Marketed as a form of permanent birth control, Essure is reportedly used by more than 750,000 women worldwide. The drug was approved for use in the United States in 2002.
While the Essure procedure, which involves placing flexible inserts into the fallopian tubes in an effort to create a scar-tissue barrier, is offered as a less-invasive and quick surgical sterilization option, the procedure has also attracted some amount of controversy. The U.S. Food and Drug Administration has issued a number of warnings related to Essure, most recently requiring a new black box warning and additional data collection to better assess risks and benefits.
Numerous lawsuits focused on the Essure procedure have also been filed against its manufacturer, Bayer Corp., alleging issues arising due to the procedure.The product was also recently banned in Brazil, classified as a “maximum risk,” and Bayer has ceased distribution in Finland and, by Sept 2017, the U.K. due to declining sales.
In the U.S., the FDA has received nearly 15,000 reports of issues with Essure since is initial approval in 2002. In 2016, the agency requested that Bayer conduct post-market studies in an effort to gather more data about the risks and benefits associated with its use. The agency notes, however, that it “continues to believe the benefits of the device outweigh its risks.”
How the Essure Device Works
In contrast to sterilization efforts requiring surgery and anesthesia, Essure presents a less-invasive, permanent birth control option that allows a patient to return to normal activity within a couple of days. The procedure, which does not require a surgical incision, involves inserting flexible coils through the vagina and cervix and into the fallopian tubes.
Once the coils are in place — inside the tubes which carry the eggs from the ovaries to the uterus — scar tissue begins to form around the inserts. This build-up of tissue takes about three months and creates a barrier that blocks sperm from reaching the eggs.
While the barrier is forming, patients must continue to use other forms of birth control. Three months after the Essure procedure, a confirmation test is conducted to determine if the procedure was successful. Some women may need to return for another confirmation test six months after the procedure, as the process takes longer to complete for some individuals.
The inserts are not meant to be removed. If it is determined that the inserts need to be removed, surgery will be required. Surgery could include the removal of the inserts or, in more complicated cases, removal of fallopian tubes or the uterus itself.