April 13, 2009

Family Planning Intervention
By Dan Harvey
For The Record
Vol. 21 No. 8 P. 28

A relatively small number of radiologists and gynecologists are offering women a sterilization alternative to tubal ligation that doesn’t involve an abdominal incision, general anesthesia, or hospitalization.

Approved by the FDA in November 2002, the Essure Micro-Insert System offers women a noninvasive and permanent form of birth control via a procedure that can be accomplished under local anesthesia in an appropriately equipped office setting.

Developed by Conceptus Inc of Mountain View, Calif., the Essure system—the first FDA-sanctioned hysteroscopic tubal sterilization technology—provides an effective alternative to laparoscopic tubal ligation without requiring an abdominal incision, general anesthesia, or hospitalization.

But the Essure System’s six-year history, clinical advantages, and demonstrated effectiveness have not yet led to its widespread use. Many women remain unaware of the procedure and its benefits, and only a limited number of physicians perform the procedure, which studies have shown to be as effective as laparoscopic tubal ligation, a widely used form of permanent female sterilization method.

“Right now, I only know of a small number of interventional radiologists and gynecologists who perform Essure sterilization,” says Robert L. Worthington-Kirsch, MD, FSIR, a member of the radiology department at Pottstown (Pa.) Memorial Medical Center.

But that could change as awareness increases and data build. Conceptus recently reported that the number of physicians trained in the Essure method increased by 25% in 2008. This growth represents the largest number of new physicians in a single year since the company launched the system. And there appears to be a potential market for the procedure. A Conceptus release noted that approximately 7.5 million women in the United States utilize a temporary form of birth control even though they have no plans to increase their families.

“This deserves to become the default method for permanent sterilization for women,” says Worthington-Kirsch, who has used the Essure system for four years.

Essure Procedure
The Essure system was developed and designed for placement using a hysteroscope, Worthington-Kirsch says. The system’s integral components include two microinserts comprised of hormone-free materials similar to those found in heart valves and stents.
Specifically, these inserts, which measure 3.85 centimeters in length and 0.8 millimeters in diameter, consist of a stainless steel inner coil, an elastic outer coil, and Dacron fibers wound around and inside the inner coil. The system also includes a disposable delivery device and disposable introducers. The delivery device includes a delivery wire, a release catheter, and a delivery catheter that house the microinsert. The introducer helps protect the microinsert and prevent splash back.

The procedure begins with the administration of cramp-reducing medication that keeps the fallopian tubes open. The microinsert is then placed via a catheter, which is directed from the vagina through the cervix and uterus, into the proximal section of each fallopian tube lumen. Upon release, the insert’s outer coil expands to 1.5 to 2 millimeters, anchoring the microinsert inside the fallopian tube.

At first, the placement only partially obstructs the tube, explains Worthington-Kirsch. But the Dacron fibers then provoke an inflammatory/fibrotic reaction, prompting tubal tissue to grow into the device, eventually resulting in complete and irreversible tube occlusion about three months after placement. That blockage prevents sperm from making contact with and fertilizing an egg.

After three months, women then need to undergo an x-ray test called a hysterosalpingogram (HSG). This examination confirms that the fallopian tubes are entirely blocked and that the permanent sterilization process is complete. However, during that three-month period between placement and HSG confirmation, when the tissue is only gradually developing over the inserts, women will need to use alternate forms of contraception but not an intrauterine device, according to Conceptus.

The Essure procedure takes only five to 15 minutes to complete, and research shows that it typically entails only minor complications. “Some patients may feel some postprocedure cramping,” Worthington-Kirsch says. Because it requires no incisions or general anesthesia, women can be back on their feet on the same day. Conversely, tubal ligation often requires a week-long recovery period.

The Essure system received FDA approval based on results of a phase 3 clinical trial that involved 518 sexually active, reproductive-age women who underwent the procedure. Study results showed a 98% effectiveness for pregnancy prevention after two years of follow-up. Along with pregnancy prevention, primary study end points included safety in both placement and long-term use, while secondary end points included patient satisfaction and bilateral placement rate (86% on first attempt and 90% on second attempt).

While physicians can’t guarantee that Essure will work for everyone, Conceptus reports that the system proved to be 99.8% effective after four years of follow-up and 99.74% effective five years after follow-up. In addition, Essure is covered by most insurance plans.

Contraindications
The system is contraindicated for women who can have only one microinsert placed and have previously undergone a tubal ligation, according to Conceptus. Other contraindications include pregnancy, suspected pregnancy, delivery or termination of a pregnancy less than six weeks before microinsert placement, and an active or a recent upper or lower pelvic infection, as well as a known allergy to contrast media or hypersensitivity to nickel as confirmed by a skin test.

Conceptus also discourages women from using Essure unless they’re positive they do not want to bear more children. This caveat is especially addressed to younger women who, either by circumstance or desire, could later regret permanent sterilization.

