Bayer’s permanent birth control device Essure will no longer be sold or distributed after Dec. 31, 2018, the company announced. The decision comes after a safety action by the Food in Drug Administration (FDA) in April during which the agency restricted the sale and distribution of the device. It was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance that Essure was safe and effective.
This action resulted in a 70 percent decline of Essure sales in the U.S., Bayer reported. As a result, the company decided to stop selling and distributing the device for commercial reasons.
Essure is the only FDA-approved permanent birth control device sold in the U.S. It consists of two coils that are implanted in each of the fallopian tubes. The device is intended to create a blockage the prevents the passage of an egg from the ovary. A significant number of adverse events have been reported to the FDA, including a significant number of recent reports that have mentioned issues involving surgery to remove the device.
The FDA became aware of an increase in adverse events to its database concerning Essure. The agency launched an ongoing effort to review the reports to better understand the concerns. In September 2015, the FDA convened a panel of experts to investigate patient complaints, which included abdominal pain, abnormal uterine bleeding, and device migration.
In February 2016, the FDA ordered Bayer to conduct a postmarket study to better evaluate the safety profile of the device when used in the real world. In November 2016, the agency approved an updated safety label for Essure that included a black box warning about potential Essure side effects as well as a Patient Decision Checklist.
In February 2018, FDA officials met with women who had been implanted with Essure along with patient advocates to listen to their concerns and experiences with the device. The following month, the FDA noted a rise in new medical device reports regarding Essure with more than 90 percent of the reports involving potential device removal. In order to address concerns that not every patient was receiving adequate risk information, the FDA in April restricted the sale and distribution of Essure.
Women who are currently using Essure to prevent pregnancy can continue to do so. Those with the device who suspect they may be having symptoms, such as persistent pain, should consult with their doctor about the steps they should take. “Device removal has its own risks,” the agency said. “Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them.”
Source: FDA Statement