Intended for healthcare professionals


Breast implants: US regulator issues “black box” warning and requires more patient information

BMJ 2021; 375 doi: (Published 29 October 2021) Cite this as: BMJ 2021;375:n2639
  1. Janice Hopkins Tanne
  1. New York

The US Food and Drug Administration has placed a black box warning—its highest level of caution—on breast implant packaging, and it now requires manufacturers and surgeons to use a checklist to ensure that patients make informed decisions about using the devices.1

US doctors do about 400 000 implant operations every year, about three quarters for cosmetic reasons and the others for reconstruction after surgery to prevent or treat breast cancer. Breast implants marketed in the US are filled either with saline or with silicone gel with an outer silicone shell, which may be textured or smooth.

For several years women with breast implants have complained of a range of problems such as “brain fog,” fatigue, …

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