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.