Dear 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
IPRAS Management Office
1st Klm Peanias-Markopoulou, 19002 Peania
Attica, Greece
Tel: +30 2111001770, Fax: +30 2106642116
Web: www.ipras.org
E-mail: maria.petsa@zita-congress.gr