UK launches inquiry into safety of PIP breast implantsBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e11 (Published 03 January 2012) Cite this as: BMJ 2012;344:e11
The UK government has launched a rapid review into the safety of a particular make of breast implants from France to try to reassure the 40 000 women in the country who have the implants. The French government has already announced that it will pay for the 30 000 women there who had the implants made by Poly Implant Prosthèse (PIP) to have them removed as a preventive measure (BMJ 2011;343:d8329, 29 Dec, doi:10.1136/bmj.d8329).
PIP went into administration last year, and use of its implants was banned amid worries that non-medical grade silicone had been used to make them.
Concerns emerged last month in the French media after it was claimed that the implants were linked to cases of cancer. Although experts in France found no evidence of such a link, they recommended that all women with the implants have them removed even if there was no evidence of deterioration, because the implants had been shown to rupture more often than other types.
In the United Kingdom the watchdog the Medicines and Healthcare Products Regulatory Agency said that it had been monitoring the safety of PIP breast implants closely since 2010 and concluded that it was wrong to recommend routine removal.
Leaders in the field of plastic surgery have, however, called for all PIP implants to be removed, and continuing speculation has prompted the Department of Health for England to launch a review of all the scientific evidence available on their safety, which is being led by Bruce Keogh, medical director of the NHS in England.
A health department spokeswoman said, “A decision was made before the weekend that we needed to look harder at this. We want to put people’s minds at rest as quickly as possible.”
The review is expected to conclude within a week and to report shortly after the BMJ went to press. One of the members of the review panel, the consultant plastic surgeon Tim Goodacre, told the BBC’s World at One radio news programme on 2 January that he believed there should be a staged removal of the implants.
Media reports that the private Transform cosmetic surgery clinic had said that the rate of implant ruptures among UK women was as high as 7% have been rejected by Transform as taken out of context, and the Medicines and Healthcare Products Regulatory Agency has said that a 1% rupture rate is more likely.
Mr Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons, said, “There is no immediate cause for concern, there’s no cancer risk with these, and even if implant gels have ruptured, there is no evidence to suggest that that in itself is of any major health detriment.
“But given the fact there is a degree of uncertainty and a lack of knowledge on this, we’re recommending that all implants do come out.”
Mr Goodacre said that who should pay for any implant removal and replacements would form part of the panel’s discussions.
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said, “We believe there is a moral and ethical obligation on the clinics who performed these operations in the first place to facilitate the removal of the faulty implants for free or at the bare minimum cost.”
Labour’s shadow health secretary, Andy Burnham, told BBC Radio 4’s Today news programme on 3 January that the cosmetic industry should foot the bill for removing the implants.
“I would have ensured that people who have had a problem—where there’s evidence of a rupture—get immediate corrective surgery paid for by the private cosmetic sector industry,” said Mr Burnham.
Cite this as: BMJ 2012;344:e11