FDA Issues New Breast Implant Guidance While Giving Another A Nip And Tuck
The US FDA gives recommendations on the labeling of breast implants in a 29 September final guidance doc. The agency also revised a separate breast implant guidance last updated in 2006 to include, among other things, information found in the new labeling guidance.
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Suggested revisions to breast implant labeling guidance from the US FDA include a boxed warning, patient decision checklist, and additional information for patients about device ingredients. The changes follow growing concerns over the safety of certain implants.
'Do Your Job': To The Dismay Of Patients, FDA Panelists On Breast Implants Advise Better Risk Warnings, Not Recalls
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.
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.