|October 2012 · Vol. 24, No. 10
Pearls to Build Your Practice: Incorporating Hysteroscopic Sterilization
Hysteroscopic sterilization has been established as an effective option for patients choosing permanent contraception. The advantages to patients and health care providers have been well documented. This transcervical approach can be performed in an office setting with minimal analgesia/anesthesia, avoids any incisions, and allows patients to return to normal activity almost immediately. The advantages to the physician include the ability to offer a safe, minimally invasive procedure in the office while avoiding the inefficiencies of the operating room (OR). Currently, reimbursement to physicians for this procedure is very favorable when performed in the office. Lastly, society benefits from a procedure that is cost-effective and enables women to quickly return to work and normal function. Given these facts, it would seem that physicians would be enthusiastic supporters of this technique for their patients; however, the adoption of hysteroscopic sterilization has been slow. In fact, only 15% to 20% of gynecologists use in-office hysteroscopy, compared to 100% utilization of in-office cystoscopy by urologists.1 The underutilization of in-office hysteroscopic sterilization may be related to several different factors, which are universal to all physicians. Below we will attempt to address some of the issues and concerns that physicians may have.
How do I learn hysteroscopic sterilization?
Teaching of basic operative hysteroscopic skills is a requirement of all obstetrics and gynecology residencies. To facilitate this, the AAGL has recently developed a course to help educate residents in this technique. For physicians already in practice an effective way to learn this procedure is to be mentored by a fellow physician who currently performs this procedure. The physician-to-physician mentoring process offers a comprehensive clinical and technical interchange between the mentor and novice. However, this is certainly not mandatory, and supervision by a nonphysician trainer for some cases is a reasonable training option.
While hysteroscopy in the OR is familiar to all practicing Ob/Gyns, office hysteroscopy does require some additional skills. As the patient is awake and alert, special attention to avoiding painful stimuli is very important; non-contact hysteroscopy is a useful technique to minimize patient discomfort. VirtaMed and Conceptus have developed an excellent simulator (EssureSim™) with various hysteroscopic sterilization case scenarios to help residents in training and physicians prior to performing in vivo cases. FIGURE 1 details a brief visualization of the Essure procedure.
How many procedures will it take me to become proficient?
Several studies have shown that there is a steep learning curve for performing hysteroscopic sterilization. In the recently published ESS305 postapproval trial, providers were divided into novice and experienced users.2 Novice users had never performed hysteroscopic sterilization and had only performed 3 to 5 proc-tored cases. Both groups had high bilateral placement rates (novice users, 96.1%; experienced users, 98%; P = .4), and experienced physicians were able to complete the procedure slightly faster than novice users (8 minutes vs 11 minutes). What is reassuring is that the bilateral placement rates were excellent even in novice users.
Which patients are good candidates?
All women seeking permanent contraception can be considered candidates for Essure. Women with unexplained vaginal bleeding or an active infection should be evaluated and treated prior to proceeding. Patients immediately postpartum should wait for uterine involution to occur (6 weeks). While patients with nickel hypersensitivity were initially excluded from having the Essure inserts placed, this contraindication has been removed from the product labeling. Data from Zurawin et al3 show that there is a minimal level of nickel leached into the system after placement of Essure inserts. Moreover, similar stents used in cardiovascular procedures do not have nickel hypersensitivity as a contraindication. Although women with comorbid medical conditions may be excellent candidates for this procedure, since it does not require the use of general anesthesia in an OR setting, they must be healthy enough for an in-office procedure. In most patients this procedure can be performed with analgesia alone or in combination with a local anesthetic.
Where should I be doing Essure?
The optimal place to perform hysteroscopic sterilization is in the office setting. Advantages of the office setting include: patient comfort and familiarity with the environment, efficient use of physicians’ time, cost savings, and favorable reimbursement. Studies have confirmed that insert placement rates are not affected by the location where the procedure is performed, with similar placement rates in the OR, ambulatory surgery center, and the office.2,4 Physicians who currently perform these procedures in the OR are often concerned about the process of transitioning these procedures to the office; a common concern is pain management in the office setting. To gain confidence in their ability to perform these cases in the office, physicians can begin by conducting these cases in the OR, using just minimal or no sedation (ie, trying to mimic the office setting). As the physician gains confidence, the transition to the office will be much easier.
What are the problems my patients and I might encounter?
