Nisse V. Clark, MD, MPH, is an ob/gyn and minimally invasive gynecologic surgeon at Massachusetts General Hospital and instructor at Harvard Medical School in Boston.

Nisse V. Clark, MD, MPH

Cervical insufficiency is defined as the inability of the uterine cervix to retain a pregnancy in the second trimester in the absence of clinical contractions, labor, or both.

 It is an important cause of spontaneous preterm birth and is estimated to affect up to 1% of pregnancies.

 The most common treatment for cervical insufficiency is a vaginal cerclage, a suture placed around the cervix vaginally to provide added support during the pregnancy. 

In cases where a woman suffers a second trimester loss or preterm birth despite a well-timed and placed vaginal cerclage, termed refractory cervical insufficiency, an abdominal cerclage should be considered. 

Newer evidence indicates an abdominal cerclage improves neonatal outcomes compared to a repeat vaginal cerclage in patients who have failed one prior vaginal cerclage.

 This finding suggests waiting until a woman has failed two prior vaginal cerclages before placing an abdominal cerclage may be too high a threshold. 

Moreover, abdominal cerclages are increasingly performed using a laparoscopic approach, often prior to pregnancy.

 Considering the numerous advantages of laparoscopy compared to laparotomy for all gynecologic procedures, laparoscopic abdominal cerclage should be considered for refractory cervical insufficiency.

When an abdominal cerclage should be considered

The abdominal cerclage was first described by Benson and Durfee in 1965 for women with extreme cervical shortening.

 The most common indication for an abdominal cerclage today is at least one prior failed vaginal cerclage (despite appropriate timing and placement of the vaginal cerclage), or inability to place a vaginal cerclage. 

The procedure entails placing a suture intraperitoneally at the level of the internal os, a technique that is believed to provide greater structural integrity to the cervix and potentially avoid vaginal contamination.

The two largest studies-to-date evaluating abdominal cerclage outcomes have demonstrated very high neonatal survival rates (defined as the percent of pregnancies with neonates surviving until hospital discharge, exclusive of first trimester losses).

The first was a large retrospective study including 300 women who underwent open or laparoscopic abdominal cerclage using their prior pregnancy as a control.6 The neonatal survival rate was 98% and the average gestational age at delivery was 37 weeks compared to 24 weeks in the prior pregnancy. The second study included 225 women who underwent a laparoscopic abdominal cerclage and found a similarly high neonatal survival rate of 98.5%, with a mean gestational age at the time of delivery of 35 weeks.

 There was no comparison group in this study.

The first multicenter randomized control trial comparing abdominal and vaginal cerclage after only one prior failed vaginal cerclage was recently published.

 The study included 111 women with a single failed prior vaginal cerclage (defined as a loss or preterm birth between 14 and 28 weeks of gestation) randomized to either an open abdominal cerclage or repeat vaginal cerclage. 

The study found that preterm birth before 32 weeks of gestation was only 8% in women randomized to an abdominal cerclage compared to 38% in women randomized to a repeat vaginal cerclage (

.008). These findings suggest an abdominal cerclage may be effective after only one prior failed vaginal cerclage. 

Obstetricians have often maintained a high threshold for placing an abdominal cerclage due to its perceived surgical risk and the need to perform a cesarean section for delivery when an abdominal cerclage is in place. While a cesarean section is very often necessary, surgical risk related to the cerclage itself is reduced when performed prior to pregnancy and using a laparoscopic approach.

Laparoscopic abdominal cerclage was first reported in 1998 by Lesser et al. and has been increasingly used since that time.

 Extrapolating the well-documented advantages of laparoscopy for hysterectomy and myomectomy, laparoscopic abdominal cerclage is likely to result in reduced blood loss, fewer wound complications, and a shorter recovery compared to open abdominal cerclage. 

In fact, one cohort study demonstrated reduced blood loss and length of stay following robotic-assisted laparoscopic abdominal cerclage compared to an open procedure.

 In addition to the benefit of small incisions, laparoscopy allows for careful dissection around the uterine vessels, helping to avoid vascular injury. 

