CHAPTER 148 Insertion of Essure (Hysteroscopically Assisted Female Sterilization)

Stephen A. Grochmal, Lydia A. Watson, Dale A. Patterson

Female tubal sterilization remains the most widely utilized method of permanent contraception worldwide. Approximately 700,000 female sterilizations are performed annually, and about of half of these are completed within 48 hours post partum. The remaining 345,000 sterilizations are “interval” procedures, meaning they do not occur immediately following pregnancy. Until recently, the majority of interval sterilization procedures in the United States were performed laparoscopically, under general anesthesia or intravenous (IV) conscious sedation, in either the hospital or an out-patient surgery setting. Although the laparoscopic approach is considered safe and effective, it is not without complications, including infection, anesthesia complications, vascular damage, failure, and injury to internal organs; and occasionally, as a result of a failed laparoscopic attempt, an unintended laparotomy may occur. Annually, an average of 14 women die in the United States from complications of tubal ligation surgery, and there is a reported 1/200 failure rate. Sterilization rates have remained the same for men and women over the past 45 years; however, the types of surgical procedures utilized have changed, influenced by improvements in medical device technologies and anesthesia.

Historically, the concept of hysteroscopic or transcervical occlusion of the fallopian tubes (using electrocoagulation) was first described by Schroeder in 1927. Unfortunately, there was sporadic interest in this hysteroscopic “scarless” tubal ligation procedure and further progress to find an acceptable method was plagued by numerous attempts and failures. An innovative technology was approved by the Food and Drug Administration (FDA) in November 2002 as the first hysteroscopic tubal occlusion device for permanent female sterilization in the United States. Now in its third generation, the Essure (ESS305, Conceptus, Inc., Mountain View, CA) is a less invasive, incisionless alternative to tubal ligation that provides significant advantages, such as decreased morbidity, rapid patient recovery, ability to detect failures, decreased expense, and a high level of patient satisfaction, when compared to tubal ligation.

Transcervical sterilization lends itself nicely to the office setting because it can be performed with little to no anesthesia or sedation in a standard gynecologic examination room. Patients describe only minimal postoperative discomfort and have a high tolerance for the procedure. A recent survey reported that more than 97% of patients who underwent the procedure would recommend it to a friend. Now, more than 8 years after its introduction, transcervical hysteroscopic sterilization (Essure) has proven to be an enduring technology, making hysteroscopic tubal occlusion increasingly popular as the option of choice for permanent interval female sterilization.

An investigation of the trends in female sterilization between January 1, 2002, and December 31, 2007, at the Detroit Medical Center, Michigan, revealed a significant decrease in the percentage of interval laparoscopic sterilizations and postpartum tubal ligations performed after vaginal delivery. Of the interval sterilizations performed, the percentage of hysteroscopic sterilizations (Essure) increased significantly from 0% to 51.3% of all procedures performed. Although not indicative of a universal shift in trends across the United States, this study suggests that a minimally invasive, incisionless procedure is an appealing alternative choice for many patients.

The transcervical hysteroscopic sterilization procedure (Essure) entails one office visit, followed by a postprocedure low-pressure hysterosalpingogram (HSG) 3 months later. (See sample Essure confirmation test checklist online at www.expertconsult.com.) The placement of the Essure microinserts can be accomplished in about 9 minutes with a 97% to 99% successful bilateral placement rate with little to no patient discomfort and downtime.

If the physician is proficient with basic diagnostic office hysteroscopy, then performing the Essure procedure (after attending a certified device user course) would be a logical “next step” office procedure. Presently, many gynecologists and a few primary care physicians perform hysteroscopic sterilizations. Increased awareness and available training for hysteroscopic sterilization for “seasoned” practitioners or recent residency graduates will increase the popularity and availability of this permanent contraception option to patients.

A second method of transcervical sterilization has also become available. In July 2009, the Adiana Permanent Contraception System (Hologic, Inc., Bedford, MA) received FDA approval in the United States. Under hysteroscopic guidance, a catheter is introduced into the tubal ostium. Once correct placement inside the intramural portion of the fallopian tube is confirmed, a radiofrequency (RF) energy burst lasting for 1 minute produces a 5-mm lesion within the fallopian tube. Following this thermal injury, a 3.5-mm silicone matrix “plug” is deployed into this thermal lesion. During the next several weeks after the procedure, tubal occlusion occurs from in-growth of fibroblasts within the matrix, which acts like a permanent scaffolding permitting a “space-filling” effect to develop. Like the Essure procedure, confirmed tubal occlusion must be assessed by hysterosalpingogram in 3 months after the device has been placed.

Presently, experience with the Adiana system in the United States is limited. The cumulative available worldwide data cover up to 3 years; however, the data from the pivotal trial provide important clinical information. Additional information for the reader can be found at the end of this chapter. Although appropriate to highlight new, emerging technologies and treatment options, our discussion in this chapter will focus only on the Essure procedure.

Anatomy

The anatomy relevant to Essure placement is identical to that described in Chapter 140, Hysteroscopy.

Indication

Hysteroscopic sterilization is indicated for any woman who desires permanent elective sterilization.

Equipment and Supplies

• Materials for a paracervical block (see Chapter 173, Paracervical Block)

• Powered examination table

• The standard hysteroscopic equipment already available in the physician’s office (see Chapter 140, Hysteroscopy)

The third generation Essure system (ESS305) consists of two Essure microinserts (Fig. 148-1) (one insert per disposable delivery catheter) and two disposable introducers (Fig. 148-2). A standard hysteroscope with a 5 French operating channel, preferably with continuous flow and an angle of view between 12 and 30 degrees is required equipment necessary for this procedure. The only uterine distention medium recommended for hysteroscopic sterilization is normal saline using a gravity flow system (see Chapter 140, Hysteroscopy).

Figure 148-1 Essure microinsert.

(Courtesy of Conceptus, Inc., Mountain View, CA.)

Figure 148-2 Delivery system.

(Redrawn from images courtesy of Conceptus, Inc., Mountain View, CA.)

The Essure microinsert (see Fig. 148-1) consists of two coils composed of a flexible stainless steel inner coil and an outer coil made of nickel-titanium alloy (nitinol) and polyethylene terephthalate (PET) fibers. The insert measures 3.85 cm in length and 0.8 mm in diameter in the “wound down” or contracted configuration. The microinserts do not contain or release hormones. Once inserted, the PET fibers stimulate a local, benign tissue growth that surrounds and infiltrates the device over the course of several weeks, leading to occlusion of the tubal lumen.

The disposable delivery device handle contains a delivery wire, release catheter, and delivery catheter housing the microinsert. An ergonomic, single-use handle provides effortless control of the microinsert deployment via a button-thumbwheel combination built in to the handle (see Fig. 148-2). The valved, DryFlow introducer permits passage of the Essure introducer catheter into the operating channel without any valve manipulation on the hysteroscope, thus preventing backflow of fluid. The ESS305 has a new gold band where the notch used to be on the previous version, making it easier to visualize and correctly place the device into the tubal ostia. The release catheter has a contrasting green color to improve visibility. Also, the device has an automatic release mechanism on the handle that eliminates the need, as was required with the previous generation, for counterclockwise rotations to disconnect the introducer catheter from the actual implanted insert (Fig. 148-3).