Silicone breast implants could be back

Perils were exaggerated by lawyers, some say, while studies failed to prove link to diseases

February 02, 2003|By Jane E. Allen | By Jane E. Allen,Special to the Sun

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 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 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.

When 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. David W. Feigal, 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, which 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 Medi-cine, 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 be held 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 body absorbs the salt water. 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 Johnson, 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."

Feigal, director of the FDA Center for Medical Devices and Radiological Health, said regulators will review all prior studies of implant safety. Those include 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 8 years old.

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.

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