Fw: Comeback for silicone?

February 10, 2003

Subject: Comeback for silicone?

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Comeback for silicone?

Monday, February 3, 2003 By JANE E. ALLENSpecial from the Los Angeles Times

Top, a traditional silicone gel breast implant; below, a new implant, less likely to leak, with contouring and a thicker gel.

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. By the mid-1990s, the devices had become a symbol of what many regarded as corporate America's indifference to women's health, with one company, Dow Corning, eventually filing for bankruptcy protection.

Now, silicone implants are 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 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 company hopes to follow. Manufacturers also are testing a thicker, gumdrop-like gel that doesn't leak.

Inamed's filing sets the stage for a new examination of silicone gel. Although some of the debate is expected to echo the original, this time the FDA will be ruling in a markedly changed climate - and will have safety data in hand.

At the time the silicone 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 scores of studies have failed to prove that implants cause the connective tissue diseases, such as rheumatoid arthritis, lupus, and scleroderma, that thousands of women claimed in class-action lawsuits against the manufacturers. In a 1996 book, Dr. Marcia Angell, then executive editor of the New England Journal of Medicine, said that unscrupulous trial lawyers had manipulated the science to convince women - and an unquestioning media - that silicone implants were dangerous. Then came a widely publicized report from the prestigious Institute of Medicine. That report, released in 2000, found that women with silicone implants were no more likely to have connective tissue disorders than women without implants.

The furor temporarily dampened the demand for breast implants. But as plastic surgery has become more acceptable, the number of women seeking the devices has grown as well. And with it has come an increasing dissatisfaction with saline implants, the only option available to most women.

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 their decision. They've changed the composition and design of silicone implants and their outer coverings, or shells. They've made the shells thicker and more durable to guard against silicone leakage, and they've added an extra membrane to keep silicone from bleeding through the shell.

The focus of yet-to-be scheduled hearings before an FDA advisory panel, which could come as soon as this 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. It feels oh-so-nice, but if it breaks, it's a bit of a hassle. Free silicone in the tissues can be nasty to get rid of."

Introduced in 1962, silicone implants went unregulated until 1988, when the FDA asked manufacturers to provide evidence they were safe.

But in January 1992, after multimillion-dollar jury awards and hundreds of lawsuits, FDA Commissioner A. Kessler called for a moratorium on the sale of silicone implants, noting that women still had access to saltwater-filled implants. That April, Kessler made an exception: Women who had undergone a mastectomy would be able to receive silicone implants through research studies; otherwise-healthy women later were allowed to enter the studies.

The mushrooming controversy and FDA action had a temporarily chilling effect, but demand has since grown dramatically. The American Society of Plastic Surgeons reported 32,607 augmentations and 29,607 breast reconstructions the year Kessler restricted silicone. In 2001, less than 10 years later, the group reported 206,354 breast augmentations and 81,089 reconstructions.

al, director of the FDA Center for Medical Devices and Radiological Health, said regulators will review all prior studies of implant safety, including an FDA-sponsored report published in 2001 that found a higher rate of fibromyalgia among women who had silicone leaks from implants that were at least eight 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. It could also request further studies.

But many women say they are not satisfied with the safety of silicone implants. And it's their testimony that is most likely to echo the earlier proceedings.

Kim Hoffman, 42, of Niangua, Mo., is among the women likely to testify at the FDA hearings.

"I lost my house, my business, my health insurance, my credit. And I lost my dignity, my faith in our government, and my faith in doctors," said Hoffman, who had owned two preschools. She has testified before Congress, contending that research studies may be ignoring health effects of the implants.

But the alternative to silicone is saline, and for many women saline implants simply aren't good enough.

Overfilled, they're hard; underfilled, they wrinkle. Saline implants 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.

Fifteen months after losing a breast to cancer, Beckie Kersting, a school nurse from Yuba City, Calif., elected to have a second mastectomy and reconstructive surgery. After weighing the pros and cons of saline and silicone implants, she and her husband chose to go with silicone; her surgery was Dec. 11.

"It's just amazing to me how natural-feeling they are," Kersting, 52, said. "I feel like myself again. I know there are some risks, but I also think the technology has come a long way in the last 20 years." 6335916

February 10, 2003

This is really maddening. They will just not give up, will they? I wish they would spend all their profits ("Blood money") on ways to help women grow breast naturally with their own tissue instead. Like making more breast tissue cells receptive to estrogen or whatever it is that makes breasts grow--it would be sooooo much more beneficial to human kind to do that kind of research than using this damnable silicone.