PARIS (Reuters) - France and Britain issued conflicting advice on Friday to tens of thousands of women with breast implants made of cheap industrial silicone that some fear pose health risks.
The French government urged 30,000 women in France to seek removal of the implants, made by now-defunct French company Poly Implant Prothese (PIP), because of the danger they could rupture and cause inflammation and irritation. There was no evidence of any increased cancer risk, it said.
But in Britain, where an estimated 30,000 to 40,000 women are affected, Chief Medical Officer Dame Sally Davies said: “Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon.”
Removing implants “carries risks in itself”, she said.
“I do think that every woman who has these implants should go and get checked ... It’s better to have them replaced than to worry about them rupturing,” said British woman Pat Demetriou, who had faulty PIP implants removed in 2010.
Nigel Mercer of the British Association of Aesthetic Plastic Surgeons said the French move was “certainly not unreasonable” while British cosmetic surgeon Kevin Hancock said the divergent government responses would cause distress for British women.
Concerns in France first surfaced about two years ago when surgeons started reporting abnormally high rupture rates, leading to a flood of legal complaints, the company’s bankruptcy and a scandal that has spread across the world.
Regulatory filings show that signs of legal problems and financial losses can be traced back as far as 2003.
Founded by Jean-Claude Mas - who was formerly a butcher, according to a surgeon who knew him - PIP produced about 100,000 implants a year for the better part of two decades before its products were ordered off the market in early 2010.
Mas is wanted by Costa Rica for “life and health” offences, according to a notice posted on the website of the international police agency Interpol.
Local investigative police in Costa Rica said a man identified as Jean Claude Mas Florent was arrested by national police in Costa Rica’s Cartago province on June 1, 2010 for reckless driving under the influence of alcohol, a crime that can carry a jail sentence.
He was handed a court date for November 21, 2010, but fled the country and never appeared before court. It was unclear if there was any link between that arrest and the Interpol notice.
As many as 300,000 women worldwide may have received the gel products, used to enhance breast size or repair lost tissue. They were exported to Latin American countries such as Brazil and Argentina, and Western European markets including Britain, Germany, Spain and Italy.
Brazil’s health watchdog called for users of PIP implants to visit their doctor for checks. More than 25,000 units were used in Brazil - a country obsessed with appearance and which has a huge cosmetic surgery industry.
Australia’s healthcare watchdog says about 8,900 of the implants were used in women there, some of whom had complained about splitting and leaking.
Germany’s medical safety board advised women with PIP implants to consult their doctors for checks, but stopped short of recommending their removal.
PIP recognizes that its products were defective but argues that it is being unduly singled out, the company’s lawyer said.
“The implants had flaws but the PIP implants are not the only ones on the market that had problems,” lawyer Yves Haddad told Reuters. “The reality is that everyone who makes implants has a percentage of failures.”
According to him, company founder Mas, 72, is in France but does not intend to make public comment.
In a statement addressed to French women, the health ministry said public healthcare funds would be used to finance the recommended implant removals, at a cost estimated at 60 million euros ($78 million).
New implants would be paid for in cases where the initial implant was inserted for medical reasons, typically for reconstruction after breast cancer treatment.
Associations representing women with PIP implants have been demanding that all replacements, including cases of implants that were purely cosmetic, be publicly funded.
“This announcement is just a smokescreen and the victims of PIP are angry,” said Alexandra Blachere, head of the association of PIP implant users in France. “PIP implants are dangerous even excluding cancer. The state can’t simply order them to be removed and then leave women to get by afterwards.”
Philippe Courtois, a lawyer for a French association of PIP implant users, said many victims were seeking more extensive compensation than basic cover of implant removals.
Among them is Annie Mesnil, 62, a breast cancer sufferer who had reconstructive surgery a decade ago but had to spend a lot of money to get PIP implants removed last June.
“This is not the end of our fight,” she said.
PIP was placed into liquidation in March 2010 with losses of 9 million euros after the French medical safety agency recalled its implants. In a subsequent inspection of its manufacturing site, officials found it was using industrial silicone not approved by health authorities, and only about a tenth as expensive as approved gel.
An investigation found a majority of implants made by PIP since 2001 contained the unapproved gel. Industrial silicone is used in a range of products from computers to cookware.
That gel, former PIP worker Mariaccia told Reuters, was an in-house production rather than bought in by the firm.
More than 2,000 women in France have filed legal complaints and another 250 have done so in Britain, where law firms said they had receive a flood of inquiries in recent days.
Despite the British authorities’ advice, plastic surgeon Hancock, of the Liverpool Women’s Hospital, told Reuters there were concerns in the profession over a high rupture rate.
“We are worried about the rupture risk because it is the rupture that brings the contents into direct contact with the body’s tissues,” he said. “We know that the contents were not what they were supposed to be. So in general we agree with the (French) decision to remove them.”
A spokesman for the German company TUV Rheinland, which provided quality certification of PIP’s production facilities until March 2010, said its remit was to check the production process, not the content of the silicone.
TÜV Rheinland sued PIP in February 2011, claiming it had been “thoroughly and continuously misled” by PIP about a change in the silicone that was used.
Several PIP executives are expected to face charges of aggravated fraud in an ongoing court case in France, which exposes them to possible jail terms of up to five years.
Courtois, the lawyer for PIP implant users, said that trial was likely to be scheduled for next October.
The scandal has been rekindled in recent weeks by the death of a cancer victim who had such implants, prompting prosecutors to open another preliminary inquiry that will assess whether there are grounds for more serious charges of involuntary manslaughter.
Additional reporting by Alexandria Sage in Paris, Jean Francois Rosnoblet in Marseilles, Estelle Shirbon and Kate Kelland in Britain, Ludwig Burger in Frankfurt and Patrick Rucker in Mexico City; Writing by Mark Trevelyan; Editing by Andrew Roche and Michael Roddy
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