Essure is a non-hormonal, permanent birth control option for women. It is advertised as the only permanent birth control available via a non-surgical procedure. since the device became available in 2002, about 750,000 women have used it. The U.S. Food and Drug Administration (FDA) has received thousands of complaints about problems with Essure from patients and doctors. In February, 2016, the agency announced that it had issued a new mandatory clinical study of Essure and that it would require a boxed warning on the device.
What is Essure and How Does it Work?
Essure is a non-surgical alternative to tubal ligation. It is permanent birth control.
The Essure insert is a tiny coil made of a nickel-titanium alloy, stainless steel, and polyester fibers. One coil is placed in each fallopian tubes through the vagina, rather than through an incision.
The coils embed in the walls of the fallopian tubes. This causes irritation and the development of scar tissue. The scar tissue that blocks off the fallopian tube, preventing sperm from reaching the eggs. After three months, a confirmation test is used to determine if the barrier is complete.
Essure Side Effects and Complications
The FDA has received thousands of complaints about Essure and there is a large movement to have the device banned. According to the FDA, there have been four adult deaths and five fetal deaths caused by Essure. Essure side effects and complications can include:
- Allergic reaction to nickel released by the coil
- Coil that migrates through the tubes
- Migration to other organs
- Hemorrhaging
- Perforation of the fallopian tube or uterus
- Vaginal bleeding
- Severe cramping
- Heavier periods
- Vaginal discharge and infection
- Abdominal pain
- Nausea
- Vomiting
- Fainting
- Pelvic pain
- Back pain
- Painful intercourse
- Arm and leg pain
- Headaches
- Ectopic pregnancy, which can be fatal
FDA Actions
Essure was approved by the FDA on November 4, 2002. When the agency searched the Manufacturer and User Facility Device Experience database (MAUDE), it found it had received over 5,000 complaints from November 2002, to May, 2015.
In September, 2015, the FDA convened an advisory committee meeting to discuss the safety and effectiveness of Essure. Bayer admitted to having received more than 17,000 adverse event reports related to Essure, from women around the world. As a result of the hearing, the FDA ordered Bayer to conduct a postmarket surveillance study to gather more data about the benefits and risks of the device. The agency also announced that intended to require a boxed warning and Patient Decision Checklist to be added to the Essure label.
On February 29, 2016, the FDA announced that it had issued a new mandatory clinical study of Essure and that it would require a boxed warning on the device.
If you were injured by Essure or if you have questions, please email us or call us toll-free at 800-DRUG-411 (800-378-4411). We will help you find answers to your questions and we can help you find an attorney who represents Essure victims.