TECHNICAL BOOKLET

OF Laboratoires Sebbin
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Recreating harmonious bodies for a new vision of rebirth.

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 TRUST AND TRANSPARENCY:
STRONG VALUES

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Recreating harmonious bodies for a new vision of rebirth…

Whether it is a matter of reconstruction or aesthetic enhancement, the aim is always

allowing the patient to rediscover harmony in body as well as in mind. With the
greatest respect for ethics, of utmost priority today than ever before, it is the desire of
the Laboratoires Sebbin, above any other consideration, to optimize permanently the
reliability of their implants. Thus they protect the peace of mind of the surgeons and
patients. In this booklet, we want to make you know, in total transparency, the technical
aspects of our products from the selection of raw materials up to their follow-up after
implantation.

Because our business operates in a medical environment, it can be considered only in

a context of absolute trust between patient, surgeon and manufacturer. Therefore the
Laboratoires SEBBIN put every effort to ensure optimum quality of their products.

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 THE sEBBIN
COMPANY

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Since near 30 years, GROUPE SEBBIN SAS is a French company located near Paris.
With an international orientation, its activities are the design, development, manufacture
and marketing of inert implants made from long term implantable medical grade silicone,
for reconstructive, plastic and aesthetic surgery.
The company has ISO 9001 and ISO 13485 certification for medical devices and has
incorporated the ISO 14971 standard.

In addition to its range of round, anatomical and inflatable breast implants, the
Laboratoires Sebbin offer surgeons specific implant solutions in response to the needs
of their patients (testicular, calf, gluteus implants and skin expanders of various shapes).
All these products are CE marked (Annex 2).
In some cases of delicate reconstruction, use of computer-aided design even enables
Laboratoires Sebbin to produce custom-made implants of high technicity with the 3D
technology.

GROUPE SEBBIN SAS supports all innovations for the future in the field of plastic,
reconstructive and aesthetic surgery and devotes a large part of its budget on research
and development.

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( Adress: Administration

GROUPE SEBBIN SAS

39-43, Parc d’activités des Quatre Vents
95 650 BOISSY L’AILLERIE

Tel. : +33 1 34 42 13 28
Fax : +33 1 34 42 16 88
www.sebbin.com

Adress: production

GROUPE SEBBIN SAS

39-43, Parc d’activités des Quatre Vents
95 650 BOISSY L’AILLERIE
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Tel. : +33 1 34 42 13 28

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 . international PrEsence.

Laboratoires SEBBIN is present in numerous international markets with a distribution

in more than 50 countries:

europe

SOUTH AmEriCA
AsiA & pacifiC
- Argentina
- Bolivia - Cambodia
- Brazil - India
- Chile AfriCA & mIDDLE EASt - Japan
- Colombia - Korea
- Cuba - Algeria - New Caledonia
- Dominican Republic - Egypt - Thailand
- Equator - Iran - Vietnam
- Mexico - Ivory Coast
- Panama - Kuwait
- Peru - Lebanon
- Uruguay - Madagascar
- Venezuela - Morocco
- Reunion Island
- Syria
- Tunisia
- Turkey

Global presence at the end of 2012

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 WHAT IS
THE CE MARKING?

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One must distinguish the CE marking, which is a mandatory product certification,
meaning that the medical device complies with the essential requirements related to
safety and performance as per the requirements of the EU directive, from the certification
of the company’s quality system according to EN ISO 9001 and EN ISO 13485.

Medical devices must be CE marked (European Conformity) by their manufacturer in

order to be marketed in Europe. This requirement allows a free circulation of medical
devices in all member states of the European Union and the European Economic Area.
This is a regulatory framework establishing the technical requirements enforced by all
European countries for the design, manufacturing and use of medical device.

According to Directives 93/42/EEC for medical devices and 2003/12/CEE

specific classification of breast implants, medical devices are divided into the following
four classes: Class I, Class IIa, IIb and III according to the level risk of the device.
Breast implants are in class III because they may represent a critical potential
risk. The sizers for breast implants are class IIa because they are surgically
invasive devices for temporary use (implanted for less than 60 minutes).

