Bayer’s second quarterly analysis report of adverse event information includes nearly 12,000 serious injuries, 45 malfunction reports and nine deaths.
The device will no longer be available after December 31, 2018.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.
Approved by FDA, the changes include a warning and a patient checklist that explains the risks and benefits of the permanent birth control device.
In terms of risk mitigation, FDA misses the boat here.
Problems have persisted with the Essure System. What’s FDA’s next move?