Women need better information on breast implants, FDA panel says
SILVER SPRING, Md. — Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding of the risks — which includes a rare cancer that is linked to several deaths around the world — posed by the devices.
The members, speaking at the conclusion of a two-day FDA hearing, signaled support for a standardized, easily understood consent form that would lay out the major risks of the devices and be reviewed by patients and their doctors before a woman underwent surgery.
They said the FDA could negotiate the format and content of the consent form with patients, plastic surgeons’ groups and manufacturers. Frank Lewis, chairman of the agency’s panel on general and plastic surgery devices, said the current documents written by manufacturers are too long — some are more than 70 pages — and unwieldy. “They were constructed to provide legal protection for the companies,” he said.
During the sometimes emotionally wrenching hearing on implants, several women testified that they had not been adequately warned of risks posed by implants and were harmed by the devices.
The FDA had asked the panel to hold the hearing and provide guidance on several complicated issues involving implants, which have stirred controversy for decades.
The panel members came up with other suggestions for the FDA. One said that the tissue removed when implants are taken out should be analyzed by pathologists to try to understand what causes illness or complication. Another said it was important to try to establish an official definition for “breast implant illness” — the constellation of autoimmune problems that many women say are caused by implants — so insurance would pay for treatment of the ailments. The FDA has said the weight of evidence does not support such “systemic” effects from implants.
But the panel did not appear to reach consensus on recommending that any implants be taken off the market, including certain textured ones that have been linked to cancer. Many patients and advocates called for such a ban, but several panel members said they opposed the step at this time.
At the end of the meeting, however, Texas plastic surgeon Pierre Chevray, a member of the panel, called for banning textured implants that have been barred in other countries.
The FDA has identified 457 cases and nine deaths in the United States associated with the cancer, called breast implant-associated anaplastic large cell lymphoma. Six hundred cases and 17 deaths have been reported worldwide. Several countries have banned one type of textured device.
Diana Zuckerman, a longtime advocate who is president of the National Center for Health Research, said the recommendations from the panel “were rather vague,” but she said the meeting was important because it allowed women to tell their stories to the FDA and the surgery panel. “We don’t know what comes next, but I’m hopeful,” she said after the meeting.
The panel also said that the FDA should change its recommendation that women with implants begin to get MRIs after three years to check for ruptures. Perhaps starting after six years would be more practical, members said, considering the cost involved.
Facebook groups have attracted tens of thousands of women who say they came down with such afflictions after getting implants and then saw that many of their symptoms eased when the devices were removed. Nicole Daruda, who had her implants removed several years ago, runs the biggest group, called Breast Implant Illness and Healing, with 70,000 members. “Hundreds of women are joining every day,” she said.
The advisory committee, which includes plastic surgeons, epidemiologists and biomaterials experts, did not take formal votes over the two-day hearing. Instead, it discussed questions posed by the FDA.
About 400,000 women a year get implants, 75 percent for cosmetic reasons and the rest for reconstruction after breast-cancer surgery. Implants are either filled with silicone gel or saline solution; their surfaces are smooth or textured. The majority of implants used in the United States are smooth.
The FDA banned most implants in 1992 but lifted that ban in 2005. The agency approved implants made by Allergan and Mentor in 2006, requiring them to conduct long-term studies on the impact on women’s health. Earlier this month, the FDA sent warning letters to Mentor and Sientra, saying they had failed to comply with those long-term study requirements.
Much of the two-day session underscored the difficulty of making regulatory decisions in the absence of reliable, long-term data about the effects of implants. Committee members complained, for example, about a lack of control groups in studies that would allow researchers to compare patients who have implants with people who do not have them.
Plastic surgeons and manufacturers defended the implants, saying they provided important option for women who undergo breast-cancer surgery or want to have their breasts enlarged. Lisa Lynn Sowder, a Seattle plastic surgeon who testified on Tuesday, said she had “never been a big fan of breast implants,” but she worries that some patient-driven social media sites make women unnecessarily anxious. She said some of the patients “are worried sick” by what they read on the sites.
The patients and advocates had asked the committee to recommend that the FDA ban some products, require a “black box” warning on all devices and direct doctors and patients to sign a two-page checklist on implant risks before surgery.
Natalie Compagni Portis, a clinical psychologist who is a member of the panel, said just acknowledging what women have suffered is progress. “Women have felt dismissed,” she said. “We can at least acknowledge that something is happening.”