Hundreds of women who needed a hysterectomy to remove Essure have filed complaints with the FDA, and now several victims are seeking justice by filing lawsuits against Bayer HealthCare and Conceptus Inc.
Essure is a sterilization device that is designed to remain in a woman’s body forever. Once implanted in her fallopian tubes, it only takes a few months before Essure is embedded in uterine tissues. It is impossible to remove the same way it was implanted. When problems occur, a hysterectomy may be the only option.
Thousands of women have been injured by Essure and hundreds have had a hysterectomy to treat complications. This surgery removes the uterus (womb) and sometimes the fallopian tubes or ovaries.
One victim, Lisa Saenz, spoke to the New York Times about her hysterectomy. She was implanted with Essure in October 2008 and suffered through six years of debilitating problems like painful intercourse, chronic fatigue, and severe menstrual bleeding that could last 15 days:
“Ms. Saenz finally had a hysterectomy last year, and after her uterus was removed, the surgeon and pathologist told her that an Essure coil was embedded in the organ and that scar tissue had grown all around it.”
FDA Investigates Essure Hysterectomy Reports
In September 2015, the FDA released a report (PDF) on Essure side effects, including 265 reports of women who had hysterectomies.
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.”
Many case reports described chronic pain that resolved “immediately” or within a few weeks of removing Essure. However, outcomes were not always positive — at least one woman died of a pulmonary embolism (blood clot in the lungs) after her hysterectomy, according to the FDA.
Over 600,000 hysterectomies are performed every year, and most women do not suffer long-term complications. Infections occur in 4-10% of women undergoing vaginal hysterectomy and 6-25% of women having an abdominal hysterectomy. Other problems involve anesthesia (nerve damage, hypersensitivity, etc.), blood loss requiring a transfusion, lacerated bowel or bladder, blood clots, hematoma, and even death.
The recovery time after a hysterectomy depends on the type of surgery:
- Abdominal hysterectomies: Patients go home 2-3 days after the procedure but it can take 6-8 weeks to fully heal.
- Vaginal or laparoscopic assisted vaginal hysterectomy (LAVH): Patients go home the same day or the next. Recovery can be as short as two weeks.
- Laparoscopic supracervical hysterectomy (LSH): Recovery time varies between 6-14 days.