LONDON/PARIS (Reuters) - Fears over the safety of breast implants made by a now defunct French firm spread to Australia, South America and across Europe on Thursday as French officials prepared to decide if thousands of women should have their implants surgically removed.
The silicone gel implants, made by a company called Poly Implant Prothese (PIP) that was shut down in 2010, appear to have an unusually high rupture rate and have sparked an investigation in France into possible links to cancer.
About 300,000 PIP implants, used in cosmetic surgery to enhance breast size or replace lost breast tissue, were sold worldwide before PIP went bust last year.
An investigation into PIP found it was using a type of silicone not approved by health authorities but about 10 times cheaper. The industrial-grade silicone PIP is accused of using is an ingredient in anything from computers to cookware.
“It’s not just France that’s concerned. We’re looking at 300,000 to 400,000 potential victims in the world,” said Alexandra Blachere, leader of a French PIP implant patient group.
She said women from Italy and Spain were in touch with her with worries about their implants and she had seen reports of problems in Venezuela, Brazil and elsewhere.
No one linked to the defunct company was immediately available to comment.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said there was no reason for patients to be alarmed and there was, as yet, no scientific evidence to suggest increased health risks.
MHRA officials said they had talked to other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta.
“They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France,” it said in a statement.
Founded in 1991, Poly Implant Prothese was based in southern France and for a while ranked as the world’s number three maker of implants, supplying about 100,000 a year.
About 80 percent were exported abroad. Health authorities around the world said they were watching closely for the results on Friday of an inquiry by France’s National Cancer Institute into whether the implants might be linked to cancer.
France’s Health Ministry is expected to make an announcement on Friday about the institute’s findings.
France has had reports of eight cases of cancer in women with breast implants made by PIP. Britain’s MHRA said there were also French reports of a woman with PIP implants who died from anaplastic large cell lymphoma, or ALCL, a rare form of cancer that affects cells from the immune system.
France’s drug and medical device regulator, AFSSAPS, ruled last year that the state would pay for the removal of all PIP implants but only fund replacements for victims of breast cancer, not women who used them for aesthetic purposes.
A French victims’ association is pushing for the state to pay for replacements for all women with PIP implants.
Australia’s healthcare watchdog, the Therapeutic Goods Administration (TGA), said about 8,900 of the PIP implants were used in Australian women, some of whom had complained about the devices splitting and leaking.
“The TGA has received 45 reports relating to PIP implants, 39 of which relate to rupture,” it said in a statement. It has had no reports of ALCL in Australian women with the implants.
Both the TGA and Britain’s MHRA said they would be looking carefully at the French safety statement on Friday.
Alfred Fitoussi, spokesman for the breast and cancer section of the French Association of Plastic Surgery, told Reuters he expected the report to say there was no cancer risk from the PIP implants. But he noted what he described as an “enormously” high rupture rate of about 10 percent.
“All kinds of tests have been done during many years and never showed any kind of cancer risk from silicone,” he said. “It’s obvious there is a problem with the quality.”
He said the normal rupture rate for breast implants was about 4 or 5 percent.
The MHRA said, based on reports it had so far, about 1 percent of women in Britain with PIP implants have suffered ruptures.
PIP was placed into liquidation in March 2010 with losses of 9 million euros after AFSSAPS recalled its implants when surgeons reported abnormally high rupture rates.
In Argentina, Colombia and Brazil, long a magnet for medical tourists looking for more affordable cosmetic surgery, imports of the implants were banned in April 2010, officials said.
“We know a high percentage of surgeons in Colombia and the rest of South America have used these implants,” said Celso Bohorquez, a spokesman for Colombia’s association of plastic, aesthetic and reconstructive surgery.
Brazil’s Anvisa health inspection agency said 25,000 PIP implants had been used but no complaints had been received so far. In neighboring Argentina, Roberto Lede from the state-run ANMAT drugs regulator said the evidence was “pretty weak” but advised concerned women to consult a doctor.
Douglas McGeorge, a consultant cosmetic and plastic surgeon and former president of the British Association of Aesthetic Plastic Surgeons, said he expected many patients would want to act sooner rather than wait and risk possible health problems.
A solicitor acting for at least 250 British women taking legal action over their PIP implants said the liquidation of the French company had limited the scope for lawsuits.
“We’re suing about half a dozen clinics that have been involved in implanting the PIP breast implants,” Mark Harvey, a partner at legal firm Hugh James, told Reuters.
“We would have preferred to sue PIP, obviously, but they are bankrupt so they have no money and no assets.”
Amanda Harrison, one of the British women seeking compensation, told Reuters she was disgusted by PIP’s actions.
“It’s sick that they could even think about putting this stuff into a human.” she said. “You wouldn’t even put it in an animal.”
Writing by Kate Kelland; Additional reporting by Estelle Shirbon in London, Pauline Mevel in Paris, Luis Andres Henao in Buenos Aires, Peter Murphy in Brasilia and Eduardo Garcia in Bogota; Editing by John O'Callaghan