Tubal Sterilization

Number: 0657

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses tubal sterilization.

1. Medical Necessity

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

   1. Falope ring
   2. Filshie clip (titanium clip)
   3. Hulka-Clemens clip
   4. Partial salpingectomy (e.g., Pomeroy technique (tubal ligation), and Parkland technique)
   5. Total salpingectomy (also known as bilateral or complete salpingectomy).

2. Experimental and Investigational

   The following interventions (not an all-inclusive list) are considered experimental and investigational for birth control and for all other indications because its safety and long-term effects have not been established:

   1. Hysteroscopic tubal sterilization/transcervical sterilization (e.g., the Essure Micro-Insert)
   2. FemBloc permanent contraceptive system.

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

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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]
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
58661	Laparoscopy, surgical; with removal of adnexal structures (partial or total oophorectomy and/or salpingectomy)
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
58565	Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants
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)
ICD-10 codes covered if selection criteria are met:
Z30.2	Encounter for sterilization
HCPCS codes not covered for indications listed in the CPB:
A4264	Permanent implantable contraceptive intratubal occlusion device(s) and delivery system [Essure microinsert]
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
Z98.51	Tubal ligation status

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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 Food and Drug Administration (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 first attempt and 90 % on second 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 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.

On April 24, 2020, the FDA issued a letter to Bayer outlining conditions for submitting additional post-market information to the agency regarding Essure – a permanent birth control device Bayer sold in the U.S. until 2018.  The letter applies to reportable adverse events (AEs) Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding Essure.  The FDA stated that "Even though the device is no longer being manufactured or distributed, and hasn’t for some time, the FDA continues its engagement with Bayer on post-market safety monitoring of Essure.  Bayer alerted us to the social media information it received in connection with litigation.  We are committed to ensuring that all reportable adverse events identified from this information are submitted to the agency and that they are made publicly available".  Bayer has reported to the agency that all unused Essure devices of which Bayer is aware have been returned to the company, and there should be no devices available for implantation in the U.S.  Bayer voluntarily stopped selling and distributing Essure in the U.S. on December 31, 2018.  In 2019, the agency reminded health care professionals and facilities to return unused Essure devices to Bayer by the end of that year.

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".

Total Salpingectomy (Also Known as Bilateral or Complete Salpingectomy)

In a randomized controlled trial (RCT), Subramaniam et al (2018) examined the feasibility of complete salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility.  This trial included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery.  Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme.  If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted.  Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure.  Secondary outcomes included clinically estimated blood loss (EBL) and surgical complications up to 6 weeks post-partum.  These investigators estimated that 80 patients (40 per group) would provide greater than 80 % power to identify a 10-min difference in the primary outcome (time) with a SD of 15 mins and a 2-sided α of 0.05.  Analysis was by intent-to-treat (ITT).  Of 221 women screened from June 2015 to April 2017, 115 (52 %) consented to the study; 80 were randomized -- 40 to complete salpingectomy and 40 to bilateral tubal ligation.  Groups were similar at baseline.  A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68 % compared with 95 %, p = 0.002).  Total operative time was on average 15 mins longer for salpingectomies (75.4 ± 29.1 compared with 60.0 ± 23.3 min, p = 0.004).  No adverse outcomes directly related to the sterilization procedure were noted in either group.  Although EBL of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median of 10 cc [inter-quartile range [IQR] of 5 to 25 compared with 5 [IQR of 5 to 10 cc, p < 0.001), total EBL and safety outcomes were similar for both groups.  The authors concluded that adding 15 mins to total operative times, complete (bilateral) salpingectomy could be successfully completed in approximately 2/3 of women desiring permanent contraception with cesarean delivery.

