Fw: Women's health at risk if FDA approves implants ...

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

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Sent: Thursday, November 13, 2003 6:56 PM

Subject: Women's health at risk if FDA approves implants ...

http://www.indystar.com/articles/8/092488-4168-021.html

Note: Ooops ... she may have gotten Dr. Zuckerman's name wrong ... but she certainly got an important message out ...

Jane LichtenbergWomen's health at risk if FDA approves implants

November 14, 2003

Would you agree to undergo surgery that wasn't necessary and likely would cause more harm than good over time? Logically, most people would say, "Of course not." But logic isn't much of a factor when deciding to have breast augmentation surgery. Most of the women who have it done are breast cancer patients, who naturally want the reconstructive surgery. They usually get saline-filled implants.

But despite the fact that there are lingering questions about safety and durability, an advisory committee of the Food and Drug Administration last month recommended, 9-6, to lift a ban on silicone gel implants. Their manufacturer, Inamed Corp., will have to meet certain conditions.

In fact, the current ban is in name only. Now, to get either a silicone gel or saline-filled implant, women must use surgeons who participate in a study of the devices, but these women often drop out within a year, points out Dr. Zuckerman, an epidemiologist who heads the National Center for Policy Research for Women and Families.

In the past 11 years, most implants have been made of saline with a silicone outer envelope. Zuckerman believes tens of thousands of women have the surgery each year. Although the number who simply want to have larger breasts is small, it's probably in the thousands, she said. "Unless there's a compelling medical reason, any woman can get one."

About 95 percent of the time, the FDA goes along with what an advisory panel recommends. The implant issue may be an exception. The chair of the General and Plastic Surgery Devices Advisory Panel, Dr. V. Whalen of the Wood Medical School, has strong reservations about FDA approval of the silicone implants. He cites difficulty in getting an accurate mammogram for detection of breast cancer, complications from leaking silicone and the lack of high-quality data on long-term effects.

The complications are about the same for saline and silicone, Zuckerman said. Almost half of the women need another surgery within three years. The real fear of silicone gel, she says, is that it can leak without women knowing. If the saline implant breaks, it deflates and is readily noticeable. But silicone gel is sticky and hard to remove. "Basically, what happens is these women end up losing their own breast because of the silicone leaking out into the healthy one," Zuckerman said.

In an unusual move, the advisory panel listed several conditions for approval, including annual exams to ensure no leakage, a detailed brochure explaining risks and a 10-year study to track health problems. But the FDA would not have the authority to enforce all of the conditions.

One major concern: When either a silicone gel or saline implant is in place, mammography X-rays are hard to interpret. Even specially trained technicians miss about 30 percent of malignant tumors in implanted women, compared to about 15 percent for those without implants.

If the implants cause health problems, don't expect a lawsuit to pay the expenses. Women who participated in the class-action suit against Dow-Corning more than a decade ago still haven't received a dime.

Even a three-year study of implants by manufacturer Inamed, which was considered too short by many experts, revealed high complication rates. Many of the women needed additional operations, which are expensive and seldom covered by medical insurance. The study asked respondents, both before and after implant surgery, about symptoms characteristic of autoimmune diseases such as muscle pain and chronic fatigue. In almost every case, women with implants had more symptoms.

But the biggest surprise, Zuckerman said, was the effect on quality of life and self-esteem. "I'm sure they expected to find women felt better afterward," she said. "But on every single measure, emotional and physical, the women felt worse, with one exception -- feeling confident about sexual attractiveness."

As a breast cancer survivor, I have great sympathy for women who have had mastectomies and want to feel "whole" again. But the risk posed by implants -- especially silicone gel -- is not worth the often serious complications. Despite pressure from plastic surgeons eager to augment their practices as well as their patients, this is a no-brainer. The FDA should say "No way" to the advisory panel's recommendation.

Lichtenberg is editorial page copy editor. Contact her at 1-317-444-6015, or at jane.lichtenberg@... .

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