Experts' report of 1.2.2012
07.02.2012 - Swissmedic is very much aware that women who are affected feel extremely concerned about the possible risks related to the defective PIP breast implants.. For that reason, Swissmedic considers it important to provide regular updates regarding the current state of affairs.
An expert group of the Scientific Committees of the European Commission that handles new health risks (SCENIHR: Scientific Committee on Emerging and Newly Identified Health Risks) has examined data concerning PIP breast implants. After analysing the scientific data available on breast implants in general and on PIP implants in particular, the experts published a summary report on 1 February 2012. Their conclusions support the recommendations previously issued by Swissmedic.
The clinical data available to date is not sufficient to draw reliable conclusions regarding whether women with PIP breast implants are at a greater risk than women with breast implants from other manufacturers. Based on the data available, it cannot be reliably established that PIP breast implants lead to more ruptures than other implants. The test results available show no genotoxic or cytotoxic (cell-damaging) effects of the PIP silicone gel. The results do, however indicate that the silicone gel in the PIP implants can lead to local reactions (irritations and inflammation reactions). The experts also state that further, for example radiological, examinations are needed to detect tears in the implants if there are no clinical problems or discomfort.
The EU experts reached the conclusion it would be necessary to continue assessing the risks on a case-by-case basis, by means of discussions between the affected patient and her physician that also take into account the overall health of the patient and the risks inherent to any surgery. Removing the implants is - depending on medical evaluation - one possibility. Regular medical controls are important. Any woman experiencing pain or having doubts should contact her physician without delay.
The full report can be consulted on the Internet:http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf
Recommendations issued by Swissmedic:
Defective "PIP" silicone-filled breast implants: Information from Swissmedic, Status as of 07.02.2012
Since 2011, the Swiss Society for Plastic, Reconstructive and Aesthetic Surgery (SGPRAC; http://www.plastic-surgery.ch/) has made a specific patient register available for all women with breast implants. Inclusion therein is possible via the physician and makes it possible to monitor patients and to send reminders for the regular checks.
Swissmedic also once again requests users of the implants (physicians) and medical professionals to report events and findings related to the use of PIP breast implants without delay to:
Swissmedic, Swiss Agency for Therapeutic Products
Medical Devices division
Hallerstrasse 7
P.O. Box
CH-3000 Bern 9
Tel. +41 (0)31 323 22 51
Fax +41 (0)31 322 76 46
E-mail: materiovigilance@swissmedic.ch