In a systematic review and meta-analysis, Yang et al (2021) examined the safety profile and feasibility of complete salpingectomy during cesarean delivery in women desiring permanent sterilization.  These investigators searched Medline, Embase, and Cochrane Central Register of Controlled Trials from inception to July 2018.  Studies comparing total salpingectomy with tubal ligation during cesarean deliveries were included.  A total of 9 studies entailing, 1274 participants were eligible.  The analyses showed that the total operative time was slightly longer for the bilateral salpingectomy than for the tubal ligation group (mean difference [MD] = 5.81, 95 % confidence interval [CI]: 0.85 to 10.77).  Two comparison groups were comparable with regard to intra-operative complications (relative risk [RR] = 1.42, 95 % CI: 0.65 to 3.11), post-operative complications (RR = 1.70, 95 % CI: 0.83 to 3.48), EBL in total procedures, need for blood transfusion, operative complications, risk of post-partum hemorrhage, surgical site infection, intensive care unit (ICU) admission, need for presentation to hospital, short-term ovarian reserve, and completion rate of sterilization surgeries (RR = 0.90, 95 % CI: 0.80 to 1.00).  The authors concluded that complete salpingectomy slightly prolonged surgical time by a reasonable range and showed similar safety profile and greater cost-effectiveness than tubal ligation as permanent sterilization procedures at cesarean delivery.

On behalf of the Flemish Society of Obstetrics and Gynecology, Tjalma et al (2019) stated that ovarian cancer (OC) is a disease difficult to diagnose in an early stage implicating a poor prognosis.  The 5-year overall survival (OS) in Belgium has not changed in the last 18 years and remains 44 %.  There is no effective screening method (secondary prevention) to detect ovarian cancer at an early stage.  Primary prevention of ovarian cancer came in the picture through the paradigm shift that the fallopian tube is often the origin of ovarian cancer and not the ovary itself.  Opportunistic bilateral salpingectomy (OBS) during benign gynecological and obstetric surgery might have the potential to reduce the risk of ovarian cancer by as much as 65 %.  Bilateral risk-reducing salpingectomy during a benign procedure is feasible, safe, appeared to have no impact on the ovarian function and appeared to be cost-effective.  The key question is whether one should wait for a RCT or implement OBS directly in daily practice.  Guidelines regarding OBS are therefore urgently needed.  The Flemish Society of Obstetrics and Gynecology’s recommendation is to inform all women without a child wish, undergoing a benign gynecological or obstetrical surgical procedure about the pros and the cons of OBS and advise a bilateral salpingectomy. Furthermore, there is an urgent need for a prospective registry of OBS.  Two of the consensus statements were as follows:

• All women undergoing abdominal surgery should be counselled about OBS when their child wish is fulfilled;
• The possibility of bilateral salpingectomy as a method of sterilization should be discussed with every patient informing about sterilization and certainly an OBS should be the method of choice above the age of 40.

The American College of Obstetricians and Gynecologists’ Committee Opinion on "Opportunistic salpingectomy as a strategy for epithelial ovarian cancer prevention" (ACOG, 2019) stated that opportunistic salpingectomy may offer obstetrician-gynecologists and other health care providers the opportunity to decrease the risk of ovarian cancer in their patients who are already undergoing pelvic surgery for benign disease.  By performing salpingectomy when patients undergo an operation during which the fallopian tubes could be removed in addition to the primary surgical procedure (e.g., hysterectomy), the risk of ovarian cancer is reduced.  Although opportunistic salpingectomy offers the opportunity to significantly decrease the risk of ovarian cancer, it does not eliminate the risk of ovarian cancer entirely.  Counseling women who are undergoing routine pelvic surgery about the risks and benefits of salpingectomy should include an informed consent discussion about the role of oophorectomy and bilateral salpingo-oophorectomy.  Bilateral salpingo-oophorectomy that causes surgical menopause reduces the risk of ovarian cancer but may increase the risk of cardiovascular disease, cancer other than ovarian cancer, osteoporosis, cognitive impairment, and all-cause mortality.  Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe and does not increase the risk of complications such as blood transfusions, re-admissions, post-operative complications, infections, or fever compared with hysterectomy alone or tubal ligation.  The risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.  Additionally, ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization.  Plans to perform an opportunistic salpingectomy should not alter the intended route of hysterectomy.  Obstetrician-gynecologists should continue to observe and practice minimally invasive techniques.  This Committee Opinion has been updated to include new information on the benefit of salpingectomy for cancer reduction, the feasibility of salpingectomy during vaginal hysterectomy, and long-term follow-up of women after salpingectomy.

