In view of the incidents reported with the use of breast implants manufactured by the company PIP in France, the « Agence Française de Sécurité Sanitaire des Produits de Santé » (AFSSAPS) conducted an inspection. This has highlighted the use in the manufacture of these implants of a silicone gel different from the one approved. As a precaution, the FAMHP, like the AFSSAPS, asked distributors of these implants, pharmacists, physicians and persons who use them, to stop the distribution, delivery, use and export, waiting for the results of controls carried out by the AFSSAPS.
On March 30th 2010 the AFSSAPS informed the FAMHP that the number of incidents reported to the AFSSAPS under materiovigilance for silicone gel pre-filled breast implants manufactured by the firm POLY IMPLANT PROSTHESIS (PIP) has increased over the last three years. These incidents are mainly ruptures of the prosthesis and local complications. They require in most cases a repair. Following this observation, the AFSSAPS conducted an inspection at the plant of PIP. The elements gathered during this inspection showed that the implants were filled with silicone gel different from the one stated in the CE folder and batch files of these implants. These devices therefore do not comply with the regulation of medical devices and have not been evalued as required.
Laboratory controls on this gel are currently under development by AFSSAPS. The results of these controls will be provided as they become available. Given these factors, the AFSSAPS, as a precautionary measure, decided to suspend the marketing, distribution, use and export of silicone gel pre-filled breast implants manufactured by the firm POLY IMPLANT PROSTHESIS.
Based on the information received by the AFSSAPS, the FAMHP has asked distributors of these implants, pharmacists, physicians and persons who use them to stop the distribution, delivery, use and export, and to put them in quarantine, waiting for results of the AFSSAPS controls.
The rupture of breast implants is a known risk, but not predictable and AFSSAPS has not identified, following the use of breast silicone gel pre-filled implants manufactured by the firm PIP in France, any complications that are different from those usually encountered with other silicone gel pre-filled breast implants. A higher incidence of ruptures of the prosthesis and local inflammatory reactions has been observed on the other hand with the breast implants of the firm PIP. However, to date, no causal link has been established for certain.
As a precaution, the FAMHP recommends that physicians who have implanted breast implants manufactured by the firm PIP to increase routine monitoring of involved patients. Further information is available on the website of the AFSSAPS including in the "Questions-réponses" document written for the attention of patients.