France urges breast implant removal
A defective silicone gel breast implant manufactured by French company Poly Implant Prothese sits near surgical instruments after being removed from a patient by a plastic surgeon in a clinic in Nice this week.
The French government today urged tens of thousands of women to seek removal of breast implants made of a suspect silicone gel by a firm that exported its product worldwide.
An estimated 30,000 women in France have had breast implants made by the now-defunct company Poly Implant Prothese SA (PIP), which produced about 100,000 implants a year before its product was ordered off the market in early 2010.
Earlier this week, the Irish Medicines Board moved to reassure 1,500 women in Ireland that there is no need to have their breast implants removed. The board recommended that patients who were concerned about the implants should consult their surgeon.
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 Ireland, France, the Netherlands, Portugal, Italy, 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 per cent 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 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 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.
