The Return of Silicone?
Dawn Miller isn’t keen on talking about her breasts in public. But there she was, 500 miles from her small Massachusetts town, in a suburb of Washington, D.C., standing at a microphone before an FDA panel and the national media, discussing the silicone implants she got at age 20. Miller, now 35, suspects they caused ills she has suffered from chronic pain to hearing loss. “Had I known the possibilities,” she says, “I wouldn’t have put these in my body.”
Terry Heide, 51, an Army congressional liaison from Alexandria, Va., was there with a different message. Two years ago after a double mastectomy, she chose silicone implants, with no regrets. “I believe they are safe,” she says. “And I believe in a woman’s right to make decisions for her body.”
After a 13-year ban, silicone implants may be back. The FDA took them off the market (except for women in clinical trials having reconstruction surgery or replacement of older silicone implants) in 1992, stating that manufacturers could not prove their safety. On April 13, following three days of impassioned testimony by professionals and women like Miller and Heide, an advisory panel recommended that the FDA lift those restrictions for one implant maker. A final decision from the FDA may may take weeks—or months—but it is already generating controversy.
Why silicone, and why now? In the early ’90s, several silicone-implant makers paid billions of dollars to settle lawsuits alleging their products had led to ruptures, leakage and ailments like lupus and cancer. The FDA’s ban left women seeking implants in the U.S.—250,000 of them last year—with only one alternative: saline. Though deemed safer, it is widely considered to look and feel less natural than silicone. “It’s the difference between a Hyundai and a BMW,” says Dr. Deborah Bash, 44, a plastic surgeon at the Mayo Clinic in Scottsdale, Ariz., who performs breast augmentation and reconstruction surgeries. Bash herself chose silicone when she got implants as a 25-year-old medical student, and again when she had them replaced in 1999. “I focus on the science, not the emotion,” she says. “Nothing is 100 percent safe.”
Manufacturers and many plastic surgeons argue that very little scientific evidence links silicone implants with health dangers. And newer models, they say, pose less risk of rupture.
Dr. Susan Kolb isn’t sold on either argument. A plastic surgeon in Atlanta who specializes in implant removals, Kolb was happy with her silicone implants for 10 years and even touted their safety to the media. “I was just telling my story,” says Kolb, 50, who routinely performed implant surgery. “I wasn’t having any problems. That was before they started to leak.” In 1995, Kolb says, she felt a burning in her chest and numbness in one arm. “I knew they were leaking; I’d had patients with the same symptoms.” She says she got “sicker and sicker,” suffering fatigue, mental clouding, dizziness and hair loss before having them removed in 1997. She now has saline implants but says she has long suffered effects of the silicone.
Dawn Miller, too, believes her implants caused her health problems. Surgery at age 12 to correct a congenital defect left her chest malformed, so in college she decided to have silicone implants to create symmetry. The soft-spoken social worker says that over the years she began suffering unexplained muscle pain and in 2002 lost hearing in her left ear. In 2004 she developed an irregular heartbeat; at about the same time, she heard about a possible link between silicone implants, which contain some platinum, and neurological problems caused by platinum. “That was the first time I thought, “These could be making me sick,’ ” she says. After a lab test found platinum in her urine last September, she had the implants removed. The surgery revealed one had ruptured. (A spokesman for the manufacturer, Mentor, told PEOPLE in an e-mail, “platinum-related health problems in women with breast implants does not exist.”) Miller returned to wearing prosthetics in her bra, as she had as a teen. “They’re fine,” says Miller, who still has hearing loss. “I don’t give it a lot of thought.”
“These women have real pain, and that’s not to be denied or taken lightly,” says FDA panel member Dr. Michael Miller, a plastic surgery professor at Houston’s M.D. Anderson Cancer Center. Nevertheless, he says, their testimony is without scientific merit. “The evidence refutes that the implants are causing these symptoms.” A 1999 report by the National Academy of Sciences’ Institute of Medicine assessed 3,400 studies and other reports on silicone implants and found no conclusive link between implants and serious health problems. But scientists continue to investigate suspected links.
The real problem, say opponents of silicone implants, is that long-term data on their safety doesn’t exist. The FDA panel rejected the application of one manufacturer, Inamed, in part because it had not provided enough information about how quickly their implants ruptured. It granted approval to a rival, Mentor, citing its lower rupture rate. Panel member Dr. Amy Newberger, a Scarsdale, N.Y., dermatologist, voted against both applications. “I don’t feel secure about safety,” she said. “I don’t feel at this time that patients can grant informed consent.”
The week before the hearings, the FDA made public its estimate that up to 93 percent of silicone implants ruptured within 10 years. According to testimony from Dr. Sahar Dawisha of the FDA’s office of device evaluation, even by Mentor’s own estimate, the wide use of their implants could mean 22,500 ruptures annually. Mentor, responding in an e-mail, said, “We do not know specifically how Dr. Dawisha calculated this number…. Since implants should not be considered lifetime devices, however, we would expect that some implants may rupture in the future.”
Mentor’s studies have been conducted over a period of two years; Dr. Kolb says that longer-term studies of “10 to 20 to 25 years” are needed. When an implant ruptures, she adds, a number of substances can leak into the body: “Silicone is not just one thing. There are 30 or 40 chemicals that could be in different implants, and some are toxic to the nerves, carcinogens.” Kolb offers augmentation with saline. Would she consider silicone again for herself and her patients? “Yes,” she says, with a big if. “If long-term safety looked good.”
Terry Heide isn’t worried. “There was no way I was going to go through the rest of my life without breasts,” she says. “And it was never a question that I’d use silicone. There’s no perfect drug out there—and there’s no perfect implant. Planes can crash; people get cancer. That’s the highway that life is.”
By Allison Adato. Susan Schneider Simison in Gaithersburg, Md., and Melody Simmons in Washington, D.C.