Re: Re:Boob Job

[Guest guest]

>From Rogene:

   

BOOB JOB

Ex-employee tries to deflate case for silicone implants

BY DEIRDRE FULTON

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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 women¹s bloodstreams. For years, most women were

left with saline ‹ silicone¹s 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, wouldn¹t 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

women¹s-health activists such as Zuckerman, president of the

Washington, DC­based 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 women¹s health? "

In a statement ‹ released after questioning the former employee¹s 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 isn¹t 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

Œapprovable¹ 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 FDA¹s handling of emergency contraception (Plan ,

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 Wood, the former FDA assistant commissioner

for women¹s 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. "

It¹s not all sketchy and shady, she insists. But " if you aren¹t sure, and

something like [the decision not to sell Plan B over the counter] happens ‹

which is something that clearly misused the system ‹ you¹re left asking

these questions about everything. "