Opposing Forces Collide at Implant Hearing
The Santa Barbara-based Inamed Corp. insisted Tuesday that its silicone gel breast implant was “safe and effective,” but a panel of independent experts advising the Food and Drug Administration appeared unconvinced.
The company’s statistics-laden presentation, based on two to three years of clinical test results, contrasted sharply with the personal accounts of pain and debilitating illness shared by former implant patients, who urged the panel to collect more information before deciding whether the FDA should make silicone implants more widely available.
The FDA ordered silicone implants off the market in 1992 amid questions about their safety, including their possible role in the development of fibromyalgia and other disorders. Since then, only breast-cancer survivors and breast-enlargement patients willing to participate in approved studies have been able to get silicone implants.
In December, Inamed applied to market its silicone implant, which company officials said Tuesday was “essentially the same product” it had previously made, to all women seeking to enlarge or reconstruct their breasts.
The FDA advisory panel will vote today on whether to recommend approval of Inamed’s product. Some time after that, FDA Commissioner Mark B. McClellan will make the final decision.
At Tuesday’s hearing, Inamed officials said their study had proved that the devices were safe, that almost all patients were satisfied with them and that the silicone implant caused fewer complications at the implant site than did saline-filled implants.
They cited previous studies to show that silicone implants did not cause increased rates of cancer or other diseases.
As for silicone gel that leaked from failed implants, it remained localized at the implant site and did “not provide a basis for health concerns,” said Thomas E. Powell, Inamed’s director of technologies.
The “vast majority” of patients undergoing breast-enlargement surgery wanted to improve their physical appearance and their self-esteem, said JoAnn M. Kuhne, Inamed’s senior director for regulatory and clinical affairs. One year after getting silicone implants, their rate of satisfaction was “extremely high,” she said.
But the physicians and scientists on the 17-member advisory panel challenged the company on all counts and questioned some of Inamed’s conclusions.
They wondered, for example, how the company could report that 93% of the 940 patients in its study were satisfied with their implants after two years when as many as 46% of the women underwent additional surgeries within three years.
The panel members also said they were concerned about how often silicone implants ruptured, what caused them to rupture and whether the silicone that leaked out of implants moved to other parts of the body, possibly causing serious health problems.
Company officials said that some ruptures appeared to be caused by surgeons nicking the device when putting it in a patient and that others were caused by a folding of the implant in the woman’s body. But they said they did not know what caused most ruptures.
FDA officials cited shortcomings in the company’s study methods and contradicted some of its findings, contending that Inamed underestimated the rate at which its implants ruptured.
Citing “overwhelming public concern” about the device, Dr. Thomas V. Whalen, a pediatric surgeon and chairman of the FDA panel, told Inamed officials that “the crux of the debate” would be whether only two to three years of data were sufficient to prove the safety and effectiveness of silicone implants.
Earlier in the day, the panel heard roughly five hours of often wrenching public testimony. Of the 62 people who spoke, some representing women’s organizations or medical societies, 36 urged the panel to recommend a continuation of the FDA’s restrictions, at least until additional scientific studies are conducted.
“Women deserve the truth,” said Kim A. Gandy, president of the National Organization for Women. “They deserve to trust that what this agency tells them is a safe product to put inside their bodies is a safe product.”
More than 20 women said they experienced years or decades of breast and joint pain, headaches, sinus infections, breathing difficulties, fibromyalgia, arthritis and other health problems until their silicone breast implants were removed.
“Today I stand before you totally breastless, and I am proud,” said Pamela Dowd of Boise, Idaho, who went through “reconstruction hell” and three sets of silicone implants after treatment for breast cancer 28 years ago.
Vanessa Rose Ferrelli, a 29-year-old New Yorker, said she spent more than $45,000 on repeated breast surgeries after becoming seriously ill when she got silicone implants. “My doctor said all the reports of problems were not true,” she said.
Sixteen speakers, including seven plastic surgeons and five people whose travel to the hearing was sponsored by Inamed, said the FDA should allow all women to choose silicone implants if they want them.
“Who determines that the benefits of breast implantation are not valid?” asked Dr. Caroline Glicksman, a New Jersey surgeon who has helped Inamed conduct studies. “Let the science of medicine speak, not emotion and hysteria.”
Mary Ann Ward, 54, who races sailboats in Florida, said she first got silicone implants in 1978 and had them replaced last year with new ones.
“All women should have the choice I had,” she said. “My story is no less compelling because it is a happy one.”
