Following reports of numerous adverse events, the FDA has issued orders restricting the sale and use of Essure birth control devices manufactured by Bayer. A non-surgical alternative to tubal ligation introduced in 2002, the device has caused complications for thousands of users of the device. These include painful intercourse, pelvic discomfort, unwanted pregnancy, and painful menstruation.
Essure is a non-surgical alternative to tubal ligation surgery. The device is inserted through the vaginal canal and cervix where it is implanted within the fallopian tubes. As scar tissue forms around the device within the fallopian tubes, this creates a permanent barrier through which sperm cannot pass.
To date, there have been more than 25,000 adverse events reported. 11,854, or slightly less than half of these were reported in 2017. Of those received in 2017, nearly 93% referenced removal of the device. This is a dangerous and complicated procedure which can cause the device to break apart and lodge pieces of the coil within the fallopian tubes, uterus, and vagina. In some cases, removal of the Essure device may require a full or partial hysterectomy. Of those who undergo a surgical removal of the device, approximately 2.5% require follow-up surgery within one year of the initial removal procedure.
FDA Restricts Sale and Use
The FDA ordered Bayer to conduct a post-market study of the efficacy and safety of the Essure device in February 2016. The agency further ordered Bayer to add additional labeling in November 2016 warning users of the known and potential risks the device posed. These included perforation of the uterus and potentially the fallopian tubes. The label change also required the company to notify patients of the potential for persistent pain and warnings that the device may migrate within the abdominal or pelvic cavity.
The new orders issued in April 2018 restrict the sale of Essure devices to health care providers and facilities who adequately inform patients of the dangers and risks associated with the device. In particular, these facilities and healthcare providers must utilize the patient’doctor acknowledgment that covers all of the known risks of using Essure as a form of permanent birth control. Once reviewed, the rules require both the patient and physician to sign the acknowledgment.