First meeting of the Follow-up Committee for Women with PIP Breast Implants

This committee is composed of the French Security Agency of Health Products (Afssaps), the National Institute of Health Surveillance (InVS), the National Institute of Cancer Research (INCa), the National Health Insurance Company (CNAM), as well as representatives from the French Breast and Breast Pathology Society (SFSPM), The French Cancer Society (SFC), the French Society of Private Cancer Research (SFCP), The French Society of Haematology (SFH), The French Society of Oncology Surgery (SFCO), the French Society of Reconstructive Plastic Surgery (SOFCPRE), the National Syndicate of Reconstructive and Plastic Surgery (SNCPRE), The National Council of Doctors, the Association in Defence of Women fitted with PIP Breast Implants (PPP), the Movement in Defence of Women fitted with breast implants (MDFPIP) and finally from the National League in the Fight Against Cancer.

During this first meeting, Afssaps reported that serious undesirable effects had been observed in women fitted with the PIP breast implants and notably mentioned that to this day, 8 cases of cancer have been reported. At this stage, no link has been made between these cases and the PIP breast implants. The cancers in question include : 1 case of large cell Anaplastic Lymphoma, 5 cases of Mammary Adenocarcinoma, 1 case of Tonsil Lymphoma and 1 case of Acute Myeloblastic Leukaemia.

This data will be updated twice a month and made available to the public on the Afssaps website.

The committee then took this opportunity to analyse the measures taken dating from the removal of the PIP breast implants from the market in March 2010. The measures taken since this time concern issues with regard to diagnosis, removal of PIP breast implants and finally the medical supervision of the women fitted with PIP breast implants.

With the data currently available, women fitted with PIP breast implants are advised to consult their surgeon or their GP and must systematically benefit from a clinical examination and undergo the necessary ultrasound scans.

Any rupture, suspected rupture or oozing of the prosthesis should lead to its removal, as well as that of the second prosthesis. The removal of a PIP implant, as a precautionary measure, even in the absence of any sign of rupture, must be discussed with the patients concerned.

Health care professionals are advised that they must contact all of their patients fitted with the PIP breast implants in order to carry out the necessary examinations. They are also advised that they must report to Afssaps when a PIP breast implant is removed, be it faulty or not.

Finally, patients’ associations are advised to inform their adherents of the updated Afssaps recommendations. These associations must also report to Afssaps any PIP breast implant removal, be they faulty or not.

These recommendations, specifically intended for health care professionals and women fitted with PIP breast implants, will be adapted in relation to the monthly updates conducted Afssaps. The recommendations for health care professionals and women fitted with PIP breast implants are also dependant upon the results of the discussions between the French Ministry of Health and the French National Institute of Cancer Research which will be made public at the end of December.

This first meeting was also used to evoke the question of who will cover the medical expenses. The state (CNAMTS Assurance Maladie) will reimburse all women fitted with PIP breast implants, their medical charges in relation to the removal of their implants. The cost of ultrasound scans, medical examinations, removal of the implants, as well as follow up consultations will all be included in the reimbursement. Women who underwent reconstructive surgery following breast cancer will also be reimbursed for the replacement of a new implant.

The National Council of Doctors will be asked to notify practitioners in order to ensure the harmonisation between the conditions of reimbursement and their fees.

Women fitted with PIP breast implants will be able to claim compensation from the Victims Commission of Compensation, (CIVI) ; as for women having undergone reconstructive surgery, following a mastectomy, due to breast cancer, they will be able to claim from the Regional Commission of Conciliation and Compensation, (CRCI).

Another meeting of this follow-up committee will be held next month.

Finally, a helpline has been put in place in order to respond to any questions the public may have regarding this situation : 0800 636636

Read the french press release/Lire le communiqué en français