Tubal Sterilization

Number: 0657

Policy

Aetna considers the following procedures medically necessary for tubal ligation sterilization:

  • Falope ring
  • Filshie clip (titanium clip)
  • Hulka-Clemens clip
  • Partial salpingectomy (e.g., Pomeroy technique (tubal ligation), and Parkland technique)

Aetna considers the following (not an all-inclusive list) experimental and investigational for birth control and for all other indications because its safety and long-term effects have not been established:

  • hysteroscopic tubal sterilization/transcervical sterilization (e.g., the Essure Micro-Insert)
  • FemBloc permanent contraceptive system 

Note: The manufacturer (Hologic) has discontinued production of the Adiana Permanent Contraception System.

Background

The Essure Miro-Insert System is a hysteroscopic approach to tubal sterilization.  The primary advantages of the Essure System over other techniques of female sterilization are that the Essure System is non-incisional and sterilization can be performed without general anesthesia.

Using a hysteroscopic approach, 1 Essure micro-insert is placed in the proximal section of each fallopian tube lumen.  The micro-insert expands upon release, acutely anchoring itself in the fallopian tube.  The micro-insert subsequently elicits a benign tissue response.  Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization. According to the labeling, a hysterosalpingogram is necessary three months after surgery to verify micro-insert placement and tubal occlusion.

Initial approval of the Essure System by the FDA was based on the results of a phase III clinical trial involving 518 sexually active reproductive-age women who underwent a placement procedure.  The Essure System was reported to be 98 % effective in preventing pregnancy after 2 years follow-up.

The primary endpoints of the phase III study of Essure were pregnancy prevention, safety of the placement procedure, and safety of long-term use.  Secondary endpoints included patient satisfaction and bilateral placement rate.  Bilateral placement rate was 86 % on 1st attempt and 90 % on 2nd attempt.  Average hysteroscopy time was 13 minutes, and average procedure time was 35 minutes.

Nichols et al (2006) compared hysteroscopic female sterilization with the Essure system performed in-office versus a hospital operating room among newly trained physicians.  Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared.  There was no significant difference in scope time between the 2 settings.  There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91 % versus 88 %).  There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (operating room = 2 %, in-office = 1 %).  The authors concluded that thereis no clear advantage to performing hysteroscopic sterilization with the Essure system in a hospital operating room.  Hysteroscopic sterilization can be performed safely and efficiently in an office setting.

In an observational, multi-center, 6-month study, Panel and Grosdemouge (2010) evaluated a new hysteroscopic method of tubal sterilization; specifically, to examine the factors associated with placement failure of Essure implants.  A total of 7 gynecology clinics, including 5 public hospitals and 2 private clinics; and a total of 495 women who provided informed consent were included in this study.  All procedures were done by a vaginoscopic approach with a 5-mm operating hysteroscope.  Data collected were age, parity, type of anesthesia, pre-medication, endometrial aspect, ostia visualization, duration of the procedure, pain during the procedure, and associated procedures.  Unilateral and bilateral placement rates were assessed.  Adverse events at 3 months (e.g., expulsion, migration, perforation) were also recorded.  Mean parity was 2.45; 20 women were nulliparous.  In 56.3 % of cases (n = 277), none or local anesthesia was used for the placement procedure.  Overall, 86 % of the women (n = 423) had non-steroidal anti-inflammatory drug (NSAID) pre-medication, and 8.1 % (n = 40) had another intra-uterine surgical procedure performed at the same time.  In 24 cases, at least one of the tubal ostia could not be visualized well during hysteroscopy.  The authors concluded that the failure rate for Essure micro-insert placement was 6 % at first attempt and 3.3 % after 2 attempts.  Success rate was not significantly associated with parity, mode of analgesia, NSAID pre-medication, or combination with another procedure.  The only factor significantly associated with the failure rate was poor visualization of the tubal ostia.

An assessment by the National Institute for Health and Clinical Excellence (NICE, 2009) concluded that current evidence on the safety and efficacy of hysteroscopic sterilization by tubal cannulation and placement of intra-fallopian implants is adequate to support the use of this procedure.

Citing the declining annual number of implantations, the manufacturer of the Essure, Bayer, announced that the device will no longer be sold or distributed in the United States after December 31, 2018. Since FDA’s 2016 decision to order Bayer to conduct the postmarket study and then to add a boxed warning and Patient Decision Checklist to the labeling, sales of Essure declined by 70 percent. The boxed warning states that some patients implanted with the Essure system have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. In 2018, the FDA decided to restrict the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and that give patients the opportunity to sign an acknowledgement of understanding before implantation. The FDA took this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.

Vancaillie and colleagues (2008) evaluated placement efficacy and reliability of a an intra-tubal occlusion device, the Adiana System for Transcervical Sterilization, for permanent contraception and assessed tolerability and overall satisfaction.  A total of 770 women with known parity were recruited to participate in a prospective, multi-center study.  Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used.  Inserts were placed bilaterally in the fallopian tube lumen.  Subsequent bilateral occlusion was assessed with hysterosalpingography.  Overall, bilateral placement success was achieved in 611 of 645 women (95 %).  Bilateral occlusion was confirmed in 570 of 645 (88.4 %).  The 1-year pregnancy prevention rate as derived with life-table methods was 98.9 %.  The authors concluded that this transcervical sterilization system offers an effective contraceptive method, which was well-tolerated and had a high satisfaction rate.

