French breast implant maker, Poly Implant Prothese (PIP), is making headlines again over a trial involving five of its executives.
We previously wrote that PIP admitted it used unapproved silicone in its so-called “silicone” breast implants, brushing off fears of a health risk and. In late 2010, the same breast implants sparked cancer fears in France after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer.
Jean-Claude Mas, 73, PIP’s founder and its long-term chief executive, admitted filling the implants with an unapproved recipe of industrial-grade silicone gel, said Reuters. Now, Mas, the firm’s chief financial officer, and three other executive have been charged with aggravated fraud and face maximum prison terms of five years each. They all also face fines for selling the defective implants globally from 2001 to 2010, said Reuters. The devices were banned in 2010.
Mas and Claude Couty, PIP’s former chief financial officer, have also been implicated separately in a civil case that involves fiscal fraud, said Reuters. Mas is also being investigated for manslaughter following a complaint from the mother of the French woman implanted with the PIP devices who died of ALCL.
A prior United Kingdom inquiry found that the controversial PIP breast implants were six times likelier to rupture. Thousands of alleged victims have filed complaints—some 5,000, at last count—about the implants; some 300,000 PIP implants have been sold worldwide and over 200 lawsuits, said Reuters, have been filed by women outside of France.
The PIP silicone breast implants were never approved for sale in the United States; however, PIP did sell roughly 35,000 saline-filled implants in the U.S. between 1996 and 2000. Those devices are the subject of U.S. product liability lawsuits alleging they deflated after several years. The U.S. Food & Drug Administration (FDA) also cited the saline implants in a warning letter in 2000, before they were taken off the U.S. market.
The inquiry also found that, while there is a significantly increased rupture risk, the PIP brand implants to do not cause cancer, wrote the Daily Mail previously. Regardless, leading plastic surgeons say women should have the defective implants removed and attorneys have said that confirmation has been made that the implants are sub-standard.
In fact, U.K.’s medical regulator warned about the safety of PIP breast implants four years before the devices were recalled. In 2006, surgeons contacted the Medicines and Healthcare products Regulatory Agency (MHRA) regarding concerns they had about PIP implants, saying that the faulty devices split more often than other brands, according to a report by Lord Howe, U.K.’s health minister. Yet, the defective implants remained on the market until March 2010 when French authorities discovered that silicone mattress filler gel, not approved materials, was fraudulently used in the implants. Regulatory watchdogs never issued a warning over concerns that such an alert would cause an “unwarranted scare, which could have serious commercial implications,” according to the Daily Mail. The review, however, revealed that current regulation would never have been able to prevent the scandal, the result of “deliberate fraud,” by the device makers.