Faulty Breast Implants for 40,000 – Silicon Rupture Scare

Around 40,000 British women were known to have been given PIP breast implants that were filled with industrial silicone meant for matress filling.

A further 7,000 women are now thought to be affected by the scandal, the Department of Health said, after it was found that the French company accused of frauduently switching to unauthorised silicone, did so years earlier than previously thought.

It was known that implants made by Poly Implant Prosthese from 2001 contained industrial silicone, but now it is thought the sub-standard material was used prior to this.

Women who have PIP implants, or those who do not know the make of their implants, are being urged to visit their GP for advice.

Most cosmetic surgeons are now offering to remove the faulty implants for free but several large companies are refusing to do so….

So far, it has cost the NHS at least £500,000 with 4,534 women seeking help from the health service.

Most breast implants need to be replaced after ten to 15 years so a proportion of the faulty implants may already have been removed as part of routine replacement operations.

The Medicines and Healthcare products Regulatory Agency has advised that there is no need to replace the PIPs unless they have ruptured, however most women are so concerned they are asking for them to be taken out.

This week a credit card company refunded the cost of surgery under the Faulty Goods Act.

The Department of Health has ordered two reviews into the situation, one looking specifically at how the PIP implants were approved and the safety of them. The second will look at the regulation of cosmetic surgery more widely.

In December the French authorities decided to recommend that all women there who had PIPs should have them removed and that the Government would pay for the surgery.

http://www.telegraph.co.uk/health/healthnews/9146091/7000-more-British-women-have-faulty-breast-implants-officials-warn.html

“Brussels, 2 February 2012 – Following today’s publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a “stress test” of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012..

Health and Consumers Commissioner, John Dalli said: “In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case”. To add : “Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased”. To conclude : “We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.

The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so theadvice remains that women who are worried should contact their surgeon.

Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.

With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said thatPIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

SCENIHR concluded on the basis of available data, that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.”

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/96&language=EN