FDA review of the silicone gel-filled breast implant devices

Jane E. Allen
01/13/2003
Copyright 2003 Los Angeles Times


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 breast implants are poised for a comeback. With no fanfare, longtime implant maker Inamed Inc., formerly known as McGhan, has taken the first step toward returning the gelfilled 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 firm 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 breast 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 breast 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 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 and Mentor Corp., both headquartered in Santa Barbara, 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 both 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.

Safety is the main issue

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, breast implant 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 breast implants rupture, the gel can migrate outside the chest, causing lumps called granulomas; longterm 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. ” 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 David 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 get 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. Feigal, 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 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 gotten the implants through research studies), the FDA could approve the sale of silicone gels next year. It could also request further studies.

Claims of health damage

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. She never gave silicone a second thought when she was 29 and had her breasts enlarged to B-cup size. Then one implant developed a bubble. In March 1995, she had them replaced with “new and improved” silicone implants through a study. Her surgeon assured her these would last a lifetime. But she soon developed health problems, including chronic demyelinating polyneuropathy, a degenerative muscle disease. Eight months later, she had the implants removed.

“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, and enlisted the help of a Missouri congressman on the House Energy and Commerce Committee. That committee has been looking over the FDA’s shoulder, conducting its own investigations of silicone implant safety issues.

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 these breast implants 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 both 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.” Nancy Dubler, a biomedical ethicist at Montefiore Medical Center in the Bronx, N.Y., says silicone implants offer clear benefits to some women. A member of the FDA expert panel that recommended approval of saline implants in 2000, she dissented. She said manufacturers’ data showed that one in four women with saline implants undergo additional surgery within five years to replace or remove her implants. Breast Implant Ruptures without leaks?

If the FDA approves traditional silicone implants, the companies plan to seek approval for a new, contoured implant containing a thicker, so-called cohesive gel that won’t leak, even if the shell ruptures. Dr. Steven Teitelbaum, a Santa Monica plastic surgeon who participated in Inamed’s cohesive-gel study, said these implants can provide peace of mind. “Women feel better knowing they can’t leak out,” he added.

Patients report cohesive gel implants feel natural, and doctors say the thicker gel is more likely to maintain its shape over the years. That’s important because over time, gravity can make standard silicone gel accumulate toward the bottom of the implant, leading to folds in the shell and possible leakage. But whether any silicone implant is approved will depend on whether the FDA decides not that they are safe, but they are safe enough.

Feigal said many people have the misconception that an FDA approved product is a safe product. In reality, he said, the agency must evaluate risks, see if they outweigh benefits and finally determine whether it’s “reasonable to let the consumer decide whether or not they’re willing to take those risks.”


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