Palmer and Greenberg (2009) compared the available data on transcervical sterilization procedures (Essure and Adiana) to study the strengths and weakness of each system.  The authors reported that the Essure implants have been offered to women in the U.S. for 7 years and have proved to be safe, effective, and well-tolerated.  On the other hand, the experience with the Adiana system is limited (with only 12-month data).  However, results from the pivotal study provided important clinical information.  As with the Essure implants, the Adiana system appears to be well-tolerated with low rates of side effects, although more data are clearly needed.  The overall bilateral placement rates for both systems are similar (94 % to 95 %), and the rates of tubal occlusion following hysterosalpingography are comparable.  There have been no reported pregnancies after Essure implantation from the phase II and pivotal clinical trials. 

Results from the Evaluation of the Adiana System for Transcervical Sterilization study (Vancaillie et al, 2008) indicated that the cumulative failure rate of the Adiana system using life-table methods was 1.07 % at the primary endpoint of 1 year, which falls within the range of other sterilization methods (0 to 2.4 %).

On July 6, 2009, the FDA approved the Adiana Permanent Contraception System for women who desire permanent birth control by occlusion of the fallopian tubes.The Adiana Permanent Contraception System has since been removed from the market.

In a prospective comparative study, Darwish and El Saman (2007) examined whether hysteroscopic tubal occlusion will produce the same efficacy as laparoscopic tubal occlusion of functionless hydrosalpinx prior to in vitro fertilization (IVF)/intra-cytoplasmic sperm injection (ICSI).  A pilot safety phase included 10 uteri removed by hysterectomy in peri-menopausal women subjected to roller ball coagulation of the peritubal bulge.  The study phase included 27 patients with unilateral or bilateral functionless hydrosalpinges, who were randomly divided into 2 groups:
  1. group A comprised 14 patients who were randomly allocated for laparoscopic occlusion, and
  2.  group B included 13 patients scheduled for a hysteroscopic approach.
Laparoscopic occlusion of the isthmic part of the fallopian tube was performed using bipolar diathermy in 9 (64 %) cases or clips in 3 (21.4 %) cases in group A.  Roller ball electrode of the resectoscope was utilized for occlusion of the tubal ostium under local, spinal, or general anesthesia in group B.  Second-look office hysteroscopy was performed in group B whenever possible.  In both groups, hysterosalpingography or sonohysterography was carried out 1 month later to confirm tubal occlusion.  Main outcome measures included safety phase aimed at confirming tubal occlusion with minimal harm to adjacent tissues as well as confirmed tubal occlusion of the functionless hydrosalpinx.  The safety phase resulted in bilateral complete occlusion of the proximal part of the tubes with secondary coagulation less than 8 mm, as indexed in the histopathological sections.  The suspected main cause of functionless hydrosalpinges was iatrogenic (pelvic surgery) in 9 (64 %) and 8 (61.5 %) cases in both groups, respectively.  The mean number of abdominal scars/patient was 1.4 and 1.5 in both groups, respectively.  Unilateral functionless hydrosalpinx was encountered in 7 (50 %) and 5 (38 %) cases in both groups, respectively.  In group A, the procedure was possible and successful in 10 cases (76.9 %), while in group B, hysteroscopic access and occlusion were achieved in 12 (85.7 %) and 9 (64.2 %) cases, respectively.  In group B, diagnostic hysteroscopy showed fine marginal adhesions in 2 cases (15 %), and a small polyp in 1 case (7.7 %).  Hysteroscopic tubal occlusion showed shorter operative time (9 +/- 2.8 versus 24 +/- 4.8 mins, p = 0.0001) and hospital stay (2 +/- 1.8 versus 5 +/- 1.1 hrs, p = 0.0001).  Second-look office hysteroscopy was performed in 8 cases in group B and revealed no significant corneal lesions at the site of hysteroscopic occlusion.  The authors concluded that this preliminary study demonstrated the feasibility of hysteroscopic tubal occlusion of functionless hydrosalpinx in all cases with acceptable efficacy.  It has the advantage of adding a valuable evaluation of the endometrial cavity prior to IVF/ICSI.  It should be an option for treatment protocol in cases of functionless hydrosalpinges.  They stated that further large sample-sized studies are needed to test its impact on the implantation rate and clinical outcome.

