A Food and Drug Administration advisory panel recommended today against allowing silicone breast implants back on the market, citing concerns about possible health effects and design problems that cause some to break prematurely.
The vote to disapprove the application by Inamed Corp. of Santa Barbara to market the devices was 5-4.
“I don’t feel secure about safety,” said Dr. Amy E. Newberger, a Scarsdale, N.Y., a dermatologist who offered the motion to disapprove the device. “I don’t feel at this time patients can give informed consent.”
It was the second time in less than two years that an advisory panel had voted on whether to make the devices available for widespread use. In 2003, the panel voted 9-6 to approve the devices, but that decision was overridden by the FDA, which asked for additional data.
“Science won the day today,” said Diana Zuckerman, president of the National Center for Research on Women and Families and a leading critic of silicone implants. “They listened to the scientists who said there was no proof on whether implants were safe.”
The advisory panel will vote Wednesday on a similar application by Mentor Corp., also of Santa Barbara, which had not previously sought FDA approval for its implants.
The FDA ordered the silicone devices off the market in 1992 amid controversy over health problems
The FDA ordered the silicone devices off the market in 1992 amid controversy over health problems suffered by women who had the implants. Since then, silicone implants which are considered more natural in appearance and feel than the saline-filled alternative have been available only to women having breast reconstruction after cancer surgery or to those who agreed to participate in strictly controlled clinical trials.
One panel member, Dr. Michael J. Miller, a plastic surgeon at Houston’s M.D. Anderson Cancer Center, said his experience in performing such reconstructive work led him to vote for approval.
“I am one of the few people on this panel for whom the care of these women is not theoretical,” he said. “I would love to know everything about the device, but that is an impossible standard. I feel I have crossed that point.”
Another panelist, Stephen Li, president of Sarasota, Fla.-based Medical Device Testing and Innovation LLC, had served on the 2003 advisory group and voted then in favor of approval. This time, though, he voted against it. “We really don’t know why this device is failing when it fails,” he said.
The panel’s vote is not the final word. The FDA could reject its advice and approve the devices
The panel’s vote is not the final word. The FDA could reject its advice and approve the devices, as it did with Relenza, an influenza treatment; and Contak CD, an implantable defibrillator for treatment of advanced heart failure. In both cases, FDA advisory panels had recommended against approval.
The timetable for the FDA’s decision on the implants could range from six weeks to several months.
“I don’t think the FDA can afford to do anything embarrassing,” Zuckerman said. “Approving [silicone implants] after this vote would be very embarrassing.”
Dan Cohen, a vice president for Inamed, said he did not see the panel’s vote as a rejection of the product. “The decision of the panel seems to be that they want more time,” he said.
Inamed, he added, will continue to submit data and seek approval.
Although Inamed had worked diligently to dispel doubts about its silicone implants, its success before the panel was tempered by notable caveats. A majority of the members expressed concern about one implant model, known as “Style 153,” and shown by the company’s own data to be prone to rupture and leakage. Inamed said it has submitted to the FDA a plan for several changes to the model.
In their testimony to the panel today, FDA staffers acknowledged that Inamed had supplied the agency with considerably more information than was available two years ago about how and why its silicone breast implants rupture in a woman’s body.
But medical reviewers for the agency said they still lacked enough data to answer some critical safety questions.
One dealt with what happens to silicone that escapes into the body. Some studies have found silicone in the lymph glands of women with breast implants.
“The FDA believes the answer to this question is crucial with respect to determining the safety of this device,” said Dr. Sahar Dawisha, one of the FDA medical reviewers.
Another central question involved how implants deteriorate in the body, and whether they rupture at the same rate year after year or become more likely to fail after years of wear.
Dawisha testified that the agency was skeptical of claims by Inamed that rupture rates would remain fairly constant, in the low single digits, year after year. “FDA has questions about these assumptions,” she said.
Studies of European women who received silicone implants for breast enhancement found that 9% of implants rupture each year, Dawisha said. Assuming half of cosmetic breast surgery patients chose silicone implants, she said, that would translate to 22,500 ruptures each year in the United States.
To illustrate the uncertainty of the long-range estimates, the FDA prepared a set of mathematical projections for the panel. The probability of rupture by the 10th year ranged from 5% to 29% for cosmetic surgery patients and from 39% to 95% for cancer patients having breast reconstruction.
Patients would need costly follow-up medical care to reliably detect silicone implant ruptures because most are “silent” and can only be identified after an MRI scan. Inamed recommends that patients repeat surgery to replace ruptured implants, even if the failure cannot be seen or felt.
Inamed argued that the FDA had painted a worst-case statistical scenario
Inamed argued that the FDA had painted a worst-case statistical scenario and that the agency glossed over psychological benefits to patients who feel they have improved their appearance.
Moreover, Inamed experts said the company’s current generation of implants has a thicker covering to decrease the risk of rupture and a type of gel that stays together if the implant covering does fail.
Dr. Patricia Walker, Inamed’s chief scientific officer, said the company’s products are made by hand to withstand “extreme safety testing.” Inamed’s examination of implants that failed and were removed from patients has shown that the majority of failures were the result of surgical damage, she said.
The company is working with surgeons to improve methods and techniques, Walker added. And he said available scientific evidence indicates that silicone largely remains in place even when implants rupture.
Walker underscored that repeated scientific investigations have failed to find any increase in rates of cancer and other serious illnesses in women with silicone breast implants.
She called the FDA’s projections of high rupture rates “highly speculative.” The company said its estimate is that the cumulative rupture rate by the 10th year would be 14%, much lower than any of the FDA’s estimates.
“We think that’s the best assumption that can be made under the circumstances,” she said.
Walker said enough is known about the risks and benefits of silicone implants that women can be reasonably confident of their safety. “In the United States, women and their physicians should be able to choose the implant that best suits their needs,” she said.
About 250,000 American women a year have surgery to improve the appearance of their breasts and pay the $5,000 to $8,000 cost themselves, since most cosmetic surgery is not covered by medical insurance. That cost is likely to go up if silicone implants are approved. Not only are such implants somewhat more expensive, but the government could require patients to receive periodic MRI scans as a condition of approval.