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'I Was Not Warned': Patients Push FDA to Ban Cancer-Linked Breast Implants

Tracy Clark-Flory Mar 27, 2019. 16 comments

Dozens of women who say their health has been harmed by breast implants called on the Food and Drug Administration on Monday to introduce better consumer protections. These patients argued that certain implants, especially those linked to cancer, should be restricted or banned. They also called for “a beefed-up informed consent process so that women have a clear understanding of the risks and benefits of the devices before they opt for surgery,” according to the Washington Post.

The meeting, part of a two-day hearing, took place with an FDA advisory panel, which heard the individual stories of several patients who have in the wake of breast augmentation suffered either a rare lymphoma linked to implants, or autoimmune or connective-tissue disease. A theme in the patients’ testimony was the lack of awareness around the associated risks. Jamee Cook, who suffered chronic fatigue and swollen lymph nodes after getting implants two decades ago, told the panel, simply, “I was not warned.” The Post reports:

Anastasia Allmendinger, a 53-year-old resident of Newport News, Va., said that she got implants in 2010 and years later was diagnosed with the cancer, called anaplastic large cell lymphoma, or ALCL. She underwent surgery to remove the implants, chemotherapy and a stem-cell transplant, and is now doing well, but said that manufacturers should be held accountable for the illnesses and women should be better informed.

The FDA has already linked ALCL to some implants, having identified 457 cases and nine deaths in the United States. But when it comes to the alleged link to autoimmune and connective-tissue disease, “the FDA and the patient community have long been at odds,” explains the Post. “Thousands of women have complained about autoimmune and connective tissue problems on social media but the FDA has repeatedly said that the ‘weight of evidence’ does not show implants cause ‘systemic’ illness.”

Diana Zuckerman, president of the National Center for Health Research, argued that the FDA has remained “close-minded” despite recent research making a link to autoimmune disease. She told the Post, “We have always said we don’t know what the percentage is—just that for women who are sick, getting [the implants] out makes them better.”

Plastic surgeons were also in attendance, calling on the FDA “to proceed carefully,” as the Post put it, and arguing “that women’s choices should not be curtailed.”

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