Uterine vessel injury is a dreaded complication of abdominal cerclage, especially when performed during pregnancy. While complication rates for laparoscopic versus open abdominal cerclage have not been directly compared in the literature, reported rates are generally lower for the laparoscopic approach.

Conversion to laparotomy can occur in up to 5% of laparoscopic cases and may be more likely to occur during pregnancy given the increased bleeding risk, enlarged uterus, and challenges with uterine manipulation.

 Other complications are rare with single reports of suture migration, suture erosion or uterine rupture with an abdominal cerclage in place.

Success rates for laparoscopic abdominal cerclage are comparable to open abdominal cerclage, according to observational data. The largest systematic review was by Moawad et al. and included 1,844 women who underwent laparoscopic versus open abdominal cerclage (before or after conception) with no significant difference in neonatal survival rates between the groups (90% for the laparoscopic group and 91% for the open group, 

Interestingly, when first trimester losses were excluded from the analysis (as these are unlikely to be related to the cerclage), women who underwent laparoscopic abdominal cerclage actually had a significantly greater neonatal survival rate (97% versus 90%, 

<.01). Neonatal survival rates with laparoscopic abdominal cerclage have also tended to increase over time with improved surgical technique.

Simultaneous with a trend toward laparoscopic placement is a trend toward preconception abdominal cerclage placement. 

This shift is likely due to a couple factors: 1) a less-invasive, lower-risk laparoscopic approach may be more acceptable as a preventative measure prior to confirmation of pregnancy, and 2) laparoscopy is generally more feasible in the nongravid state when the uterus is not enlarged and a manipulator can be placed. 

Preconception abdominal cerclage, regardless of the surgical approach, also avoids the risk of perioperative miscarriage (estimated to occur in 1-3% of postconception abdominal cerclages).

 Literature comparing pre versus postconception abdominal cerclage is limited to observational data and often bias in that a disproportionate number of preconception abdominal cerclages are performed laparoscopically as compared to postconception abdominal cerclages which are most often performed abdominally. 

A systematic review by Tulandi et al. analyzed 678 women who underwent laparoscopic and open abdominal cerclage outcomes separately, showing no difference in the rate of third-trimester delivery or live birth between pre versus postconception abdominal cerclage for either method.

A cohort study of 161 women by Dawood and Farquharson did show a greater likelihood of delivery beyond 34 weeks with pre versus postconceptional abdominal cerclage (90% versus 74%, 

 Most conclude that preconception abdominal cerclage placement carries lower surgical and obstetric risk.

Laparoscopic abdominal cerclage technique

Several techniques for laparoscopic abdominal cerclage are described in the literature.

 In general, the procedure starts with standard laparoscopic positioning and port placement using either a conventional or robotic-assisted set-up. 

Port placement is at the discretion of the surgeon though should consider uterine size and allow the surgeon to tie a strong knot with two hands. When the procedure is performed prior to pregnancy, a uterine manipulator is placed to aid with dissection and suture placement. The dissection begins by opening the vesicouterine peritoneum overlying the internal os (

This helps to reflect the bladder caudad and delineate the uterine vessels anteriorly. A nonabsorbable suture, most commonly a double-armed 5-mm Mersilene polyester tape with CTX or BP-1 needles is used. The needles can be straightened beforehand to facilitate trocar passage and ease suture placement. 

Each needle is then passed between the uterine vessels and the cervix either anteriorly or posteriorly, with the final knot location depending on the suture type (double-arm versus single-arm) and insertion point. For anterior knot placement, the uterosacral ligaments provide a useful reference, with the needles inserted just above the insertion of the uterosacral ligaments on either side (

While passing the needle with one hand, it can be helpful to control the uterine manipulator with the other hand, ensuring placement of the suture between the uterine vessels and cervical stroma while simultaneously visualizing the needle’s entry and exit point. 

Care should be taken not to deviate laterally which risks uterine vessel injury or deviate medially into the cervical stroma which can weaken the cerclage. Once the suture is placed and manipulator removed, the first knot is tightly secured and a total of six square knots placed (

Nonabsorbable suture such as silk can be secured to each suture end to aid in knot identification during future removal. The overlying peritoneum can then be closed if desired.

