Fw: Yet anolther Inamed advert in LA Times/Newsday

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

Sent: Tuesday, January 28, 2003 8:13 AM

Subject: Yet anolther Inamed advert in LA Times/Newsday

http://www.newsday.com/news/health/ny-dsochs3106294jan28,0,1609561.story?coll=ny-health-headlines

EXCERPT:

"With no fanfare, longtime implant maker Inamed Inc." ...

that's got to be the most absurd line written in the LA Times for years!

Silicone Spin Doctor Angell also claimed a rupture rate of "only" "4-6" percent ... her best estimate in her book ... basically a "get out of jail free card for the manufacturers"

Silicone Breast Implants Making a Comeback

By Jane E. LOS ANGELES TIMES

January 28, 2003

For more than a decade, silicone breast implants have been banned in the United States, pulled from the market amid claims that they made women ill.

Now, they're poised for a comeback.

With no fanfare, longtime implant maker Inamed Inc. has taken the first step toward returning the gel-filled devices to the marketplace. On New Year's Eve, the company quietly asked the Food and Drug Administration to allow it to again sell silicone breast implants. A rival company expects to make a similar request soon, and a third hopes to follow.

Inamed's filing sets the stage for a new examination of silicone gel.

At the time the implants were pulled from the market, an estimated 1 million to 2 million women had gotten them. No one denies that some implants ruptured, requiring repair or removal, and that some women became ill. "We know there hasn't been a breast implant manufactured that doesn't sometimes rupture," said Dr. W. al, the FDA's top regulator of devices. Even Inamed's patient literature tells women they may need additional surgery at some point to replace or remove the implant.

But studies have failed to prove that implants cause the connective tissue diseases, such as rheumatoid arthritis, lupus and scleroderma, which thousands of women claimed in lawsuits. In a 1996 book, Dr. Marcia Angell, then executive editor of the New England Journal of Medicine, said that trial lawyers had manipulated the science to convince women - and an unquestioning media - that silicone implants were dangerous. Then came a 2000 report from the prestigious Institute of Medicine that found women with silicone implants were no more likely to have connective tissue disorders than other women.

As plastic surgery has become more acceptable, the number of women seeking the devices has grown. And so has dissatisfaction with saline implants.

Meanwhile, even as Inamed (formerly known as McGhan) and Mentor Corp., both headquartered in Santa Barbara, Calif., continued to produce saline implants, they were working to improve the durability of silicone implants - laying the groundwork to ask regulators to reconsider. They've made the shells thicker and more durable and added an extra membrane to keep silicone from bleeding through.

The focus of yet-to-be scheduled hearings before an FDA advisory panel, which could come as soon as summer, is likely to come down to whether today's silicone implants are safe enough. Much of the attention will focus on the rate of complications: Implants don't last a lifetime and can cause infection, rupture and capsular contracture - the painful shrinkage of the scar tissue that forms around implant shells. When saline implants rupture, the salt water is absorbed by the body. When silicone implants rupture, the gel can migrate outside the chest, causing lumps called granulomas; long-term effects aren't known.

Nevertheless, many women gravitate to the more natural look and feel of silicone.

"A good silicone you can't feel, and a good saline you can always feel," said Dr. Debra , a plastic surgeon in Sacramento, Calif. "Silicone is not a perfect implant. ... Free silicone in the tissues can be nasty to get rid of."

Silicone implants went unregulated until 1988, when the FDA asked manufacturers to provide evidence they were safe. In 1992, FDA Commissioner A. Kessler called for a moratorium on their sale, then made an exception: Women who had undergone a mastectomy could receive silicone implants through research studies; otherwise healthy women later were allowed to enter the studies.

al, director of the FDA Center for Medical Devices and Radiological Health, said regulators will review all studies, including a 2001 FDA-sponsored report that found a higher rate of fibromyalgia among women who had silicone leaks from implants that were at least 8 years old.

"The [institute of Medicine] report didn't find convincing evidence about connective tissue diseases but commented quite extensively about local complications," he said. Depending on the agency's satisfaction with manufacturers' silicone studies and two years of patient follow-up (90,000 women have received the implants through research studies), the FDA could approve the sale of silicone gels next year.

Kim Hofman, 42, of Niangua, Mo., has testified before Congress, contending that research studies may be ignoring health effects of the implants. "I lost my house, my business, my health insurance, my credit," she said. "And I lost my dignity, my faith in our government and my faith in doctors."

But the alternative is saline, and for many women, that simply isn't good enough.

Overfilled, they're hard; underfilled, they wrinkle. They also make a sloshing sound and rupture easily. If a woman has scant tissue left after a mastectomy, a saline implant is harder to camouflage. As a result, many women are willing to take a chance on the still unknown effects of silicone in the body.

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