FDA aims to publish Essure safety review in February
WASHINGTON (AP) — Federal health officials aim to complete their review of a much-debated contraceptive implant by the end of February.
The Food and Drug Administration posted a brief statement online about the metallic device, Essure, which has been subject to thousands of complaints by women reporting chronic pain, bleeding and headaches.
The implant has been sold for more than a decade and is frequently pitched to women as the only non-surgical option for permanent birth control. While Essure's label warns of pain and bleeding after implantation, some women say these problems persist and can be so severe they require surgery to remove the device.
In September, the FDA convened a public meeting on the issue where dozens of women urged the agency to recall the device.