How and when to remove an abdominal cerclage

Given the risk of cervical injury or obstructed labor with an abdominal cerclage in place during labor, an elective cesarean section is typically performed at the time of delivery. The cerclage can be removed during the cesarean section or left in place for a future pregnancy. 

A small study of 22 women with a laparoscopic abdominal cerclage retained from a prior pregnancy found a neonatal survival rate of 86% in the second pregnancy and 100% in the third pregnancy.

 In the event of previable fetal loss, a dilation and evacuation can be performed with the abdominal cerclage in-situ. 

This has been performed without major complication up to 19 weeks of gestation.

 The cerclage can also be removed laparoscopically before dilation and evacuation and has been described in a single case report at 19 weeks of gestation.

A novel technique using an anterior or posterior colpotomy and the assistance of a hysteroscope to cut and remove the stitch has been reported up to 23 weeks of gestation.

 If this is feasible at later gestational ages, a cesarean section could potentially be avoided in some viable pregnancies.

In summary, laparoscopic abdominal cerclage is a highly effective option for refractory cervical insufficiency with obstetric outcomes comparable to an open abdominal cerclage. The minimally invasive approach reduces surgical risk, especially when performed prior to conception. 

Given new evidence favoring an abdominal cerclage over a repeat vaginal cerclage in women who have failed one prior vaginal cerclage, laparoscopic abdominal cerclage could be strongly considered for women with refractory cervical insufficiency.

Increased surgical experience and promising advances in the management of pre-viable pregnancy loss with an abdominal cerclage in-situ suggest that laparoscopic abdominal cerclage is a low-risk option for appropriate candidates. 

Rust O, Odibo A; American College of Obstetricians and Gynecologists. Practice Bulletin: Cerclage for the Management of Cervical Insufficiency. Number 142, February 2014.

Ludmir J. Sonographic detection of cervical incompetence. 

Shennan A, Chandiramani M, Bennett P, et al. MAVRIC: A Multicentre Randomised Controlled Trial of Transabdominal Versus Transvaginal Cervical Cerclage. 

Benson RC, Durfee RB. Transabdominal cervicouterine cerclage during pregnancy for the treatment of cervical incompetency. 

Debbs RH, DeLa Vega GA, Pearson S, Sehdev H, Marchiano D, Ludmir J. Transabdominal cerclage after comprehensive evaluation of women with previous unsuccessful transvaginal cerclage. 

Foster TL, Moore ES, Sumners JE. Operative complications and fetal morbidity encountered in 300 prophylactic transabdominal cervical cerclage procedures by one obstetric surgeon. 

Ades A, Parghi S, Aref-Adib M. Laparoscopic transabdominal cerclage: Outcomes of 121 pregnancies. 

Lesser KB, Childers JM, Surwit EA. Transabdominal cerclage: a laparoscopic approach. 

Smith RB, Brink J, Hu C, Gerkin R, Perlow JH, Mourad J. Robotic Transabdominal Cerclage vs Laparotomy: A Comparison of Obstetric and Surgical Outcomes. 

Clark NV, Einarsson JI. Laparoscopic abdominal cerclage: a highly effective option for refractory cervical insufficiency. 

Burger NB, Brölmann HA, Einarsson JI, Langebrekke A, Huirne JA. Effectiveness of abdominal cerclage placed via laparotomy or laparoscopy; systematic review. 

Xu J, Wang L, Yang W, Zhang Y. Intravesical invasion of a Mersilene tape and secondary stone formation. 

Hawkins E, Nimaroff M. Vaginal erosion of an abdominal cerclage 7 years after laparoscopic placement. 

Dandapani M, Pflugner LP, Fanning NS. Uterine Rupture at Term in a Patient With Abdominal Cerclage. 

Moawad GN, Tyan P, Bracke T, et al. Systematic Review of Transabdominal Cerclage Placed via Laparoscopy for the Prevention of Preterm Birth. 

Tulandi T, Alghanaim N, Hakeem G, Tan X. Pre and post-conceptional abdominal cerclage by laparoscopy or laparotomy. 

Dawood F, Farquharson RG. Transabdominal cerclage: preconceptual versus first trimester insertion. 

