FDA Issues Warning Letters To Breast Implant Makers Allergan And Ideal Implant
The US agency warned Allergan about failing to meet postmarket study requirements and Ideal Implant about Quality System Regulation violations.
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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 US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.
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