Thousands of women (mainly in France and U.K.) are currently affected by defective silicone gel breast implants manufactured by French company Poly Implants Prostheses (PIP), which contain non-medical industrial silicone. Women with these implants have been asked to consider consulting their surgeons.

ALDE MEPs are asking the European Commission for the forthcoming revision of the EU legislation on medical devices by:

• clarifying the EU authorization framework (higher standards) for medical devices,

• reinforcing the patient safety and preventive measures,

• providing consumer confidence by better information on medical devices,

• strengthening the market monitoring (inspections of manufacturers and distribution chains) and

ensuring full traceability of products

For that reason, ALDE recommends the revision of legislation as a necessary step for improving safety in this sector and maintaining a level of human health.

ries90.jpgMEP Fréderique Ries (MR, Belgium), ALDE Member of the Committee on Environment, Public Health and Food Safety said:

"The scandal of breast implants registered Poly Implant Prosthesis (PIP), with more than 400,000 carries in the world, reminds us once again that the introduction of foreign matter into the human body is not a risk-free operation, especially when these prostheses are not up to standards and contain toxic gel. Obviously, we must strengthen controls on medical devices, to ensure that they are as strict as those for drugs; therefore the Directive 2007/47/EC relating to active implantable medical devices must be updated.

"I also believe, as a consequence of this health scandal, the European Commission has a duty to look into the "business" of breast augmentation, and must immediately request a study on the possible health risks (risk of breast cancer) of silicone implants in general. "

MEP Corinne Lepage (CAP 21, France), Member of the ENVI Committee commented: "Prior authorization for certain categories of medical devices before they are placed on the market should be a fundamental requirement. There should also be much stricter monitoring of this market. This requires a system allowing patients to directly report incidents. This scandal is further evidence of the need for a system of collective redress to assist consumers and patients in obtaining compensation”.