French-Made Silicone Breast Implant at Center of Cancer ScareDec 22, 2011 | Parker Waichman LLP
Fears that a recalled silicone breast implant could cause a rare form of cancer are spreading around the world. According to a report in The New York Times, regulator in at least a half dozen countries are trying to ease fears among women who have received silicone breast implants made by Poly Implant Prosthese (PIP), a now-defunct French company.
The fears are most acute in France, where 30,000 women received PIP silicone breast implants before they were pulled from the market last year. The company faces a criminal probe there for using industrial silicone, rather than medical-grade material, in the implants. French regulators have received about 1,000 reports of PIP silicone breast implants rupturing. But most worrisome, at least 8 cases of a rare cancer called anaplastic large cell lymphoma (ALCL), including one death, have been reported in French women who received the implants.
So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry said yesterday it would recommend that the government there cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.
Alexandra Blachere, the leader of a French PIP implant patient group, told Reuters that en from Italy and Spain had been in touch with her with worries about their implants, and she'd seen reports of problems in other countries, including in Venezuela and Brazil.
"It's not just France that's concerned. We're looking at 300,000 to 400,000 potential victims in the world," Blachere said.
According to CNN, PIP never sought approval from the U.S. Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here. In March 2000, the FDA decided not to approve saline PIP implants for sale here.