Marie Thibault

The Essure permanent birth control device is set to receive more scrutiny. FDA recently announced that it will convene a September 24 meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to review Bayer HealthCare's Essure System.

The Essure system, which came to Bayer with its 2013 acquisition of Conceptus, consists of nickel-titanium alloy inserts that are placed in the woman's fallopian tubes using a hysteroscopic procedure. Three months after insertion, patients undergo a confirmation test to make sure that tissue ingrowth around the Essure inserts has blocked the fallopian tubes. This should cause permanent sterilization. The device received FDA approval in 2002.

Earlier this year, FDA announced that its Office of Compliance would review and investigate complaints about Essure following a citizen petition from a law office representing numerous women who alleged harm after receiving the device. 

MD+DI last reported on the Essure device in late April, noting at the time that FDA had received over 900 adverse event reports through late 2013, including pain, headache, device migration, device breakage, hemorrhage, and menstrual irregularities. At that time, FDA said it found now new safety problems on causal link between the device and the adverse events.

Now, FDA's review of Essure has been updated to include reports through May 31, 2015, and the number of complaints is up significantly, to 5093. FDA says that "the majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants."

According to FDA, frequent patient problems include "pain/abdominal pain (3353 [reports]), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936)." Frequent device problems include "patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133)."

Alarmingly, there were five fetal deaths and four adult deaths reported. FDA describes the adult death reports: "one death due to Group A Strep infection post-procedure, one death reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery and one death from suicide. Confirming whether a device actually caused a specific event can be difficult based soledly on information provided in a given report."

Along with these updates, FDA scheduled the September 24 panel to review the risks and benefits of the Essure technology.

Patient activist group "Essure Problems" cheered the news of the panel, writing on its Web site, "We feel like the FDA has really been listening to us, to our group, and is taking some steps in the right direction to address the serious complications and problems with this device."

According to an e-mailed statement from a Bayer spokesperson, “Bayer looks forward to an open and transparent discussion regarding Essure at the meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015.  Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients.

“Patient safety is Bayer’s top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.

“Bayer is strongly committed to women having access to safe and effective birth control options.  The only FDA-approved non-surgical option for women who have completed their families and want permanent contraception, Essure is supported by more than a decade of science and real world clinical experience.”

In a recent press release, Bayer announced that FDA had granted approval for use of transvaginal ultrasound (TVU) as an alternate confirmation test to check that Essure has caused permanent sterilization. TVU can be used in place of modified hysterosalpingogram (HSG). If confirmation cannot be made with the TVU test, an HSG must be done. 

According to the company press release, "Bayer and the FDA have agreed on the importance of a comprehensive training program for TVU which will begin in September with physicians who most frequently perform the Essure procedure. All physicians who offer Essure are expected to be trained and certified on the TVU confirmation test by mid-2016. Certification on TVU is required before a physician can offer this option to patients. Physicians should continue to use the HSG method as outlined in the Essure Instructions for Use until they have received training and certification on the use of TVU for Essure confirmation." 

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of SIXNINEPIXELS/FREEDIGITALPHOTOS.NET]