Female permanent contraception is among the most widely used contraceptive methods worldwide. In the United States, more than 640,000 procedures are performed each year and it is used by 25% of women who use contraception.1–4 Female permanent contraception is achieved via salpingectomy, tubal interruption, or hysteroscopic techniques.
Essure, the only currently available hysteroscopic permanent contraception device, approved by the US Food and Drug Administration (FDA) in 2002,5,6 has been implanted in more than 750,000 women worldwide.7 Essure was developed by Conceptus Inc, a small medical device company that was acquired by Bayer in 2013. The greatest uptake has been in the United States, which accounts for approximately 80% of procedures worldwide.7,8
Essure placement involves insertion of a nickel-titanium alloy coil with a stainless-steel inner coil, polyethylene terephthalate fibers, platinum marker bands, and silver-tin solder.9 The insert is approximately 4 cm in length and expands to 2 mm in diameter once deployed.9
Potential advantages of a hysteroscopic approach are that intra-abdominal surgery can be avoided and the procedure can be performed in an office without the need for general anesthesia.7 Due to these potential benefits, hysteroscopic permanent contraception with Essure underwent expedited review and received FDA approval without any comparative trials.1,5,10 However, there also are disadvantages: the method is not always successfully placed on first attempt and it is not immediately effective. Successful placement rates range between 60% and 98%, most commonly around 90%.11–15 Additionally, if placement is successful, alternative contraception must be used until a confirmatory radiologic test is performed at least 3 months after the procedure.9,11 Initially, hysterosalpingography was required to demonstrate a satisfactory insert location and successful tubal occlusion.11,16 Compliance with this testing is variable, ranging in studies from 13% to 71%.11 As of 2015, transvaginal ultrasonography showing insert retention and location has been approved as an alternative confirmatory method.9,11,16,17 Evidence suggests that the less invasive ultrasound option increases follow-up rates; while limited, one study noted an increase in follow-up rates from 77.5% for hysterosalpingogram to 88% (P = .008) for transvaginal ultrasound.18
Recent concerns about potential medical and safety issues have impacted approval status and marketing of hysteroscopic permanent contraception worldwide. In response to safety concerns, the FDA added a boxed safety warning and patient decision checklist in 2016.19 Bayer withdrew the device from all markets outside of the United States as of May 2017.20–22 In April 2018, the FDA restricted Essure sales in the United States only to providers and facilities who utilized an FDA-approved checklist to ensure the device met standards for safety and effectiveness.19 Most recently, Bayer announced that Essure would no longer be sold or distributed in the United States after December 31, 2018 (See “FDA Press Release”).23
FDA press release (July 20, 2018)
"The US Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018... The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use. For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device."
Reference
"The US Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018... The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use. For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device."
Reference
- Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed [press release]. Silver Spring, MD; U.S. Food and Drug Administration. July 20, 2018.
So how did we get here? How did the promise of a “less invasive” approach for female permanent contraception get off course?
A search of the Manufacturer and User Facility Device Experience (MAUDE) database from Essure’s approval date in 2002 to December 2017 revealed 26,773 medical device reports, with more than 90% of those received in 2017 related to device removal.19 As more complications and complaints have been reported, the lack of comparative data has presented a problem for understanding the relative risk of the procedure as compared with laparoscopic techniques. Additionally, the approval studies lacked information about what happened to women who had an unsuccessful attempted hysteroscopic procedure. Without robust data sets or large trials, early research used evidence-based Markov modeling; findings suggested that hysteroscopic permanent contraception resulted in fewer women achieving successful permanent contraception and that the hysteroscopic procedure was not as effective as laparoscopic occlusion procedures with “typical” use.24,25
Over the past year, more clinical data have been published comparing hysteroscopic with laparoscopic permanent contraception procedures. In this article, we evaluate this information to help us better understand the relative efficacy and safety of the different permanent contraception methods and review recent articles describing removal techniques to further assist clinicians and patients considering such procedures.