Silicone Breast Implants Face Hearings in Congress

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.

Implant Boom Expected

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 a Concern

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.