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FDA puts restrictions on birth control implant but no recall
Technology
Published in 10-4-2018
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WASHINGTON (AP) U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market. The Food and Drug Administration said only women who read and have the opportunity to sign a brochure about the risks of the device will be able to receive the implant made by Bayer. The checklist of risks must also be signed by the woman's doctor. The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device's safety.
Reference: www.chron.com