Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare. The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
FDA sets date for advisory panel meeting on breast implants
The FDA announced today that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md. The meeting will discuss a range of topics concerning benefit-risk profiles of breast implants, according to the FDA. Breast implants are […]
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