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All other medical devices manufactured by the Groupe SEBBIN are class IIb because
they are long-term implantable (implanted for more than 30 days).

Breast implants from Groupe SEBBIN are assessed according to the Annex II of the
European Directive - Complete quality assurance - including Section 4, the product
design review.

The manufacturer must demonstrate compliance of its products with the essential
requirements of Directive 93/42/EEC, before being authorized by the notified body
to affix the CE mark for the design of a new product or the change of an existing one
(change in raw materials, manufacturing processes, shapes ...).

The tasks of the Notified Body are:

- To implement the certification procedures for the issue of the CE mark certificate,
- To evaluate the conformity of the product based on the technical and design file that
include:
• Product Description,
• Design drawings, manufacturing methods,
• Risk analysis,
• List of Standards to comply with,
• Solutions adopted to meet the essential requirements,
• Description of methods of sterilization,
• Tests report and clinical data,
• Labeling and instructions for use.

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- To issue the CE mark certificate,
- To audit the manufacturer each year to check its quality system components and
product safety and to ensure it fully complies with current standards.

After gaining the CE mark certificate for a given product, the manufacturer issues a
Declaration of Conformity. Doing so, the manufacturer provides clear evidence that
its product meets the Essential Requirements of safety and performance of Directive
93/42/EEC and thus formalizes the manufacturer’s responsibility to market medical
devices compliant with the applicable regulation. For products other than class I,
Declaration of Conformity is always linked to the CE certificates issued by the Notified
Body. (

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 method
of manufacture

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THE STAGES OF implant MANUFACTURE.

Production of implants pre-filled with silicone gel follows a complex manual manufacturing
process backed by a modern Enterprise Ressource Planning (ERP) tool, 26 years of
know-how, staff professionalism and an efficient Quality System including numerous
inspections at all stages of manufacture on every implant.

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 MORE THAN
10 100%
OF OUR produCts
contrOls BY FDA
ARE contrOlLED
PRODUCT APPROVED
RAW
MARKETING MATERIALS

STERILIZATION pREPARATION OF THE MIXTURE

FOR MANUFACTURE OF THE ENVELOPe

PACKAGING ENVELOPe DIPPING

FILLING OF THE ENVELOPE ENVELOPe TEXTURIZATION

OCCLUSION PATCHES REMOVAL OF THE

OF THE ENVELOPE ENVELOPe FROM THE MOULDS

INSPECTION
OF THE ENVELOPE

HIGHLY
qualifiED PERSONNEL
3% OF OUR
PRODUCTION
>10 ans USED FOR
expErience DESTRUCTIVE TESTING

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 THE TESTS

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In a constant drive for quality, GROUPE SEBBIN SAS obtains test results that are superior to
those of the ISO 14607 standard (the international standard for breast implants).

. destructiVE STATISTICAL TESTS CONDUCTED routineLY:

- On 3 % of the production:
• Elongation test: the apparatus applies traction until the rupture of the sample;
it calculates the percentage of elongation until the rupture.
• Tear resistance test: same test as for the elongation test but the sample is cut
on 1mm in order to evaluate the tear resistance of the envelope. There is no
specified value requested by the standard.
• Tensile test: we measure the sample, the apparatus applies traction of 300%
during 3mn on the sample and we let it come back to its initial shape. Then,
we measure again the sample and this measure mustn’t represent more than
10% of the previous one.

- On 0,3 % of the production:

• Strength of seals: we take a sample including the patch and the envelope and
we place it in the apparatus to perform an elongation of 300% during 10 seconds.
There mustn’t have signs of detachment between the patch and the envelope
of the sample.

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- On each batch of gel:
• Penetration of the gel: this test, not required in the standard, is more
representative of reality than the cohesion test: it makes it possible to
obtain a gel of reproducible quality. It consists of measuring the resistance
of the gel to penetration with a constant mass over a given distance, the
more the gel resists this penetration, the more it will be called “high cohesive”.

. mechanical tests results vs standards.

Tests STANDARD ISO 14607 SEBBIN REFERENCE

VALUES
Elongation ≥ 450 % Average 690 %*

Tear resistance Not specified Average 20 kN/m

Tensile set ≤ 10 % Average 3 %

Strength of seals Compliance of the bonding after Complies

elongation to 300% during 10s

* Results obtained on the last tests realized by an independant laboratory.

