FDA requires new ‘black box warning’ label for Essure
A new ‘black box warning’ label has been made mandatory for Essure by the US Food and Drug Administration. Essure is an implantable permanent contraceptive device.
According to the FDA website, a black box warning in products’ labeling has been planned to call attention to severe and life-threatening risks.
The FDA has made an announcement on Monday after it received grievances from over 5,000 women between November 2002 and May 2015. The women complained of unplanned pregnancies, miscarriages, stillbirths and severe pain and bleeding post an Essure implantation.
In 2002, the FDA approved Essure, which is a permanent form of birth control wherein a coil is non-surgically put into the fallopian tubes of a woman. It supposedly forms scar tissue around the device, preventing sperm from coming in contact with eggs and fertilizing them, thus avoiding pregnancy.
The FDA has also asked Bayer, which makes and markets Essure, to carry out surveillance that will evaluate vulnerability of the device in a real-world environment. It said the agency will use the study findings to find out what, if any, additional actions linked to Essure are required for public health protection.
The company needs to track over 2,000 women for more than three years. The study isn’t going to be bound to women being implanted with Essure but it will compare women with Essure to women who used other sterilization methods like surgery.
As per Dr. William Maisel, FDA deputy director for science and chief scientist at the agency's Center for Devices and Radiological Health said that the FDA wants Bayer to come up with a study protocol within a month and by law the company has to start the study within 15 months. In case Bayer fails to do so, the FDA can list the device as misbranded. The company also has to submit study-based interim reports, including data and analysis.