Women at Breast Implant Hearing Call for Disclosure of Safety Risks
SILVER SPRING, Md. — Women with illnesses linked to breast implants challenged plastic surgeons, regulators and implant makers, saying risks of the devices have not been fully disclosed, at an emotionally charged meeting on Monday before a panel of experts advising the Food and Drug Administration.
The women called for more information to be disclosed at the time patients are considering breast implant surgery. They included the release of details about the materials in implants and a “black box”warning — a label noting heightened problems with a drug or device that can be issued by the F.D.A. Some patients and advocates also called for implants with a textured or slightly roughened surface to be taken off the market, because they have been associated with a type of lymphoma, a cancer of the immune system.
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 whatsoever.
Woman after woman said plastic surgeons had reassured them that breast implants were safe, and had described only the routine risks associated with any surgery and while not passing along informational pamphlets from manufacturers that gave a more detailed accounting of risks associated with the implants themselves.
Christine Avila, from San Jose, Calif., 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 implant 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.
The two-day meeting of the F.D.A.’s general and plastic surgery devices panel was called to respond to patient advocates’ demands for a public forum and to explore the growing scientific evidence about both breast implant-associated lymphoma and a constellation of debilitating symptoms generally referred to as breast implant illness, said Stephanie Caccomo, a spokeswoman for the F.D.A.
Four hours of public comments are built into the two-day meeting, and some 80 members of the public, including both patients and plastic surgeons, are expected to testify.
The agenda does not call for a vote or any immediate action on the part of the panel. The agency will use the deliberations and information gathered at the meeting as it considers ways to promote better consent discussions between doctors and patients, and as a guide to “what if any additional steps should be taken to improve breast implant safety,” Ms. Caccomo said.
Last week, the F.D.A. issued warnings to two manufacturers in the United States, criticizing them for not conducting adequate followup studies of women who had undergone surgery to have breast implants.
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.
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