. ContrOls ACROSS THE ENTIRE production:

• Control of the conductivity for the textured shells.

• Control of the tightness of the envelope.
• Control across 24 points of the shell to ensure a uniform specified thickness.
• Visual controls at each stage of manufacture.

The anti-bleeding barrier for our shells was tested at the time of the CE marking by the
LNE, Laboratoire National d’Essais and has been controlled again at the end of 2010 by
an independant laboratory.

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 COMPONENTS
OF THE IMPLANTABLE BREAST PROSTHESES

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RAW matErIALs.

Any raw material entering into the manufacture of the shell, the digital points, the patch
and the gel of these medical devices is of medical quality, biocompatible and implantable
at more than 29 days, in conformity with the ISO 14630 and 14607 standards.

Our suppliers of these raw materials are Nusil Technology and Applied Silicone
Corporation, the only two manufacturers of long term implantable medical quality
silicone, thus biocompatible. This quality is recognized by health authorities all over the
world including the French Agence Nationale de Sécurité du Médicament et des produits
de santé (ANSM) and the Food and Drug Administration (FDA). Both our suppliers have
ISO 9001 certification and exercise rigorous controls over their products (Annex 1).
Further information can be found on the websites:

www.appliedsilicone.com www.nusil.com

. THE SHELL.

The trilaminar shell is made of silicone elastomer. It is obtained by successive dippings

of a mould defining the shape, the profile and the volume of the implant, and includes a
barrier thus limiting the risk of the gel diffusion.
It complies with the ISO 14607 standard.
Our envelope exists in four surfaces: smooth, micro textured, textured, macro textured,
this last one being designed for the anatomical breast implants.

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. THE patCH.
The patch is made of silicone elastomer and includes a barrier limiting the risk of gel diffusion.
It comprises the elements making it possible to identify and trace the device – To know
more, see chapter on identification and traceability.

. THe FILLING gel.

The NaturgelTM filling gel is a biocompatible, medical quality, high cohesive silicone gel,
implantable at more than 29 days, compatible with its shell and satisfying the ISO 14607
standard. The cohesion / penetration and the filling rate of the gel determine the different
families of round mammary implants.

The cohesion of the gel is one of the factors which conditions the consistency of the
implant, as also:
• the raw materials used,
• the thickness and softness of the shell,
• the filling rate.

. PACKAGING AND LABELLING.

Each mammary implant comes in a package that meets the ISO 14630 and ISO 11607
standards.
The packaging:
• protects the implant from any damage and deterioration,
• permits the sterilization of the medical device using the sterilization method
selected as well as maintains the device sterility during storage and transport.

This package is made of a double blister, placed within a cardboard box.

A pad, turning from burgundy to green in contact with ethylene oxide and glued to a foot
of the inner blister, is the witness of the gas contact.

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 INFORMATION MENTIONED ON THE BOX AND THE BLISTER

An identification label is stuck on the box.

Filling product Description in French and English

Product reference Unique serial number Symbols indicating:

- the word “Sterile” and the
sterilization method,
Dimensions - do not use if packaging is
damaged,
- read the enclosed
instructions for use,
- cannot be sterilized twice,
- single use.

Use-by-date Sterilization Bar code

batch number

Description in 4 other languages

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 On the operculum of the external blister, is stuck an identification label
giving the following information:
Manufacturer’s name, address Unique serial number

CE marking
+
identification of the
Notified Body
Symbols indicating:
- the word “Sterile” and the
sterilization method,
- single use,
Product reference - cannot be sterilized twice,
- read the enclosed instructions
for use,
Description and dimensions - use-by-date.

Filling Product Bar code

The following elements are included into the box:

• a set of 6 stickers

2 under this form 4 under this form

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• an implant patient’s card on which the identification product sticker for the patient has
to be stuck,
• the instructions for use.
The information supplied on our labelling complies with ISO 14630 and NF EN 980 standards.
These devices require no accessories in order to be used.

. stEriliZation METHOD – STORAGE conditions.

