Patients and surgeons need regulatory bodies such as the FDA to evaluate products strictly on the basis of evidence. And if you think that is what is going on, then you are mistaken.
Companies making a “substantially similar” product to one that is already in the market are often approved without submitting their own data. (That’s actually what happened for a brief time before the turn of the century when PIP actually sold their horrible saline implants in the USA.)
And even when data demonstrating superiority exists, the FDA does not necessarily respond. There are breast implants made by the two American manufacturers which have been studied in the United States for over 10 years. The published data on these implants exceeds that of the implants on the market.
So how can they not be approved? Because “activist” groups ostensibly protecting the health of women are so against any breast implant that they are against a better breast implant. Politics influences the FDA, yet the FDA only does its job well only to the extent that it is guided by objective data.
The decision to have a breast augmentation is a rational, individual decision. And patients have the innate right to select the best implants that are made. So while the PIP scandal is part of the delay in approving of these implants in the United States, what the PIP story should do is encourage the FDA to give us an even better option for some women. FDA – are you listening?
By now everyone has heard about the French breast implant manufacturer that filled breast implants with industrial silicone. But in all the discussion, the most important lessons have been missed.
