- Bayer's permanent birth control system Essure now carries a black box warning cautioning users of heightened risks and complications associated with the device.
- The Food and Drug Administration decided on the changes to the product's label back in February, but had asked for comment from stakeholders on the boxed warning and new patient decision checklist.
- Essure, which was approved in 2002, has been a lightning rod for criticism due to problems with pain and device migration. In its February decision, the FDA indicated Essure remained appropriate for many women, but presented increased risks of serious complications for some.
In addition to the new warning and patient checklist, the FDA also ordered Bayer to carry out a post-market surveillance study to assess the device's risks in a real-world environment.
Bayer will have to evaluate the rates of complications, including unplanned pregnancies, pelvic pain and surgery to remove the device.
The new patient checklist will also emphasize the importance of conducting "confirmation" tests three months after the device is implanted to ensure proper placement.
All of this will place more regulatory scrutiny on the birth control device. The FDA left room for further action too, indicating in February it would review the results of the required post-market study to determine if any further actions are needed to protect patient health.