Sukur YE, Saridogan E. Tips and tricks for laparoscopic interval transabdominal cervical cerclage; a simplified technique. 

Smith AV, Cabrera R, Zomer MT, Ribeiro R, Talledo R, Kondo W. Laparoscopic Transabdominal Cerclage for Cervical Incompetence: A Feasible and Effective Treatment in 10 Steps. 

Ades A, Hawkins DP. Laparoscopic Transabdominal Cerclage and Subsequent Pregnancy Outcomes When Left In Situ. 

Dethier D, Lassey SC, Pilliod R, Einarsson JI, McElrath T, Bartz D. Uterine evacuation in the setting of transabdominal cerclage. 

Carter JF, Savage A, Soper DE. Laparoscopic removal of abdominal cerclage at 19 weeks’ gestation. 

Burger NB, van ‘t Hof EM, Huirne JAF. Removal of an Abdominal Cerclage by Colpotomy: A Novel and Minimally Invasive Technique. 

Articles

An effective option for refractory cervical insufficiency.

Laparoscopic abdominal cerclage

 Jon I. Einarsson, MD, PhD, MPH, and Nisse V. Clark, MD, discuss their novel technique for Essure reversal in this video. To read their full article, click 

Videos

Jon I. Einarsson, MD, PhD, MPH, and Nisse V. Clark, MD, discuss their novel technique for Essure reversal in this video.

Video: Essure Removal Tips

For over a decade, transcervical sterilization revolutionized gynecology by offering an office-based procedure for sterilization under local anesthesia. Essure® was the most successful hysteroscopic sterilization device on the market, approved for almost 16 years in the United States and with an estimated 750,000 devices sold worldwide.

While Essure proved to be very effective in preventing pregnancy, recent years have seen a dramatic rise in the number of adverse events (AEs) associated with it reported to the US Food and Drug Administration (FDA).

Several countries have withdrawn the product from the market and Bayer AG recently announced it will discontinue sales in the United States by the end of 2018.

A growing number of women are now seeking surgical removal of Essure due to suspected AEs such as pelvic pain, heavy bleeding, allergic reaction, and a multitude of other symptoms that may be related to the device.

Essure removal is typically performed laparoscopically by removing both fallopian tubes as well as the interstitial portion of the microinsert. Many women also choose to undergo a cornual wedge resection or hysterectomy to ensure that the device and any fragments are completely excised. 

Less commonly discussed is the issue of sterilization regret, a condition that affects up to 20% of sterilized women and likely some women with Essure.

Traditionally, Essure sterilization is considered irreversible due to extensive scarring along a large portion of the fallopian tube. Most patients desiring pregnancy after Essure are advised to undergo in vitro fertilization (IVF), a readily-available alternative that has shown some success with Essure in situ.

But what about women who desire removal of the device and restoration of fertility? For them, a procedure that removes the device and offers even a small chance of spontaneous pregnancy might be worthwhile. 

Essure reversal is uniquely challenging. The device’s polyethylene terephthalate fibers induce permanent fibrosis along almost half of the fallopian tube, including the interstitial segment. This leaves only a short segment of the distal fallopian tube available for direct attachment to the uterus. This type of procedure is termed a tubouterine anastomosis; a technique that dates back to the late 19

Tubouterine anastomosis was first described for treating women with proximal tubal occlusion unrelated to sterilization.

Proximal tubal occlusion can be caused by conditions such as chronic salpingitis, salpingitis isthmica nodosa, cornual fibroids, adhesive disease, and endometritis.

Long before IVF, tubal cannulation and tubouterine anastomosis were attempted to restore tubal patency in women with proximal tubal occlusion. Tubouterine anastomosis was classically an open procedure in which fundal hysterotomy or cornual wedge resection was performed for excision of the affected fallopian tube and reimplantation of the distal fallopian tube to the uterine cornua. Conception rates following the procedure were variable, ranging from 14% to 42% in the literature.

Montieth et al. are the only authors to publish their experience using tubouterine anastomosis to reverse Essure sterilization. Their technique uses a 5-to 10-cm laparotomy and transfundal posterior uterine incision or cornual wedge resection to reimplant the distal fallopian tubes into the uterine cornua. In a published series of 70 cases, the 12-month post-procedural conception rate was 36%.

