MEPs of Parliament's environment committee today adopted a resolution asking the European Commission for the forthcoming revision of the current legislation on medical devices to avoid future cases like the defective silicone gel breast implants made by French company Poly Implants Prostheses (PIP), which did not meet quality criteria.

PIP silicone breast implants have been placed on the market in many countries (mainly in France and U.K.) and thousands of women are currently affected. The implant scare originated in France, apparently as a result of flawed national controls.

For that reason, ALDE considers the revision of legislation as a necessary step for improving safety in this sector and maintaining the level of human health. The PIP scandal raises a number of questions and shows weaknesses in the regulatory framework on medical devices in EU legislation and national authorities such as lack of traceability, lack of information and lack of a register.    

ALDE MEP Corinne Lepage (CAP 21, France) underlines: "We are sending a strong message to the Commission before the revision of the medical devices regulation that it must set up a prior authorization system for certain categories of medical devices. We strongly ask for much stricter monitoring of this market, and for much stricter authorization criteria of notified bodies. This scandal is also further evidence of the crucial need for a system of collective redress to assist consumers and patients in obtaining compensation”.

ALDE MEP Antonyia Parvanova (NMSP, Bulgaria) said: "We should draw lessons from the PIP case in France. An improved traceability and a risk-based approach are definitely needed to ensure the highest level of consumer protection and patient safety in this field, and most particularly when it comes to breast implants and other related plastic surgery activities."

ALDE MEP Frédérique Ries (MR, Belgium) added: "The scandal over PIP implants have shown a failure of the current system of certification of compliance with safety and health requirements but also of inspections by the national competent authorities. We absolutely need to conduct unannounced and frequent inspections in the whole supply chain and of the operations of certain unscrupulous suppliers, notably for the medical devices which entail the greatest risks".
 
Notes: MEPs will finally adopt the Resolution during the May Strasbourg Plenary session.