E-Mail This Article to a Friend BOOB JOB Ex-employee tries to deflate case for silicone implants BY DEIRDRE FULTON

Women who were excited that silicone implants may be coming back on the market be warned. A former employee of implant manufacturer Mentor claims he was part of a group asked to fix leaky silicone breast implants that are up for review at the federal Food and Drug Administration (FDA), stirring up more questions about the already-controversial falsies.

First, some history: in 1992, the FDA placed an indefinite moratorium on the silicone-gel implants, citing a lack of long-term safety data about oily discharge that oozed into women’s bloodstreams. For years, most women were left with saline — silicone’s safer, but less realistic, counterpart.

More than a decade later, two corporations (Mentor and Inamed) came back to the FDA, making their case that thanks to technological advances, implant-leakage is now both minor and benign. And the FDA believed them: last month, the agency issued "approvable" letters to both manufacturers.

But around the time the letters went out, the former Mentor employee wrote to the FDA, asserting that he was told to create a "low-bleed patch" for "sizers" — the implant models women wear externally as try-outs. The patch would stem that worrisome oily leakage, which one assumes is not a big Mentor selling point. Trouble is, if the company believed it needed patches for sizers, wouldn’t it be safe to assume that patches might also be needed for the real (so to speak) things, when implanted in the body?

These recent allegations beg the questions constantly raised by women’s-health activists such as Diana Zuckerman, president of the Washington, DC–based Center for Women and Families, who has spent years researching and testifying against silicone breast implants. She asks: "If this patch is bleeding silicone, how much silicone, and how much is that going to amount to over several years? And most importantly, how is that going to affect women’s health?"

In a statement — released after questioning the former employee’s character, and accusing him of stealing from the company — the corporation claims that "the sizers are not the same as Mentor implants, and are not for implant purposes."

Apparently, this he-said, she-said isn’t enough to warrant additional FDA investigation. An agency spokesman wrote in an e-mail sent on Tuesday: "We believe we have received adequate data to support issuance of the ‘approvable’ letters." While the FDA is "not aware that a specific company has developed a demonstration model for educational/training purposes that differs from the device implanted in patients ... [t]his would not be a concern for FDA, provided that the demonstration model was not misleading or was not inconsistent with the labeling information."

Contrast this with the FDA’s handling of emergency contraception (Plan B), which the agency has indefinitely shelved for more investigation before it can be approved for over-the-counter sale. Before long, the FDA is going to lose its credibility, says Susan Wood, the former FDA assistant commissioner for women’s health who resigned last month in the wake that decision, because she felt "there were disturbing elements all the way through about how the evidence was not allowed to drive the decisions."

It’s not all sketchy and shady, she insists. But "if you aren’t sure, and something like [the decision not to sell Plan B over the counter] happens — which is something that clearly misused the system — you’re left asking these questions about everything."