By Andrew Emett
Due to the health risks associated with the Essure birth control device, the U.S. Food and Drug Administration (FDA) recently issued an order restricting the sale and distribution of the device. Despite the fact that Bayer has announced discontinuing sales of Essure across the world, the U.S. remains the only country where the device is marketed and sold.
On April 9, the FDA ordered changes to the Premarket Approval (PMA) of Bayer’s Essure sterilization procedure, requiring doctors and patients to sign off on a checklist of potential health problems, to ensure that the patient is fully informed about the risks. Although there has been an approximately 70 percent decline in sales of Essure in the U.S. within the past few years, the FDA has determined that some women still are not receiving information about the known risks of Essure before implantation.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb. “We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Inserted into the fallopian tubes via catheterization, the Essure implant is intended to be a permanent birth control device that prevents conception by building a layer of scar tissue around the implant. Major complications associated with Essure include pain, hemorrhages, severe cramping, blood clots, infection, unintended pregnancy, migration of device, and device breakage.
Besides migrating to other parts of the body and causing organ perforation, Essure devices can also lead to other adverse effects, including excessive bleeding, pelvic pain, ectopic pregnancy, and an allergic reaction to nickel in the coiled implant. Complications with Essure devices have resulted in hysterectomies, salpingectomies, and death.
“Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure.”
According to Gottlieb, the FDA received nearly 12,000 adverse event reports related to Essure last year with the majority of the reports sent in the last quarter of 2017. More than 90 percent of the reports last year mentioned issues involving potential device removal, which the FDA is further investigating.
The FDA is currently waiting for Bayer to finish a safety study involving thousands of women and designed to examine the hazardous side effects of Essure coils. Although the FDA has seen an increase in the total number of enrolled patients over the past six months, the study is not scheduled for completion until 2023.