Essure Background Information
Essure is a permanent birth control method for women that was approved by the FDA in 2002. By the end of 2015 the FDA had received nearly 10,000 complaints from patients and doctors that the device caused serious side effects.
In 2016 the FDA required Essure to add a black box warning to the Essure labeling. This label warned users of the risks of perforation, abdominal pain, allergy, and other potential complications.
After this black box warning the number of lawsuits began to rise rapidly. Bayer stopped distributing Essure in the United States on December 31st, 2018, but cites commercial reasons and not safety issues. There are currently more than 16,000 lawsuits filed.
Short-term risks as reported in clinical trials include:
- Mild to moderate pain during and immediately following the Essure placement procedure.
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks as reported in clinical trials include:
- Abdominal, pelvic, or back pain
- Perforation of the uterus or fallopian tubes
- Allergy or hypersensitivity reactions
- Essure inserts unexpectedly moved to the abdominal or pelvic cavity
It is important for women considering Essure to know that based on clinical studies, approximately 8 percent of women who undergo attempts at Essure placement are not able to rely on the device to prevent pregnancy.FIND OUT MORE
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