Tag Archives: breast implants

FDA warns that breast implants are not “lifetime devices”: Tips for covering this story

About Kerry Dooley Young

Kerry Dooley Young (@kdooleyyoung) is AHCJ's core topic leader on patient safety. She has written extensively about the Food and Drug Administration, medical research, health policy and quality measurements. Her work has appeared in Medscape Medical News, Congressional Quarterly/CQ Roll Call and Bloomberg News.

Photo by Docteur Spitalier Philippe via Flickr

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 The FDA in 2019 issued a draft guidance document that offered recommendations for makers of breast implants about addressing potential risks.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.

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Controversy over breast implants spreads across Europe

About John Lister

John Lister, European web coordinator for AHCJ, has been a journalist for 35 years, specializing in reporting health policy in England. He is the author of "Health Policy Reform: Driving the Wrong Way?," a critique of market-style reforms, and "The NHS After 60: for Patients or Profits?," a critical history of the British National Health Service.

British clinics delivering cosmetic surgery were thrown into crisis by the decision last month of the French government to fund the removal of thousands of breast implants manufactured by the now-closed French company Poly Implant Prostheses (PIP). The implants were found to have used industrial grade silicone made for use in mattresses. Continue reading