France recalls breast implants after fraud, leakage

French health authorities said they had ordered a recall of a certain type of breast implant after it emerged that the company making them had fraudulently used non-authorised silicone gel.

The agency that oversees health care products here, the AFSSAPS, also ordered a ban on new sales of the implants, which are made by the French company Poly Implant Prothese (PIP).

Around 90 percent of PIP's breast implants are exported.

Between 35,000 and 45,000 women have had an implant supplied by the French company since 2001, said Jean-Claude Ghislain of AFSSAPS, adding that up to 1,000 of them will get a replacement.

The agency said it began investigating the company's products after it had been informed of abnormally high rupture rate of PIP's implants, which was double that of implants from other companies.

Inspectors were sent to the firm's production sites in southern France where they discovered that PIP was using a type of silicone gel that had not been approved by health authorities.

"Therefore these were products that had not been evaluated," Ghislain said, adding that what he called "the fraud" had been going on for several years.

He said that unsuitable gel could damage the shell which contains it and thus could leak more easily than approved gel, which might explain why PIP implants had such high rupture rates.

Ghislain noted that breast implants normally have a lifespan of ten years.