Since 2000 there has been a warning about Poly Implant Prosthese (PIP) breast implants. The FDA refused to approve their use in the U.S. because of concerns that they might rupture. Meanwhile, until recently these fragile bags of silicone have been implanted in thousands of women in Europe, and elsewhere. They were cheaper than other brands.
The recall was expanded to PIP implants exported to Italy, Australia, and Great Britain. It is initially estimated 35,000 to 45,000 women worldwide are affected, but the British Association of Aesthetic Plastic Surgeons estimated 50,000 British women have the implants.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
Medicynical Note: We have a “movement” in the U.S. that believes less regulation will lead to a thriving economy. This despite evidence, from the thalidomide problem in medicine and the S and L fiasco in the 80’s, the Enron disaster, and most recently the world wide banking crisis, that less regulation can lead to abuses and disaster.
In the case cited today, the FDA saved tens of thousands of U.S. citizens from the problems of a substandard breast implant device. In medicine as in other fields where profit overrules reason, regulation is essential.
PIP implants WERE available in the US in the late 90’s, sold from an office in Florida. Afer the FDA’s warning, they knew they would not be certified and the company pulled out of the US, leaving women with PIP implants with a worthless warranty.