FDA Panel Recommends Against Approval Of Integra Mesh For Breast Reconstruction
The data supporting SurgiMend PRS ABDM isn’t enough to fully prove safety and effectiveness for that indication, the US FDA’s General and Plastic Surgery Devices Advisory Committee says.
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'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 agency allows IVD developers to use assays with different instrument systems without submitting a new 510(k), as long as they meet certain safety and efficacy criteria.
The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.