EU must speed up laws to protect against faulty breast implants - Childers

Issued : Wednesday 11 January, 2012

 

Nessa Childers MEP, member of the Public Health Committee, today called on the European Commission to speed up promised EU legislation that will better protect women against faulty breast implants.

"Unlike medicines, where there is a European authorisation process to get on the market, there is not one today for medical devices, like breast implants. Patient safety, public confidence, and ethical behaviour should always be the top priorities of the healthcare industry.

"The EU is drawing up new regulations to protect women against faulty breast implants. The revision of the Medical Devices Directive is already planned for later this year, however in light of the PIP scandal in France I am calling on the Commission to bring this legislation to the European Parliament as soon as possible.

"The new EU directive on medical devices would tighten inspection regimes for silicone implant manufacturing companies and ensure each faulty implant could be traced back to production - two of the major factors behind the current French implants scandal. It would force every EU country to apply tougher safety measures to production and surgery.

"Launched in 1990, the current European regulatory system for medical devices has given a high level of safety and quality for medical devices. And we know no system can entirely guard against fraud or deliberate abuse. But we need more effective measures that prevent a similar case happening in the future.
"PIP it seems was not adequately supervised by the French authorities and without a much tougher EU directive transposed into national law, we will see other scandals emerging elsewhere."