WASHINGTON, D.C. (WPVI) -- A local congressman says the FDA grossly underestimated the harm caused by a contraceptive device. And he alleges the maker paid doctors kickbacks to recommend the device to ...
PHILADELPHIA (WPVI) -- The FDA slapped new restrictions on the sale of a controversial birth control device on Monday. The agency said some women aren't being properly informed of the risks of Essure ...
Federal health regulators plan to warn consumers more strongly about Essure, a contraceptive implant that has drawn thousands of complaints from women reporting chronic pain, bleeding and other health ...
Yesterday, the FDA announced that Essure, a popular sterilization implant, could have serious side effects and ordered Bayer to conduct new safety trials on the device. In addition, the FDA drafted a ...
At the request of the Food and Drug Administration, Leverkusen, Germany-based Bayer will now add a box warning and patient decision checklist to the label of its permanent birth control device Essure.
Last month, the FDA scheduled a September panel meeting to take a hard look at Bayer's controversial birth control device, Essure, after getting complaints of clinical trial fraud and serious side ...
(Reuters) - The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer AG's controversial contraceptive device, Essure, in a public panel meeting after receiving ...
FDA takes actions to help women, doctors better understand potential problems associated with Essure
The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential ...
Medical companies are responding to a new documentary that claims the health care industry’s loose regulations on medical devices are putting patients at risk. The filmmakers of “The Bleeding Edge” ...
NEW YORK, July 20 (Reuters) - Healthcare company Bayer on Friday said it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the ...
WASHINGTON -- A tiny, spring-like device threaded into the fallopian tubes seems to offer women permanent birth control without surgery and should be approved for sale, advisers to the Food and Drug ...
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