Call for tougher EU rules after breast implant safety scare
Different reactions from member states to health scare.
The growing safety concerns over breast implants used by an estimated 300,000 women in 65 countries have prompted calls for a change in the European approval process.
The implants, marketed by Poly Implant Prothèse (PIP), are feared to be prone to rupture, allowing silicone to leak inside the body.
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The European Commission already had plans to propose a revision to the certification system this year. Under the current rules, dating from 1990, medical devices are given pre-market authorisation by independent certification bodies approved by member states. It is the role of these bodies to ensure that devices meet EU standards. Breast implants are in the group of devices with the strictest standards.
PIP is alleged to have used an industrial-grade silicone instead of medical silicone in manufacturing the implants. It then allegedly lied to the German certification body, TUV Rheinland, tasked with their oversight. TUV, a private company, has been criticised for apparent failure in detecting irregularities.
On Tuesday (10 January), Françoise Grossetête, a French centre-right MEP, said that the Commission should propose centralised authorisation of medical devices, similar to the system applicable to medicines. “It is time, for those medical devices which pose the greatest risks to our health, to implement a marketing authorisation at the European level,” she said.
But Eucomed, the European medical technology industry association, said that the system of member state-approved certification bodies does not need to be abandoned.
It claims that central authorisation – as takes place in the United States – is no safer than the European system, and slows down access to medical devices by an average of two years. It also says that a centralised authorisation system cannot eliminate fraud.
Instead, Eucomed wants co-ordinated national reco-gnition of certification bodies, and a strengthening of harmonised standards.
“Europe needs smart regulation that makes efficient and effective use of existing resources and structures,” said John Brennan, Euromed’s director of regulatory and technical affairs.
Different responses
Member states have differed in their reaction to the medical scare. France has recommended that all 30,000 French women with PIP breast implants have them removed. Germany and the Czech Republic have followed suit.
But the British health ministry said it has found no link between the implants and cancer, and there is not sufficient evidence to recommend removal if the implants show no sign of rupture. More than 40,000 women in the UK received the implants.
The UK’s National Health Service will remove the implants without charge only if a doctor has deemed it medically necessary, and if the implants were for medical reasons, such as reconstructive surgery after breast cancer.