In a retrospective case-series study, Hitkari et al (2007) described the use of Essure microinsert placement in patients with hydrosalpinges before IVF.  A total of 5 women with unilateral or bilateral hydrosalpinges on transvaginal ultrasound, laparoscopy, or hysterosalpingogram who were planning further fertility therapy were included in this study.  In all patients, laparoscopy was felt to be relatively contraindicated because of previous extensive abdominopelvic surgery.  Hysteroscopic placement of the Essure microinsert was carried out in 4 patients under general anesthesia.  One patient underwent fluoroscopically guided placement.  Main outcome measures included placement rates and post-operative recovery, technical challenges in Essure placement, and results of subsequent treatment with IVF when available.  Successful bilateral Essure placement was confirmed in 2 of 5 patients.  Unilateral placement was achieved in 2 of 5.  There were no post-operative complications.  No pregnancies have occurred thus far.  The authors concluded that hysteroscopic placement of the Essure microinsert is a minimally invasive option for proximal tubal occlusion.  In patients requiring occlusion of hydrosalpinges before IVF and with contraindications to abdominal surgery, this technique may offer a safer alternative.  Pre-operative documentation of proximal tubal patency helps predict placement success.  They stated that further research into this unique clinical scenario is needed.

In a prospective, single-arm, clinical study, Mijatovic and colleagues (2010) examined the success rate of proximal tubal occlusion with Essure devices in sub-fertile women with hydrosalpinges, and observed the results of subsequent treatment with in IVF.  A total of 10 women with unilateral or bilateral hydrosalpinges prior to IVF were included in this trial.  In all patients laparoscopy was felt to be contraindicated.  Hysteroscopic placement of Essure devices were carried out in an office setting.  Main outcome measures were placement rate, successful proximal tubal occlusion, and pregnancy rate after IVF.  All patients had successful placement of the Essure devices without any complications.  Proximal tubal occlusion was confirmed by hystero-salpingography in 9 out of 10 patients.  A 40 % ongoing pregnancy rate was achieved with 20 % life births after one IVF cycle and/or frozen embryo transfer.  The authors concluded that proximal occlusion of hydrosalpinges with Essure devices before IVF is a successful treatment for patients with a contraindication for salpingectomy.  The findings of this small study need to be validated by well-designed studies.

In a Cochrane review on surgical treatment for tubal disease in women due to undergo IVF, Johnson et al (2010) concluded that surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment.  Previous evidence supported only unilateral salpingectomy for a unilateral hydrosalpinx (bilateral salpingectomy for bilateral hydrosalpinges).  This review provided evidence that laparoscopic tubal occlusion is an alternative to laparoscopic salpingectomy in improving IVF pregnancy rates in women with hydrosalpinges.  They stated that further research is needed to evaluate the value of aspiration of hydrosalpinges prior to or during IVF procedures and also the value of tubal restorative surgery as an alternative (or as a preliminary) to IVF.  Hysteroscopic tubal sterilization was not mentioned as an option.

Oligbo and colleagues (2010) compared the failure rate (pregnancies) of a Pomeroy procedure and Filshie clips tubal occlusion at the time of Caesarean section.  This was a retrospective observational study done in a district general hospital in the United Kingdom.  There were 290 sterilizations performed at the time of Caesarean section over the period of 1994 to 2007.  Studied population included 203 Pomeroy procedures and 87 Filshie clips applications.  Follow-up period ranged from 2 to 15 years.  A birth register and an operating theatre database were used to identify patients who underwent Caesarean section with a tubal occlusion.  These patients' names were checked against the antenatal booking database, the early pregnancy assessment unit database, the operating theatre database in case of ectopic pregnancies, and a termination of pregnancy database to recognize failed sterilization.  There was no failure of tubal occlusion with a Pomeroy procedure (0/203).  The failure rate of Filshie clips tubal occlusion was 1.15 % (1/87) (p = 0.3).  The length of the follow-up period ranged from 2 to 15 years (for Pomeroy procedure, median was 9 years and inter-quartile range (IQR) was 7; for Filshie clip, median was 8 years and IQR was 7).  The authors concluded that Pomeroy technique appears to carry a lower risk of a failed sterilization than Filshie clips tubal occlusion at the time of Caesarean section.  However, Pomeroy procedure needs to be balanced against the speed and simplicity of Filshie clips tubal occlusion.

In a Cochrane review, Lawrie et al (2011) compared the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' views.  Originally MEDLINE and The Cochrane Controlled Trials Register were searched.  For the 2010 update, searches of Popline, Lilacs, PubMed and The Cochrane Controlled Trials Register were performed.  Reference lists of identified trials were searched.  All randomized controlled trials (RCTs) comparing different techniques for tubal sterilization, regardless of the route of Fallopian tube access or the method of anesthesia were include in the analysis.  Trials under consideration were evaluated for methodological quality and appropriateness for inclusion.  A total of 9 relevant studies were included and the results were stratified in 5 groups: tubal ring versus clip, modified Pomeroy versus electrocoagulation, tubal ring versus electrocoagulation, modified Pomeroy versus Filshie clip and Hulka versus Filshie clip.  Results were reported as odds ratio for dichotomous outcomes and weighted mean differences for continuous outcomes.  Tubal ring versus clip: Minor morbidity was higher in the ring group (Peto odds ratio [OR] 2.15; 95 % confidence interval [CI]: 1.22 to 3.78).  Technical difficulties were found less frequent in the clip group (Peto OR 3.87; 95 % CI: 1.90 to 7.89).  There was no difference in failure rates between the 2 groups (Peto OR 0.70; 95 % CI: 0.28 to 1.76).  Pomeroy versus electrocoagulation: Women undergoing modified Pomeroy technique had higher major morbidity than those with the electrocoagulation technique (Peto OR 2.87; 95 % CI: 1.13 to 7.25).  Post-operative pain was more frequent in the Pomeroy group (Peto OR 3.85; 95 % CI: 2.91 to 5.10).  Tubal ring versus electrocoagulation: Post-operative pain was more frequently reported in the tubal ring group.  No pregnancies were reported.  Pomeroy versus Filshie clip: In the only trial comparing the 2 interventions only 1 pregnancy was reported in the Pomeroy group after follow-up for 24 months.  No differences were found when comparing Hulka versus Filshie clip in the only study that compared these 2 devices.  The authors concluded that electrocoagulation was associated with less morbidity including post-operative pain when compared with the modified Pomeroy and tubal ring methods, despite the risk of burns to the small bowel.  The small sample size and the relative short period of follow-up in these studies limited the power to show clinical or statistical differences for rare outcomes such as failure rates.  Aspects such as training, costs and maintenance of the equipment may be important factors in deciding which method to choose.

