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

[Guest guest]

Unfortunately vanity will also win. Most women will choose to ignore the risks involved with silicone and get implants. I just wish society didn't pressure women to do this.*~Patty~* <fdp@...> wrote:

What else is there to say? God help us...----- Original Message -----From: "ilena rose" <ilena2000@...><ilena@...>Sent: Wednesday, October 15, 2003 3:12 PMSubject: 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>> _________________________________________________________________> Send instant messages to anyone on your contact list with MSN Messenger> 6.0. Try it now FREE! http://msnmessenger-download.com>>

[Guest guest]

You are so right on this one. Thousands of women will be getting silicone gel, and will completely ignore the risks...and will be in denial even when they do get sick. This decision will bolster the idea that implants are safe in the minds of anyone who has not investigated the controversy. I believe we will also be seeing women going to their plastic surgeons in droves to exchange their saline for silicone gel, with the emphasis on how much more natural the silicone gel are supposed to feel.

There may be one saving grace in this....(can we dare to have hope?) From the article:

"All implant recipients also must be enrolled in a registry to track their health."

If this registry is done right, with ALL recipients followed, monitored and scientifically validated, we may see the beginnings of some real science regarding breast implants and their long term safety...gosh, do you think this is expecting too much? I'm afraid to even let myself think that the FDA could REALLY want to know the truth. As Ilena said, they have proven themselves to be unworthy of our respect.

Patty

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

From: me lee

Sent: Wednesday, October 15, 2003 5:45 PM

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

Unfortunately vanity will also win. Most women will choose to ignore the risks involved with silicone and get implants. I just wish society didn't pressure women to do this.*~Patty~* <fdp@...> wrote: What else is there to say? God help us...----- Original Message -----From: "ilena rose" <ilena2000@...><ilena@...>Sent: Wednesday, October 15, 2003 3:12 PMSubject: 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 wa nt 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 eviden ce 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> Ame rican Society of Plastic Surgeons. But, he said, ``the procedure> significantly improves the quality of life for many patients.''>>>> Guardian Unlimited © Guardian