose its functions if the mesh is 
trimmed.
STERILIZATION TECHNIQUE
Sterile single-use device. Sterilized by gamma radiation. Do not re-sterilize.
STORAGE
Recommended storage conditions: room temperature.
Do not use the device past the last day of the labeled month of expiration.
Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if theintegrity of the 
packaging appears compromised.
TRACEABILITY
A traceability label is attached to every device package which identiﬁes the type and lot number of the device. This label should be aﬃxed to the patient’s 
permanent medical record to clearly identify the device which was implanted.
FR
Renfort Composite
AVANT D’UTILISER CE PRODUIT, LIRE ATTENTIVEMENT LES INFORMATIONS CI-DESSOUS.
IMPORTANT !
Cette notice est destinée à faciliter l’utilisation de ce produit. Elle ne constitue pas une référence en matière de techniques chirurgicales. Ce dispositif a été 
conçu, testé et fabriqué pour un usage chez un seul patient. Sa réutilisation ou son retraitement peut provoquer un dysfonctionnement et des blessures 
chez le patient. Son retraitement et/ou sa restérilisation peuvent entrainer un risque de contamination et d’infection du patient. Ne pas réutiliser, retraiter 
ou restériliser ce dispositif.
DESCRIPTION
Le renfort Symbotex™ composite est constitué d’un textile tridimensionnel en polyester monoﬁlament recouvert sur une face, par un ﬁlm hydrophile, 
continu et résorbable à base de collagène d’origine porcine et de glycérol. Le ﬁlm de collagène est essentiellement résorbé en moins d’un mois. 
Des ﬁls de suture pré-placés, non résorbables, sont accrochés au renfort tridimensionnel.
Un marquage en polyester monoﬁlament de couleur verte (D&C Green No. 6) est placé au centre du textile, sur la face opposée du ﬁlm, et aide à centrer et 
à orienter le renfort.
INDICATIONS
Le renfort Symbotex™ composite est utilisé pour le renforcement des tissus mous de la paroi abdominale en présence d’une faiblesse, dans les procédures 
chirurgicales impliquant les hernies primaires de la paroi abdominale et les hernies incisionnelles. 
Le renfort en polyester tridimensionnel non résorbable permet le renforcement à long terme des tissus mous. Sur la face opposée, le ﬁlm hydrophile 
résorbable réduit les phénomènes d’adhérence pouvant survenir entre la prothèse et les tissus en cas de contact direct avec les viscères.
CONTRE INDICATIONS
t$PNNFMFSFOGPSU4ZNCPUFYDPNQPTJUFOFTBMMPOHFSBQBTBWFDMBDSPJTTBODFTPOVUJMJTBUJPOOFTUQBTBQQSPQSJée chez les patients en période de 
croissance.
t5PVUNBUériau étranger est susceptible de provoquer ou de prolonger une infection en présence d’une contamination bactérienne et, de ce fait, l’utilisation 
du renfort Symbotex™ composite peut ne pas convenir en cas d’intervention en site infecté ou contaminé. De plus, ce produit doit être utilisé en sachant que 
l’infection peut nécessiter le retrait du dispositif.
COMPLICATIONS EVENTUELLES
Les éventuelles complications associées à l’utilisation du renfort Symbotex™ composite sont celles classiquement associées à l’implantation d’un renfort 
chirurgical: sérome, hématome, récidive, adhérence, formation de ﬁstules, infection, inﬂammation, douleur chronique, et/ou réactions allergiques aux 
constituants du produit.
L’état de l’art des renforts utilisés conformément à l’indication, établie que les évènements suivants peuvent se produire : dommages aux organes (tels 
que dommages aux intestins et aux viscères), hernies de trocart, occlusion intestinale et rétention urinaire (qui peut se produire lors de l’utilisation 
d’anesthésiques).
AVERTISSEMENTS
1. Pour prévenir toute blessure, une attention particulière est requise lors de la ﬁxation du dispositif en présence de nerfs ou de vaisseaux.
2. Aﬁn de préserver l’élasticité et la porosité du renfort, il est recommandé de ne pas le tendre exagérément au moment de la pose. La tension doit être 
modérée et équivalente dans toutes les directions pour ﬁxer le renfort aﬁn de tenir compte de la rétraction de plaie lors de la cicatrisation.
3. Une attention particulière doit être apportée pour ne pas découper le marquage vert. En cas de découpe du renfort, il se peut que le marquage ne soit 
plus centré et ne conserve pas ses fonctionnalités. 
4. L’eﬃcacité et la sécurité relatives à l’utilisation de ce dispositif chez la femme enceinte n’ont pas été établies. Pour les femmes en âge de mener une 
grossesse, le chirurgien doit être attentif au fait que le dispositif ne s’allongera pas de manière signiﬁcative lors de la croissance survenant lors de la 
grossesse.
5. Le dispositif est livré sous emballage stérile. Vériﬁer l’intégrité de l’emballage avant toute utilisation. Ne pas utiliser le dispositif si l’emballage est ouvert 
ou endommagé.
6. Le dispositif se présente sous double emballage stérile. Il est recommandé de n’ouvrir le dernier emballage qu’au moment de la mise en place du renfort 
et de manipuler celui-ci à l’aide de gants et d’instruments non souillés.
PRECAUTIONS D’EMPLOI
Les utilisateurs doivent être familiers des procédures et techniques chirurgicales impliquant l’utilisation de renforts chirurgicaux avant d’utiliser le dispositif. 
Ce dispositif est réservé aux praticiens spécialistes qui l’utilisent sous leur seule responsabilité.
1   VUE SCHÉMATIQUE
A) MARQUAGE VERT EN TEXTILE POLYESTER
B) TEXTILE TRIDIMENSIONNEL POLYESTER MONOFILAMENT
C) FILM À BASE DE COLLAGÈNE ET DE GLYCÉROL
INTERVENTIONS  MISE EN PLACE
1. Avant toute manipulation, le renfort Symbotex™ composite doit être hydraté dans son emballage d’origine par immersion complète, quelques secondes 
dans une solution physiologique stérile aﬁn de restituer au renfort sa conformabilité et sa souplesse.
2. Au moment de la mise en place, il est indispensable de repérer parfaitement la face du ﬁlm de la face poreuse du textile, de façon à correctement 
l’orienter : la face poreuse du textile contre la paroi pour une intégration tissulaire / la face du ﬁlm en regard des structures pour lesquelles on souhaite 
limiter les adhérences tissulaires.
3. Le marquage vert est placé contre la paroi abdominale. Il devrait être visible à travers le renfort composite. La partie circulaire du marquage sera centrée 