Madari et al (2011) noted that the modified Pomeroy procedure is currently the most widely used method for post-partum sterilization.  Alternative options are Filshie clips, Hulka-Clemens clips and Falope rings.  In this systematic review these researchers pooled the available evidence in order to compare the failure rates, complications, technical difficulties, and reversibility of the Pomeroy method and Filshie clips when resorted to for post-partum sterilization.  These investigators gathered data from MEDLINE, EMBASE (1970 to 2010), the Cochrane database, and reference lists of RCTs and observational studies.  They extracted information on study design, sample characteristics, interventions, and outcomes.  These investigators search yielded 294 citations of which 43 were retrieved for detailed evaluation.  A total of 14 studies were included in the systematic review; 1 RCT and 3 observational studies compared failure rates of the Pomeroy method versus Filshie clips.  A random-effects analysis of the pooled studies showed no difference in the failures rates between these 2 methods (odds ratio 0.76 [95 % CI: 0.30 to 1.95]).  Complication rates were similar although the Filshie clip technique was reported to be easier.  The authors concluded that Filshie clip application is easier to perform.  The failure and complication rates are comparable to those of the modified Pomeroy method, when performed in the post-partum period.

In a systematic review, Rodriguez et al (2011) examined the effectiveness of the titanium clip in post-partum sterilization.  These investigators searched the Medline and Cochrane databases from their inception through January 2011 for all articles in any language pertaining to the titanium clip use in post-partum sterilization. Reference lists and device registration files were also searched.  They identified 13 articles for this review -- 10 observational trials and 3 reports from 1 single RCT.   Studies were included if they used the titanium clip for sterilization during the post-partum period and reported subsequent pregnancy as an outcome.  Studies of the Hulka clip (spring-loaded) without a titanium comparison group or of the post-abortion population were excluded.  Data abstraction was independently performed by 2 authors.  Standard data abstraction templates were used to systematically assess and summarize the data.  Quality of the evidence was rated with the U.S. Preventive Task Force System.  Effectiveness of the titanium clip was estimated from the only RCT identified.  This trial found a significantly increased risk of pregnancy at 24 months with clip sterilization post-partum (cumulative rate 1.7 compared with 0.04, p = 0.04) compared with post-partum partial salpingectomy.  The authors concluded that based on limited data, the titanium clip has reduced effectiveness than partial salpingectomy in the post-partum population.  They stated that routine use of the titanium clip during the post-partum period should not be recommended.

Sonigo et al (2013) stated that tubal diseases are a common cause of female infertility.  Among them, hydrosalpinges are frequent.  In addition, the presence of hydrosalpinges is a factor of failed attempts at IVF.  It is now well-recognized that the management of hydrosalpinges prior attempts to medically assisted procreation increases the chances of pregnancy.  Nowadays, laparoscopic salpingectomy is the treatment of choice but this therapeutic approach is not consensual and several other surgical techniques have been proven in this indication.  Among these, the exclusion of hydrosalpinx by laying Essure(®) micro-inserts seems promising. 

Legendre et al (2013) reported a successful pregnancy after proximal occlusion of a fallopian tube with Adiana(®) micro-insert in a patient with hydrosalpinx.  A 32-year old nulligravid patient with pelvic adhesive disease and unilateral hydrosalpinx underwent a successful occlusion of the hydrosalpinx by Adiana(®) matrix with a pregnancy after IVF cycle.  The authors concluded that Adiana(®) hysteroscopic tubal occlusion device can be used prior to IVF and seems to be an alternative to Essure(®) procedure.  The theoretical advantage of Adiana(®) is the ability to maintain a uterine cavity free of all foreign matter.

