jueves, 24 de octubre de 2019

FDA wants stronger warning on breast implants about risks

Morning Rounds
Shraddha Chakradhar

FDA wants stronger warning on breast implants about risks

The FDA wants women getting breast implants to receive stronger warnings and more details about the risks and complications associated with the procedure. The agency issued a draft guidance document calling on breast implant makers to include a boxed warning as well as a checklist that patients can use to better understand the risks, including pain and scarring. The FDA is also recommending that labels include information about what’s in the implants. The new guidance comes after reports in recent months linking certain kinds of implants with illnesses in women with the products. In July, the FDA asked Allergan to recall a type of its textured breast implants after several hundred women who received the implants developed a rare type of lymphoma. The guidance is now subject to a 60-day public comment period before being finalized. 

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