In a systematic review and meta-analysis, Roeckner and colleagues (2020) compared the differences in operative time and surgical outcomes between salpingectomy and standard tubal interruption at the time of cesarean delivery.  PubMed, Medline, Google Scholar, Cochrane, and ClinicalTrials.gov were searched from inception until July 2019 for articles reporting outcomes for women undergoing salpingectomy during cesarean delivery compared with women undergoing standard sterilization methods.  Studies were selected if they included the main outcome of operative time or additional outcomes, which included infection, transfusion, re-admission, change in hematocrit, and estimated blood loss.  The Newcastle-Ottawa Quality Assessment scale or Cochrane Handbook were used to assess quality of cohort and RCTs, respectively.  A random-effects model was used to calculate pooled relative risk (RR) or weighted mean difference (WMD) for each outcome with their 95 % CI.  Heterogeneity was assessed using the I statistic, and L'Abbé plots were inspected visually to assess for homogeneity.  These researchers identified 11 studies comprising 320,443 women undergoing total salpingectomy or standard sterilization methods at the time of cesarean delivery; 3 RCTs and 8 retrospective cohort studies were examined separately by meta-analysis.  When compared with standard sterilization methods, total operative time for patients receiving salpingectomy was significantly longer (6.3 mins, 95 % CI: 3.5 to 9.1, 7 studies, 7,303 patients) for cohort studies.  With the 3 RCTs of 163 patients, total operative time was not significantly increased in women receiving salpingectomy (8.1 mins, 95 % CI: -4.4 to 20.7).  The salpingectomy group did not have an increased risk of wound infection, transfusion, re-admission, re-operation, internal organ damage, blood loss, change in hemoglobin, or length of stay (LOS) when compared with standard sterilization methods.  The authors concluded that salpingectomy at the time of cesarean delivery was associated with a small increase in operative time; however, it was not associated with an increased rate of surgical complications.  These investigators stated that this option should be considered for patients desiring sterilization during cesarean delivery.

An UpToDate review on "Female interval permanent contraception: Procedures" (Braaten and Dutton, 2020a) states that "Salpingectomy has not traditionally been the method of choice for laparoscopic sterilization since electrosurgical and mechanical techniques are technically easier.  However, there is increased interest in use of complete salpingectomy for sterilization based on a potential reduction in ovarian cancer risk.  We, therefore, routinely offer bilateral salpingectomy to patients seeking tubal sterilization and counsel patients about the potential benefits and risks".

Furthermore, an UpToDate review on "Overview of female permanent contraception" (Braaten and Dutton, 2020b) states that "Female permanent contraception (also referred to as sterilization and tubal ligation) can be performed using several different procedures and techniques that prevent pregnancy by occluding or removing the fallopian tubes.  It is indicated for women who are certain they have completed childbearing and do not wish to use a reversible contraceptive method or consider vasectomy of their male partner.  Permanent contraception procedures vary by timing, surgical route (laparotomy, mini-laparotomy, or laparoscopy), and technique (tubal occlusion, partial or complete salpingectomy) … Complete salpingectomy has been proposed as a strategy to reduce the risk of ovarian, tubal, and peritoneal cancers.  This is based on increasing evidence that some ovarian cancers are actually primary fallopian tube malignancies.  This has led to the proposal to prophylactically remove fallopian tubes in women who are otherwise undergoing tubal ligation or hysterectomy.  This option is discussed in detail separately".

Tubal Ligation and Breast Cancer Risk

Najdi et al (2022) noted that based on previous studies, it has been hypothesized that tube sterilization may be associated with a lower risk of breast cancer.  In a systematic review and meta-analysis, these investigators examined the relationship between tubal ligation and the risk of breast cancer.  PubMed/Medline, Web of Science, Scopus, and Google Scholar were searched for relevant non-randomized studies published up to November 2020.  These researchers screened the articles to include the eligible studies in the meta-analysis.  They pooled the extracted results of individual studies to estimate the summary effect size.  All analyses were carried out using Stata software version 13 (Stata Corp, College Station, TX).  A total of 464 studies were retrieved from PubMed/Medline (n = 160), Scopus (n = 165), and Web of Science (n = 139), and 21 articles from Google Scholar and manual search of references in selected full texts.  After the removal of duplicates and screening of the articles, 11 studies (6 cohort and 5 case-control study) were included in the final analysis.  The results of cohort (RR = 0.99, 95 % CI: 0.97 to 1.0, I2 = 21.1 %) and case control studies (OR = 0.87, 95 % CI: 0.62 to 1.12, I2 = 88.9 %) revealed that tubal ligation was not significantly associated with breast cancer risk.  The authors concluded that according to these findings, tubal ligation cannot be considered as a risk factor associated with breast cancer risk.

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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.

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References