"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.