When a female sterilization device called Essure arrived on the market in 2002 through Bayer, it presented women who had completed their ideal family size and were interested in permanent birth control with a new, in-office option. Unlike traditional laparoscopic tubal ligation surgery — or “tube tying” — Essure wouldn’t require anesthesia or abdominal incision and would be available even to those women at a higher risk of intraoperative and postoperative complications who couldn’t have tubal ligation surgery.
And initially, Essure’s flexible inserts, which spur the fallopian tubes to form a barrier around them, thereby preventing sperm from passing through the tubes to cause pregnancy, received high marks from patients and physicians alike. In the decade following its launch, the Food and Drug Administration (FDA) received only 152 complaints about the Essure procedure, which has been used by nearly 1 million women to date.
But by 2015, the number of complaints had risen drastically to 5,000. By 2017, that number rose to 16,000.
In 2017, the FDA selected nationwide principal investigators to lead a 36-month study to assess the post-procedural outcomes of 2,800 women who choose either Essure or a laparoscopic surgical sterilization procedure. Among these principal investigators is Dr. Nadia Gomez, assistant professor of gynecology and director of the UNLV School of Medicine’s minimally invasive gynecology division.“It’s important to find out what’s going on here,” Gomez said. “I sympathize with women that have had health issues related to Essure. We have to make sure we continue to provide alternative choices to women that may be at a higher risk of undergoing laparoscopic surgery as well. As patient advocates, physicians guide patients to make health care decisions based on individual health risks and benefits, not fear. That’s why this research is so important.”
Through the study, Gomez and other investigators hope to find an explanation for the sudden increase in women complaining of chronic pelvic pain, autoimmune-like reactions, and unwanted pregnancies associated with their Essure implants. They also hope to catalog any adverse effects related to tubal ligation surgery, which can be particularly dangerous for morbidly obese patients, patients with a history of prior surgery that may have created scar tissue, and patients with cardiac disease who can’t undergo general anesthesia. Considering that a Centers for Disease Control and Prevention survey recently found that roughly 27 percent of American women of reproductive age use female sterilization as their form of birth control, it’s critical to provide women with the information they need to make the best choices for their bodies.
Gomez, whose gynecology research has been published in the Journal of Minimally Invasive Gynecology, Journal of Gynecologic & Obstetric Investigation, and the Journal for the Society of Laparoendoscopic Surgeons, began performing the Essure procedure in her first year of residency training at Temple University Hospital in Philadelphia and has performed the procedure on a number of her patients in the Las Vegas area. She’s also performed several hundred tubal ligation procedures.
While she has not heard any complaints to date from her own patients who got the Essure procedure, Gomez noted how critical the first three-month period after placement is to the success of the device and procedure overall, as this is when barrier tissue is forming and women could still become pregnant. She also indicated that the three-month checkup after the Essure procedure takes place is essential, as this is when physicians make sure the procedure was successful at blocking the fallopian tubes.
“If all the steps of the procedure are not followed exactly by both patients and doctors, there can be problems,” Gomez said.
In 2015, the FDA required that Essure carry a black box warning to acknowledge potentially serious health risks and began requiring patients’ informed consent. While some work to get Essure taken off the market, including famous consumer advocate Erin Brockovich, Bayer officials and several doctors who are members of the American College of Obstetricians and Gynecologists argue that the vast majority of women have had a safe experience using Essure. They echo Gomez’s call for proper procedural steps by doctors and patients and believe that Essure remains an effective alternative to tubal sterilization. Her research should shine a light on whether or not that is the case.
“Evidence-based medicine is what we should support,” Gomez said. “We want what’s best for patients, and without research, we can’t give our patients the best medical options.”