DEFECTIVE BREAST IMPLANTS : A CASE OF FRAUD, NOT DYSFUNCTION, SAYS HSC.

• Position: Health Security Committee

During a meeting of the Health Security Committee (HSC), the European Commission has proposed the establishment of a common system for evaluating the effects of adulterated breast implants. Member states have also made a commitment to carrying out national risk assessments, and the United Kingdom should make its assessment available by the end of the week.

In March 2010, French authorities discovered that the company Poly Implant Prothese (PIP) was using an adulterated industrial gel, suspected to be the cause of an abnormal number of ruptured implants. For the last few weeks, Paris has been studying the link between these breast implants and twenty cases of cancer.

When questioned about the situation at the European level, a spokesperson for Health Commissioner John Dalli said: "Implants produced by Poly Implant Prothèseá were already removed from the European market in the spring of 2010. But that was a case of fraud, and therefore this is not a general alert about breast implants but about products from that particular company".

REGULATORY FRAMEWORK TO BE REVISED

Mammary implants are covered by Directive 93/42/EEC concerning medical devices. Under this directive, they are considered as critical (Class III) devices, which require explicit prior authorisation before they can be placed on the market. Once the product has obtained the CE label', the monitoring and traceability of that product then falls under the responsibility of member states. Currently, there is no European organisation overseeing the 70 or 80 monitoring organisations...