FDA Calls For More Warnings On Breast Implant Labeling
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.
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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.
'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.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.