The founder of a French medical device firm that made defective breast implants now at the center of a worldwide cancer scare is being sought by Interpol on an unrelated drunk driving charge. Jean-Claude Mas, the 72-year-old founder of Poly Implant Prothese (PIP), the company that made the controversial silicone breast implants, could face prison time in Costa Rica on the charge, but fled the country before he could be brought to trial.
PIP silicone breast implants, which were already among the cheapest and most fragile on the market, were recalled last year after it was learned that they contained industrial, rather than medical grade, silicone. PIP has since gone out of business, but faces a French criminal probe for misreporting the type of silicone used in the implants.
The PIP silicone breast implants sparked cancer fears in France after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants. Last week, French health authorities advised some 30,000 women there who had received the PIP silicone breast implants to have them removed. While French regulators said they had not found a link a between the implants and cancer, they urged women with the implants to have them removed because of the risk of rupture, which can lead to inflammation and irritation. At least 1,000 women in France have reportedly suffered from PIP silicone implant ruptures.
PIP produced about 100,000 silicone breast implants a year before they were recalled last year. Fears about ruptures and cancer have spread to many of the other countries where they were sold, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel. More than 2,000 women in France have filed legal claims over the PIP breast implants, while 250 implant recipients in Britain have done the same
According to a new BBC report, Interpol posted a notice on its website in June alerting member countries that PIP-founder Mas was wanted on Costa Rican drunk driving charges related to an incident occurred in June 2010. The recent controversy surrounding his company’s implants brought Mas’ status as an Interpol fugitive to the attention of the media.
The New York Times is reporting that Mas has as not been seen or heard from in public since the PIP breast implant scandal broke. French authorities also said they would like to speak with him involving that matter.
“It’s obvious we have to find him and those who had an interest in this company,” Health Minister Xavier Bertrand told Europe 1 radio on Saturday. “It’s a shady business with lots of money involved.”
Mas’ lawyer told the BBC that he is the south-eastern Var region of France and intended to stay there. The attorney also maintained that Mas has maintained his silence since the scandal broke out of “decency and discretion.”
Meanwhile, it’s recently been learned that health regulators in the U.S. voiced concerns about some PIP breast implants as far back as 2000. According to a Reuters report, an inspector with the U.S. Food & Drug Administration (FDA) visited a PIP manufacturing plant in May of that year. Shortly afterwards, the FDA sent warning letter to Mas saying the implants were “adulterated” and citing at least 11 deviations from good manufacturing practices. While the problems cited by the FDA had to do with PIP’s saline implants, the same manufacturing facility also made the silicone breast implants at the center of the recent scandal, Reuters said. It isn’t known why the FDA’s warning didn’t trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere
The FDA warning letter was cited in a lawsuit filed in the U.S. District Court for the Southern District of Texas on behalf of U.S. patients who received the saline implants in the late 1990s, and one who received them as recently as 2001, Reuters said. The plaintiffs said that the implants deflated several years later. The FDA letter, dated June 22, 2000, cited PIP’s failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA.
According to Reuters, the PIP saline breast implants sold in the U.S. were cleared by the agency in 1996 via its 510(k) approval process, which does not require human testing. In 2000, due to concerns about possible complications such as infections and rupturing, the agency finally required all implant companies to submit formal applications for saline breast implants. PIP’s application was ultimately rejected by the FDA. However, by that time, the company had already sold 35,000 of its pre-filled saline implants in the U.S.
PIP has never sold the silicone breast implants at the center of the current controversy in the U.S.
