Federal health regulators plan to add new warnings to Essure
, a much-debated contraceptive implant that has been subject to thousands of complaints from women reporting chronic pain, bleeding, the device breaking into pieces inside the body and other problems.
The Food and Drug Administration says it will also require manufacturer Bayer to conduct more tests and study the risks of the metallic device for various groups of women.
Essure has been sold for more than a decade and is advertised as safe alternative to tubal ligation (commonly known as having your tubes tied). Bayer estimates 750,000 women have received the device since 2002.
Since 2013, the FDA has received thousands of reports of problems with the device. Many women have said problems including pelvic pain and bleeding were so severe they required surgery to remove the device.
Facing increasing pressure from patients and a mounting list of formal "adverse event" reports, the FDA invited patients to testify at a hearing about Essure last year. The FDA has maintained that Essure's benefits outweigh its risks, but promised after the hearing to conduct its own investigation into Essure, which led to today's announcement.