French public health agencies are recommending that women who received breast implants from the now defunct Poly Implants Protheses (PIP) manufacturer receive an explant, or removal of the implant, following reports of excessive ruptures. For those who do not wish to undergo this preventive, non-emergency procedure, an ultrasound every six months to monitor the implants is advised. According to French health officials, PIP is accused of fraud for using cheap industrial-grade silicone that was never approved for human use. Prior to being shut down in March 2010, the manufacturer exported hundreds of thousands of such implants internationally, mainly to countries in Western Europe and Latin America. None were marketed in the U.S.
Out of the 30,000 French women who received the PIP implants, 1,000 have experienced ruptures or other problems. The news story also refers to eight patients with cancer; however, there is no evidence that the recipients of the substandard implant had a higher risk of the disease. In fact, even the French Health Ministry and its National Cancer Institute have concluded that there is no more risk of cancer associated with the PIP implants than with any other. The British Medicines and Healthcare Products Regulatory Agency confirmed these findings as well.
Such allegations, however, remind ACSH's Dr. Gilbert Ross of a similar scare in the U.S., which occured in the early 90s: Women began to fear that silicone breast implants caused cancer. This unfounded fear, along with other trumped-up hysteria about various auto-immune diseases, was based on one alarmist news report, the onslaught of the plaintiff-lawyer implant industry, and the hyper-precautionary measures of FDA Commissioner David Kessler, who instituted the FDA s 14-year moratorium on the implants only finally lifted in 2006. Following nearly two decades of litigation, no link between breast implants and cancer or any other disease has been established; even the FDA finally determined that these products were not harmful.
As Dr. Ross explains, There are differences between complications arising from fraud and those from routine surgical procedures. In the case of PIP implants in France, the ruptures seem to have been the result of blatant fraud by the device manufacturer. However, even in situations where no misconduct is suspected, cosmetic procedures that involve surgery are still not free from the risks associated with any form of surgery. But just because breast implant surgery causes problems from time to time does not mean that the implants cause cancer.