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Fda Committed To Studying Breast Implant Safety - Latest News


FDA warns two breast implant makers for failure to comply with post-approval study requirements

We expect these manufacturers to meet the pre-specified study requirements in order ... enhance our understanding of the long term safety and risks associated with breast implants. The FDA remains ... read more

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug ... safety of medical devices and protect patients.” The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s ... read more

US FDA issues warning letters to breast implant mfrs, Mentor Worldwide & Sientra for failure to comply with post-approval study requirements

The US Food and Drug ... the safety of medical devices and protect patients.” The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s ... read more

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Statement from Binita Ashar, M.D., of the FDA's Center for Devices and Radiological Health on agency's commitment to studying breast implant safety

SILVER SPRING, Md., Sept. 14, 2018 /PRNewswire/ -- Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo ... read more


FDA revisits breast implant safety debate

U.S. medical authorities are revisiting the safety ... and FDA regulators. But earlier this month the FDA appeared to signal a shift in its thinking. The agency said it would begin studying whether ... read more

FDA reviews breast implant safety as women raise concerns

Nearly 700 cases have been reported worldwide, and most involved textured implants. Canada and the Netherlands are suspending sales of textured implants, and France has banned them. An FDA advisory ... read more

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

We expect these manufacturers to meet the pre-specified study requirements in order ... enhance our understanding of the long term safety and risks associated with breast implants. The FDA remains ... read more

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant ... of the Medical Device ... read more



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