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Despite Cancer Concerns, FDA Refuses To Ban Textured Breast Implants

Silicone breast impalntsAmerica loves plastic surgery, with breast augmentation being the top requested cosmetic surgery in the nation; in 2016, an estimated 290,465 breast augmentation procedures were performed. While there are always risks involved with going under the knife for any reason, many women have been protesting a certain kind of textured breast implant on the grounds that it causes anaplastic large cell lymphoma (BIA-ALCL), a rare cancer that affects cells in the lymph nodes, spleen, thymus, and bone marrow. Despite concerns — and a dramatic hearing in which many women claimed they were not warned of the risks of their implants –, the FDA has refused to ban the products.

“There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL),” the FDA statement read. “While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis.”

The statement also addresses a phenomenon referred to as breast implant illness (BII), which causes a variety of uncomfortable and disorienting symptoms. Some women’s bodies simply reject their implants, causing chronic fatigue, cognitive issues, and joint and muscle pain. Others experience hair loss (the average healthy individual only sheds between 50 and 100 hairs every day) and ovarian cysts. Most functional cysts are the result of estrogen imbalances, and resolve themselves without treatment in six to eight weeks; if they rupture, the pain can become unbearable.

“While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms,” the statement said, “the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed. We believe women considering a breast implant should be aware of these risks

Although the FDA is not removing the implants in question from the market, they have outlined a new process regarding the information women have before undertaking the augmentation surgery. The agency also said it is considering requiring implants to carry what’s called a boxed warning — the agency’s strongest safety warning.

“They are not moving as far forward as we wanted, but I think they are making an effort to address our concerns,” said Jamee Cook, who had her breast implants removed in 2015 and co-founded Breast Implant Victim Advocacy.

As of September 30, the FDA had identified 457 cases of implant-related lymphoma and nine deaths worldwide. The American Society of Plastic Surgeons reported 16 disease-related deaths worldwide as of January 1. Time will tell if the FDA decides to make any major changes; considering the fact that they’ve only banned two devices in history (powdered surgeons gloves and prosthetic hair fibers), an improved warning is better than nothing.