The FDA has received hundreds of reports of women who had to get a hysterectomy to remove Essure and stop debilitating complications. At least one report involves a woman who died from a pulmonary embolism after her hysterectomy.
What is the problem?
Essure is a permanent sterilization device for women that is implanted in the fallopian tubes. It is designed to stimulate inflammation and scar-tissue growth that blocks off the fallopian tubes. After just a few weeks, Essure is permanently embedded in a woman’s body. It cannot be removed the same way it was inserted. When debilitating complications occur, often the only cure is a hysterectomy.
What is a Hysterectomy?
A hysterectomy is a surgery to remove a woman’s uterus (where a baby grows) and sometimes reproductive organs like the fallopian tubes and ovaries. With 600,000 procedures performed every year, it is the most common gynecological procedure in the United States.
Complications of a Hysterectomy
Hysterectomies can cause serious complications, including death. Complications may be linked to anesthesia (nerve damage, allergic reaction, etc.), bleeding, organ damage to the bowel or bladder, infection, blood clots, pulmonary embolism (blood clot in the lungs), hematoma, and more. The FDA has received one report of a woman who died 13 days after a hysterectomy to remove Essure.
FDA Reviews Hundreds of Essure Hysterectomy Reports
In September 2015, the FDA issued a report (PDF) on safety issues linked to Essure.
The FDA reviewed 265 reports of women who had a hysterectomy to remove Essure. In cases where the woman was suffering from chronic pain, most women improved “immediately” or within several weeks of removing Essure. According to the FDA:
“The majority of the hysterectomy removals were related to device removal due to perforation and migration issues. The device removals related to allergy / hypersensitivity symptoms were nearly evenly split between hysterectomy and non-hysterectomy removal.”
Risk-Factors for an Essure Hysterectomy
- Nickel allergy / hypersensitivity
- Migration of device outside of fallopian tubes
- Chronic Pain
- Heavy Bleeding
- Fractured device
- Perforation of fallopian tubes
- Organ damage
- Ectopic pregnancy
- And more