sur l’oriﬁce, la partie triangulaire devra être alignée par rapport à la ligne médiale du corps.
4. Dans le cas d’une utilisation par voie laparoscopique, le renfort Symbotex™ composite doit être roulé après hydratation, face ﬁlm orientée vers l’intérieur, 
de façon à protéger le ﬁlm lors du passage dans le trocart.
5. Les ﬁls de couleur placés sur la face textile aident à la manipulation du renfort une fois déroulé dans la cavité abdominale. Ces ﬁls permettent de repérer 
plus facilement la face textile du renfort. Ils peuvent servir à la ﬁxation transpariétale du renfort.
6. Le renfort doit déborder d’au moins 5 cm les berges du ou des oriﬁce(s). La technique de ﬁxation du renfort (sutures ou agrafes) est laissée au choix du 
praticien. Il est recommandé de ﬁxer le renfort à une distance d’environ 1cm du bord du renfort.
7. Le renfort Symbotex™ composite peut être découpé à la taille désirée, sans perte de la propriété de minimisation des adhérences du ﬁlm.
NOTE : Le marquage vert ne devra pas être découpé. En cas de découpe du renfort, il se peut que le marquage ne soit plus 
centré et ne conserve pas ses fonctionnalités.
Symbotex™ 
Composite Mesh 
(99)7500073
1074069
A
B
C
EN
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for 
single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this 
device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.
DESCRIPTION
Symbotex™ composite mesh is made out of a three-dimensional monoﬁlament polyester textile, which is covered with an absorbable, continuous and 
hydrophilic ﬁlm on one of its sides. This ﬁlm is made up of a mix of collagen from porcine origin and glycerol. The collagen ﬁlm is essentially degraded in 
less than 1 month.
Non-absorbable pre-placed sutures are tied to the three-dimensional mesh.
A dyed monoﬁlament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the ﬁlm, and helps center and 
orient the mesh.
INDICATIONS
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary 
abdominal wall and incisional hernia surgeries.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic 
ﬁlm minimizes tissue attachment to the mesh in case of direct contact with the viscera.
CONTRAINDICATIONS
t"T4ZNCPUFYDPNQPTJUFNFTIXJMMOPUTUSFUDIUPBDDPNNPEBUFHSPXUIJUTVTFJTOPUBQQSPQSJBUFJOQBUJFOUTJOBQFSJPEPGHSPXUI
t"OZGPSFJHONBUFSJBMNBZQPUFOUJBUFPSQSPMPOHJOGFDUJPOJOUIFQSFTFODFPGCBDUFSJBMDPOUBNJOBUJPOBOEBTTVDIUIFVTFPG4ZNCPUFYDPNQPTJUFNFTI
is not appropriate in an infected or contaminated site. Furthermore, this product should be used with the understanding that infection may require removal 
of the device.
POSSIBLE COMPLICATIONS
The possible complications associated with the use of Symbotex™ composite mesh are those typically associated with surgically implantable mesh: seroma, 
hematoma, recurrence, adhesions, ﬁstula formation, infection, inﬂammation, chronic pain, and/or allergic reactions to the components of the product.
Potential events associated with state of the art mesh with similar indication may include: organ injury (including bowel and visceral injury), trocar-site 
herniation, bowel obstruction and urinary retention (related with the use of anesthetics).
WARNINGS 
1. To avoid injury, exercise caution if ﬁxating the device in the presence of nerves or vessels.
2. In order to maintain the elasticity and the porosity of the reinforcement, it is recommended that the mesh should not be overly stretched when it is 
being put in place. A moderate and equal tension should be applied in all directions for ﬁxation in order to account for wound shrinkage during the healing 
process.
3. Particular attention should be paid not to cut the green marking.  It may no longer be centered and lose its functions if the mesh is trimmed.
4. The eﬀectiveness and safety related to the use of this device in pregnant women have not been established. For women planning future pregnancies, the 
surgeon should be aware that this product will not stretch signiﬁcantly as the patient grows.
5. The device is provided in a sterile packaging. The packaging is to be checked for any damage before use. Do not use the mesh if the packaging is opened 
or damaged.
6. The device is provided in a double sterile packaging. It is recommended to open the last packaging only for the placement of the mesh and to handle the 
latter using clean gloves and instruments. 
PRECAUTIONS
Users should be familiar with surgical procedures and techniques involving the use of surgical mesh before employing this device.
This device should only be used by experienced practitioners who do so under their own responsibility.
1   SCHEMATIC VIEW
A) GREEN COLORED POLYESTER MARKING
B) THREE-DIMENSIONAL MONOFILAMENT POLYESTER TEXTILE
C) FILM MADE OF COLLAGEN AND GLYCEROL
OPERATING STEPS  POSITIONING
1. Symbotex™ composite should be hydrated in its original blister before being handled. This is carried out by immersing it completely in a sterile saline 
solution for several seconds to ensure its conformability and ﬂexibility.
2. When putting it in place, it is essential to perfectly diﬀerentiate the ﬁlm side from the porous textile side in order to situate the device correctly: the porous 
textile side is placed against the wall for tissue integration while the ﬁlm side is facing the structures on which the tissular attachment is to be limited.
3. The green marking is then placed against the abdominal wall. It should be visible through the composite mesh. The circular portion of the marking 
should be centered on the defect, while the triangular portion shall indicate the orientation of the mesh in order to correctly align it to the medial line of 
the body.
4. Should it be used in a laparoscopic approach, Symbotex™ composite mesh is to be rolled after hydration, with the ﬁlm facing the inside. The ﬁlm is then 
protected when inserted in the trocar.
5. The pre-placed sutures are positioned on the textile side to help with the mesh handling once it is unrolled in the abdominal cavity. These yarns allow to 
easily pinpoint the mesh textile side. They can be used for the transparietal ﬁxation of the mesh.

