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Faulty breast implants in Europe may spawn litigation

Maker bankrupt, raising questions on target of suits

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Faulty breast implants in Europe may spawn litigation

CARDIFF, Wales—At least one lawyer already has hundreds of clients ready to sue over faulty silicone breast implants, but whether a suit would target the now-bankrupt French firm that made them or medical facilities that implanted them remains unknown.

According to U.S. Securities and Exchange Commission reports, Poly Implant Prothèses S.A., which filed for bankruptcy in Toulon, France, in 2010, had product liability insurance with limits of about $1 million, excluding the United States.

Sources said, however, that the fact that PIP is in bankruptcy and unlikely has much insurance coverage outside of France means that claimants outside of France may seek damages from individuals or medical facilities that implanted them.

The implants were widely sold in Europe, Australia and South America.

In December, the French government advised women who had received implants made by La Seyne-sur-Mer, France-based PIP to have them examined and, in some cases, removed because of fears they had a higher-than-usual rupture rate.

PIP reportedly used non-medical grade silicone gel in the implants.

The French government said it would pay for the removal of implants that were performed for reconstructive, not cosmetic, reasons and seek to recoup some of its damages by filing a criminal complaint against PIP.

This month, Germany, the Czech Republic and the Netherlands recommended that women with PIP implants have them removed.

Last week, the Welsh government said it would pay for the removal of implants from women who were treated in the private sector. The U.K. government reiterated last week that there was no need for women with PIP-made implants to have them removed unless they had developed a problem.

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The government said, however, that it would pay for the removal of implants given to patients by the National Health Service, the United Kingdom's government-backed health system. It stood firm, however, that the government would not pay for replacing the implants.

The London-based British Assn. of Aesthetic Plastic Surgeons said that if women are concerned or have any adverse symptoms, they should have a scan and, if there is any weakening or rupture, have the implants removed.

“We believe there is a moral and ethical obligation on the clinics who performed these operations in the first place to facilitate the removal of the faulty implants for free or at the bare-minimum cost,” Fazel Fatah, president of BAAPS, said in a statement.

Mark Harvey, a partner and head of litigation at Cardiff, Wales-based law firm Hugh James Solicitors, is putting together a group action claim on behalf of more than 700 women in the United Kingdom who received PIP implants.

The law firm will seek to have the cases treated as a group action in a court hearing in Cardiff this month.

Mr. Harvey said he originally intended to pursue PIP and its insurers for damages, but that is not a viable option because the company no longer is in business.

Legal actions in the United Kingdom and elsewhere in Europe likely will be against medical facilities that used PIP's products, said Manoj Vaghela, a partner in the insurance and reinsurance practice of London-based law firm Clyde & Co. L.L.P.

Those facilities, however, likely would use the defense that the products were approved by regulators, he said.

Even if such a defense is successful, however, clinics will incur costs that may not be recoverable from their product liability policies, Mr. Vaghela said.