The Food and Drug Administration (FDA) announced last week a series of steps meant to address long-standing concerns about breast implants. These include new labeling with a boxed warning about risks, a patient decision checklist and updated silicone gel-filled breast implant rupture screening recommendations.
These actions follow years of efforts by patient advocates and journalists to make public information about risks associated with breast implants, including a rare form of cancer of the immune system.
Laurie McGinley of the Washington Post offered a broad overview of the issue in her 2019 story about an earlier step the FDA took that helped pave the way for last week’s announcement. The FDA in 2019 issued a draft guidance document that offered recommendations for makers of breast implants about addressing potential risks. In 2020, the FDA issued a final version of this guidance document, a tool the FDA often uses to tell companies what it expects of them in terms of manufacturing, testing and promoting their products.
Last week, the FDA leveraged its authority over the regulation of medical devices to ensure that doctors discuss risks associated with breast implants with patients seeking them.