May 18, 2000 (Washington) -- After a battle that raged throughout the '90s, proponents of saline breast implants finally won their fight to get the controversial products approved by the FDA, but that didn't end the war.
Last week the agency decided to allow two companies, Mentor and McGhan Medical, to continue marketing their devices over the intense objections of consumer activists and women who say they've been injured by the implants. Reactions on both sides were predictable.
"It's a victory that plastic surgeons and manufacturers, [and] many women who've had implants, have fought hard to say clearly what the real issues are," Bruce Cunningham, MD, director of plastic surgery at the University of Michigan and safety study director for Mentor tells WebMD.
"I'd like to say I'm stunned, but I'm not. ... The whole FDA hearing seemed like a sham to me. But I am appalled," cancer patient Eileen Swanson tells WebMD. She believes that her four implant-related surgeries over the last 10 years, beginning with a postmastectomy breast reconstruction, virtually destroyed her health.
Contrast that with Nicole Cummings' experience. Like most women who have the surgery, Cummings got her $8,000 implants for cosmetic reasons. She received the devices 2-1/2 years ago when her breasts sagged after nursing two children.
"Now I have more confidence. ... I could not imagine being my age, and living the rest of my life, and having a normal sexual relationship with my husband the way I was," Cummings tells WebMD.
Both women now lead support groups on different sides of the implant issue.
Clearly, the safety studies done by the implant makers for the FDA reveal a number of problems associated with these saline-filled silicone shells, including infection, tissue hardening around the implant, leakage, and even implant removal. In fact, the agency says implants don't last a lifetime.
"Once you have breast implants, your breasts are never going to be the way they were before. It's not like you can change back," David Feigal, MD, FDA's director of the Center for Devices and Radiological Health tells WebMD.
Still, in spite of the risks the FDA and its expert medical advisors listened to the collective voice of implant recipients. "At three years when you ask people if they were satisfied with their implant [about] 95% were satisfied," says Feigal. Most of the complaints had to do with aesthetics, such as wrinkling or visible scars, but he insists safety was paramount.
"It wasn't that we ignored this issue. We asked the manufacturers to look for these problems, and to document them, and to be prepared to evaluate them," says Feigal.
Depending on where you sit, the FDA's action either validates patient choice or represents a capitulation to the powerful medical and manufacturing lobby that simply overwhelmed the regulators.