This report comes courtesy of Yahoo news.
Note from Dr. Fiala: We have never used “PIP” brand silicone implants…so our patients don’t need to worry about this news item.
DRAGUIGNAN, France (AFP) – A French court Tuesday ordered the closure of a company making breast implants after health authorities ordered a recall of its products for using non-authorised silicone gel. “The company’s 100 employees have been made redundant and the plant must close,” insolvency administrator Xavier Huertas told AFP after the Toulon court ruling.
The Poly Implant Prothese (PIP) company is alleged to have made the implants fraudulently using unsanctioned silicone gel.
The agency that oversees health care products in France, the AFSSAPS, also ordered a ban on new sales of the implants.
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 would get a replacement.
AFSSAPS said women wearing implants made by PIP should consult their surgeon.
The agency began investigating the company’s products after it had been informed of abnormally high rupture rates of PIP’s implants, which was double that of implants from other companies.
Inspectors were sent to the firm’s production sites at La Seyne-sur-Mer 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 10 years.
PIP has had financial problems for months which were exacerbated by the latest investigation. It eventually ran up losses of nine million euros.