For their medical devices, Laboratoires SEBBIN choose ethylene oxide sterilization
because of its efficiency and its common use in medical areas like intra ocular lenses, co-
chlear implants or heart valve.
Sterilization with ethylene oxide is subcontracted to an ISO 9001, ISO 13485 and
ISO 11135 certified establishment.

Each sterilization batch is subjected to:

Before sterilization:
- an evaluation of the initial contamination of the implants or Bioburden: by transfer of
the micro-organisms present on the surface of the implant to a culture medium by
immersion and successive rinsings in an eluate.
After sterilization:
- checking the biological indicators: by placing in a culture of biological indicators containing
at least 106 Bacillus subtilis.
- measuring the residual ethylene oxide: by gas-phase chromatography with exhaustive
extraction by DMF, in accordance with the NF EN ISO 10993-7 standard. The content
of the residues from sterilization with ethylene oxide other than ethylene oxide: ethylene
glycol and ethylene hydrochloride, have been validated in design.
- search for pyrogenic substances.
- release of a batch by the Quality Manager at the Laboratoires SEBBIN.
Protected units should be stored flat and protected from water and shocks.

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. Identification AND traCEabilitY.

The implant is identified by the information printed by laser on its patch in the following
way:
- its product reference:

Commercial reference LS 91 335 Volume

- and its unique serial number of 10 figures:

Marking date (year + day) 12 107 91 053 Sequential

Commercial reference
These identification details are found on:
- the labelling,
- and the device patch, as shown below:

BBIN
Commercial reference
SE Volume

LS 91 335
Marking date +
sequential

1 3
21
079105

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The identification system selected is a laser marking system.This marking allows to obtain
a legible and non-invasive marking of the patch.

Our traceability system, an integral part of our ISO 9001and ISO 13485 certified quality
system and integrating the ISO 14971 standard, allows to recognize and follow the
realization of a device from the raw materials delivered by our suppliers until its delivery
to the customer, thanks to the unique serial number given to each medical device,
inseparably linked to its item reference.

At each stage of their manufacture, the components and/or the devices are subject to
various checks and the results of these checks are recorded.

The recordings are classified and archived for a period of 30 years.

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 QUALITY system
and CLINICAL DATA

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. quality system.

Our company’s quality system is NF EN ISO 9001 and NF EN ISO 13485 certified for
the development, manufacturing and final inspection of medical devices and incorporates
ISO 14971 - Certificates attached in Annex 2.
Attestations certifying the absence of any derivatives of animal origin and of latex type
allergens in our products or absence of phtalates are attached in Annex 3.

Controls from various entities may take place in our company:

• At any time, by our government entity, the ANSM, Agence Nationale de Sécurité du
Médicament et des dispositifs médicaux (French national agency for the safety of
medicine and medical devices).
• At any time, by a foreign government entity as agencies for Health and Safety.
• Every year by our notified body to ensure that we follow the requirements of the 93/42/EEC
Directive.
• Every 5 years, by our notified body to renew our certificates of CE.

The customers are informed by the Commercial department of any modification

relating to the devices or the Quality System which may have an influence on them; this
department is at their disposal for any further information.

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 FLOW CHART GIVES AN OVERVIEW OF OUR QUALITY SYSTEM:

Customer Raw materials Purchases – Supplier evaluation Management

requirements released – Acceptance checks responsability

Supervising
the monitoring
and measuring
Process relating Manufacture of the Monitoring activity
to the customers various components and measuring
activity

Assembly of the
various components Delivery Customer
Design & Making satisfaction
Development resources,
documentation
available End product
answering our

Conservation
Unique requirements and
identification those contained in the
of the product regulations and
normatives Customer
claims − Material
vigilance − Clinical
register
Packaging Release

Sterilization

Identification – Traceability

Continuous improvement Monitoring

by our Notified
Body and the
Production Process validated ANSM
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. matEriovigilance.

Materiovigilance is monitoring incidents or potential incidents that may result from

the use of medical devices after they are on the market. Materiovigilance includes
the reporting, recording, evaluation and exploitation of information reported in a
goal of prevention.
Laboratoires SEBBIN has established since 2001 a vigilance data base which
extracts are given below.

