Rupture rates estimate unacceptable, says member of investigatory panel
All women with faulty breast implants should have them removed given the "uncertainty and lack of knowledge" about the extent of the problems, a leading surgeon has warned.
Tim Goodacre, a member of the government-commissioned panel investigating the Poly Implant Prothese (PIP) scandal, said the latest estimate of rupture rates was "very much higher" than he would consider acceptable.
About 40,000 British women are thought to have received the silicone implants made by PIP.
The Medicines and Healthcare products Regulatory Agency (MHRA) has said the risk of rupture is only 1%, but a cosmetic surgery chain told ministers privately that the figure could be as high as 7% or 8%.
Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (Bapras), told BBC Radio 4's The World At One: "Even with a very low rupture rate, we would want to see most implants removed on a staged basis.
"If you believe a device is faulty – I think this would be true in your car or any other object that you buy – you would want to have that replaced on a staged basis. Certainly this is a very much higher rupture rate than we would consider acceptable at all. Good implants put in by reputable people really have an extraordinarily low failure rate so this is quite out of the ordinary."
Goodacre stressed that there was no immediate cause for concern as there was no cancer risk and no evidence of "major health detriment". But he added: "Given the fact that there is a degree of uncertainty and lack of knowledge in this, we really are recommending that all implants do come out."
The French authorities shut down PIP last year after the company was found to be using cheaper industrial silicone. France has since recommended that women have the prosthetics removed.
In the UK, the MHRA has said that removal is not necessary. But the health secretary, Andrew Lansley, launched a review of the risks from faulty breast implants after receiving new evidence from cosmetic surgery company Transform. The NHS medical director, Prof Sir Bruce Keogh, is in charge of the review.
The MHRA will also be auditing evidence to resolve concerns about the "content and quality of the data that cosmetic surgery providers are sharing with the regulator".
The shadow health secretary, Andy Burnham, urged Lansley to "take a much clearer lead" to address women's anxiety about the implants. "Mixed messages from the department have not helped and families affected are looking for a stronger response from the government," he said.
He called for the government to agree a protocol with the cosmetic surgery industry to ensure there is proper support for women affected by the scandal.
Burnham said: "As a minimum, it must include these three basic points – first, that all medical records will be provided on request without delay and without charge. It is unacceptable that some women are being asked to wait or even pay an admin fee to see their records.
"Second, where there is evidence of a rupture, private providers must arrange for urgent removal at no expense to the individual and with any costs to the NHS reimbursed.
"Third, that all women given PIP implants must be offered an urgent, free consultation with a doctor once the results of the urgent review are known to discuss options.
"Where the NHS reverses private cosmetic operations because of risks to the individual, the health secretary must negotiate a clear expectation that those costs will be reimbursed.
"By agreeing this protocol today, the health secretary will help women and families potentially affected by giving them clarity about their rights. They need help through a difficult time and can't be passed from pillar to post by providers looking to evade their responsibilities."