What is Essure?
Essure is a hysteroscopic sterilization procedure, a type of tubal sterilization that does not require an incision. If a woman undergoes the Essure birth control procedure, a soft metal spring-like device wound with synthetic fibers is implanted in her fallopian tubes. The metal part of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil. The fibers are used to encourage the surrounding tissue to adhere to the device, ultimately creating a barrier of scar tissue intended to block sperm from reaching the eggs.
Essure Side Effects
Reports of severe complications following the Essure procedure include, and are not limited to:
- Additional surgeries, including hysterectomy to remove the device and repair internal organs
- Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain
- Chronic pelvic pain
- Fetal Death
- Life-threatening ectopic pregnancy
- Migration of the device or a device component (in some cases, the device may even ‘disappear’ in the body, becoming undetectable even through standard scanning)
- Expulsion of the device
- Perforation or tear of pelvic organs, including uterus or colon
- Severe migraines and allergic reactions to the device or device components
Complaints about Essure
From the time Essure was approved by the FDA in 2002 to December 31, 2015, the FDA has received 9,900 reports from doctors and women that the permanent birth control device has caused serious side effects, including 11 deaths, five of which were for fetal deaths that occurred in women who became pregnant after the Essure procedure. As a result, in June 2015, the FDA updated the number of adverse event reports involving the Essure system on its website, along with the system’s short- and long-term risks, as part of its review of potential Essure problems.
On Sept. 24, 2015, the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel “to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.”
After thousands of people reported complaints, the FDA announced in February 2016 that it would require Bayer to conduct a clinical study on the safety and efficacy of Essure. In October 2016, the FDA required Bayer to add a black box warning to Essure labelling. Black box warnings are the FDA’s highest level and indicate that a product may cause death or serious injury.
If you or a loved one underwent the Essure permanent birth control procedure and experienced side effects or complications as a result, please contact our attorneys at Bighorn Law and tell us your story. We’re here to listen. We want to help.