The PIP breast implant manufactured by the now defunct French company, Poly Implant Prosthese, has been surrounded by scandal and controversy over the past two years. It was discovered that the company had been fraudulent about their manufacturing process, while manufacturing these implants with non-medical grade silicone. This was at one time the third leading manufacturer of silicone breast implants and some 300,000 women worldwide are affected by this information. Fortunately, the implants were never FDA approved in the U.S. and women in the U.S. would have had to have the implants placed elsewhere or used without approval.
These implants are found to have a very high rupture rate as much as 5 – 10 x that of silicone implants used in the U.S. The type of silicone used in these implants has not been studied to determine its safety if there is a rupture. For this reason, there has been a general consensus that women with these implants should have them removed with replacement of approved implants as desired.