Reader Laura’s Comment:
“I am wondering what the true time frame was that PIP was allowed to market their product in the US. It is my understanding from all that I have read-the FDA strongly recommended that PIP send 2 separate letters to more than 1000 doctors to have the pre-filled implants returned (May 2000 time frame) However I received a pair of PIP pre-filled implants in April of 2002. My right implant ruptured less than 2 weeks ago, and once the rupture happened only then did I learn of all the trouble that PIP has had in the last few years. Contrary to your situation with the patient and having her sign a waiver, my doctor said the PIP were be the best option for me
and he really offered nothing else.”
As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost 10 years before the company came under scrutiny from European regulators. One panel member, Boyd Burkhardt, a plastic surgeon from Arizona, said the company’s data was incomplete, and he found it difficult to understand why the company was “as ill prepared as you appear to be” to meet regulatory standards. Asked to comment on the PIP controversy, Burkhardt, in a brief interview, said that he stands by the prior comments he made to the FDA. It was not immediately clear why after the panel’s rejection the FDA then carried out an inspection of the PIP plant in May 2000. PIP said it stopped selling its saline implants in the United States that same month, according to an SEC filing.
I am not quite sure what to tell you. According to the information I was able to find online, the PIP saline implants were pulled from the US market in 2000. From what I remember of the few pairs I handled, they did tend to rupture early. That’s why I stopped using them far before the FDA acted.
Needless to say you need your ruptured implant (or better both of them) removed. The FDA did not make any formal requirements regarding contracting PIP saline implant patients that I can recall. You are actually lucky these implants lasted as long as they did.
It was not standard for doctors to have patients sign statements about PIP implants back in the day. I did that because I felt they were poor quality back then. I was right.
John Di Saia MD