Update on checking procedures performed by the health authorities on the poly implant prothèse company

Ansm

Description

Medical devices
18/10/2012

Sujets

• Medical device

Informations

• Publié par: ansm-medical-devices
• Publié le: 18 octobre 2012
• Nombre de lectures: 7
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

SITUATION UPDATE ON CHECKING SERUPREDOC

PERFORMED BY THE HEALTH TIEIHTROAUS

ON THE POLY IMPLANT PROTHÈSE COMPANY

1 / 170

The Minister

Our Ref.: cab/CR/

MINISTRY OF LABOUR, EMPLOYMENT AND HEALTH

Paris, 07 DEC 2011

OBJECT: Overview of all the controls performed on the company Poly Implant Prothese (IPP)

Afssaps found an abnormal increase in the number of premature ruptures observed on implants pre‐
filled with silicone gel manufactured by Poly Implant Prothese (IPP) during the last quarter of 2009.

An inspection of PIP facilities took place from 16 to 18 March 2010: the collected findings showed
that the implants were filled with a different gel from that declared by the company during
marketing and in the manufacturing files.

The conclusions of this inspection lead to the issue of an Afssaps health policy decision on 29 March
2010, which suspended the marketing, ribution,dist export and use of PIP silicone‐gel‐filled breast
implants.

Without anticipating the results of criminal proceedings, please could you send me a complete
overview of the controls conducted by the health authorities on the company Poly Implant Prothese
(PIP) since its creation, as well as measures implemented after these inspections.

The deadline for sending this overview is end January 2012.

Mr. Jean‐Yves GRALL
Director‐General of Health
14 avenue Duquesne 75007 PARIS

Mr. Dominique MARANINCHI
Director‐General of Afssaps
143‐147 Boulevard Anatole France
93285 Saint Denis cedex

127 RUE DE GRENELLE‐75700 PARIS
TELEPHONE: [phone]‐FAX: [phone]

[Signed]

Xavier BERTRAND

2 / 170

HEALTH
Directorate‐General for Health
The Director‐General

Dear Sir,

Paris 01FEB 2012

AGENCY
The General Director


To

and Health

In your letter of 07 Dec. 2011 you asked us to send a complete overview of the controls performed
by the health authorities on the company Poly Implant Prothese (PIP) and the measures taken after
these inspections.
In order to best illustrate this analysis by factual evidence, the methodology adopted is based on a
chronological analysis from 1995 until today exclusively using documents found in the Ministry
archives and at AFSSAPS.
Please find below all the findings presented in the enclosed report.
This report first provides a review of the regulations and organisation of the administrative
authorities and treatment by cosmetic and reconstructive surgery. This is followed by a detailed
chronological historical analysis, an analysis of device vigilance data, detailed accounts of the
inspections performed by the health authorities, a summary of the currently available toxicology
data on the silicone gels used to fill PIP breast implants, the specific actions implemented by the
health authorities from 2010 and the international repercussions of this dossier.
The main conclusions drawn after this analysis allowed us to make several proposals to prepare the
future and ensure the improved safety of use of these medical devices.
Yours Sincerely

The General Director of Health
[Signed]
Dr Jean‐Yves GRALL

The General Director
[Signed]
Prof. DominiqueMARANINCHI

3 / 170

Introduction

the production of breast implants.

silicone gel‐prefilled breast implants.

Afssaps.

over the following weeks.

patients with these breast implants.

women ,ocnsulting even in the absence of any clinical signs of a deterioration of the implant.

official documents, or were identified from an archived document.

This report is the subject of the present citauplboi.n

4 / 170

1. REGULATION AND ORGANISATION OF THE ANIMDRTSIVITAE AUTHORITIES AND
CARE MODALITIES IN COSMETIC AND RECONSTRUCTIVE SURGERY 6
1. Regulation of medical devices 6
2. Specific regulations and health policy measures regarding breast implants 7
3. Regulation and organisation of the Medical Device Vigilance system 11
4. Organisation of the isinattreivmda authorities and sites for fitting breast implants 11

II. CHRONOLOGICAL ANALYSIS OF THE AVAILABLE DATA 14
1. From creation PIP society until the the health policy decision of 29 March 2010 14
2. 1995 to 1999 14
3. 1998 to May 2000 17
4. 2000 (June, onward) 18
5. 2001‐2010 (March) 21
2. From the consequences of the marketing suspension of the PIP implants up to 2012 35
1. 2010 (from March) 35
2. YEAR 2011 49
3. YEAR 2012 55

