US FDA Issues Additional Warnings On Breast Implants
Reports of cases of breast-implanted associated large cell lymphoma are on the rise, with by about 246 new reports since last year, FDA said last week.
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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.
'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.