With the hysteroscopic approach there will be a small percentage of patients who will not be able to have the devices placed. Using the current data, patients should be counseled that placement rates are approximately 97%. However, the remaining 3% of patients will need to choose another method of permanent sterilization.2 Common causes for inability to place a device include anatomic issues and primary tubal occlusion. If one is unable to place a device and the patient desires another attempt, a hysterosalpingogram (HSG) can be performed prior to the second procedure to confirm that insert placement is feasible and reasonable.
Patients who only have unilateral placement cannot rely on the device. Rarely, devices can abort into the uterine cavity; these patients can undergo removal of the aborted device and placement of a new device. Cases of perforation with the device should be handled on an individual basis. Removal of these devices has been reported in the literature using hysteroscopic and laparoscopic approaches.5,6
What about pain management; can I really do this in my office?
Several published studies examining the pain associated with hysteroscopic sterilization provide guidance in this area. In one study that reviewed 253 patients undergoing hysteroscopic sterilization, the average pain that patients felt on a 0 to 10 pain scale was 2.5. In comparison, the average menstrual pain score for these women was 3.5.7 A double-blind, placebo-controlled trial reviewing the use of paracervical block versus placebo showed that paracervical block did decrease pain at the internal os, but there was no change in pain scores with device placement.8 Of note, patients identified the injections for the paracervical block as the most painful part of the whole procedure. Currently, many providers are using an anti-inflammatory, such as ketorolac 30 mg intramuscular, approximately 30 to 60 minutes prior to the procedure, and using vaginoscopy to avoid having to place a speculum in the vagina. Each physician can tailor the anesthetic choice to their individual patient population and to what they feel comfortable administering in the office. If sedation is used, physicians should be cognizant of their local regulations about sedation for office procedures.
How do I get patients to follow up in three months?
Confirmation of proper placement of the Essure inserts and tubal occlusion is an important component of this procedure. If the devices are correctly placed and tubal occlusion is confirmed the failure rate is negligible. However, pregnancies have occurred in clinical use and often these failures could have been avoided. Tubal occlusion does not happen immediately. Currently, it is recommended that the postprocedure confirmation test is performed at 3 months. Patients must use alternative contraception for this interval. This counseling should be done prior to performing the procedure. The confirmation test performed after the Essure procedure is able to identify the small percentage of women with improper insert placement who would ultimately fail to achieve bilateral tubal occlusion. It should be emphasized that no sterilization procedure is 100% effective. Even with tubal ligation, the CREST data show that there is a cumulative 10-year failure rate of approximately 1.8% when considering all types of sterilization procedures.9
One way for physicians to explain the need for this confirmatory test is that it is a “graduation present” that confirms tubal blockage; if there is proper placement, the device is nearly 100% effective. It is important to develop a system within the practice to help assure that the confirmation test is performed. Scheduling an appointment at the time of the procedure and/or calling shortly before 3 months with a reminder may be helpful. By raising the level of importance of this follow-up, similar to that which is routinely done in following up abnormal Pap smear or mammogram results, helps everyone involved understand why the procedure needs to be done. If the confirmation HSG is being performed by another physician, the confirmation test protocol should be reviewed with them to ensure familiarity with the landmarks and images needed to confirm proper placement (FIGURE 2).
What should I know about the hysterosalpingogram?
Currently in the United States the Essure procedure requires an HSG at 12 weeks postprocedure. This confirmation test is performed differently than the HSG for fertility patients—it is a low-pressure confirmation to localize position of the inserts. The inserts must span the utero tubal junction. The device is not considered properly located if greater than 50% is in the cavity or if it is further than 4 cm from the cornua. If the inserts are properly positioned but there is contrast noted beyond the distal portion of the insert, a repeat HSG at 6 months is warranted.10
What other advantages are there to bringing hysteroscopy into my office?
Retained/impacted IUDs and small endometrial polyps can be removed in the office using the same equipment as for in-office hysteroscopic sterilization. Patients with nondiagnostic imaging for irregular or postmenopausal bleeding can have uterine cavity evaluation and biopsies performed with a simple office hysteroscopy. See-and-treat algorithms for irregular bleeding have been shown to be cost- effective and avoid procedures using general anesthesia in approximately 30% of patients.11
Is hysteroscopic sterilization really cost effective?
