Fw: FDA looks at the disaster that are silicone gel implants ... 4 articles

October 15, 2003

----- Original Message ----- From: ilena rose

ilena@...

Sent: Wednesday, October 15, 2003 7:14 AM

Subject: FDA looks at the disaster that are silicone gel implants ... 4 articles

Here are excerpts from the latest press coverage:

#1

http://www.theolympian.com/home/news/20031015/frontpage/124486.shtml

Please go to this page and see the photo of Dr. Melmed!

EXCERPTS:

WASHINGTON -- The women told regulators of breast implants that caused rock-like scars, of silicone leaching into their organs and oozing through their skin, of unending pain.

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Inamed's own research found 46 percent of breast cancer patients getting silicone implants needed additional breast surgery within three years -- as did one in five otherwise healthy women who had breast enlargements

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Carolyn Wolf of Centerville, Va., described "a long thin greasy glob" of silicone oozing from her eye and X-rays showing it lodged elsewhere in her body.

We beg you, please protect the younger generation," she said.

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"My bones still scream with pain," breast cancer survivor Pam Dowd, of Boise, Idaho, said at the hearing. She described having silicone scraped off her chest wall when leaking implants were removed in 1995.

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But it was the critics' wrenching stories that appeared to move FDA advisers. They grilled Inamed about why it couldn't provide long-term studies proving how long implants really last.

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#2

http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20031015-000044-0114

EXCERPTS: Panelist Dubler, professor of bioethics at Albert Einstein College of Medicine in the Bronx, was on the FDA's panel 11 years ago when silicone implant sales were curbed. Dubler said after almost a dozen years off the mainstream market, it "boggles" her mind that the company submitted such short term data.

"Over 11 years, the company has made no attempt to make this a better implant so that it might have a lower rupture rate," Dubler said.

~~~~ "I don't understand why they rupture," McGrath said. "Why aren't these products more durable."

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#3

http://www.newsday.com/news/health/ats-ap_health10oct15,0,2919291.story?coll=sns-health-headlines

FDA Advisers Want Silicone Implant Data

EXCERPTS: "A decade has passed and we sat here today talking about two- and three-year data. I'm flabbergasted," said Dr. Whalen of the Wood Medical School, the advisory panel's chairman.

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But even after three years, up to 46 percent of silicone implant recipients in a key Inamed study needed additional surgeries because of painful scar tissue and other complications. Up to a quarter of the women had to have the devices removed or replaced.

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#4

Ban on implants splits US women

http://www.smh.com.au/articles/2003/10/15/1065917482089.html

EXCERPTS:

"My body was racked with joint pain" after having silicone implants, Cunningham told the panel. She said her health improved after she had the implants removed but she is still too sick to work.

Carolyn Wolf said she had silicone implants in 1971 following a double mastectomy with no problems for about 10 years. Then she experienced blisters on her neck, rheumatoid arthritis, and neurological damage to an eye as silicone moved throughout her body and deposited in her armpits.

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For more information, please visit:

www.BreastImplantAwareness.org

www.BreastImplantInfo.org (Dr. Zuckerman's site)

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If you have not yet done so, please sign the Petition to the FDA ... there are now over 10,000 signatures expressing very real and serious concerns.

http://www.thepetitionsite.com/takeaction/705718085

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Take the Squawkback Poll at:

http://moneycentral.msn.com/content/CNBCTV/Promos/P63310.asp?ShowResults=1#Vote

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Tell the PS's and silicone makers who fund implantinfo.com "NO!"