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'Do Your Job': To The Dismay Of Patients, FDA Panelists On Breast Implants Advise Better Risk Warnings, Not Recalls

 
• By Sue Darcey

Despite pleas from breast implant patients at a March 25-26 US FDA advisory committee meeting for the agency to take off the market silicone and saline breast implants that have initiated a serious range of symptoms in some women, the panel instead recommended FDA get out stronger public advisories warning of the risks of breast implants and a lymphoma associated with the products.

Silicone breast implant on hands - Image

Panelists at a recent US FDA advisory committee meeting offered a variety of solutions – from mandatory biopsies of every silicone or saline breast explanted, to use of breast implant recipient wallet cards, to clearer warnings – to help lower risks of documented deaths and illnesses in breast implant patients.

However, none of the members of FDA’s General and Plastic Surgery Devices Advisory Committee, who met at the agency’s Silver...

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More from Regulation

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• By Brian Bossetta

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More from Policy & Regulation

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

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European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
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