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US FDA proposes warning label for breast implant products

The U.S. Food and Drug Administration has proposed that manufacturers put warning labels on breast implant products to better inform patients of the risks associated with their use.

Risks stated on the boxed warning label should include that implants are not considered lifetime medical devices, risk of complication increases over time, and that breast implants have been associated with breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, according to the guidance. Along with the labeling recommendations, the agency also proposed that a checklist outlining risks associated with breast implants be provided to patients.

If finalized, the guidance will not be legally binding on manufacturers, according to the agency. The draft was released Oct. 23 and will be in a public comment period through Dec. 23.

Certain breast implant products have been connected to BIA-ALCL, a form of the immune system cancer non-Hodgkin's lymphoma. The cancer tends to be located in scar tissue and fluid around the implant but can spread across the entire body, according to the FDA.

"An individual's risk of developing [anaplastic large cell lymphoma] is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly," the agency said in its Oct. 23 draft guidance.

The FDA was cautious about connecting a separate health risk that it called "breast implant illness" to use of certain products in the draft guidance, saying the "exact relationship of these symptoms with breast implants is unclear at this time."

Breast implant illness refers to a set of symptoms reported to the agency that include fatigue, memory loss, rash and joint pain.

The FDA updated safety information on July 24 that showed the agency has received 573 reported cases of BIA-ALCL, including 33 patient deaths. Of the total reports, 481 were reported to have been patients who had Allergan PLC products. The FDA recommended at the time that Allergan pull certain breast implant products from the market. The company issued a worldwide recall of all Biocell breast implants and tissue expanders in response.

Health Canada banned the Allergan products from being sold in the country May 28. Allergan pulled the products from the European market in December 2018 after its regulatory approval expired.