Diagnosed with advanced breast cancer two decades ago, Sybil Goldrich underwent a double mastectomy at age 44—then promptly consulted plastic surgeons about silicone gel implants, which since the early 1960s had been the prevailing method of breast reconstruction. "The doctors all said the same thing," she recalls. "Implants are the best for you. They'll last a lifetime."
Not for Goldrich. Instead, they brought her years of hell. She went through four sets of implants because of cascading complications—including fever, rashes and a buildup of scar tissue from the surgeries that left her in excruciating pain. After she had a hysterectomy in May 1988, surgeons found that silicone had leached into her uterus, ovaries and liver. The ordeal transformed Goldrich into an activist. In 1988, along with Kentucky nurse Kathleen Anneken, she started Command Trust Network, providing information to 22,000 women, many of whom claimed their implants brought on debilitating autoimmune diseases such as lupus. Taking on Dow Corning and six other manufacturers, she helped facilitate legal action leading to settlements in the billions of dollars. Finally, in 1992, the Food and Drug Administration restricted silicone breast implants except for research or medical necessity. In 2000 the agency approved saline implants, currently the only option for purely cosmetic breast enlargement.
Now all that may change: On Oct. 14 an FDA panel will meet to consider research by Inamed, a California manufacturer, that could put silicone implants back on the open market. "It's like a horror movie—The Return of the Glob," says Goldrich, 64, curled up in a chair in her Beverly Hills home. "I didn't think I'd have to fight this battle again."
She's not alone. Implant survivors from around the country and groups including the National Organization for Women and the National Women's Health Network are up in arms, arguing that far more study is needed before silicone gets a pass. "This is reckless," says internist Dr. Sidney Wolfe, director of Public Citizen's health research group. "The FDA is relying on clinical tests done by the company that wants to market [the silicone implants]. The company is only about three years into a 10-year study. The history of these devices is that women start having enormous problems after five to eight years."
The FDA has declined to comment until after its panel meets. But Joann Kuhne, Inamed's director of clinical and regulatory affairs, points out that "numerous studies have shown no link between silicone and any diseases" and that silicone has continued to be used in hip replacements and other procedures. To be sure, the scientific community has found little to suggest that silicone implants cause health problems. The Institute of Medicine, an arm of the National Academy of Sciences, reviewed some 2,000 studies and found "there is no evidence that the silicones used in implants are toxic to humans."
Not only that, but some women prefer the more natural look of silicone. "Ninety percent would select the gel over the saline," says Dr. James Wells, president of the American Society of Plastic Surgeons, which would support the reintroduction of silicone implants if the FDA deems them safe. "It doesn't ripple like the saline implant."
A little rippling would have been the least of Goldrich's woes. Wed 42 years to Jimmy, a retired physician, the New York City-born Goldrich once worked as a production assistant on Candid Camera but took time out from her career to raise daughters Amy, now 40 and a lawyer, and Zina, 38, a composer. In 1984 she had a mammogram. "Bingo," she says. "I had six places where there was breast cancer."
After her first implant, she awoke with fever and a rash, which she claims were a reaction to the polyurethane shell that houses the silicone gel. She was horrified at the sight of her "new" breasts. "They were grotesque," she says. "One was up here, one was down here." In later corrective surgeries, Goldrich says she suffered fever, pain and more rashes. Finally, in 1984, she'd had enough. She underwent a "tram flap" operation in which tissue from the stomach is used to rebuild the chest wall. "I have never regretted it."
In June 1988 Goldrich wrote of her ordeal in Ms. magazine. Flooded with letters from women who had suffered similar problems—and worse—she launched CTN. In 1991 Goldrich helped push through litigation that won a $4.3 billion settlement for more than 150,000 claimants against Dow Corning. Now she's working the phones, calling senators, congressmen and FDA officials, not asking them to ban silicone for eternity but to continue seeking "an implant that works." The decade between campaigns hasn't slowed her down. "If I didn't think this was so disgusting," she says, "I'd have stopped years ago."
RICHARD JEROME
John Hannah in Beverly Hills, Jane Sims Podesta in Washington, D.C., and Vicki Sheff-Cahan in Los Angeles
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