France advises 30,000 to have breast implants removed
France's health ministry Friday advised 30,000 women with breast implants made by French firm PIP to have them removed as, while there is no proven cancer risk, they could rupture dangerously.
The government stressed there was no urgency but the advice will likely add to the concern of tens of thousands of other women around the world who have the implants made from industrial rather than medical quality silicone.
Women with PIP implants "do not have a higher risk of cancer than women who have implants manufactured by other firms", a health ministry statement said but added there were "well-established risks of ruptures."
But Health Minister Xavier Bertrand called for their removal as a "precautionary measure", while stressing that this was not urgent. The eight cancer cases involved mainly breast cancer.
Medical insurance will pay for the implants' removal, but only women who had the implants as part of reconstructive surgery after breast cancer, rather than for purely aesthetic reasons, will have new implants paid for.
The government advised women with PIP implants to contact their doctor and "a precautionary removal will be offered, even without clinical signs of deterioration of the implant."
Any woman who declines the removal must have a breast scan every six months, the health ministry added.
The now-bankrupt Poly Implant Prothese (PIP) was shut down and its products banned last year after it was revealed to have been using non-authorised silicone gel that caused abnormally high rupture rates in its implants.
Facing financial difficulties, the company, once the world's third-largest producer of silicone implants, replaced the medical-grade silicone in its implants with industrial-strength material.
Documents obtained by AFP on Wednesday showed that tens of thousands of women in more than 65 countries, mainly in South America and western Europe, received implants produced by PIP, which ceased trading last year.
The government statement came after the National Cancer Institute (INCA) handed its experts' report to the health ministry on Thursday evening.
"Given the absence of new information about the substandard gel or new clinical data on specific complications, the experts feel there is insufficient proof to advise the preventative, systematic removal of the implants," the statement said.
It nevertheless advised removal because the implants have a "well-established risk of rupture, which would cause inflammation and make removal difficult," it said.
Prosecutors in Marseille, near PIP's home base of Seyne-sur-Mer, have received more than 2,000 complaints from French women who received the implants and have opened a criminal investigation into the firm.
Yves Haddad, a lawyer for 72-year-old PIP founder Jean-Claude Mas, told AFP his client was prepared to face prosecution and denied the implants could be linked with health problems.
"For the moment there is no evidence that the product can cause illness," the lawyer said.
According to PIP's 2010 bankruptcy filing in the French city of Toulon, it exported 84 percent of its annual production of 100,000 implants.
Between 2007 and 2009, 50 to 58 percent of its exports went to South American countries including Venezuela, Brazil, Colombia and Argentina, the filing showed.
In the same period, 27 to 28 percent of exports went to western European nations including Britain, Spain, Italy and Germany.
© 2011 AFP