France recalls French-manufactured breast implant, says company misreported type of silicon

Wednesday, March 31, 2010

France recalls type of silicon breast implant

PARIS — France’s health authorities pulled a French-manufactured type of breast implant off the market Tuesday after discovering that the company had misreported what form of silicon it contains.

The implants in question were manufactured by Poly Implant Prothese, or PIP. The company, which specializes in silicone implants and is based in southern France, says on its Web site that it exports its products to 66 countries.

France’s health regulatory agency, Afssaps, said it inspected the company’s offices because of an increase of cases of its pre-filled silicone gel implants rupturing.

It discovered the company used “a silicone gel different than the one that was reported when it was put on the market.” The agency said it was recalling the implants at issue and recommended that women who have such implants see their surgeons for an examination and get annual ultrasounds.

The agency said there is no sign the implants caused “different complications than those usually seen with other types of breast implants pre-filled with silicone gel” — though it said there was a “higher frequency of rupture and local inflammatory reactions.”

Poly Implant Prothese, founded in 1991 and based in the southern French town of La Seyne-sur-Mer, did not immediately return calls and an e-mail seeking comment.

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