© 2013 Covidien.
         Sofradim Production, 116, avenue du Formans-01600 Trévoux-France.
www.covidien.com
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. Other brands 
are trademarks of a Covidien company, ™* brands are trademarks of their respective owner. 
Made in France. 2014/02 - 2
Single use
0459
Caution, consult
accompanying
documents
Do not 
resterilize
Do not use if package is opened or damaged. / Ne pas utiliser en cas d’endommagement ou d’ouverture de l’emballage.
MODE DE STERILISATION
Dispositif stérile à usage unique. Stérilisé par irradiation gamma. Ne pas restériliser.
CONSERVATION
Conditions de stockage recommandées : température ambiante.
Ne pas utiliser le dispositif au-delà du dernier jour du mois d’expiration ﬁgurant sur l’étiquette.
A réception du dispositif, s’assurer que le conditionnement n’a été ni ouvert ni endommagé et conserve intègre son scellage. Ne pas utiliser le dispositif si 
l’emballage présente un défaut d’intégrité pouvant compromettre la stérilité.
TRACABILITE
Une étiquette de traçabilité identiﬁant le type et le numéro de lot du dispositif est jointe à chaque emballage de dispositif. Cette étiquette est destinée à être 
collée sur le dossier médical permanent du patient aﬁn de clairement identiﬁer le dispositif implanté.
Marquage CE initial: 2014

