Fw: Corporate greed & deception wins ... Women and their health lose ...

[Guest guest]

What else is there to say? God help us...

----- Original Message -----

From: " ilena rose " <ilena2000@...>

<ilena@...>

Sent: Wednesday, October 15, 2003 3:12 PM

Subject: Corporate greed & deception wins ... Women and their health lose

....

> ~~~ This is a very sad day in history. The FDA has proven itself to be

> unworthy of respect and the abililty to make sound decisions. ~~~~

>

>

>

>

>

> http://www.guardian.co.uk/uslatest/story/0,1282,-3268127,00.html

>

> FDA Panel Recommends Lifting Silicone Ban

>

> Wednesday October 15, 2003 10:16 PM

>

>

> By LAURAN NEERGAARD

>

> AP Medical Writer

>

> WASHINGTON (AP) - Eleven years after most silicone-gel breast implants

> were prohibited, government advisers recommended on Wednesday that the

> ban be lifted despite lingering questions about safety and durability.

>

> But the Food and Drug Administration's advisers urged that Inamed

> Corp.'s sales be allowed only under certain conditions, including

> ensuring that all users get detailed brochures explaining the devices'

> known risks - such as a need for frequent reoperations for pain or

> breakage.

>

> Women will need annual exams to be sure their implants haven't

> silently begun leaking, the panel stressed. That will be expensive and

> hard to ensure, the scientists acknowledged, but crucial because

> implants can break without immediate symptoms and should be removed

> when that happens.

>

> ``This is as important as your annual mammogram,'' said FDA adviser

> Barbara Manno, a Louisiana State University toxicologist.

>

> All implant recipients also must be enrolled in a registry to track

> their health.

>

> The vote was 9-6.

>

> The panel also said Inamed must do more research tracking women's

> health for 10 years after implants, a time when many say their devices

> begin breaking and causing painful disorders. So far, Inamed's

> research tracks women's health for three years.

>

> Still, after two days of debate, the panel ultimately agreed with

> Inamed's argument that it is not fair to restrict women's access to

> silicone implants when research suggests they break and cause other

> problems no more frequently than today's main alternative - implants

> filled with salt water.

>

> The decision came after emotional testimony pitting woman against

> woman: those who say implants broke inside their bodies to leave them

> permanently damaged and those who want implants they say feel more

> natural to repair cancer-ravaged breasts or make their breasts bigger.

>

> If women keep their implants long enough, they all may break

> eventually, panelists said.

>

> The question is how to tell: Saline-filled implants deflate so fast

> that women know they've broken, but silicone leaks slowly and may not

> cause immediate symptoms. Because women may not be able to get all the

> leaking silicone out of their bodies, ``we have to hold this to a

> different standard,'' argued adviser Dr. Amy Newburger, a New York

> dermatologist.

>

> The FDA ended routine sales of silicone breast implants in 1992,

> restricting them to breast cancer patients in strictly controlled

> clinical trials.

>

> Seeking to restart broader sales, Inamed Corp. argued that the

> implants have been exonerated.

>

> Indeed, studies to date show little evidence the implants cause major

> diseases such as cancer.

>

> But the FDA worries that rare disease issues aren't settled, and that

> subsets of women - especially the small proportion who have silicone

> leaking through scar tissue into the breast or beyond - might be more

> vulnerable to painful conditions like fibromyalgia.

>

> ``I wanted to be more beautiful. Instead, my breasts became hard,

> scarred and ugly,'' -Miles, of Michigan, told the FDA

> panel. She as one of more than 100 women, plastic surgeons and

> consumer advocates who spoke over the two days.

>

> Schambeck pleaded for women to have a choice. ``I didn't like

> the feeling of wrinkled water bags in my body,'' she said, explaining

> why she exchanged salt-water implants for those filled with silicone

> gel.

>

> ``It is not a perfect device,'' said Dr. Wells, president of the

> American Society of Plastic Surgeons. But, he said, ``the procedure

> significantly improves the quality of life for many patients.''

>

>

>

> Guardian Unlimited © Guardian

>

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