FDA Targets Dangerous Contraceptive Device

The Food and Drug Administration (FDA) has cracked down on Bayer’s controversial birth control device, Essure, after repeated reports of the device migrating or causing other significant side effects. Though the FDA initially approved the device in 2002, the government agency is now requiring Bayer to conduct further safety tests.

Marketed as a safe alternative to hormonal therapy, Essure is designed to be implanted in the fallopian tubes, where it causes scar tissue to develop, limiting the ability of an egg to be fertilized and travel to the uterus for implantation. Essure was not on the market long before reports of side effects, including:

• Device migration resulting in inflammation in other areas
• Abdominal pain
• Bleeding
• Ectopic pregnancies

Unlike many contraceptive devices, removing Essure was problematic, requiring hysterectomies in many cases. Many women sought out Essure as a non-hormonal solution, only to be faced with the prospect of long-term hormone therapy following hysterectomy.

In July of 2018, Bayer announced plans to discontinue the device as of December 31st of the same year, citing diminishing sales while insisting the safety profile of the device was not a factor. Yet the announcement came after the FDA issued a special requirement that Bayer demonstrate the safety of the device due to the significant side effects being reported.

Advocates of removing Essure from the market consider Bayer’s announcement a victory, and the result of years of work lobbying congress and the FDA to intervene to prevent other women from suffering as a result of the device. If you suffered significant side effects due to Essure, it may be reassuring to know that other women will not have to suffer now that the device is being discontinued. But it is not too late to hold Bayer accountable for the damage done to you by their dangerous device. Please consult with an experienced attorney regarding your case.