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April 2, 2001
Saline or Bust?
FDA approves breast implants despite complications
By Leah Shafer

illustration: Barbara Shone

Eileen Swanson is a walking substantiation of all that can go wrong with saline-filled breast implants. She decided to to get saline implants after her breast cancer diagnosis in 1988, when she was told she needed a mastectomy of her left breast. A high-risk patient, she had her right breast removed as well, as a preventive measure. Swanson was only 37. At the time, controversy over silicone-gel implants was mounting, and saline seemed like the safest option.

Her problems started in the recovery room, where the implant in her right breast deflated. She experienced wound-healing problems, pain, infection, swollen lymph nodes, and extreme fatigue. Cosmetically, her breasts looked terrible. Her left breast was swollen and her right implant had hardened -- a complication called capsular contracture -- and drifted up about an inch. Swanson switched plastic surgeons twice and had a new saline implant put in each breast but still suffered from fatigue, pain, irritable bowel syndrome, sleep difficulties, and hair loss. Her implants were removed in May 1991.

Swanson's story of multiple complications is not unusual. Somewhere in the neighborhood of 2 million American women have breast implants; 130,000 received saline implants in 1999. According to studies done by the manufacturers of the implants, at least 27,300 of these women -- 21 percent -- will have complications severe enough to warrant removal or replacement of their implants. Despite these high numbers, the U.S. Food and Drug Administration (FDA) recently approved saline implants, albeit with conditions.

Conditional approval

In March 2000, the FDA approved saline implants manufactured by two companies, McGhan Medical and Mentor Corporation, after 13 hours of tense advisory-committee meetings. During the 25-plus years saline implants have been on the market, the FDA had never rated their safety because they hit the market before the FDA gained regulatory control over medical devices, in 1976. After the advisory-committee meetings on silicone -filled implants and the FDA's ban on them for most women in 1992, however, the FDA decided to call for safety data on saline implants.

Complication rates differ between women who choose saline implants for cosmetic breast augmentation, about 70 percent of all implant cases, and those who do so for breast reconstruction after mastectomy. In two studies of women with cosmetic implants, between 21 and 27 percent experienced complications within three years that required surgery to remove or replace the devices. For women with breast reconstruction after cancer, like Swanson, that percentage jumped to between 39 and 40 percent.

Some doctors and consumer groups call the complication rates of saline implants unacceptably high. About a dozen women with implants testified before the FDA in March, describing complications that ranged from loss of sensation in the breast to severe infection. Some of them pleaded with the panel to take the saline implants off the market. Swanson was one of them. "I really thought they would not approve them," she says.

The FDA did place nine conditions on the manufacturers, one of which is that women must be fully informed of possible risks. Greg Loshak, a market manager for McGhan Medical, explains that McGhan and Mentor are working with the FDA to create a new consent form containing information about the complications associated with breast implants and those associated with surgery in general. "It will have study information and ... the possible complications and benefits of breast augmentation and reconstruction, as well as the [other] things a woman should know to give her a full picture," he says.

sidebar: complications from saline implants

So why get them?

Diana Zuckerman, Ph.D., executive director of the National Center for Policy Research for Women and Families, says she believes that if women really understood the possible complications, they would never choose to get implants. "If [plastic surgeons] told the patients about all the risks in a clear and unbiased way, they'd go out of business," she says. "A plastic surgeon is going to have to decide how much to tell the patient and how to still have patients. That's too much to expect."

However, despite complication rates, many patients are satisfied with their saline implants, according to a recent study by the University of Minnesota. Among the 450 women studied, most of whom chose saline implants for cosmetic enhancement, 93 percent were "satisfied" or "very satisfied" with their surgery after ten years. Satisfaction rates among large numbers of cancer reconstruction patients, who have higher complication rate than cosmetic cases, have not been studied.

Loshak explains the seeming contradiction between high complication rates and high patient satisfaction by drawing a distinction between the two. "They're really two separate things, complications and satisfaction levels," he says. "Many women are satisfied although they may have had some pain; a few may have had deflation."

A lifelong commitment

According to Dr. David Feigal, head of FDA's Center for Devices and Radiological Health, "Women should understand that breast implants do not last a lifetime."

This is an unfortunate understatement, says Zuckerman. "It is correct that they don't last a lifetime, but women need to understand that these things don't even necessarily last ten years," she explains. Women are likely to need additional surgeries and doctor's visits throughout their lives.

So how long will a saline implant last? That is the question of the hour, says Zuckerman. No one knows how many years the current saline implants will last; some studies suggest 7-12 years, but some implants will break very soon after implantation and some last more than 15 years. "An implant does not have a set lifetime; it could deflate in a year. But it's reasonable [to think] that an implant could last 15-20 years," says Loshak. "Implants are getting better, quality control is improving."

The partnership between the FDA, Mentor, and McGhan should result in a clearer process that informs women of the warnings and potential risks associated with saline implants. Eileen Swanson says she wishes she had known more about possible complications when she elected to get implants. "None of us understood what we were getting into," she says. "I didn't even know there was such a process as FDA approval." Ultimately, the decision is personal, but understanding the risks is an essential first step.

Related link:

Rx.magazine feature story: What's New in Breast Cancer Prevention

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