FDA puts restrictions on birth control implant but no recall

FILE - This May 13, 2015, file photo, shows the North American headquarters of Bayer Healthcare in Whippany, N.J. U.S. health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women. But the metal implant, called Essure, will remain on the market. The Food and Drug Administration said Monday, April 9, 2018, that only women who read and sign a brochure about the risks of the device will be able to receive the implant made by manufacturer Bayer. (AP Photo/Julio Cortez, File)

WASHINGTON - U.S. health officials are placing 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 Monday that 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 new requirement comes about two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant.

Patients have reported cases of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.

The FDA ordered Bayer to conduct a follow-up study in 2016.


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