THE BREAST IMPLANT NIGHTMARE CONTINUES

A WEAK FDA TAKES ANOTHER LOOK

By Nicholas Regush

The big news today was Hormone Replacement Therapy and why it may be more harmful than beneficial. But another hugely important issue was being given some scrutiny - again - by an FDA panel: breast implants.

When I first began covering this issue extensively back in the 1980s, it was very clear that there was no science to speak of - much like the lack of science for hormone replacement. Women were essentially being treated like guinea pigs. The culprits in the breast implant debacle were plastic surgeons who didn’t have their heads screwed on correctly. They thought anecdotes ("my patients are doing just fine") were the equivalent to scientific research. Knowing the intellectual profiles of some of these characters ( I had interviewed scores of them), they still probably don’t get it. They think smiling confidently through their pinched, sculpted, plastic faces somehow absolves them of being known as stupid.

So, after the FDA finally banned the science-free silicone implants for widespread use, they are now still tackling the ones made with saline. The agency actually approved the implants in May 2000 with the proviso that a follow-up study be conducted. That might turn out to be a leap that only brings further shame to plastic surgeons and their manufacturer pals.

The meeting held yesterday allowed two manufacturers of approved saline inflatable breast implants to present their postmarket data to the FDA panel. As far as I’m concerned, given what I know, they can blow it out their ears. And if the FDA has any guts, it would yank the product without further delay.

More interesting and compelling is the prepared testimony of Kim Hoffman (who has had three operations because of breast implants), who feels strongly - and rightly so - that important information might have been withheld from the FDA advisory panel back in May 2000.

Hoffman is particularly perplexed that Mentor, one of the manufacturers given approval for saline implants, was at the time under an open criminal investigation for "allegations of serious irregularities in breast implant studies" and other issues involving Mentor products.

The Chairman of the House Commerce Committee was obviously wondering about the same thing when he wrote to the FDA asking why the agency even took the Mentor application to its advisory panel.

So, asked Hoffman in her testimony yesterday, "Why should the FDA trust the integrity of the [Mentor breast implant] data?"

So then, come on FDA, answer Hoffman’s question. Meanwhile, what on earth is Congress doing? Or is that an irrelevant question these days?

The issue is science once again. Is it valid? Is Mentor Corporation going by the book in manufacturing its products? Hoffman would like to know. I would like to know. The American women thinking about having saline breast implants SHOULD know.