PARIS (AP) — France wants the European Union to stiffen its rules on authorizing medical devices amid a breast implant scandal involving a French company and affecting tens of thousands of women worldwide, the health minister said Thursday.
Xavier Bertrand called for “an unprecedented change” in EU rules to put authorizations for medical devices, including silicone breast implants, on a par with rules already in place for prescription medicines.
The implants, made by now-defunct French company Poly Implant Prothese, were pulled from the market last year in several countries in and beyond Europe due to fears they could rupture and leak silicone into the body. France has recommended that the estimated 30,000 women in France with the implants get them removed after more than 1,000 ruptures, and agreed to pay for the procedure.
A lawyer for the company’s former director said in a statement Thursday that Jean-Claude Mas, who ran PIP until it was closed in March 2010, won’t speak publicly on the case.
“The numerous un-truths, nonsense and aberrations” being discussed in the case are behind Mas’ decision to only speak to judicial authorities, the statement by his lawer Yves Haddad said.
The scandal has put pressure on French health authorities for allegedly not doing enough to vet the quality of a product used by untold thousands of women both in France and abroad.
Jean-Yves Grall, France’s top doctor as head of the national health directorate, was holding a closed-door meeting with industry players and top health officials on Thursday.
“We need new rules … and this modification needs to happen at the European level,” Health Minister Bertrand told LCI TV. He said he planned a conference call on the matter with EU counterparts.
Frederic Vincent, spokesman for EU Health and Consumer Policy Commissioner John Dalli, said Brussels had already planned to revise its directive on medical devices — which covers some 10,000 items, as varied as bandages, contact lenses and hip replacements — in the first half of 2012. It would strengthen national regulators and improve information-sharing.
Vincent acknowledged that “traceability is an issue” and said that at the moment each member government is responsible for tracing medical devices used by patients in its country.
France’s Health Safety Agency has said the suspect PIP implants appear to be more rupture-prone than other types. Investigators say PIP sought to save money by using industrial silicone — whose potential health risks are not yet clear.
But Wednesday, Australia’s medical watchdog said health officials had found no evidence that the PIP implants had an increased risk of rupture in Australian women, and said lab testing of the silicone gel used indicated that it was non-toxic to the tissue around the implant even if it did rupture.
Authorities in places such as Britain and Italy have asked hospitals and private clinics to track down women who received the implants. Several countries, including Colombia and Venezuela, have agreed to use state money to pay for the removal of the suspect implants. In some other countries, recipients have demanded to have their governments pay for replacements, too.
PIP’s website said the company had exported to more than 60 countries and was one of the world’s leading implant makers. The silicone-gel implants in question are not sold in the United States.
According to estimates by national authorities, over 42,000 women in Britain received the implants, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy. Nearly 25,000 of the implants were sold in Brazil.
AP Business Writer Gabriele Steinhauser in Brussels contributed to this report.
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