U.K. Considers Registry In Wake Of French Breast Implant Scandal

In the wake of a French breast implant scandal, health ministers and other officials in the United Kingdom are considering a registry of patients who have received faulty implants and other types of cosmetic procedures.

As we’ve explained, Poly Implant Prothèse (PIP) silicone breast implants, already among the cheapest and most fragile on the market, were recalled last year after it was learned they contained industrial, not medical grade, silicone. Although now defunct, PIP faces a French criminal probe for misreporting the 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 received PIP silicone breast implants to have them removed. While French regulators said they found no link between the implants and cancer, they urged women with the implants to have them removed over rupture risks, which can lead to inflammation and irritation. At least 1,000 women in France have reportedly suffered PIP silicone implant ruptures.

In the U.K, some members of The House of Commons are pushing for way in which to improve patient traces to minimize the type of fall-out such as what was seen in the PIP scare. U.K. health secretary, Andrew Lansley, and other officials are scheduled to discuss the matter and the chairman of the Commons health select committee and former health secretary, Stephen Dorrell, is hoping to induce manufacturers and suppliers—as an element to their license to operate in the U.K—to maintain registry records of who received their products, said The Guardian. Speaking to the U.K.’s The Times, Dorrell said, “This is a product being put into a human body—it should have a proper audit trail for where and when it is used.”

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. Both France and Venezuela are offering PIP implant removal surgery at no cost.

We just wrote that PIP founder, Jean-Claude Mas, 72, is being sought by Interpol on an unrelated drunk driving charge. Mas could face prison time in Costa Rica on the charge, but fled the country before he could be brought to trial.

Also recently, it was revealed that U.S. health regulators voiced concerns about some PIP breast implants as far back as 2000. An inspector with the U.S. Food & Drug Administration (FDA) visited a PIP manufacturing plant in May of that year. Shortly after, the FDA sent warning letter to Mas saying the implants were “adulterated,” 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. It isn’t known why the FDA’s warning didn’t trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere.

Meanwhile, 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. The FDA rejected PIP’s application; however, by that time, the company had sold 35,000 of its pre-filled saline implants in the U.S.

This entry was posted in Breast Implants, Defective Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.