Arora and colleagues (2014) noted that hydrosalpinges in infertile women reduce the success of IVF by 50 %.  Surgical management of hydrosalpinges before IVF improves outcome but these procedures are often contraindicated in women with dense pelvic adhesions.  Tubal occlusion achieved by Essure(®) via hysteroscopy provides an alternative.  These investigators conducted a systematic review on the safety and effectiveness of Essure(®) in the management of hydrosalpinx before IVF.  They searched MEDLINE (January 1950 to July 2013), EMBASE (January 1980 to July 2013) and Web of Science (1899 to July 2013).  They also searched reference lists of relevant articles and proceedings of relevant international conferences (2000 to 2013).  All types of studies where women with suspected infertility and presence of hydrosalpinx had hysteroscopic tubal occlusion with Essure(®) before IVF were selected for analysis.  Two authors independently selected studies and extracted data.  Where necessary, study authors were contacted for further data.  In all, a total of 115 women in 11 studies received Essure(®) , mainly in the outpatient setting where local anesthesia by para-cervical block and/or intravenous sedation was used.  Successful placement of Essure(®) was achieved in 96.5 % (95% CI: 91.1 to 98.9 %) of women and tubal occlusion in 98.1 % (95 % CI: 93.1 to 99.9 %).  Subsequent IVF resulted in 38.6 % pregnancy rate (95 % CI: 30.9 to 46.8 %), 27.9 % live birth rate (95 % CI: 21.1 to 35.8 %) and 28.6 % combined ongoing pregnancy and live birth rate (95 % CI: 21.7 to 36.6 %) per embryo transfer.  The authors concluded that Essure(®) appears to be an effective option for management of hydrosalpinx in women before IVF although evidence from a RCT is lacking.

Closon and Tulandi (2015) noted that hysteroscopy has become an important tool to evaluate intrauterine pathology. In most cases, the pathology can be diagnosed and treated in the office or outpatient setting. The ability to use normal saline as a distending medium allows the procedure to be performed using bipolar energy. During hysteroscopic myomectomy, visualization can remain unobstructed with the use of a hysteroscopic morcellator. Its use is also associated with decreased operating time. The use of Essure to block the proximal fallopian tube by a hysteroscopic approach is an approved procedure for tubal sterilization. However, it has been increasingly used to prevent hydrosalpinx fluid from entering the uterine cavity in women undergoing IVF. The hysteroscopic approach has also been used to treat a variety of conditions such as treatment of interstitial pregnancy, caesarean scar pregnancy and retained placenta. However, the number of cases is still relatively small, and no RCT has ever been conducted. One of the potentially important developments is the use of falloposcopy to obtain distal tubal cytology as a screening for ovarian cancer. The technique remains to be refined.

Endometrial Ablation and Hysteroscopic Sterilization

An ACOG Committee Opinion on hysterosalpingography (HSG) after tubal sterilization advises against performing radiofrequency endometrial ablation on the same day as hysteroscopic sterilization because ablation significantly decreases success rate of sterilization when done on the same day. In addition, the prescribing information for the Essure implant recommends against performing the Essure procedure concomitantly with endometrial ablation. The prescribing information explains that ablation causes intrauterine synechiae which can compromise (i.e., prevent) the Essure confirmation test (modified HSG). The prescribing information states that women with inadequate confirmation tests cannot rely on Essure for contraception.

Hopkins, et al. (2015) evaluated the accuracy of hysterosalpingography (HSG) in patients who underwent concomitant radiofrequency endometrial ablation and hysteroscopic sterilization. The investigators conducted a historical cohort study at a Midwestern academic medical center. A total of 186 women (94 with combined procedure and 92 with sterilization alone) were identified as having undergone intervention between January 1, 2003, and June 30, 2011. Two reviewers blinded to the surgical procedure interpreted the standard clinically indicated HSGs in each group. The primary outcome assessed was the inability to rely on the microinserts for contraception based on HSG interpretation using manufacturers’ guidelines (unsatisfactory HSG). Position of the devices and occlusion of tubes were assessed on all 3-month and, when available, all 6-month repeat HSGs. At the 3-month HSG, 5 of 76 (6.6%, 95% confidence interval [CI] 2.2–14.7%) in the sterilization-only group had unsatisfactory HSG compared with 13 of 71 (18.3%, 95% CI 10.1–29.3%) in the combined group (P = 0.03). After accounting for the seven patients who underwent repeat HSG at 6 months, 3 of 76 (3.95%, 95% CI 0.8–11.1%) in the sterilization-only group had unsatisfactory HSG compared with 13 of 71 (18.31%, 95% CI 10.1–29.3%) in the combined group (P = 0.005). The investigators concluded that, after completing all clinically indicated HSGs, patients who undergo concomitant radiofrequency endometrial ablation and hysteroscopic sterilization have an approximate fivefold increase (odds ratio 5.45, 95% CI 1.48–20.0) in the rate of unsatisfactory HSG for purposes of documenting tubal occlusion.

FemBloc Permanent Contraceptive System

FemBloc permanent contraceptive system (Femasys, Inc) is a non-surgical, permanent female contraception solution (female sterilization) performed in a medical office setting without anesthesia or implants. FemBloc consists of a temporary biopolymer that initiates a wound healing response in the fallopian tubes to form a permanent closure with the patient’s own scar tissue. The biopolymer completely exits the uterine cavity and fallopian tubes naturally over time.

