Risk from breast implants cannot be judged

Regulator admits it does not have sufficient data as Government tackles rupture scandal

Jeremy Laurance,Melanie Newman
Thursday 05 January 2012 01:00
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The safety of breast implants inserted into tens of thousands of British women is impossible to judge, the body responsible for regulating them has admitted, because an accurate record of the number of procedures has not been kept.

Figures obtained from the UK regulator in response to a freedom of information request show there were 138 reports of ruptures across all types of implant in 2009 and 546 reports in the six years from 2004 to 2009.

But the Medicines and Healthcare Products Regulatory Agency (MHRA) admitted it did not have accurate data for the total number of implants inserted, making it impossible to calculate the true rupture rate. On Tuesday, the Health Secretary, Andrew Lansley, who has ordered an investigation into the rupture rate of the banned PIP implants which is due to report tomorrow, criticised private clinics for providing "poor quality" data. Sir Bruce Keogh, the NHS medical director who is leading the review, said he was "pursuing with vigour" those clinics that had failed to provide meaningful information.

Mr Lansley said the review had, so far, found no evidence for removing PIP implants. But his department admitted yesterday that it was still trying to determine the implant rupture rate.

Nigel Mercer, the former president of the British Association of Aesthetic Plastic Surgeons, said: "No one knows how many breast implants there are, or how many have failed. That is the problem. Surgeons don't have to report them. We've a 'yellow card' warning system to report adverse effects of drugs, but no mandatory system for implants."

Tougher regulation of cosmetic surgery was recommended in 2005 by the then patients' tsar, Harry Cayton, including a licensing system for clinics. The plans were accepted by Labour but the former Health Secretary, Andy Burnham, reneged on them.

The MHRA said earlier that the rupture rate for PIP implants given to more than 40,000 women in Britain was between 1 and 2 per cent, which was within the expected level. But in France, where 30,000 women have received the implants, the regulator AFFSAPS said it had received 1,140 reports of ruptures, a failure rate of 3.8 per cent.

Confusion deepened as the US-based International Society of Aesthetic Plastic Surgery, which has more than 2,000 members in 93 countries, said that the rupture rate for PIP implants "appears to be five times higher" than for comparable ones and urged their immediate removal. In the UK, the Independent Healthcare Advisory Services, which represents private clinics, said the failure rate for PIP implants was in line with that for other brands.

Its director, Sally Taber, added: "Following an audit of our members, which includes data on thousands of patients from leading groups including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group, we can confirm that the average rupture rates reported for PIP implants is within the industry standard of 1 to 2 per cent."

Case study: 'You assume the products would be safe'

Charlie Mooney, 21, from Bristol, said: "I had to have one PIP replaced after it became infected. My new surgeon, from Liberate cosmetic surgeons, advised me to replace both to make sure they were both the same age. It was only this decision that led me to discover the other one had disintegrated.

The whole process dragged on for three years and has left me with no small amount of scarring. It is not how I'd imagined it. I paid £4,000 for both operations. You just assume that at those prices the companies performing these procedures would be properly regulated, and the products they use would be safe.

By the time I discovered the problems with my PIPs, the company which did them had gone out of business and there was no one to complain to. It may be cosmetic surgery, not life-saving surgery, but the consequences of mistakes are just as severe."

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