'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.
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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.
Allergan PLC announced that it would take its Biocell textured breast implants and tissue expanders off the market worldwide shortly after the US FDA released additional information linking the use of the implants to a rare cancer.
The agency is redoubling efforts to warn women about the risks of silicone and saline breast implants after feedback from a recent advisory panel meeting. On 2 May, the regulator said it is requiring manufacturers to file individual Medical Device Reports for each adverse event regarding implants – part of a bigger effort to end its Alternative Summary Reporting Program for all devices.