Substandard Breast Implants from France Did Not Reach the US—ASPS

About 30,000 women in France will receive surgery to remove the defective breast implants which are highly prone to rupture and leak, while approximately 50,000 patients in UK have these substandard devices which were manufactured by Poly Implant Prothese (PIP).

While the defective siliconebreast implants were exported to Brazil, UK, Chile, Argentina, Spain, Colombia, and Venezuela, the American Society of PlasticSurgeons (ASPS) said the products were never approved in the US.

In Germany and possibly elsewhere in Europe, the substandard PIP breast implants were sold under the brand name “M,” according to the ASPS website.  Meanwhile, about 80 percent of devices were exported outside France.

In a statement published on its web site, the ASPS said that “an American woman would need to have been implanted outside the United States in order to have received the implants that are now the subject of concern in France.”

According to earlier reports, about 50 clinics in UK have reported implant ruptures although the government said “there is no need to remove the products en masse.”

While the total number of British women with ruptured implants—which have been found to have a fragile shell—is still unknown, experts have estimated that about 1,000 patients could be affected.  However, this is just a conservative estimates assuming that implant failure rate is only 2 percent.

PIP’s cheap implants have been reported to be made of low-grade industrial silicone designed for mattress, making them “unfit for human use.”

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said the “quality of the silicone in PIP implants is not of medical grade, therefore, these are not fit to be implanted into humans.”

While there is a call for the UK government to “require women with the substandard devices to undergo implant removal” and “to shoulder the surgical expenses,” the spokesman for private medical clinics said that it would be “irresponsible” to remove all the implants as clinics could not afford to pay all the related costs.

The spokesman added that their study has suggested that the rupture rate of PIP implants is “between 1 and 2 percent” which is described as “within the acceptable industry standard.”  However a separate study has shown that failure rate is approximately 7 percent.

PIP, which filed for bankruptcy two years ago, has been warned by US Food and Drug Administration in 2000 that its implants were substandard as the company failed to follow “good manufacturing practices.”