By Molly M. Ginty
Tuesday, February 6, 2007
After the FDA lifted a 14-year ban on silicone breast implants many women are weighing the devices' potential side effects. Congresswoman Rosa DeLauro questions the FDA's decision and plans congressional hearings later this year.
(WOMENSENEWS)--Cheryl Henley loves her second set of breasts.
After developing breast cancer in 1988, she had a bilateral mastectomy and had her surgeon insert two silicone implants before the devices were banned amid health concerns in 1992.
"Now that silicone is available again, I'll likely get it a second time if I need my implants replaced," says Henley, a 62-year-old health administrator in Albany, Ga. "I know there are risks, but I think they're worth it because this type of implant looks and feels so natural."
Since the Food and Drug Administration approved silicone breast implants in November, the questions Henley is considering also face the 365,000 U.S. women who have breast augmentation and the 46,000 who have reconstruction each year.
"When they talk to their doctors about breast surgery, the first thing women want to know is if it's true that silicone is more realistic," says Dr. Walter Erhardt, a spokesperson for the Arlington Heights, Ill.-based American Society of Plastic Surgeons. "Second, they ask, 'Is it safe?'"
The FDA, based in Rockville, Md., has approved silicone implants for reconstruction in women of all ages and for augmentation in those over 22, basing its decision on large-scale studies (including one from the Washington-based Institute of Medicine) that found the implants safe.
Due to the possibility of leakage, the agency recommends checking for ruptures with magnetic resonance imaging, or MRI, three years following surgery and every two years after that. Due to concerns about silicone's connection to autoimmune diseases and other health problems, it is also requiring implant manufacturers to track safety and efficacy in 80,000 patients for 10 years.
After the FDA gave silicone a green light in November, the two current U.S. makers--Allergan, based in Irvine, Calif., and the Mentor Corporation, based in Santa Barbara, Calif.--saw their stock prices soar, and surgeons were barraged with calls about the new option.
In the wake of the FDA announcement, Wall Street analysts predicted breast implant sales in the United States would skyrocket, hitting $2 billion by 2012.
"Though many patients are now taking a wait-and-see approach, the number of women having implant surgery could grow," says Erhardt.
So, too, could the controversy. Rep. Rosa L. DeLauro, D-Conn., plans to hold congressional hearings on silicone implants later this year. "The FDA's decision is very disturbing given the unproven safety record of these devices," she says, contending the studies used to justify lifting the ban are not convincing.
Some grassroots health groups--including the Washington-based National Women's Health Network, the Boston-based Our Bodies, Ourselves and the San Francisco-based Breast Cancer Action--also object.
Health advocates say the FDA is not taking into account silicone implants' high price and possible health problems: joint pain, mental confusion, headaches, rupture (reported in 69 percent of patients in one study) and leakage of silicone outside the breast area (reported in 21 percent of patients in another study).
On top of these concerns come the potential problems of implants in general: scarring, loss of sensation, blurring of breast cancer detection images and difficulty breastfeeding.
Critics point to women like Karen Guerriero, a 39-year-old Houston mother who had breast augmentation at age 21 and learned five years ago that both her silicone implants were leaking, causing dizziness, nausea and blurred vision. "I don't have the money to have them removed," says Guerriero. "I want this poison out of me, and can't sleep at night worrying about it."
Cost is another concern. Unless implants are deemed medically necessary, usually only the case with reconstruction after mastectomy, they are not covered by health insurance. Surgery can run $5,000 to $10,000, which covers the $1,800 to $2,000 price of a pair of silicone implants.
"Even if women can afford the initial surgery, they may not be able to pay for potential problems that arise or for the replacement implants that are eventually necessary," says Diana Zuckerman, director of the Washington-based National Research Center for Women and Families.
For women with silicone implants, biannual MRIs recommended by the FDA, which cost about $2,000 each, would not be covered by insurance and would over time likely cost a woman far more than her initial surgery.
Women cite various reasons for wanting breast implants: lopsidedness, droopiness, loss of tissue after cancer, self-consciousness about small size or a simple desire to change their appearance.
Available in the United States since the 1960s, silicone implants--which are made of a silicone shell filled with silicone gel--were for decades a popular way to address these concerns. Allowed but not heavily regulated, they were in a statutory limbo called "pre-market approval." They did not undergo rigorous studies until 1991, when the FDA, responding to complaints by women who reported leakage and health problems, demanded further research.
For lack of proof that silicone devices were safe and effective, the FDA pulled them from the mainstream market in 1992, allowing them only for patients having reconstructive surgery or pre-existing implants replaced, and then only in FDA-approved clinical trials.
Two years later, women claiming they were injured by silicone implants won $3.75 billion in compensation from manufacturers. The largest legal settlement in U.S. history at the time, it helped plunge Dow Corning--a major implant manufacturer in Midland, Mich.--into bankruptcy the next year.
After the silicone ban, the only type of breast implant widely available in the United States was the saline implant (made of a silicone shell and filled with saline or salt water). Half the price of its silicone counterpart, it proved in studies to be half as likely to leak.
But many patients didn't think saline made for believable breasts. "Silicone is softer, more pliable and feels more like human breast tissue," says Dr. Brent R.W. Moelleken, a Beverly Hills, Calif., plastic surgeon. "It is also less detectible because it ripples less."
From 1992 to 2006, while surgeons honed techniques that gave saline implants a better result, the FDA continued gathering evidence on silicone devices. They reviewed studies by manufacturers, university researchers and independent scientific bodies.
In 1999, an Institute of Medicine report found silicone implants did not boost the risk of connective tissue disease, cancer or immune disorders. And in 2000, a study published in the New England Journal of Medicine found the implants did not cause systemic disease. Along with other evidence, these studies influenced the FDA's decision to lift the ban.
"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," says Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
While debate over this assertion heats up, a new generation of silicone breast implants is winding its way through the FDA approval process. Available in Europe and described as having the consistency of "gummy candy" (which makes them less likely to leak), these implants could be available in the United States within the next two years.
Molly M. Ginty is a freelance writer based in New York City.
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