The popular contraceptive device, Essure, has been removed from sale in multiple countries after thousands of women reported that the device was ineffective and caused dangerous reactions. Essure was created by Bayer Healthcare Pharmaceuticals and approved for U.S. distribution in 2002 by the FDA. However, the FDA has since issued a black box warning, their highest safety notice, after receiving more than 30,000 reports of adverse reactions such as organ perforation, device migration, and severe allergic reactions. As a result, many health administrations now consider Essure to be extremely dangerous.
International Sales Drop
In February of 2017, Brazil banned all imports, distribution, and sales of Essure birth control. Anvisa, the country’s health authority, made the announcement throughout Brazil, which caused Bayer to pull Essure from two European countries, Finland and the United Kingdom. Additionally, Canada has announced that Essure will be pulled from their markets for a decline in sales, though hundreds of Canadian women have sued Bayer after suffering adverse reactions. European Union nations also suspended sale of Essure birth control for three months during 2017 because of licensing issues. Other companies have cited similar problems.
Despite all of these complaints and health warnings, the U.S. markets continue to value Essure for its benefits over the potential hazards. The United States is the largest market for Essure and is now one of the only countries in the world to continue selling the device.
Essure was introduced as a permanent birth control device in the early 2000’s. It was extremely popular when it was initially sold because of the nonsurgical method that allowed women to enjoy the benefits of permanent birth control without having to go under anesthesia. Essure is a small metal coil that is inserted into the woman’s fallopian tubes, where it forms a blockage of scar tissue. This blockage then acts to prevent pregnancy on a permanent basis. However, the initial popularity of this device lost steam as hundreds of women complained of ineffectiveness and serious health complications.
Problems with Essure
Many women complained that Essure was ineffective at preventing pregnancy, but the majority of complaints were associated with chronic pain or serious health defects. Many issues stemmed from migration of the device, which occurred when the device was implanted in an incorrect place, or if the device moved away from the fallopian tubes and became implanted elsewhere in the body. Because of the small metal coil structure, migration of Essure can be highly dangerous, causing organ perforation, abnormal bleeding, hair loss, chronic abdominal pain, and unintended pregnancy. Many of the women who have become pregnant while using Essure report serious issues, including ectopic pregnancy and fetal death. Either of these issues can pose a serious threat to the life of both the mother and the unborn baby.
If you or someone you love was harmed by an Essure birth control device, our firm wants to help. Contact Kaiser Gornick, LLP to discuss your case with our San Francisco defective product attorneys.