“Once the device is in place, removal is not just unfeasible, it’s impossible,” emphasizes Worthington-Kirsch. “Women need to be absolutely positive that they have completed their child bearing and have no desire whatsoever to become pregnant again. So, in general, the patients best served are women over 35 who are less likely to rue their decision.”

Preprocedural counseling is just as important as the procedure itself, says John C. Lipman, MD, FSIR, medical director of interventional radiology at Emory-Adventist Hospital in Atlanta. As he suggests, physicians must make it perfectly clear to potential patients that there is no turning back. “This is not a temporary birth control method,” he stresses. “The Essure system results in a permanent occlusion of the fallopian tube.”

Postprocedural confirmation is equally important. Patients must return after three months for the follow-up HSG test, or Essure confirmation as it’s more accurately called. “The test differs from an HSG performed on women who are infertile or conceiving,” clarifies Lipman. “In those cases, physicians use HSG to evaluate the endometrial cavity and to determine if the fallopian tubes are open.”

Three-Month Follow-Up
For hysteroscopic sterilization, women need to understand that such confirmation is an integral part of the overall process, and that it ultimately contributes to a successful outcome. “The performing physician needs to emphasize that the procedure is not truly complete until an Essure confirmation test is conducted,” says Lipman, who was one of the investigators involved in the original Essure trial, which included placement under both hysteroscopic and fluoroscopic guidance—the latter of which is an investigational use of the device—and confirming placement through HSG.

During the Essure confirmation test, the physician inserts a speculum to gently expand the vaginal opening. This enables easy insertion of a thin tube that passes through the cervix and into the uterus. A small amount of contrast flows through the tube and into the opening of the fallopian tubes. Once that is accomplished, x-rays are taken of the abdominal area. Resulting images verify the microinsert positioning and ensure that fluid can’t breach the barrier, thus indicating a complete and successful fallopian tube blockage.

The Essure confirmation test requires less pressure and produces minimal discomfort compared with the traditional HSG, in which the tubes are pressure tested. “Essure confirmation involves a necessarily slow and careful injection of the required contrast agent,” Lipman explains. “After patients have had their tubes blocked, contrast injection could be uncomfortable, even painful. Also, you should take a number of images early on, even taking some pictures before the contrast is even injected.”

Lipman concedes that the confirmation can be a challenge for referring obstetrician/gynecologists (OB/GYNs), radiologists, and the patients. Patients may not understand the importance of the HSG, and a “disconnect” may exist between the radiologist performing HSG and the OB/GYN because the radiologist may not fully understand that HSG-applied Essure confirmation to confirm tubal occlusion differs from HSG used to diagnose and treat infertility.

Further, radiologists need to be thoroughly familiar with the Essure device, including its preinsertion and postinsertion appearance, as well as the radiographic markers on the microinsert, says Lipman. Such barriers are easily overcome through thorough postprocedural investigation and report.

Reporting Recommendation
Conceptus recommends deploying the Essure-specific HSG protocol that provides physicians with six radiographic views confirming the complete occlusion of each fallopian tube. Moreover, Lipman says the subsequent radiology report should include specific information required by the referring OB/GYN professional. “I refer to this information as the ‘3Ps’, which indicate data associated with presence, position, and plugging.”

Presence relates to confirmation of the presence of the microinserts. “Sometimes these devices can migrate or be expelled, so radiologists need to make sure the two devices are present in the images,” says Lipman.

Position (or placement), he continues, also needs confirmation, as the procedure requires exact placement of the devices within the fallopian tube. “Proper positioning in the exact location is essential,” he says. “They need to be positioned near the utero-tubal junction, within 3 centimeters of that area. They can’t be far down the ends of the tube, which would be too distal, or hanging in the uteral cavity, which would be too proximal. The radiologist needs to check for this.”

Plugging indicates whether the device is serving its purpose, he says. A radiologist report isn’t complete unless all three P elements are addressed. “Those elements are crucial, but I’ve reviewed some reports that only include one or two of the three Ps,” Lipman says. “I’ve also read reports where radiologists refer to these devices as wires or other things. They need to realize that these are Essure microinserts, and they need to be aware of how they’ll look on an x-ray, where they should be positioned within the fallopian tube, and what they are supposed to accomplish.”

Lipman adds that when he provides a written report, he’ll review findings over the phone with the gynecologist. Also, if he spies a partial occlusion, he will follow up with both the gynecologist and the patient for additional evaluation. “In my experience, tubes that are not fully occluded at three months show complete occlusion when reevaluated at six months,” he reports.

Looking ahead, Worthington-Kirsch believes that this form of permanent sterilization will gain greater usage, as it appears as effective as tubal ligation but doesn’t entail the invasion of the peritoneal cavity. Underscoring his own enthusiasm, he indicates that if any of his female relatives were considering permanent sterilization, he’d strongly recommend this noninvasive option.

— Dan Harvey is a freelance writer based in Wilmington, Del.