Are Saline Implants Safe?

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http://content.health.msn.com/content/article/1691.50198Tuesday, March 28, 2000 Are Saline Implants Safe?By Towle WebMD Medical News March 27, 2000 (Chantilly, Va.) -- Six months after the birth of hersecond daughter, was trying on a swimsuit when she looked out thewindow. "I remember [seeing] all the young women on the beach, andthinking, 'I used to look like that,' " she recalled. "I decided rightthen and there that I was going to get implants." It's a decision she now regrets. The Dulles, Va., woman, who asked that her last name not be used, iscontemplating a lawsuit against her surgeon and the company that made herimplants: In the five years since her breast augmentation surgery, she hashad to have her implants replaced twice. Last month, she had them removed for good. The breast tissue surrounding 's implants had become so sensitivethat she could hardly touch her breasts. "The pain had gotten to be almostunbearable at times," she said. "I had gotten them to boost myself-esteem, but by the time I had them out I decided there was nothingsexy about me." Women like are watching Washington, D.C., these days following theFood and Drug Administration's (FDA) first formal review of salineimplants. Earlier this month, an FDA advisory panel recommended that two leadingbrands -- manufactured by McGhan Medical Corp. and Mentor Corp., both ofSanta Clara, Calif. -- remain on the market as long as women are fullyinformed of the risks, including the possibility that their implants mayrupture, leak, or cause an infection. Among the panel's recommendations: that the FDA review the consent formsthat women sign prior to surgery, and that implant makers provide morecomplete information about postsurgical complications such as reoperationsto replace leaky or ruptured implants. The FDA is expected to issue a final decision in mid-May. Most observersexpect it to endorse the panel's recommendations. A Legacy of Worry Saline implants have been the only option for many women since 1992, whenthe FDA banned silicone implants based on concerns that they might becausing autoimmune disorders, such as lupus, arthritis, and body aches. An Institute of Medicine report last year found no link between siliconeimplants and autoimmune problems; so did a study reported in the NewEngland Journal of Medicine earlier this month. Yet the controversy oversilicone has put pressure on the FDA to take a harder look at saline. At the recent panel hearings, saline implant maker McGhan Medicalacknowledged there were at least minor problems among 60% of patientswithin four years of implantation and among 84% of breast reconstructionpatients. Meanwhile, Mentor said its study of 1,680 saline implantrecipients found that up to 27% of the implants were removed within threeyears, mostly due to infections, pain, or leaking. In a published report, panel member Li, M.D., of New York'sHospital for Special Surgery, called Mentor's failure rates "alarminglyhigh" and said, "it's amazing to me it seems to be tolerated as justsomething you have to live with." Nevertheless, implant makers and others will likely take the FDA panel'sfinal decision "as a blessing," says , an attorney who hasrepresented women in lawsuits over silicone implants. "The medical industry likes to use the FDA as a shield. " They believethat if the FDA has OK'd it, then that should be the end of it." Increasing Attention on Informed Consent That's not likely. Legal experts say a woman will still have grounds to sue if her doctorfails to inform her adequately of the risks involved or if she experiencesproblems that are worse or different than the ones described in acompany's product literature. And depending on the FDA's final decision, doctors and implant makers maywell have to provide additional information on specific risks (see Detailsof the FDA Panel's Hearings). Since the early 1990s, many plastic surgeons have required womencontemplating implant surgery to sign a special consent form; the contentcan vary from state to state although the American Society for AestheticPlastic Surgery (ASAPS) has published guidelines (see A Guideline toRisks). Many doctors make it a point to emphasize the downside: "All I do is talkabout complications," says Sherwood Baxt, a New Jersey plastic surgeon. But Zuckerman, Executive Director of the Washington-based NationalCenter for Policy Research for Women and Families, says some doctorsaren't so clear. "Many women will tell you that their doctors told themtheir implants were perfectly safe and nobody told them about the failurerate or that implants could break," she said, adding that consent formsoften read like a "mortgage application." "Everybody knows that there is a huge gap between what a written documentsays and what the doctor tells a patient," says Zuckerman. "If the doctorsays, 'Don't worry, my patients are all very happy,' few women will get upand leave." Calls for Change and Caution Mark Jewell, a California plastic surgeon who represented ASAPS at thehearings, called for a single consent form to be used nationwide. "We needsomething that is a plain English explanation for whatever the problemsare that could occur," he said. Ultimately, however, it's up to a woman to ask questions. , forexample, signed a consent form but now wishes she had read it moreclosely. "My advice to other women considering implants is to learn everythingabout it," she says, "or don't do it." D. Towle is based in Chantilly, Va., and writes regularly onhealth and legal issues for WebMD.