FDA puts restrictions on birth control implant but no recall
WASHINGTON - 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 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.
Patients have reported cases of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place. Those reports are submitted to the FDA by patients, physicians and the manufacturer.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information,” said