These figures are only indicative as they also take into account implants returned
which have been manufactured before 2001.

Cumulating incidents from 2001 to 2011 corresponding to

international claims on 11 years and according
to the implants sales during these 11 years worldwide.

INTERNATIONAL 2001-2011

Incident Implant Pre-filled Textured Implant Pre-filled Smooth

Intra / extracapsular rupture < 0,10 % < 0,06 %

Capsular contracture < 0,03 % < 0,02 %

Folds < 0,01 % < 0,01 %

Infection/ Lymphorrhoea < 0,01 % < 0,01 %

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. POST MARKET CLINICAL FOLLOW-UP:

In accordance with the requirements of Directive 93/42/EEC, the Laboratoires Sebbin

implemented since 2004 a follow-up of the clinical use (the so called “Post Market Clinical
Follow-up” or “PMCF”) of its silicone gel pre filled breast implants. This prospective
follow-up is carried out in the post marketing phase: it is conducted in 4 centers in
France and the intermediate report is related to 256 patients having received breast
implants within the scope of breast augmentation for aesthetic or restorative purposes
to correct an asymmetry/anomaly (Aesthetic/Plastic Surgery Group) or within the
context of breast reconstruction following breast cancer (Reconstructive Surgery
Group).

The main objective of this follow-up is to consolidate the data identified at the design
stage and check the safety and effectiveness of the Sebbin breast implants prefilled with
silicone gel. The rates of implants ruptures and capsular contractures (Baker grade III or
IV) were defined as the main criteria of this follow-up.

The intermediate results at 4 years included 256 patients:

- 184 patients were implanted for Aesthetic/Plastic surgery purposes (92.4% with round
implants and 7.6% with anatomical implants),
- 72 patients were implanted for Reconstructive surgery purposes (59.7% with round
implants and 40.3% with anatomical implants).

The implants used are mainly breast implants with textured surface (91.4% of the patients
were implanted with textured breast implants and 8.6% with smooth breast implant).

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The 4 years* follow-up generated the following intermediate data versus the above
mentioned safety criteria:

Aesthetic/Plastic Reconstructive
Surgery Group Surgery Group
(N=184 patients) (N=72 patients)
Baker grade III or IV capsular 1,1 % 2,8 %
MAIN contracture (N=2 patients) (N=2 patients)
COMPLICATIONS
Implant rupture 0% 2,8 %
(N=0 patient) (N=2 patients)
* The follow-up distribution of patients on the 4th of June 2012 is as follows: 9.4% at 3 months, 7.4% at 6 months, 12.5% at 1 year,
16.8% at 2 years, 14.4% at 3 years, 39.5% beyond 3 years.

The severe capsular contractures rate at 4 years is 1.6% (4 patients out of 256 patients) for
the total number of patients who have been implanted: such contractures occurred during
the first 9 months after implantation.
In the Aesthetic/Plastic Surgery Group, such rate is at 1.1%. One patient had bilateral capsular
contracture which occurred 6 months after implantation and one patient had a unilateral
capsular contracture 9 months after implantation.
In the Reconstructive Surgery group, the capsular contractures rate is at 2.8% and those
occurred on the 3rd and 4th month following implantation.

The rupture rate is at 0.8% at 4 years (2 patients out of 256 patients) for the total number
of patients who have been implanted.
No implant rupture is reported in the Aesthetic/Plastic Surgery Group.
In the Reconstructive Surgery Group the rupture rate is at 2.8%. These two unilateral
ruptures occurred on the 44th and 48th month after implantation.

General conclusion:
The 4 years intermediate report data match those generated during the design phase
of the Laboratoires Sebbin breast implants. For consolidation purposes of those results,
the data collection continues.

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 ANNEXES

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ANNEX 1: SUPPLIERS ATTESTATION

ANNEX 2: EC CERTIFICATES

ANNEX 3: LIABILITY INSURANCE

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Annex 1: Suppliers attestations

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Annex 2: EC certificates

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Annex 3: Liability insurance

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 GS097-A-V01-2012/08
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Recreating harmonious bodies for a new vision of rebirth.

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