GLOBAL/EUROPEAN MEDICAL DEVICES CO:MPETENT AUTHORITY REPORT

FormN9R11
This form should be used for the exchange of information between Nationa l Competent Authorities (NCA)
and the Commission only

I. Is this report confidential? Yes [ J No [X]

Rfi
e erence an dR eport er Dtaa
2. NCA report ref. no.: 3. Local NCA case no.: 4. Related NCA rep ort no s. (if
FR-2010-03-30-007 any):
5. Manufacturer Ref/Recall no.: 6. Sent by: (Name and 7. Contact person: (if differentfrom
Organization) 6)
-
AFSSAPS
8. 10. E-mail:
-
' -
Device Data
11a. Generic name/ kind of device: 11b. Category: 20. CAB/Not ified Body no.:
Silicone filled breast implant 0197
12. Nomenclature id: 13. No.:
GMDN 35270
14. Trade Name and Make and Model: IMGHC -TX, IMGHC-MX, 21a. Device approval status:
IMGHC-LS
15. Software version: NA [X] CEmark
16. Serial no.: ALL 17. Lot/batch no.: ALL 21b. Risk Class: Class III
18. Manufacturer: POLY 19. Authorized rep (if different Action taken:
IMPLANT PROTHESE from 18): [] None
Country: FRANCE Country: [X] FSCA/Recall
Full Address: Full Addre ss: [ ] Safeguard Clause
337 avenue de Bruxelle s Contact: [] Other (sp ecify)
83507 La Seyne Sur Mer Cedex Tel:
France Fax:
Contact: E-mai l:
I
'
IFax: ,
E-mail:
- - -
Event Data
23a. Background information and reason for this report:
Afssaps have registered an increase of reported incident s over the last three years concerning silicone filled
breast implants manufa ctured by POLY IMPLANT PROSTHESE (PIP). These incident s are mainly
breakings of breast implants and local complications. These incidents often require a re-sur gery .
Further to these vigilance repo1ts, Afssaps carried out an inspection in PIP implants manufacturing plant.
The element s collected during this inspection showed that most of breast implants manufactured since 2001
have been filled with a sil icone gel different from the one describ ed in the CE marking file and in the batch
manufa cturing files. These breast implants are thu s not conform to the 93/42/CEE directive.
Samples have been picked up during the inspection in order to perform severa l controls.
These controls are currently perfom1ed by Afssaps and independent laborator ies.
The results of these controls will be commun icated as soon as they are available.
More over, Afssaps learnt yesterday that PIP company will officially be going into receivership as from today
evening.

23b. Is the investigation of the report complete?: [ ]Yes [ X] No

24a. Conclusions:
Considering these elements, Afssaps took yesterday a decision of recall and suspension of the marketing, the
distribution, the export and the use of the silicone filled breast implants manufactured by PIP company.

Surgeons have been informed of this decision this morning, they were asked to stop the implantation of these
breast implants and to notify their patients of a clinical examination. If necessary, they will prescribe a
ultrasound scan within 6 months.

A press release was sent this morning and a "FAQ" (frequently asked questions) has been prepared.

All the documents and information are available on our website at www.afssaps.sante.fr

24b. [ X] Afssa s is willin to take the lead and co-ordinate the investi ation

25a. Recommendation to receivers of this report:

To be aware of the issue and to take the appropriate actions.

25b. Device known to be in the market in: WORLDWIDE

25c. Device also marketed as (trade name):

Report Distribution
26. This report is being distributed to:
[X] the GHTF NCA R Secretariat for further distribution to all non EEA GHTF NCAR participants
(AU CA JP NZ US).
[X ] EEA states, EC and Switzerland
[ ] The following targeted NCAs:
[] The manufacturer / authorized rep.: