Fw: AP on FDA Panel Decision ... Bravo to Lynda Roth

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

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Sent: Friday, October 17, 2003 7:46 PM

Subject: AP on FDA Panel Decision ... Bravo to Lynda Roth

Note: This outstanding quote of Lynda Roth's ... who has worked diligently for years (in front of and behind the scenes) for women harmed worldwide by breast implants, got quoted 47 times in various papers in this AP piece.. The Guardian was just one. Bravo to her, and Amen.

EXCERPT: ``It's a black day for the women of this country when ourgovernment doesn't protect us from such dangerous products,'' saidLynda Roth of Greeley, Colo., who heads the Coalition of SiliconeSurvivors.

http://www.guardian.co.uk/uslatest/story/0,1282,-3268386,00.html

FDA Might Lift Ban on Silicone Implants

Wednesday October 15, 2003 11:01 PM

By LAURAN NEERGAARD

AP Medical Writer

WASHINGTON (AP) - Eleven years after most use of silicone-gel breastimplants was halted, government advisers recommended Wednesday thatthe ban be lifted despite lingering questions about safety anddurability.

The Food and Drug Administration's advisers stressed that InamedCorp.'s resumption of sales should come only under certain conditions.At the top of the list: All women will need annual exams to ensuretheir implants aren't silently leaking.

Other requirements include giving women a detailed brochure explainingthe implants' known risks - such as needing frequent reoperations forpain or breakage - and enrolling them in a registry to track theirhealth.

The panel told Inamed it must do more research tracking women's healthfor 10 years after they receive implants, a time when many say theirdevices began breaking and causing painful disorders. So far, Inamed'sresearch tracks women's health for only three years.

If regular audits show that research isn't adequate to track safetyquestions, the company must end sales, the panel said - a contingencythe FDA admits it lacks the legal authority to enforce.

The panel voted 9-6. The FDA is not bound by that recommendation, butusually follows the panel's advice.

``We did not have enough long-term data ... to assure safety,'' saidDr. Ellice Lieberman of Brigham and Women's Hospital in Boston, apanel member who voted no.

Dr. Ann Marilyn Leitch of the University of Texas Southwestern MedicalSchool voted yes. ``As a cancer surgeon, I want my patients to haveall the options,'' she said.

Many advisers said they were swayed by Inamed's proposal to do theextra research and patient education.

The vote came after two days of emotionally charged testimony frommore than 100 women, plastic surgeons and consumer advocates. Somesaid the implants can break apart to cause permanent damage; otherscalled them the most natural-feeling option to repair cancer-ravagedbreasts or make them bigger.

The panel ultimately agreed with Inamed that it's not fair to restrictwomen's access to silicone implants when research suggests they breakand cause other problems no more frequently than today's mainalternative - implants filled with salt water.

``It's a black day for the women of this country when our governmentdoesn't protect us from such dangerous products,'' said Lynda Roth ofGreeley, Colo., who heads the Coalition of Silicone Survivors.

Schambeck pleaded for women to have a choice. ``I didn't likethe feeling of wrinkled water bags in my body,'' she said, explainingwhy she exchanged salt-water implants for those filled with siliconegel.

``It's not a perfect device,'' acknowledged Dr. Wells, presidentof the American Society of Plastic Surgeons. But ``the proceduressignificantly improve the quality of life for many patients.''

Silicone gel implants were highly popular until 1992, when fears thatleaking silicone was causing serious diseases prompted the FDA to endroutine sales. Since then, breast cancer patients and a few otherwomen have been able to get silicone gel implants only throughstrictly controlled research studies; women wanting bigger breasts hadto get saline-filled implants.

Eleven years later, what's known about the implants?

-Studies show no evidence that silicone implants cause major diseaseslike cancer or lupus. But those studies were too small and too shortto rule out rare diseases or subsets of women especially vulnerable,FDA scientists warn.

-Local complications are the main risk. In three years, one in fivewomen getting silicone implants for enlargement and 46 percent ofcancer survivors getting them needed additional operations to treatsevere pain, scarring and other problems. Up to a quarter had to havethe implants removed or replaced in those three years.

-No one knows how often the implants silently break and leak beforeany symptoms appear, but the FDA's advisers said broken implantsshould be removed.

The question is how to tell. Saline-filled implants deflate so quicklythat women know they've broken, but silicone leaks slowly. Hence theadvice that every implant recipient get an annual doctor's exam.

It will be hard to get young women who feel healthy to do that - andexpensive, panelists acknowledged.

But ``this is as important as your annual mammogram,'' said FDAadviser Barbara Manno, a Louisiana State University toxicologist.

Silicone implants are widely sold in Europe, where 90 percent ofrecipients choose them over saline-filled ones, Inamed says.

In the United States, 236,000 women had their breasts enlarged lastyear, a number expected to increase if the FDA allows women to beginchoosing the silicone-gel option.

If the FDA follows the advice, the decision would apply only tosilicone gel implants made by Inamed. A competitor, Mentor Corp., alsoplans to seek FDA approval for its version of the implants.

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For more information and links, please visit:

www.BreastImplantAwareness.org

To see the 47 mediium this was quoted in, click below.

http://news.google.com/news?num=100 & hl=en & ie=UTF-8 & oe=UTF-8 & scoring=d & as_drrb=b & as_mind=17 & as_minm=9 & as_miny=1981 & as_maxd=31 & as_maxm=12 & as_maxy=2003 & q=%22lynda+roth%22 & btnG=Search+News & as_mind=17 & as_minm=9 & as_maxd=31 & as_maxm=10

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