In January 2018, a pivotal trial (BLOC) was initiated to evaluate the FemBloc in an open-label, multi-center, international, non-randomized, two-arm study. Female subjects (between 21-45 years of age) were divided into the FemBloc group (study duration approx. 65 months) or laparoscopic bilateral tubal sterilization group (Control, study duration approx. 62 months). The primary endpoints for the study include pregnancy rate at one year and successful confirmation at three months post treatment. Secondary endpoints are safety, satisfaction and comfort with a comparison to surgical tubal ligation at the same time points, including long-term follow up annually for two to five years post market. The BLOC trial requires treatment of at least 500 patients with FemBloc in order to establish safety and efficacy. A positive safety profile was demonstrated in the BLOC pilot study (n=49) with no reported serious or unanticipated adverse events. The BLOC pivotal trial will be required to establish efficacy and safety. The estimated primary completion date for the pivotal trial was December 2019, with the estimated study completion date set for March 2024. The FemBloc is not commercially available (Femasys, 2020).

Hysterosalpingo-Foam Sonography for Assessment of the Efficacy of Essure Hysteroscopic Sterilization

Rosic and colleagues (2018) stated that hysterosalpingo-foam sonography (HyFoSy) has been suggested to be a possible less invasive alternative to HSG, which is the reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization.  In a prospective study, these researchers evaluated the accuracy of HyFoSy compared to HSG for confirmation of tubal occlusion after Essure hysteroscopic sterilization.  This trial included 90 patients who underwent Essure hysteroscopic sterilization; 12 weeks after the sterilization, 2-D trans-vaginal ultrasonography (US) was performed to evaluate the micro-insert position and was followed by HyFoSy and HSG for evaluation of tubal occlusion.  Patients with patent fallopian tubes on HSG were scheduled for additional HSG procedures at 3-month intervals until tubal occlusion was documented.  Of 90 enrolled patients, 86 patients with 170 fallopian tubes underwent the complete imaging protocol.  Tubal occlusion was evaluated by HyFoSy as an index test and HSG as a reference standard.  The accuracy of HyFoSy was 97.1 % (95 % CI: 93 % to 99 %).  The sensitivity and specificity were 100 % (95 % CI: 97 % to 100 %) and 54.6 % (95 % CI: 23 % to 83 %), whereas the positive and negative predictive values (PPV and NPV) were 97.0 % (95 % CI: 93 % to 99 %) and 100 % (95 % CI: 42 % to 100 %), respectively.  No long-term complications were reported for HyFoSy or HSG.  The authors concluded that given that the concordance rate for tubal occlusion between HyFoSy and HSG was not 100 %, an occluded fallopian tube on HyFoSy should be confirmed by HSG, which remains the reference standard for confirmation of tubal occlusion after Essure hysteroscopic sterilization.

van Rijswijk and associates (2018) stated that tubal pathology is a causative factor in 20 % of sub-fertile couples.  Traditionally, tubal testing during fertility work-up is performed by HSG; HyFoSy is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly.  HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes.  These researchers aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG.  Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up.  The study group will consist of 1,163 sub-fertile women between 18 and 41 years old who are scheduled for tubal patency testing during their fertility work-up.  Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male sub-fertility or a known contrast (iodine) allergy will be excluded.  These researchers anticipate that 7 % (n = 82) of the participants will have discordant test results for HyFoSy and HSG.  These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromo-pertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management).  The primary outcome is ongoing pregnancy leading to live-birth within 12 months after randomization.  Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments.  Costs will be estimated by counting resource use and calculating unit prices.  These investigators stated that this trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in sub-fertile women.

Partial Salpingectomy (e.g., Parkland Technique)

In a Cochrane review, Lawrie and colleagues (2016) compared the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' satisfaction.  This was an update of a review that was first published in 2002.  The authors concluded that tubal sterilization by partial salpingectomy, electrocoagulation, or using clips or rings, is a safe and effective method of contraception.  Failure rates at 12 months post-sterilization and major morbidity were rare outcomes with any of these techniques.  Minor complications and technical failures appeared to be more common with rings than clips.  Electrocoagulation may be associated with less post-operative pain than the modified Pomeroy or tubal ring methods.  They stated that further research should include RCTs (for effectiveness) and controlled observational studies (for adverse effects) on sterilization by minimally-invasive methods, i.e. tubal inserts and quinacrine.

Furthermore, an UpToDate review on “Postpartum sterilization” (Braaten and Dutton, 2017) states that “There are a variety of options for the method of tubal occlusion used for postpartum sterilization.  Partial salpingectomy is the preferred method.  We do not routinely advise complete salpingectomy based on concerns regarding increased risk of bleeding and against titanium clip placement because of data regarding low efficacy … Complete salpingectomy is an option for postpartum sterilization.  However, no studies have compared the contraceptive efficacy or risk of complications with complete or partial salpingectomy for postpartum sterilization.  Partial salpingectomy methods are highly effective, and likely require less surgical dissection and risk of bleeding or injury to proximal structures.  For postpartum women, we do not routinely perform complete bilateral salpingectomy for tubal sterilization due to concern for additional bleeding from enlarged postpartum vasculature … In our practice, we find the Pomeroy or Parkland methods to be the most time efficient. In general, we prefer the Parkland method because the end result allows visualization of the tubal stumps divided and secured at a distance of 2 to 3 cm apart”.

