Executive Summary
The Essure method of permanent birth control was the subject of a September 2015 FDA panel meeting held to weigh all evidence following complaints regarding the sterilization option.
- Essure was approved by the FDA in 2002 as a permanent birth control option for women who have completed their families. The FDA says it saw a significant increase beginning in late 2013 in the number of adverse event reports related to the device.
- The American College of Obstetricians and Gynecologists submitted a letter to the FDA prior to the panel meeting and stated its support for less-invasive tubal occlusion options such as Essure. The FDA is reviewing the panel recommendations to determine the best course of action regarding the device.
The Essure method of permanent birth control (Bayer HealthCare Pharmaceuticals, Wayne, NJ) was the subject of a September 2015 meeting of the FDA Medical Devices Advisory Committee’s Obstetrics and Gynecology Devices Panel. The daylong meeting included expert scientific and clinical opinions, as well as reports from women who have used the device. The panel meeting was called to weigh all evidence following complaints regarding the sterilization option.
The Essure System was approved by the FDA in 2002 as a permanent birth control option for women who have completed their families. Originally brought to market by Conceptus of Mountain View, CA, Essure was acquired by Bayer in June 2013. According to the FDA, in late 2013, it received a significant increase in the number of adverse event reports related to Essure, particularly from patients who had received the device. The agency conducted a review of data related to the Essure System and determined that the information should be vetted and discussed in an open forum panel meeting. (All material presented at the panel meeting may be viewed at http://1.usa.gov/1Jl92dI.)
Essure represents a “high-priority issue” for the agency, says Eric Pahon, FDA press officer. “We are reviewing the panel recommendations and docket to determine the best course of action,” states Pahon. “After considering the recommendations of the advisory committee, and the public comments made at the meeting and submitted through the docket, the FDA will determine what additional actions, if any, are necessary to assure the safety and effectiveness of the device; the FDA intends to issue communications to inform the manufacturer and the public of any further actions.”
Essure is commercially available in the United States, Canada, Australia, several European countries, and several Latin/South American and Asia Pacific countries. About one million Essure systems have been distributed worldwide, according to information presented at the FDA hearing.1
The Essure System includes an implantable insert and a delivery system for the placement of the insert. In contrast to other permanent sterilization procedures, Essure inserts are placed into each fallopian tube through the cervix using a hysteroscope. Once in place, the fibers within the insert elicit a local, fibrotic reaction, which causes fibrous tissue to grow in and around the implant, thus blocking the fallopian tubes. As part of the Essure procedure, patients undergo a radiologic confirmation test via hysterosalpingography (HSG) or ultrasound three months after insert placement to ensure the proper placement and/or occlusion of the fallopian tubes. Women are advised to use alternate contraception for the first three months until the confirmation test assures tubal occlusion.
The Essure System is contra-indicated for those women who:
- are uncertain about ending fertility;
- can have only one insert placed;
- have previously undergone a tubal ligation;
- are pregnant or suspect pregnancy;
- have delivered or terminated a pregnancy less than six weeks prior to the Essure procedure;
- have an active or recent upper or lower pelvic infection;
- have a known allergy to contrast media.2
In clinical trials, 9.3% of women experienced mild to moderate pain during the insertion process. Following the insertion procedure, some of the women in clinical trials experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting (10.8%) or fainting (1.3%).3
The FDA looked at postmarket surveillance data sources to monitor the safety and effectiveness of Essure. In its review, the agency analyzed Essure patient reports of problems, including Web-based testimonials, and reports of problems submitted from other sources, including doctors, patients, and the device manufacturer.
The agency conducted a search of its Manufacturer and User Facility Device Experience (MAUDE) database. Prior to June 1, 2015, the FDA received 5,093 medical device reports related to Essure. Most reports were voluntary reports, mostly from women who received Essure implants.
The most frequently reported patient problems during this period were pain/abdominal pain (3,353), heavier menses (1,408), headache (1,383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems.
The most frequent device problems reported were patient device incompatibility (941), such as possible nickel device allergy, migration of the device or migration of a device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Multiple device problems also can be listed in each report, the FDA notes.4
Seventeen of the reports received by the FDA were coded as death reports; however, six of these reports were mistakenly coded as death, but no death occurred. Five reports involved fetal deaths that occurred in women who became pregnant following placement of Essure. The remaining six death reports were related to a total of four adult deaths:
- 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;
- one death from suicide.
Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report, the FDA states.4
What is the next step?
Bayer HealthCare Pharmaceuticals has provided Essure-trained physi-cians with communication to keep them abreast of the issues involved, says Tara DiFlumeri, a Bayer spokesperson.
“We are working closely with FDA and will keep physicians updated if there are any actions to be taken based on the panel recommendations,” she states.
The American College of Obstetricians and Gynecologists (ACOG) submitted a letter to the FDA prior to the panel meeting. In that letter, ACOG stated its support for less-invasive tubal occlusion options, such as Essure, to remain available to women.5 To improve the use of hysteroscopic tubal occlusion in the future, the society called for the FDA to take steps toward obtaining more high-quality data on its safety and efficacy.
The ACOG letter to the FDA panel prior to its meeting called upon clinicians to obtain HSG confirmation of tubal occlusion three months after the operation, notes Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta.
“I am concerned that people who perform tubal sterilization using the Essure technique may not get HSG confirmation for one of three reasons: First, the woman may not return (loss to followup),” notes Hatcher. “Second, the cost of the procedure may not have been included in the cost of the Essure placement, and this additional cost may discourage the patient or the program doing this procedure from obtaining HSG confirmation. And three, the clinician performing the placement of the Essure implants may be so secure in his or her excellence in placing the implants that he or she may deem HSG confirmation unnecessary.”
The post-marketing evaluation of the effectiveness of Essure did not include women who became pregnant prior to the three-month HSG confirmation procedure. It included analysis only of the women whose HSG procedures found both tubes to be completely occluded, notes Hatcher.
“In other words, there was no typical use failure rate including all the errors clinicians and patients may make obtaining and following up this tubal sterilization procedure,” Hatcher states.
Tubal sterilization and vasectomy represent safe, effective methods of permanent contraception. Some 15 million U.S. women rely on permanent female or male contraception, which makes it the most commonly used form of birth control.6
Essure initially was introduced to provide permanent contraception for women with contraindications or risk factors to more traditional approaches, and it still offers a viable option for women for when laparoscopy would be challenging, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. Outside of that situation, its superiority has not been established, especially its cost effectiveness, states Nelson.
“Of course, often implants, or intrauterine devices, or vasectomy can be better options,” states Nelson. “Important questions about potential nickel allergies were discussed, but not answered, by the hearing.”
REFERENCES
- Bayer HealthCare Pharmaceuticals. Essure. Obstetrics and Gynecology Devices FDA Advisory Committee. Sept. 24, 2015. Accessed at http://1.usa.gov/1WVebTA.
- Food and Drug Administration. Review of the Essure System for Hysteroscopic Sterilization. Accessed at http://1.usa.gov/1LelsX6.
- Bayer HealthCare Pharmaceuticals. Essure Safety Considerations. Accessed at http://bit.ly/1MpQ4sZ.
- Food and Drug Administration. FDA Activities. Accessed at http://1.usa.gov/1RwZ4Lq.
- American College of Obstetricians and Gynecologists. Letter to the Food and Drug Administration. Sept. 14, 2015. Accessed at http://bit.ly/1VMhMWZ.
- Roncari D, Hou MY. Female and male sterilization. In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
The Essure method of permanent birth control was the subject of a September 2015 FDA panel meeting held to weigh all evidence following complaints regarding the sterilization option.
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