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.
"They [the FDA] seem to be acting as if they think there's almost nothing they can say no too," says Cynthia Pearson, executive director of the National Women's Health Network. Diana Zuckerman, PhD, who heads the National Center for Policy Research for Women and Families calls the approval scientifically and politically "baffling."
However, Feigal says the FDA's primary interest remains the patient, a commitment that hasn't changed.
The approval of saline implants stands in stark contrast to the fate of silicone gel-filled breast implants. The FDA pulled them off the market in 1992 following a similar debate about whether the devices were causing a number of immune-related diseases. Those arguments are still resonating in the courts and in medical journals, although a major study conducted by the Institute of Medicine supports the view that the implants weren't linked to the illnesses.
Meanwhile, saline-filled implants have been on the market for 30 years, long before the FDA had jurisdiction over devices. Since the mid-1990s, demand for them has been increasing to an estimated 130,000 patients per year in the U.S. Finally, safety studies involving some 9,000 women were enrolled and completed allowing the agency to reach its decision last week.
Now the argument is shifting to the product's label, which guides surgeons on how to describe the risks and benefits to the patients. The FDA says drawings or pictures of bad outcomes will be shown to women prior to the operation.
"We want to have graphical representations of what the poor cosmetic outcomes are, because that's the major problem with the products," says Feigal.
Plastic surgeons are understandably unhappy with that idea. "Unfortunately, there's a great deal of possibility of misinformation being given by such a tack, and we have not actively encouraged the FDA to proceed in that way," says Daniel Morrello, MD, president of the American Society for Aesthetic Plastic Surgery.
Activists want patients to get explicit information. "So we're going to try to do as much as we can on a grassroots level to let women know: if you're talking to a doctor about implants, and you're not getting handed the FDA brochure, you're not getting good quality care. Don't go any further," says Pearson. Another question is whether doctors will follow the three-to-seven day waiting period suggested by the FDA before doing the operation. Individual states, not the FDA, must enforce that requirement.
The FDA specifically approved the implants for women at least 18 years old, but some doctors at their discretion will probably put the devices in younger patients. "That [limitation] short changes many younger women who've got congenital birth defects who could really have their adolescence and their life significantly improved," says Cunningham.
But is that a decision some patients will come to regret? "No breast is worth your life. These are cosmetic devices, whether you receive them for augmentation or reconstruction," says Swanson.