Appendix

Hysteroscopic tubal sterilization is contraindicated in any woman who:

  • Can have only occlusion device placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or
  • Has previously undergone a tubal ligation; or
  • Is uncertain about her desire to end fertility.

Hysteroscopic tubal sterilization is also contraindicated for women with any of the following conditions:

  • Active or recent upper or lower pelvic infection; or
  • Delivery or termination of a pregnancy less than 6 weeks before occlusion device placement; or
  • Known allergy to contrast media; or
  • Pregnancy or suspected pregnancy.
Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:
58340 Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or hysterosalpingography [three months after hysteroscopic tubal sterilization to verify insert placement and tubal occlusion]
58565 Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants [not covered for Essure microinsert]
58600 Ligation or transection of fallopian tube(s), abdominal or vaginal approach, unilateral or bilateral[Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
58605 Ligation or transection of fallopian tube(s), abdominal or vaginal approach, postpartum, unilateral or bilateral, during same hospitalization (separate procedure)[Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
+58611 Ligation or transection of fallopian tube(s) when done at the time of cesarean delivery or intra-abdominal surgery (not a separate procedure) (List separately in addition to code for primary procedure)[Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip]
58615 Occlusion of fallopian tube(s) by device (e.g., band, clip, Falope ring) vaginal or suprapubic approach
58671 Laparoscopy, surgical; with lysis of adhesions with occlusion of oviducts by device (eg, band, clip, or Fallope ring) [Pomeroy technique, Filshie clip, Hulka-Clemens clip]
58700 Salpingectomy, complete or partial, unilateral or bilateral (separate procedure).
74740 Hysterosalpingography, radiological supervision and interpretation [three months after hysteroscopic tubal sterilization to verify insert placement and tubal occlusion]

CPT codes not covered for indications listed in the CPB:
0567T Permanent fallopian tube occlusion with degradable biopolymer implant, transcervical approach, including transvaginal ultrasound

Other CPT codes related to the CPB:
58353 Endometrial ablation, thermal, without hysteroscopic guidance [Not covered when performed at the same time as hysteroscopic sterilization]
58670 Laparoscopy, surgical; with fulguration of oviducts (with or without transection)

HCPCS codes covered if selection criteria are met:
A4264 Permanent implantable contraceptive intratubal occlusion device(s) and delivery system [Pomeroy technique, Falope ring, Filshie clip, Hulka-Clemens clip] [not covered for Essure microinsert]

ICD-10 codes covered if selection criteria are met:
Z30.2 Encounter for sterilization

ICD-10 codes not covered for indications listed in the CPB:
E23.0 Hypopituitarism [Patient undergoing in vitro fertilization cycle]
N70.11 - N70.13 Chronic salpingitis and oophoritis [hydrosalpinx]
N97.0 - N97.9 Female infertility [Patient undergoing in vitro fertilization cycle]
Z31.83 Encounter for assisted reproductive fertility procedure cycle [Patient undergoing in vitro fertilization cycle]

ICD-10 codes contraindicated for this CPB:
N73.0 - N73.2 Parametritis and pelvic cellulitis
N73.3 - N73.5 Female pelvic peritonitis
N73.8 - N73.9 Other and unspecified female pelvic inflammatory diseases
O00.00 - O9A.53 Pregnancy, childbirth and the puerperium
Q50.6 Other congenital malformations of fallopian tube and broad ligament
Q51.0, Q51.2 - Q51.4
Q51.810 - Q51.818, Q51.9		 Congenital malformations of uterus
Z34.00 - Z34.93 Encounter for supervision of normal pregnancy
Z39.0 Encounter for care and examination of mother immediately after delivery
V26.51 Tubal ligation status

The above policy is based on the following references:

