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Letter from IPRAS / URGENT WARNINGDear colleague, German Health Authorities informed us today that the French company PIP has used a Silicone gel in the production process that does not fulfil the requirements. Please read the warning which just came out minutes ago. We urge you to follow the recommendations of the French and German Health Authorities. We shall inform you immediately when new information is available. For very urgent matters that may occure, please contact us at: 0030 6942414799
Sincerely yours
WARNING PUBLISHED BY THE GERMAN FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES Affecting Silicone gel filled breast implants produced by the French company PIP (Poly Implant Prothese) French and German Health Authorities (Afssaps and BfArM) informed IPRAS today that the French Health Authorities found out during an inspection that most of the breast implants produced by PIP since 2001 are not filled with the specific Silicone gel which should be used for this application. Therefore these implants do not fulfill the requirements outlined in the European Medical Device Law e.g. 93/42/EWG. At present French Health Authorities investigate whether the use of this material affects the safety of these implants. Afssaps and BfArM recommend that plastic surgeons who inserted implants produced by PIP should inform their patients and should stop using these products. Patients with PIP implants should contact their plastic surgeons.
Zita Congress Letter from IPRAS / URGENT WARNING (2)Dear colleague, Unfortunately the information we are getting from the health authorities is that the company already filed bankruptcy. We recommend to approach the insurance companies of the patients. They usually accept taking care of the expenses for implant removal, but hardly ever for new implants. Although the investigation of the French Health Authorities is still ongoing, I suggest that you prepare the patient that the recommendation will be most likely implant removal. Sorry to confront you with these very unpleasant news after your Easter holidays, but we felt that you should know immediately since there will be a lot of media coverage within the next days.
Sincerely yours Marita Eisenmann-Klein Zita Congress S.A. |
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