Urgent inquiry launched over breast implants

THE UK government has changed its stance over the potential risks posed by faulty breast implants and called for an urgent investigation of the data, it was announced yesterday.

Tens of thousands of women in Britain are believed to have been fitted with silicone implants made by Poly Implant Prothese (PIP), including hundreds who underwent reconstructive surgery through the NHS.

The firm was shut down last year after it was found to be using cheap, non-medical grade silicone filler and French authorities have recommended that about 30,000 women have their implants removed as a precautionary measure, with the government footing the bill.

Despite the fears in France, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had indicated that its research suggested the chances of a rupture in one of the implants was only 1 per cent, compared with the 3.6 per cent chance estimated by Paris. The UK body also said there was no evidence of cancer links and, on that basis, removal of the implants was not necessary.

Speaking yesterday, however, Health Secretary Andrew Lansley expressed concern that the evidence about potential dangers to the estimated 40,000 British women with PIP implants was not reliable.

Professor Sir Bruce Keogh, the NHS’s medical director, had now been asked to carry out a review. The MHRA will also be conducting an audit of its evidence to resolve concerns about the “content and quality of the data that cosmetic surgery providers are sharing with the regulator”.

Lansley said: “We are doing everything we can to ensure women with these implants get the best possible advice. So far, all the evidence from around the world suggests that women should not be worried and that there have not been abnormal levels of problems reported with these implants. But if any woman is worried, then they should contact their surgeon or GP.

“We have, however, received data from an organisation yesterday that was not previously acknowledged or communicated to the MHRA. The validity of this data still requires full assessment and evaluation, so I have asked Prof Sir Bruce Keogh to lead an urgent investigation so that we can establish exactly what has happened and whether we need to improve the regulatory regime.

“I want to reassure women that if any new data comes to light which calls into question the safety of these implants, we will act swiftly to help them. Our top priority is making sure that women get the correct advice.”

The MHRA is expected to report to ministers next week, before a decision is taken about whether further action is required.

In France, eight cases of cancer have been reported in women with the implants, but authorities in the country say these are not necessarily linked to faulty implants. One woman with an anaplastic large cell lymphoma (ALCL) cancer died. However, French and US experts have said there appears to be a small increased risk of this kind of rare cancer with any brand of implant.

PIP used industrial silicone believed to be made for mattresses, according to the British Association of Aesthetic Plastic Surgeons. This meant the low-cost devices were more likely to rupture and leak silicone gel. Last week, it emerged that the US Food and Drug Administration warned PIP 11 years ago that its saline breast implants were “adulterated” and did not meet medical quality requirements.

It is believed that more than 300,000 implants have been sold globally by PIP, spanning about 65 countries. The company began using the new type of silicone in 2001 as part of a cost-cutting measure. More than half of its exports went to South America, including to Venezuela, Colombia, Argentina and Chile. In Brazil, around 25,000 women are believed to have had the implants fitted

Western Europe was another significant market for the firm. In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs.