Findings expected soon on leaking PIP breast implants

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Thousands of British women with banned PIP breast implants should know soon whether the government believes the implants, which were made from industrial not medical grade gel, should be removed.

Manufactured by the French firm Poly Implant Prothese (PIP), the implants were banned in France in 2010 due to a high risk of leaking. It emerged that industrial-grade silicone had been used in their manufacture, instead of medical-grade material which has passed safety tests for use in a human body.

PIP Breast Implant – Risk of leaking

Although no increased risk of toxicity has been reported, the PIP implants are more likely to rupture. However, the Harley Medical Group, a private cosmetic surgery company, has insisted there is no cause for concern.

The company said that it fitted 13,900 women with PIP implants between September 2001 and March 2010. Its records showed the risk of implant rupture was not high, with only 1.3% of implants rupturing within 4 years of surgery.

Whilst insisting the risk is low, the government has ordered a review and says private clinics have a "moral duty" to remove implants they fitted. The Harley Medical Group has not yet stated whether it will comply.

The key question will be over the implants' confirmed rupture rate, which the French authorities estimate at 5%: a stark contrast to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) assessment of 1%.

Amid reports from Transform, the cosmetic surgery group, of 7% rupture rates, the health secretary, Andrew Lansley, ordered the review. However, Transform says the review's preliminary findings were based on just 7 out of 108 patients it fitted with PIP implants since 2005.

Although Mr Lansley has stated that private companies' data had been "inconsistent", the director of the Independent Healthcare Advisory Services, Sally Taber, said: "Following an audit of our members, which includes data on thousands of patients... we can confirm that the average rupture rates reported for PIP implants are within the industry standard of 1-2%."

The leader of the review, NHS medical director Prof Sir Bruce Keogh, said: "I am disappointed at the ability of some private providers to submit accurate and meaningful data. I am pursuing this with vigour."

The president of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, has argued that all implants should be removed, saying that determining exact rupture rates would be impossible. "The important issue was the quality of the silicone, as it is not fit to be implanted into humans."

Simpson Millar LLP is co-ordinating legal action on behalf of a number of women across the UK who have had PIP implants. Many affected women are concerned that whilst the NHS may fund removal of leaking implants it remains to be seen whether those implants will be replaced. That places a great number of people possibly having to face the risks of not one but 2 surgical procedures. If the implants are defective, affected women should be compensated.


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