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MARSEILLE, France—France's national insurance agency reportedly has filed a criminal complaint in an effort to recoup some of the damages it will incur in paying for women to have potentially dangerous breast implants removed.
Last month, the French government advised women who had received implants made by La Seyne-sur-Mer, France-based Poly Implant Prothèses S.A. to have them removed because of fear that they have a higher-than-usual rupture rate.
The government said it would pay for the removal of implants that were for reconstructive, not cosmetic, reasons.
France's medical and health care products regulator, the Agence Française de Securité Sanitaire des Produits de Santé, recommended that all women who have the PIP-made implants to receive an ultrasound scan, and that any women with ruptures or suspected ruptures should have the implants removed.
About 30,000 women in France are believed to have received PIP implants. In a 2010 bankruptcy filing, PIP said it once made 100,000 breast implants a year.
According to reports, PIP had product liability insurance coverage with limits of about $1 million, excluding the United States.
Filings made by PIP's parent company, Delaware-based Heritage Worldwide Inc., with the U.S. Securities and Exchange Commission show PIP was ordered in 2008 to pay damages totaling about $2.3 million as a result of product liability litigation in the United Kingdom. The company said it could not afford those payments.
The damages were awarded as a result of two cases in Nottingham, England, and London that were filed in 2006.
In May 2006, PIP was sued under the U.K. Consumer Protection Act in Nottingham County Court by 28 plaintiffs who alleged that the envelope surrounding their implants was not resistant enough and that the implants could cause pain and inflammation when they leaked.
And in December 2006, a plaintiff sued PIP in the High Court in London alleging that the envelope surrounding her implants was not sufficiently resistant.
In addition, suits have been filed against private clinics in the United Kingdom that inserted the PIP implants.
Kevin Timms, a trainee solicitor at Garden House Solicitors, a plaintiff law firm in Hertford, England, said his firm has filed a group action representing 27 claimants against 13 clinics. The firm is not pursuing PIP because implant manufacturer does not have adequate insurance coverage to meet its liabilities outside of France, he said.
Lawyers have been contacted by more than 400 claimants out of an estimated 50,000 women in the United Kingdom with PIP-made implants, he said.
The SEC filings show that PIP was the subject of several other complaints, many of which did not make it to court.
France's national insurance agency filed a complaint alleging fraud on the part of PIP, according to reports last week. The effort would aid the agency's effort to recoup funds it pays.
In the United States, the U.S. Food and Drug Administration issued a warning about PIP-made implants as long ago as 2000, although those were filled with saline.
While the French government has recommended that women with PIP implants have them removed, the advice from governments in many other countries where the implants were sold has varied.
The implants also were sold in Europe and South America. The Venezuelan government last month said women with PIP reconstructive and cosmetic implants could have their implants checked and that the government would cover the cost of removal.
The Italian consumer association, Coordinamento delle Associazioni per la Difesa dell'Ambiente e dei Diritti degli Utenti e dei Consumatori, said it that would launch a class action on behalf of women who had received PIP implants.
Gavin Souter contributed to this report.