PIP Implants: Review Won't Provide Reliable Data, Says Member Of Panel Fazel Fatah
A government review on the risk of breast implants rupturing will not provide reliable data, a member of the review panel said today.
Consultant plastic surgeon Fazel Fatah, who is sitting on the government-commissioned panel investigating the PIP implant scandal, said there are simply no firm figures in the UK on what proportion of devices have ruptured.
He said it was time for the government to make it "crystal clear" to anxious women whether they should have the implants removed.
Health Secretary Andrew Lansley held discussions this morning 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% of implants in the UK have ruptured, however one clinic, Transform, put its own implant rupture rate nearer 7%.
Some 42,000 women in the UK are thought to have have had the implants, manufactured by the now-closed French PIP company.
In France, the government has told women they should have the implants removed after they were found to contain non-medical grade silicone intended for use in mattresses.
There have also been fears 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 (BAAPS), said the review of rupture rates, expected to be published this week, would not provide robust data.
"The truth of the matter is that none of these figures are completely reliable or are a true reflection of what's happening.
"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 with in 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.
"They are substandard, they are defective.
"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.
"I think we have reached a point and the level of anxiety is such that there should be clear advice over what is the right course of action for women to take."
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.
Yesterday, another member of the review panel, Tim Goodacre, also called for all women who have the implants to have them removed because of the "uncertainty and lack of knowledge".
He said: "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."
The comments come amid warnings from other experts that anti-ageing injections will be the next scandal in the cosmetic surgery industry.
There are concerns that the practice of administering injectable fillers, including Botox, is unregulated.
Leading surgeons have been calling for years for tighter regulation of the industry, saying anyone can "set up shop" to administer injectables.
The government was criticised in 2007 for setting up a scheme to allow the industry to police itself.
Mr Fatah said today: "We would like to see much tighter regulation. We would like to see anything that's injected into bodies in this way to be classed as medicines."
He said there was no way of checking the quality or effectiveness of more than 100 different fillers, adding the issue was "another problem waiting to happen at some stage".