Increased scrutiny following breast implant scare

Closer scrutiny of invasive medical devices has been proposed by the European Commission today (26 September).

The European Commission proposed today (26 September) revisions to EU rules on invasive devices that involve the body. The changes, which apply to everything from pacemakers to breast implants to dental fillings, would increase scrutiny over the 80 assessment bodies across Europe which authorise these products.

Under current rules, dating from 1990, medical devices such as implants and pacemakers are given pre-market authorisation by independent assessment bodies approved by member states. These may be either private or public.

The proposal would require stronger supervision of independent assessment bodies by national authorities and introduce unannounced factory inspections and sample testing. It would also introduce an EU-level supervisory coordination group and create an extended EU-wide database on medical devices so member states can share information.

The Commission stopped short of proposing centralised EU authorisation of medical devices, as called for by some campaigners and MEPs following the Poly Implant Prothèse (PIP) breast-implant controversy in France earlier this year. PIP is alleged to have used an industrial-grade silicone instead of medical silicone in the implants, making them prone to rupture. The implants were approved by a private German certification body.

Speaking at a press conference, health commissioner John Dalli said a centralised system would not have prevented the PIP case. “PIP was using products under specifications that were totally different than what was authorised,” he said. He said the new requirements for more thorough checking after an authorisation would rectify this problem.

Eucomed, the European medical-technology industry association, welcomed most aspects of the proposal. But they said the new scrutiny procedure on the assessment bodies would slow patient access to these devices. “This procedure will fundamentally change the system,” they said in a statement. “The measure would address some political calls to move the system towards a centralised pre-market authorisation system as found in the United States, but will ultimately result in harming European patients and negatively impact mostly European small and medium sized enterprises.”

But Dalli said greater scrutiny is needed. He pointed to the fact that out of 80 assessment bodies, 75 have been approved by national authorities to authorise products with the highest risk levels. The capabilities of the bodies to assess these products should be given more scrutiny.

European consumers organisation BEUC criticised the proposal for focusing on increased surveillance after the products reach consumers rather than before. “High risk devices, such as hip implants, need much more thorough controls before being put on the market,” said BEUC secretary general Monique Goyens. “If there is a problem with medicine, a patient simply stops taking it. If an implanted decide is problematic patients must undergo invasive and risky surgery to have it removed.”