Calls at Hearing for Label on Breast Implants’ Risks

SILVER SPRING, Md. — Women with illnesses linked to breast implants challenged plastic surgeons, regulators and implant makers at an emotionally charged meeting Monday at the Food and Drug Administration, demanding more information about the risks of the implants and calling for a ban on one that is associated with an unusual type of cancer.

They asked implant makers to disclose the materials used in the devices and also called for a “black box” warning — a label that the FDA can require, noting heightened problems with a drug or device.

The implants that some patients and advocates want removed from the market have a textured or slightly roughened surface and have been associated with anaplastic large cell lymphoma, a cancer of the immune system. Dozens of other countries have already banned one type of textured implants, made by Allergan.

Industry representatives defended implants, as did plastic surgeons, including several female surgeons who said they had implants themselves and had many patients who were pleased with implants and had no health problems.

The FDA’s general and plastic surgery devices panel is holding the two-day public forum to hear from researchers, advocates, patients and the industry about the implants, which have been available for decades.

While the panel took no formal votes, its members were to consider further steps for the agency to take in exploring the growing scientific evidence about both breast implant-associated lymphoma and a constellation of debilitating symptoms generally referred to as breast implant illness.

The panel’s experts repeatedly expressed frustration and astonishment at the dearth of good data on implants and the failure of breast-implant makers to complete promised studies or follow patients for long enough to collect meaningful data.

“We have a surprisingly limited amount of clear and consistent data given the number of years and the number of women involved,” said Natalie Compagni Portis, a patient representative on the panel.

“I feel like we failed women with regard to implants,” Portis said. “We failed to inform, we failed to follow, and we failed to listen.”

At the meeting, one woman after another who said she became ill from the implants testified that plastic surgeons had reassured the women the implants were safe and had described only the routine risks associated with any surgery. Some said they did not receive informational pamphlets from manufacturers that gave a more detailed accounting of the risks.

“We do not feel we have been effectively and appropriately informed,” said Holly Davis, of Charleston, South Carolina, who got implants after a mastectomy.

She said she developed memory problems and asked to be tested for Alzheimer’s disease. Now that the implants have been removed, her memory is coming back. “The pamphlets manufacturers are giving to plastic surgeons are not making it to us,” she said. “Don’t ignore us,” Davis pleaded with the panel. “We are real.”

Christine Avila, of San Jose, California, got implants for reconstruction after a mastectomy six years ago when she was 38. She said she felt pushed into doing so during “a time of intense shock and vulnerability,” and did not realize that complications from the surgery could require repeat operations and interfere with her cancer treatment.

“Women like me who would rather be alive than have something that looks like boobs need to have this information,” she said.

But another breast cancer patient, Marie Jobson, 50, of San Jose, California, said reconstruction was an integral part of her recovery after a double mastectomy in 2013, and she implored the committee to make sure the option of implants would be available to future patients.

“This medical device has allowed me to live in the present moment, in the now, whether it’s wearing a bikini or having intimacy with my husband,” Jobson said.

Though silicone has long been regarded as inert, that idea was disputed by Dr. Jan Willem Cohen Tervaert, from the University of Alberta. He said silicone affects the immune system, and can set off a series of reactions that can lead to the pain and fatigue that many women have reported. Silicone can leak out of implants, even ones that have not ruptured, and he described two patients in whom silicone had been found in other parts of the body, including the brain.

He said women with allergies or a personal or family history of autoimmune diseases seemed to have an increased risk of becoming ill from breast implants and should be warned about it if they were considering the surgery.

Other speakers suggested that lymphoma, and possibly other problems associated with implants, might occur in some patients as a result of a chronic infection caused by bacterial contamination of the implant at the time of surgery. Some researchers suspect textured implants, with more crevices and surface area, can foster the growth of bacteria.

The expert panelists debated whether to restrict the use of textured implants, which have been more closely linked to the risk of lymphoma than smooth implants, but which also offer certain surgical advantages.

But only a minority of the panelists seemed to favor banning them. The panel expressed interest in identifying what specific personal and family medical histories may make women more vulnerable to becoming ill after receiving implants.

Many of the patients at the meeting wore two ribbons pinned to their lapels, one with pink and green stripes to express solidarity with those who have implant-associated lymphoma, and a second black-and-white ribbon for those suffering from less clearly defined implant illnesses.

Last week, the FDA issued warnings to two manufacturers in the United States, criticizing them for not conducting adequate follow-up studies of women who had undergone surgery to have breast implants.

Two national registries, recently created, may fill in some of the gaps. One will follow patients with implant-related lymphoma, and the other will capture as much information as possible about all patients receiving breast implants. Panel members discussed what data the comprehensive registry needed, and settled on details about the patients’ health and risk factors before receiving implants, how they fared later and what type of implants they received. About 400,000 women in the United States get breast implants every year, including 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer. Worldwide, about 10 million women have breast implants.