III. MEDICAL DEVICE VIGILANCE 57
1. Period before March 1999 57
2. Period after March 1999 58
3. Minor events act as background noise. 58
1‐ The specific evaluation of reports related to breast implants 58
2‐ Medical Device Vigilance data concngerni the PIP silicone gel breast implants 60
3‐ Vigilance analysis and ectiveretrosp isnoitagitsevn following the DPS 70
4‐ The emergence of new sanitary signals following the report of one case of anaplastic lymphoma of
the breast 82

IV. INSPECTIONS PERFORMED BY THE TSARITEVINIMDA AUTHORITIES 83
1. Inspection of Poly Implant Prothèse conducted in 1996 83
2. Inspections of the Poly Implant Prothèse company conducted in 2001 and 2010 84

V. SUMMARY OF THE AVAILABLE LACITICOXOGOL DATA ON SILICONE GELS USED TO FILL
POLY IMPLANT PROTHESE BREAST IMPLANTS 94
1. Introduction 95
2. cochhysiPcimela and mechanical acarritechasitno of breast implants 96
1. Raw materials 96
2. Mechanical tests and cosihyplacimehc analyses 98
3. Conclusion 101
3. gilolcaoTixoc studies on finished products 102
1. oTixlgicacolo tests in the NUSIL gel conformity assessment documents 102
2. aciglToxicolo tests conducted on PIP gels 106
3. Summary tables of studies conducted with PIP gels 112
4. General conclusion 113
5. References 119

VI. SPECIFIC HEALTH SAFETY ACTIONS TAKEN FROM 2010 121

VII. NATIONALITNRE REPERCUSSIONS OF THE POLY IMPLANT PROSTHESIS BREAST
IMPLANT DOSSIER 132

VIII. MAIN CONCLUSIONS AND PROPOSALS 135

143

5 / 170

1. admithe ratinistev atulegRd ann ioasinagro fo noit
authorities and care modalities in cosmetic and
reconstructive surgery

1.

Regulation of medical devices

Breast implants are governed by the current law and regulations on medical devices.

implantable medical devices.1

Law no. 94/42 on Public Health and social Welfare2 came into effect on 18 January 1994.

goods.

throughout the European Community market. The latter, alone, may be marketed and installed.

based on a total sinomrahn.ioat

process and the product. This leads to the granting of CE marking.

commission for ificcertntaoi from all European NBs.


1 tum a ob9109nu elegithe ing atch eht fo snoitalsres teta SermbMecaitev agdrni ge SereDiivct90e 583/CEE/ fo J 02
implantable medical devic es.
2 er CEE/5t evitaltiecir D380/ 9vem debaeld vcilativeo aclant impictIs sethbora tponseand no. 93/42/EEC of the Council of
14 June 1993 relative to medical devi ces.
6 / 170

Regarding class IIa, IIb, and III medical devices, the NB evaluates both the technical donoitatnemuc and the
manufacturers quality assurance system. The depth of review by the notified body will depend on the risk
associated with the product under ioatn.nscoerid

For class III devices (such as breast implants since 2003, see below), the design file of the product is
systematically reviewed. The assessment of the whole quality assurance system includes an initial audit at the
manufacturer's premises. Following the assessment of these two aspects, the NB delivers two reitcet,sifac
allowing the afunrutcrmea to declare its product compliant with the essential ntsequiremer of the Directive
and use the EC mark. The afunrutcearm can then market its product in all European countries.

For IIa and IIb‐class devices, only parts of the design file are reviewed.

The dturefucamna and marketed products should comply with the technical documents, in particular with the
design file on which the notified body based and delivered its certificate. Any change to the product in(udclgin
the raw materials) should be declared to the NB by the mtuacufaner,r bfena.drohe Once the EC certificate has
been delivered, on‐site audits are regularly carried out by the NB, general once a year, as long as the product is
on the market. All audits by the NB are described in a report submitted to the rermanufactu by said body.

Therefore, according to European legislation, the NB is sponreesibl for assessing, auditing and certifying the
compliance of the process followed by the rerutcafunam to demonstrate that the essential tsemenquirre of
the European directive are being met. The NB informs the qualified authority (the authority which appointed
the NB) of all delivered, modifie