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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 Spring, Md., headquarters March 25-26, took up what was many...

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More from Regulation

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
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‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
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More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
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