By Rebecca Bowers

EXECUTIVE SUMMARY

International pharmaceutical company Bayer has announced that it will cease U.S. sales of its Essure sterilization device as of December 2018. Although the company is halting distribution because of declining sales, the decision comes amid mounting concerns surrounding its use.

  • The company says that it will continue to stand behind Essure’s safety and efficacy, providing ongoing support services through its consumer and healthcare provider websites and its customer call center.
  • Unlike other forms of female sterilization, Essure requires no incisions, abdominal entry, or general anesthesia, and it can be implanted in office-based settings.

International pharmaceutical company Bayer has announced that it will cease U.S. sales of its Essure sterilization device as of December 2018. Although the company is halting distribution because of declining sales, the decision comes amid mounting concerns surrounding its use.

In a press statement, the company said that it will continue to stand behind Essure’s safety and efficacy, providing ongoing support services through its consumer and healthcare provider websites, Essure.com and EssureMD.com, and its customer call center, 1-888-84-BAYER.

“The health and safety of the patients who rely on our products is our top priority,” reads the statement. “Most importantly, we want to let the many women who have chosen Essure for their reproductive health know that our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure.”

Approved for use in 2002, the Essure form of permanent birth control is made up of an implantable insert and a placement delivery system. In contrast to other permanent sterilization procedures, the device involves using a hysteroscope to place inserts into the fallopian tubes through the cervix. When the device is in place, a local reaction is elicited by fibers within the insert. This reaction causes fibrous tissue to grow in and around the implant, which then blocks the fallopian tubes. Three months after placement, it is recommended that patients undergo hysterosalpingography or ultrasound to confirm proper placement of the insert and fallopian tube obstruction. Unlike other forms of female sterilization, Essure does not require incisions, abdominal entry, or general anesthesia, and the insert can be placed in a medical office setting.1

Regulatory Monitoring to Continue

In 2015, the Food and Drug Administration’s (FDA) Medical Devices Advisory Committee’s Obstetrics and Gynecology Devices Panel convened a day-long meeting to gather scientific and clinical expert opinions on Essure, in addition to reports from women who had used the device. The meeting was conducted to evaluate the evidence after complaints about the sterilization option. Following the meeting, the FDA ordered Bayer to conduct a postmarket study to evaluate Essure’s safety profile when used in the real world. Updated labeling for Essure was issued in 2016, along with a boxed warning and a patient decision checklist.

In April 2018, the agency asked for changes to the checklist, which calls for clinicians to go over the document with prospective patients to ensure their understanding of the risk and benefit information about the use of Essure. The changes called for the patient to sign an acknowledgment of risks, and for the physician responsible for device insertion to sign the checklist. Sales and distribution of the device were limited to those physicians who followed the terms of the checklist. (Contraceptive Technology Update reported on the change; see the July 2018 article, “FDA Issues Restrictions for Sterilization Option,” available at https://bit.ly/2M7m6Sg.)

According to a statement issued by FDA Commissioner Scott Gottlieb, MD, the postmarket safety of Essure will continue to be a top priority for the agency.

“The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device,” said Gottlieb in the statement.

Review Other Options

Sterilization remains the most popular contraceptive option. Results from the 2006-2010 National Survey of Family Growth show that of the 38.4 million women ages 15-44 who use contraception, 47.3% of married couples rely on sterilization (tubal occlusion, 30.2%; vasectomy, 17.1%).2 In the United States, most tubal occlusion procedures are performed during the early postpartum period. Data indicate that sterilization procedures are performed after 8-9% of all hospital deliveries.3

Sterilization using the laparoscopic approach is performed for interval and postabortal tubal occlusion procedures. Providers may perform sterilization as an outpatient procedure using electrocoagulation, mechanical devices, or tubal excision. Mechanical devices include a silicone rubber band, a spring-loaded clip, and a titanium clip lined with silicone rubber.4

Women who have completed their childbearing are candidates for sterilization. Providers who offer sterilization should be sure to provide comprehensive preoperative counseling that includes discussions about the surgical techniques, safety and effectiveness of the procedure, potential complications, and sterilization alternatives, such as long-acting reversible contraception methods and vasectomy.4 Data indicate that women younger than 30 years of age at the time of sterilization have high levels of regret after sterilization and are almost two times as likely to report regret as older women.5

REFERENCES

  1. Dhruva SS, Ross JS, Gariepy AM. Revisiting Essure — toward safe and effective sterilization. N Engl J Med 2015;373:e17.
  2. Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Rep 2012;60:1-25.
  3. Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril 2010;94:1-6.
  4. ACOG Practice bulletin no. 133: Benefits and risks of sterilization. Obstet Gynecol 2013;121(2 Pt 1):392-404.
  5. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: Findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999;93:889-895.