Up to 50,000 British women with defective breast implants have been warned about their safety as the French government prepares to order the products be removed from every woman who has had them fitted.
The implants were made by a French company from substandard, industrial-grade silicone and exported around the world. Eight cancer cases, including one death, have been tentatively linked to them in France and hundreds of other women have reported ruptures in the devices.
The newspaper LibEration reported yesterday a decision had been taken, in principle, to have all "PIP" implants that were fitted in France removed. The French health ministry said the call would be made at the end of this week. But in Britain regulators said tests had shown evidence of a potential for cancer (genotoxicity) or chemical toxicity of the filler material inside the implants and there was no reason for their routine removal.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said women who were concerned "should seek clinical advice from their implanting surgeon".
The implants, among the cheapest on the market, were filled with a silicone made for mattresses rather than medical use, in what is being treated as a medical fraud. There is also a French criminal investigation into possible manslaughter.
Initial tests showed there was no cancer-causing potential in the silicone, but the French regulatory authority Afssaps suggested the irritant quality of the gel could be an aggravating factor.
The British Association for Aesthetic Plastic Surgery said it was reasonable for British women to consider removing the implants. A spokeswoman said: "We are very much in line with France. It is not unreasonable to recommend they be taken out because of their high failure rate and poor quality control."
But Douglas McGeorge, a former president of the association who is a consultant plastic surgeon, said: "I don't think there is any rush to take them out, but women may sleep better in their beds knowing they are out. It is certainly not a blue-light emergency situation. But if I were sitting on a potential problem in my own life I would choose to remove them in the reasonably near future."
He said private patients who had the operation for cosmetic reasons should go back to the clinic that inserted the implants. The cost could range from £2,000, if the surgeon worked free of charge, to £5,000 for new implants inserted by a new surgeon.
"I would hope clinics would do the operation at cost price," Dr McGeorge said. "They chose the implants, not the patient. There is a duty of care involved."
Investigations began last year into the activities of Poly Implant ProthEses (PIP), a company that made 100,000 breast implants a year. The now-defunct firm, based near Marseilles, is suspected of saving up to A1m ((pounds sterling)835,000) a year by using a form of silicon gel 10 times cheaper than that officially authorised for breast implants.
PIP, once the third-largest company of its kind in the world, came under suspicion after doctors reported an abnormal number of rips and leaks in its products. Public prosecutors in the Marseilles area, who are investigating fraud and manslaughter, have received formal complaints from 2,172 women. A celebrated French plastic surgeon, Laurent Lantieri, told LibEration that the authorities no longer had a choice. "We are facing a health crisis caused by fraud," he said. "There is no great hurry but all the implants must be removed." The French national cancer institute also said that a decision to operate to remove the transplants was inevitable.
The surgery will be paid for by the French state health service, but new implants will be provided only to women who had the original operations for medical reasons. More than 80 per cent of the potentially defective implants were for cosmetic purposes.
French authorities said last week that eight cancer cases had occurred in women who had suffered PIP implant failures. One of the women, who suffered a rare form of lymphoma, died. But officials warned that a direct link between the implants and cancer had not yet been established. The MHRA said it was aware of the death from anaplastic large cell lymphoma (ALCL) in France, but that it had received no reports of such cases in the UK.