A direct cost comparison of laparoscopic tubal ligation versus office hysteroscopic sterilization using actual institutional costs of the procedures identified a $2,075 difference between the procedures: $3,449 for laparoscopy versus $1,374 for office hysteroscopy.12
An economic decision tree analysis performed recently by Kraemer et al13 found that Essure saves $1,178 (33%) compared with laparoscopic bilateral tubal ligation (BTL). See the TABLE for a cost comparison of Essure versus BTL.12-15
Physicians are often concerned about the cost that a new procedure in the office will incur to a practice. Start-up costs of purchasing the necessary equipment can be challenging; however, there are several leasing or financing options to help with the upfront costs of the equipment. The current environment is very favorable for reimbursement of in-office procedures. Bringing this equipment into the office will allow you to perform not only hysteroscopic sterilization but also a myriad of other diagnostic and therapeutic procedures. Scheduling procedures in the OR is time consuming for your staff, the patient, and yourself. Performing a tubal ligation in the OR requires you to travel to and from the OR and introduces the unpredictability of case start times and equipment issues inherent to any OR. Incorporating hysteroscopic procedures into the practice will allow you to spend more time in the office, where productivity is greatest. Lastly, bringing minimally invasive procedures into your office will make your practice more attractive to patients. You will now be offering the least invasive diagnostic and therapeutic procedures to your patients in an environment where they are comfortable. The future of medicine seems to be heading toward increased cost-effectiveness and decreased hospitalization. Incorporating office hysteroscopy into your practice now will allow you to be on the leading edge of the curve rather than being left behind.
Hysteroscopic sterilization is an excellent option for those seeking permanent contraception. It has advantages to both patients and their physicians. Relocating procedures to the office by adding hysteroscopy to a practice’s capabilities is a win-win situation for both patients and practice. The effectiveness of hysteroscopic sterilization, as well as the clear safety advantages it has over a laparoscopic approach, makes it clear that hysteroscopic sterilization is the best option for the majority of women seeking permanent sterilization. The cost- effectiveness and rapid patient recovery further bolster the argument that this should be considered the standard of care for sterilization.
Cost comparison of Essure versus bilateral tubal ligation
||Cost per patient
|Levie et al12
Essure in office
|Thiel et al14
Essure in ASC
|Hopkins et al15
Essure in OR
|Kraemer et al13,b
Essure in office
1. Isaacson K. Office hysteroscopy: a valuable but under-utilized technique. Curr Opin Obstet Gynecol. 2002;14(4):381–385.
2. Levie M, Chudnoff SG. A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial. Fertil Steril. 2011;96(3):643–648, e1.
3. Zurawin RK, Zurawin JL. Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts. J Minim Invasive Gynecol. 2011;18(4):475–482.
4. Nichols M, Carter JF, Fylstra DL, Childers M. Essure System US Post-Approval Study Group. A comparative study of hysteroscopic sterilization performed in-office versus a hospital operating room. J Minim Invasive Gynecol. 2006;13(5):447–450.
5. Jain P, Clark TJ. Removal of Essure® device 4 years post-procedure: a rare case. J Obstet Gynaecol. 2011;31(3):271–272.
6. Lannon BM, Lee SY. Techniques for removal of the Essure hysteroscopic tubal occlusion device. Fertil Steril. 2007;88(2):497, e13–e14.
7. Levie M, Weiss G, Kaiser B, Daif J, Chudnoff SG. Analysis of pain and satisfaction with office-based hysteroscopic sterilization. Fertil Steril. 2010;94(4):1189–1194.
8. Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010;115(1):26–34.
9. Peterson HB, Xia Z, Wilcox LS, Tylor LR, Trussell J. US Collaborative Review of Sterilization Working Group. Pregnancy after tubal sterilization with silicone rubber band and spring clip application. Obstet Gynecol. 2001;97(2):205–210.
10. Essure [instructions for use]. Mountain View, CA: Conceptus Incorporated; 2012.
11. Saridogan E, Tilden D, Sykes D, Davis N, Subramanian D. Cost- analysis comparison of outpatient see-and-treat hysteroscopy service with other hysteroscopy service models. J Minim Invasive Gynecol. 2010;17(4):518–25.
12. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis. J Minim Invasive Gynecol. 2005;12(4):318–322.
13. Kraemer DF, Yen PY, Nichols M. An economic comparison of female sterilization of hysteroscopic tubal occlusion with laparoscopic bilateral tubal ligation. Contraception. 2009;80(3):254–260.
14. Thiel JA, Carson GD. Cost-effectiveness analysis comparing the essure tubal sterilization procedure and laparoscopic tubal sterilization. J Obstet Gynaecol Can. 2008;30(7):581–585.
15. Hopkins MR, Creedon DJ, Wagie AE, Williams AR, Famuyide AO. Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation. J Minim Inv Gynecol. 2007;14(1):97–102.
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