Inquiry into implants will be unreliable, admits expert

A GOVERNMENT review on the risk of breast implants rupturing will not provide reliable data, a member of the review panel has said.

Consultant plastic surgeon Fazel Fatah, who is sitting on the panel investigating the Poly Implant Prothese (PIP) implant scandal, said there were simply no firm figures in the UK on what proportion of devices had ruptured. He said it was time for the government to make it “crystal clear” to anxious women whether they should have the implants removed or not.

Health Secretary Andrew Lansley held discussions yesterday with Professor Sir Bruce Keogh, who is leading the review, chief medical officer Sally Davies and the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA has said its figures indicate 1 per cent of implants in the UK have ruptured. However, one clinic, Transform, put its own implant rupture rate nearer 7 per cent. A statement from Transform said the 7 per cent figure was based on 108 patients.

Some 42,000 women in the UK are thought to have had the implants, manufactured by PIP, the now-closed French company. In France, a full investigation into the scandal was ordered yesterday. French health minister Xavier Bertrand branded the implants “truly contaminated” as he announced the government inquiry into the global scare.

The implants were found to contain non-medical grade silicone intended for use in mattresses. There have been fears also of a link to cancer, although the MHRA insists it has found no evidence of a link.

Mr Fatah, president of the British Association of Aesthetic Plastic Surgeons, said the review of rupture rates, expected to be published this week, would not provide robust data.

“None of these figures are completely reliable or are a true reflection of what’s happening,” he said. “In all cases so far, they are simply recording the ones they have seen with ruptured implants. There may be a significant number of silent ruptured implants that we don’t know about.

“A significant number of patients also do not go back to the clinic where they had their surgery if they suffer a rupture. Instead, they go to the NHS and are dealt within the NHS. We do not know the exact rupture rate in the UK.”

Mr Fatah said he believed women should plan for having implants removed. “The point is not so much the rupture rates, but that the quality of the silicone in these implants is not of medical grade.

“Therefore, the implants are not fit to be implanted into humans.

“The government must make sure that women who have these implants are not caught in the middle of an argument over who’s going to pay for their removal.”

He said private clinics who carried out the surgery had a moral obligation to women and must not be allowed to profit from removing the devices.

A statement from the International Society of Aesthetic Plastic Surgery said: “Even without any clinical signs of rupture, these implants should be removed or exchanged immediately to avoid further health risks.”