The Essure contraceptive device has injured thousands of women since it was approved by the FDA in 2001. Over 15,000 adverse events have been reported through the FDA reporting process. It is estimated that fewer than one in ten injuries by drug or medical devices are reported to the FDA. So, it is likely that over 100,000 women have been injured by the Essure Device. FDA reported injuries include perforations of the fallopian tubes, pain, heavy bleeding, fatigue, hair loss and even death.
At an FDA doctors panel meeting on September 24, 2015 doctors sharply questioned Bayer, the manufacturer of the Essure Device about the company’s failure to properly test the device. There was compelling testimony before the advisory panel from Gabriella Avina who had taken part in the original clinical trials who testified about how her health deteriorated after she had the device implanted. Ms. Avina had worked for Bayer promoting the device to other women. She testified at the hearing that she was wrong about the safety of the Essure device.
Bayer was also criticized about failing to follow up on the adverse events that have been reported to them and to the FDA.
The FDA is following up on this looming public health disaster.
November 2016 Update:
FDA a Toothless Tiger-Essure Birth Control Guidelines Unenforceable and Non-Binding
In what has become commonplace in the world of regulatory affairs, the FDA has issued guidelines concerning a controversial birth control device that are non-binding on the manufacturer (Bayer) and unenforceable. The useless guidelines have come under withering criticism from consumer safety advocates and women who’ve been injured by the dangerous device.