Commissie gaat regels betreffende medische hulpmiddelen aanpassen om herhaling schandaal borstimplantaten te voorkomen (en) - Montesquieu Instituut

BRUSSELS - The European Commission has promised to re-write EU legislation on medical devices to avoid a repeat of the breast implant scandal involving now defunct French-firm Poly Implant Prothese (PIP) which emerged last year.

Consumer Protection Commissioner John Dalli told MEPs on Wednesday (13 June) that the issue would be addressed in the upcoming re-draft of the five-year-old Medical Devices directive, which the Commission is expected to publish in September. Although national governments are responsible for public health policy, EU legislation covers over 10,000 medical devices sold in Europe.

Speaking during the Parliament session in Strasbourg, Dalli promised to introduce “a robust proposal that will drastically improve our safety, without overreacting to an incident.” The proposal would include measures to scrutinise all high-risk medical devices before they could be sold, alongside ‘implant cards’ with detailed consumer information to be provided to all patients.

However, despite describing the PIP case as “appalling”, Dalli admitted that the case was “a fraud which could have happened under the most robust authorisation process you could have.”

He added that he had written to national health ministers to demand tight market controls on medical devices in advance of the new legislation.

Last December the French government issued a cancer alert and advised women to remove implants made by PIP.

The implants were banned in 2010 by which time PIP had been illegally selling defective silicone breast implants over several years. By the time the fraud was uncovered an estimated 300,000 women, including 100,000 in Europe, had received the faulty implants, which had been made using industrial silicone normally used in mattresses rather than material approved for medical surgery. Most implants have to be replaced between 10 or 15 years after the initial surgery.

Centre-left MEP Linda McAvan, who co-authored the Parliament’s resolution, called for the cosmetic surgery industry to be tightly regulated and a ban on advertising plastic surgery. She described the PIP case as “a scandal which has highlighted just how casually cosmetic surgery is presented.”

Commissioner Dalli was responding to a resolution initiated by Parliament’s Environment and Public Health committee. The non-binding resolution adopted by MEPs on Thursday (14 June) called for medical devices to be subject to the same pre-authorisation inspection rules as medicines, including unannounced test visits by inspectors. They also called for compulsory breast implant registers in all 27 member states along with a mandatory patient-passport traceability system.

For her part, Monique Goyens, director general of European consumer lobby group BEUC, noted that “health authorities across Europe failed to give consistent information on what to do about defective PIP implants”.

“The PIP fraud is another example for the need of a collective redress system which allows consumers to defend their rights and obtain compensation for the damage they suffered,” she added.

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