  1. Alberta Heritage Foundation for Medical Research (AHFMR). Hysteroscopic tubal sterilization (Essure (TM) system). Technote TN 57. Edmonton, AB: AHFMR; 2006.
  2. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 458: Hysterosalpingography after tubal sterilization. Obstet Gynecol. 2010;115(6):1343-1345.
  3. American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 133: Benefits and risks of sterilization. Obstet Gynecol. 2013;121(2 Pt 1):392-404.
  4. Anderson TL, Vancaillie TG. The Adiana system for permanent contraception: Safety and efficacy at 3 years. J Minim Invasive Gynecol. 2011;18(5):612-616.
  5. Arora P, Arora RS, Cahill D. Essure(®) for management of hydrosalpinx prior to in vitro fertilization -- a systematic review and pooled analysis. BJOG. 2014;121(5):527-536.
  6. Bayer Healthcare LLC. Essure permanent birth control. Instructions for Use. 6907100. Milpitas, CA: Bayer; 2002.
  7. Bouillon K, Bertrand M, Bader G, et al. Association of hysteroscopic vs laparoscopic sterilization with procedural, gynecological, and medical outcomes. JAMA. 2018;319(4):375-387.
  8. Braaten KP, Dutton C. Postpartum sterilization. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2017.
  9. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective tubal occlusion procedure. Emerging Device List No. 5. Ottawa, ON: CCOHTA; June 2001.
  10. Castaño PM, Adekunle L. Transcervical sterilization. Semin Reprod Med. 2010;28(2):103-109.
  11. Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: A randomized controlled trial. Obstet Gynecol. 2010;115(1):26-34.
  12. Closon F, Tulandi T. Future research and developments in hysteroscopy. Best Pract Res Clin Obstet Gynaecol. 2015;29(7):994-1000.
  13. Conceptus Inc. Essure Confirmation Test (Modified HSG) Protocol. CC-2988 22DEC11F. Mountain View, CA: Conceptus; 2012.
  14. Conceptus, Inc. Essure Microinsert System. Prescribing information. Document No. CC-0366.  San Carlos, CA: Conceptus; July 16, 2004.
  15. Connor VF. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fertil Steril. 2006;85(6):1791-1793.
  16. Darwish AM, El Saman AM. Is there a role for hysteroscopic tubal occlusion of functionless hydrosalpinges prior to IVF/ICSI in modern practice? Acta Obstet Gynecol Scand. 2007;86(12):1484-1489.
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  21. Hopkins MR, Creedon DJ, Wagie AE, et al. Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation. J Minim Invasive Gynecol. 2007;14(1):97-102.
  22. Hopkins MR, Laughlin-Tommaso SK, Wall DJ, et al. Hysterosalpingography after radiofrequency endometrial ablation and hysteroscopic sterilization as a concomitant procedure. Obstet Gynecol. 2015;126(3):628-634.
  23. Hurskainen R, Hovi SL, Gissler M, Grahn R, et al. Hysteroscopic tubal sterilization: A systematic review of the Essure system. Fertil Steril. 2010;94(1):16-19.
  24. Hysterosalpingoraphy after tubal sterilization. Committee Opinion No. 458. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2010:115:1343-1345.
  25. Johnson N, van Voorst S, Sowter MC, et al. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010;(1):CD002125.
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  27. Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol. 2001;41(4):364-370.
  28. Kerin JF, Levy BS. Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations. J Minim Invasive Gynecol. 2005;12(1):50-54.
  29. 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.
  30. Lawrie TA, Kulier R, Nardin JM. Techniques for the interruption of tubal patency for female sterilisation. Cochrane Database Syst Rev. 2016;(8):CD003034.
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  32. Legendre G, Gallot V, Levaillant JM, et al. Adiana(®) hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization: A case report. J Gynecol Obstet Biol Reprod (Paris). 2013;42(4):401-404.
  33. Lessard CR, Hopkins MR. Efficacy, safety, and patient acceptability of the Essure™ procedure. Patient Prefer Adherence. 2011;5:207-212.
  34. Madari S, Varma R, Gupta J. A comparison of the modified Pomeroy tubal ligation and Filshie clips for immediate postpartum sterilisation: A systematic review. Eur J Contracept Reprod Health Care. 2011;16(5):341-349.
  35. McMartin K. Hysteroscopic tubal sterilization: An evidence-based analysis. Ont Health Technol Assess Ser. 2013;13(21):1-35.
  36. McSwain H, Shaw C, Hall LD. Placement of the Essure permanent birth control device with fluoroscopic guidance: A novel method for tubal sterilization. J Vasc Interv Radiol. 2005;16(7):1007-1012.
  37. Medical Services Advisory Committee (MSAC). Hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant. Assessment Report. MSAC Application 1055. Canberra, ACT: MSAC; November 2003.
  38. Mijatovic V, Veersema S, Emanuel MH, et al. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril. 2010;93(4):1338-1342.
  39. National Horizon Scanning Centre (NHSC). Selective tubal occlusion (Essure) for female sterilisation - horizon scanning review. Birmingham, UK: NHSC; 2002.
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  42. Oligbo N, Revicky V, Udeh R. Pomeroy technique or Filshie clips for postpartum sterilisation? Retrospective study on comparison between Pomeroy procedure and Filshie clips for a tubal occlusion at the time of Caesarean section. Arch Gynecol Obstet. 2010;281(6):1073-1075. 
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  47. Podolsky ML, Desai NA, Waters TP, Nyirjesy P. Hysteroscopic tubal occlusion: Sterilization after failed laparoscopic or abdominal approaches. Obstet Gynecol. 2008;111(2 Pt 2):513-515.
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  50. Rosic M, Zegura B, Vadnjal Donlagic S. Use of hysterosalpingo-foam sonography for assessment of the efficacy of Essure hysteroscopic sterilization. J Ultrasound Med. 2018 Jan 18 [Epub ahead of print].
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  52. Sills ES, Rickers NS, Li X. Surgical management after hysteroscopic sterilization: Minimally invasive approach incorporating intraoperative fluoroscopy for symptomatic patients with >2 Essure® devices. Surg Technol Int. 2018;32:156-161.
  53. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG. 2007;114(6):676-683.
  54. Sonigo C, Collinet P, Rubod C, Catteau-Jonard S. Current position of Essure(®) micro-insert in the management of hydrolsalpinges before in vitro fertilization. Gynecol Obstet Fertil. 2013;41(2):133-138.
  55. 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.
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  58. U.S. Food and Drug Administration (FDA). FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information. FDA Statement. Silver Spring, MD: FDA; April 9, 2018.
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