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
Protocol number: COVSYMB0441 
 
 
 
Page 17 of 19 
APPENDIX C    
 
Quality of Life and patient satisfaction Questionnaire 
  
 At 1 month (D30 Follow up) 
 
1- Do you currently feel post-operative discomfort? 
-No  
-Discomfort 
-“Pins and needles” 
-Loss of sensation 
-Moderate pain 
-Severe pain 
-Other symptoms (please specify) 
 
2-  Where are these symptoms located?  
-Several possible answers:  
-Operated side 
-Scar region 
-Other side 
-Both sides 
-Elsewhere (specify)  
 
3- When exactly do you feel these symptoms? 
-Several possible answers:  
-During lifting, coughing or pushing 
-During others types of effort (please specify) 
-After physical effort or and the end of the day 
-At any other particular time (please specify)  
-At any time 
 
4- How often do you feel them? 
-Rarely 
-several time a week 
-Several time a day 
-Throughout the day 
-24/24h 
 
5- The symptoms felt: 
-Do not hinder your activities 
-Allow you to pursue your activities but at a slower pace 

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014- 
Protocol number: COVSYMB0441 
 
Page 18 of 19 
-Cause temporary interruption in your activities 
-Prevent certain activities (which one?) 
 
6- These symptoms 
-Are more of a nuisance than those of the hernia you previously had 
-Are less of a nuisance than those of the hernia you previously had 
 
 
 At 1 Year and 2 Year Follow up  
 
1- Since your surgery does your abdomen seems:  
-firm  
-not firm 
 
2- Do you have a new hernia or bulge?  
-No  
-yes (if so Operated side; Scar region; other side; both side, elsewhere (specify) 
 
3- Do you currently feel any post-operative discomfort? 
-No  
-Discomfort 
-“Pins and needles” 
-Loss of sensation 
-Moderate pain 
-Severe pain 
-Other symptoms (please specify) 
 
4-  Where are these symptoms located?  
-Several possible answers:  
-Operated side 
-Scar region 
-Other side 
-Both sides 
-Elsewhere (specify)  
 
5- When exactly do you feel these symptoms? 
-Several possible answers:  
-During lifting, coughing or pushing 
-During others types of effort (please specify) 
-After physical effort or and the end of the day 
-At any other particular time (please specify)  

Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair. Version A- 6 March 2014 
Protocol number: COVSYMB0441 
 
 
 
Page 19 of 19 
-At any time 
 
6- How often do you feel them? 
-Rarely 
-several time a week 
-Several time a day 
-Throughout the day 
-24/24h 
 
7- The symptoms felt: 
-Do not hinder your activities 
-Allow you to pursue your activities but at a slower pace 
-Cause temporary interruption in your activities 
-Prevent certain activities (which one?) 
 
8- These symptoms 
-Are more of a nuisance than those of the hernia you previously had 
-Are less of a nuisance than those of the hernia you previously had 
 
9- Have you had a re-operation on your abdominal wall? 
-No  
-Yes (if so please specify) 
 
10- Looking back, how do you assess the result of your abdominal 
hernia operation 
-Excellent 
-Good 
-Medium 
-Bad