One unsettling finding to emerge from the FDA hearings is how often breast jobs have to be redone. The McGhan study showed that more than one out of five women with cosmetically enhanced busts–and 39 percent of cancer patients–need additional surgery within three years. The top reasons for such procedures include replacement of ruptured and leaking implants and alleviation of hardened breasts caused by capsular contracture and other factors. And new implants don’t always solve the problem. After a second surgery, nearly half of cancer patients (whose remaining breast tissue and immune systems may be more fragile due to surgery, radiation and chemotherapy) develop severe capsular contracture, and 26 percent require a third set within two years.

Kim Green, a 36-year-old homemaker with two children in West Hartford, Connecticut, got breast cancer in 1998, when she was seven months pregnant, and had her breasts rebuilt after a double mastectomy. So far, she has endured 11 operations, at a cost of more than $70,000 (all of it covered by insurance). And with only one implant right now, she faces still more surgery this coming January for the second. Each time implants have been removed, she says, "it’s like having a mastectomy all over again, with total anesthesia and drains in my chest. It’s been devastating–I spent a whole year having surgery almost every month. When I was diagnosed with breast cancer–which killed my mother when she was 35–I just wanted to live. I never dreamed reconstruction could be this bad. It’s worse than chemotherapy." Yet she’s determined to keep trying. Getting her "breasts" back is somehow a symbol that she’s gotten past her disease. "I want to look as normal as possible," she confesses.

Despite stories like this and the complication rates shown in the latest studies, FDA officials feel it’s ultimately up to consumers to decide what risks they will take. Thanks to the hearings, both implant companies now have new package inserts that detail the study findings, which are also posted on the FDA Web site at www.fda.gov. "Patients can [now] look at the brochures to find out about the experiences of women who have these implants," says the FDA’s Dr. Feigal. "The whole purpose of the FDA approval process was to gather information so patients know exactly what to expect."