Repeat Procedure Risk Increased With Essure Contraceptive

Nancy A. Melville

January 16, 2019

Patients who underwent sterilization with the now-discontinued Essure (Bayer AG) permanent contraceptive device are significantly more likely to need additional tubal resection or ligation compared with those receiving conventional laparoscopic sterilization, new research indicates.

However, the risk is limited to the first few years after implantation, according to this study, which examined 7-year outcomes with the device.

But beyond 7 years, it's not known what the risks are.

"For the hundreds of thousands of women with the Essure device already implanted, continuous monitoring of the long-term outcomes after hysteroscopic sterilization is crucial given the limited evidence of the risks of the device beyond 7 years," say Jialin Mao, MD, of the Department of Healthcare Policy and Research, Weill Cornell Medical College, New York City, and colleagues in their article published online January 8 in Obstetrics & Gynecology.

Experts commenting on the study in an accompanying podcast, however, noted that the overall risk of needing a repeat operation with the device is relatively small.

"One of the important findings here is although the risk is elevated for a secondary procedure compared to laparoscopic sterilization, the actual risk is very low," explained Nancy C. Chescheir, MD, of the Division of Maternal-Fetal Medicine at the University of North Carolina in Chapel Hill.

"More than 95% of women with either procedure do not get a second procedure done," said Chescheir, who is also editor-in-chief of Obstetrics & Gynecology. "I think it's always important for us to compare things but also to keep in mind what the absolute risks are, which are quite minimal here."

Long-Term Data Needed on Hysteroscopic Sterilization With Essure

Essure, or hysteroscopic sterilization, was marketed as the only nonsurgical form of permanent birth control in the United States, but has been associated with various adverse events — ranging from persistent pain to perforation of the uterus and migration of the implant's coils to the pelvis or abdomen — which has led to several lawsuits.

In April 2018, the US Food and Drug Administration (FDA) announced restrictions on the sales and distribution of Essure, as reported by Medscape Medical News.

And in July, Bayer announced that it would discontinue sales of Essure in the United States at the end of 2018 because of declining sales. Sales of the device were halted outside the United States in the fall of 2017.

But with more than 750,000 patients having received the device since its approval in 2002, as estimated by Bayer, data on Essure's longer term safety is still needed.

For the current study, Mao and colleagues evaluated data from the New York State Department of Health Statewide Planning and Research Cooperative System, identifying 10,143 women who received hysteroscopic sterilization with Essure.

Those women were compared with 53,206 women who underwent conventional laparoscopic sterilization from 2005 to 2016. The database notably includes all ages, all types of payers, and patient and treatment information for every hospital discharge, surgery, and emergency department visit in New York.

Overall Risk of Repeat Procedure Low, Highest With Essure in First Year

In a propensity score-matched cohort of 10,109 pairs of women undergoing sterilization, the authors found that the estimated risk of undergoing an additional tubal ligation or resection within 7 years was significantly higher after hysteroscopic sterilization with Essure than with laparoscopic sterilization (3.9% vs 1.6%, hazard ratio [HR], 2.89).

In the entire cohort, 438 (4.3%) of 10,143 women undergoing hysteroscopic sterilization and 1241 (2.3%) of 53,206 patients undergoing conventional laparoscopic sterilization required at least one subsequent procedure in the 7 years following the first operation.

The difference was most pronounced within the initial year after attempted sterilization (1.5% of those receiving Essure needed a repeat procedure vs 0.2% of those undergoing conventional sterilization; HR, 6.39).

And there were no significant differences in the risk of subsequent hysterectomy between those receiving hysteroscopic or laparoscopic sterilization (0.9% vs 1.2%; HR, 0.73).

And although concerns have also been raised regarding a potentially harmful systemic effect of exposure to nickel in the Essure device, the results showed no increase in cancer between the two groups of women.

"We found no differences in gynecologic or nongynecologic cancers," Mao specified in the podcast.

Bayer Plans Continued Support After Discontinuation

The Essure device, a small, flexible metal coil, is implanted into each fallopian tube through the cervix and uterus, prompting the formation of scar tissue that permanently seals each tube within 3 months.

Despite the FDA's patient safety actions, Bayer maintains that the phasing out of sales is voluntary and not indicative of the safety issues. The company says it is "working closely with the FDA and [has] planned a slow wind-down process to ensure patients and providers are appropriately supported," according to a CNN report.

From 2002 through 2017, the most frequent patient problems associated with Essure reported to the FDA were pain/abdominal pain (n = 21,215 cases), heavier menses/menstrual irregularities (9846), headache (7231), fatigue (5842), and weight fluctuations (4970).

In December, the agency approved a new protocol for a post-marketing study of Essure, which will now monitor women implanted with the device for 5 years, up from 3 years previously.

Wondering if the device has had a fair rap, John R. Fischer, MD, chair of the Department of Obstetrics, Gynecology and Women's Health at the University of Minnesota, Minneapolis, who moderates the Obstetrics & Gynecology podcast, reiterated the relatively low percentage of repeat procedures observed in the current study, asking Mao if she thinks the [poor] reputation Essure has received is deserved.

"It doesn't seem to be," he noted. "There are issues with every procedure we do."

Mao responded that the key concern should be keeping patients informed.

"For me, the issue is the patient should know what the risks are before they undergo the surgery," she said.

"[In deciding] whether it's a tolerable risk, they should be able to know before they make a decision, and that's what we aim to do — to put the evidence out there for patients and physicians.”

Mao added that, with the potential for developments beyond 7 years, research should continue to track those patients who already have the device.

"There are reports of interventions as far as 10 years out, so we should be looking at things in addition to tubal intervention, and since cancer can take a really long time to develop, we want to continue to look at that as well," she concluded.

The study was supported in part by the FDA. Coauthor Maryam Guiahi's was supported by a Society of Family Planning Junior Investigator Career grant. The authors have reported no relevant financial relationships.

Obstet Gynecol. Published online January 8, 2019. Abstract

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