F.D.A. Chooses Not to Ban Textured Breast Implant Linked to Rare Cancer in Patients

Worth the Risk? Breast Implants

Last week, the F.D.A. decided against banning a type of textured breast implants linked to cancer risk in humans. The F.D.A. did not refute the data indicating that these types of implants, usually products made by the global pharmaceutical company Allergan, have been tied to an increased risk of developing anaplastic large-cell lymphoma.

“While the F.D.A. doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed,” they explained in an official statement. Essentially, the F.D.A. concluded that the cancer risk was not high enough to justify a federal ban, passing the buck to women and health care providers to decide whether to risk acquiring a potentially fatal illness by choosing a textured implant over a smooth one. Instead, the F.D.A. simply hopes to make the risk more transparent to patients and health care providers.

ALCL is a rare type of cancer. In women with textured breast implants, the cancer cells are usually found in the fluid and scar tissue near the implant site, developing months or years after the implant surgery. According to figures cited by the New York Times, over 600 people around the world, including over 265 in the U.S., have been diagnosed with breast implant-associated ALCL. About 20 have died of ALCL (which is an especially troubling possibility for cancer survivors who receive these implants following mastectomies). NBC News estimates that the odds of developing ALCL is 1 in every 1,000 women with textured implants, a much higher risk than the F.D.A. has acknowledged. To date, no one who has smooth implants has yet been diagnosed with breast cancer-associated ALCL.

Almost 40 countries around the globe have discontinued the use of Allergan’s textured implants since the cancer link first came to light, including Canada who suspended sales in early April. Europe suspended sales of the textured implant back in December, with France issuing an outright ban earlier this year. Europe typically has stricter regulations on chemicals additives in food products and cosmetics with probable links to cancer in humans, espousing a “better safe than sorry” approach to protecting the public.

Symptoms of breast implant-associated ALCL are similar to other types of breast cancers, usually resulting in redness and swelling near the implant site as well as fluid buildup in the breast. So far, health experts have not recommended preemptive implant removal surgery; the health risks of surgery far outweigh the odds that one will develop ALCL from a textured breast implant. The implant, however, must be removed after an ALCL diagnosis.

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