FDA Adds Boxed Warning Requirement to Essure Device
In addition, manufacturer Bayer must conduct further study of real-world risks
MONDAY, Feb. 29, 2016 (HealthDay News) -- A new boxed warning is needed on the Essure implantable birth control device, the U.S. Food and Drug Administration said in a guidance released Monday. The FDA also said Essure maker Bayer needs to conduct a study to assess the "risks of the device in a real-world environment."
"The FDA will use the results of (the Bayer) study to determine what, if any, further actions related to Essure are needed to protect public health," the agency said in a news release. In addition, the FDA wants patients and physicians to sign a checklist before the device is implanted. It would include agreeing to a test three months after Essure is implanted to assess if it is in the correct location and functioning properly, CNN reported. Patients are already advised to have a check-up three months after receiving the device, but some don't follow through.
Between November 2002 and May 2015, more than 5,000 women filed complaints with the FDA about Essure. Problems include unplanned pregnancies, stillbirths, severe pain, and bleeding, CNN reported.
In September, the FDA held a hearing about Essure and heard from women who filed complaints, health care providers and Bayer officials. There is now a 60-day comment period for the public and industry to give feedback on the guidance, CNN reported.