FDA: Some Mesh Brands May Lead To More Complications In Breast Reconstruction Patients
Patients who receive breast reconstructive surgery using some brands of acellular dermal matrix seem to have a higher risk of major complications than those whose surgeries did not use the mesh, says a safety alert from the US FDA.
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The US FDA reports the numbers on women globally who've died or been sickened by two types of breast implant illnesses.
'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.
A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.