17.01.2012 - Swissmedic is very much aware that women who are affected feel extremely concerned about the possible risks related to the defective PIP breast implants. Their concern is further heightened by the differing recommendations on the part of the competent authorities in various countries. For that reason, Swissmedic considers it important to provide regular updates regarding the current state of affairs.
The investigation results to date confirm the findings that were already available in December. For that reason, the recommendations published by Swissmedic on 23 December 2011 remain valid:
Switzerland is a part of the European network for the monitoring of medical devices. Numerous teleconferences have been held in the last few weeks that have permitted the authorities to coordinate their findings regarding the defective PIP breast implants. The information now available from 29 EU Member States, plus data and test results from other countries affected (including Australia and South American states), is currently being analysed in detail.
At present, no new scientific findings indicate the need to change the recommendations last published on 23 December 2011. Based on the analysis results available to date, most European authorities - including Swissmedic - still consider a general recommendation to have the implants in question removed as disproportionate, and particularly given the risks that are inherent to any surgery. Only a small number of European countries are recommending global removal.
We nevertheless wish to issue a reminder that - as stated in our recommendations - in the case of any problems (such as troubles in the breast area or armpits), those concerned should undergo a medical examination and consider the possibility of having the implants removed. Removal as a preventive measure is also possible. This must, however, be discussed on a case-by-case basis between the physician and the patient.
Since 2011, the Swiss Society for Plastic, Reconstructive and Aesthetic Surgery (SGPRAC; 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