A more up-to-date analysis on their website reports a 38% pregnancy rate  for 282 procedures performed over 9 years.

Also reported is a 5% ectopic rate and 4% uterine rupture rate. 

We have tested a new method for Essure reversal using a laparoscopic approach that does not require a large abdominal or uterine incision. With this method, laparoscopy and hysteroscopy are performed simultaneously to remove the device and reimplant the distal fallopian tube into a new site on the uterine fundus. We present a description and video of our technique as well as our experience with three cases.

The microinserts are identified and laparoscopic scissors are used to partially transect the fallopian tube at the distal end of the device (Figure 2). Electrosurgery is avoided to preserve as much healthy fallopian tube as possible. Once the distal end of the Essure device emerges, it is grasped laparoscopically and pulled out of the fallopian tube (Figure 3). The device uncoils and elongates as it is removed and can easily fracture. Pulling the device parallel to the tube and intermittently regrasping it near its exit from the tube can help avoid device fragmentation.

Simultaneous hysteroscopic guidance is used to ensure that the intracavitary portion of the microinsert is completely removed. We have found that a fractured device may appear to be completely removed laparoscopically, when in fact, a small portion of the proximal microinsert remains visible hysteroscopically. 

Once both Essure microinserts are removed, semi-rigid stents are inserted into the tubal ostia through the operative channel of a 5-mm hysteroscope (Figure 4). Despite insertion of the stents into the tubal ostia, the stents do not emerge from the proximal fallopian tube because of the fibrosis caused by Essure. In our experience, the device instead perforates the uterine fundus slightly posterior and medial to the tubouterine junction. Once the stent emerges, it is cannulated into the distal fallopian tube segment laparoscopically.

The distal fallopian tube is brought to the uterus along the stent and the anastomosis performed. Interrupted stitches are placed circumferentially around the new tubouterine junction with knots tied intracorporeally (Figure 5). Stitches are placed until the fallopian tube is well-approximated to the uterus and the stent is no longer visible. The process is repeated on the other side and the stents are removed. At the end of the procedure, chromopertubation is used to assess tubal patency (Figure 6).

Three laparoscopic Essure reversal procedures were performed at Brigham and Women’s Hospital between 2017 and 2018 using this technique (Table 1). All three patients were in their 20s when they underwent Essure sterilization and later regretted the procedure. All were experiencing side effects of the Essure device and had a history of spontaneous pregnancies prior to sterilization. The three women were 27 to 35 years of age at the time of Essure reversal. 

Operative time ranged from 87 to 142 minutes and estimated blood loss was minimal at 20 to 75 mL. All procedures were uncomplicated and patients were discharged home on the same day as surgery. A follow-up hysterosalpingogram was done 1 to 3 months following the procedure and showed bilateral patency in one case and unilateral patency in the other two cases. While restoration of tubal patency is promising, no pregnancies have occurred over a follow-up period of 5 to 11 months. If the patients are able to conceive, risk of uterine rupture may be reduced by avoiding a hysterotomy or cornual wedge resection. 

IVF is still a good option for most women who desire pregnancy after Essure, especially if the device is not causing symptoms. Literature on IVF for Essure regret is limited to a report of two cases, both of which resulted in a live birth.

Several small studies have also evaluated intentional placement of Essure prior to IVF for infertile women with hydrosalpinx.

In this setting, the microinserts occlude the proximal fallopian tube and prevent hydrosalpingeal fluid from spilling into the uterine cavity. A systematic review of Essure and IVF for infertile women with hydrosalpinx reported a 29% ongoing pregnancy and live birth rate.

Presumably, IVF success rates for Essure regret are greater than those in women with underlying infertility.

When weighing the risks and benefits of IVF compared to Essure reversal, it is worth considering what we know about IVF and tubal reanastomosis after tubal ligation. As with any fertility procedure, tubal reanastomosis after tubal ligation is more likely to benefit younger women.

A retrospective study by Boechxstaens et al. found that cumulative delivery rates were significantly greater after tubal reanastomosis compared to IVF in women younger than age 37 (72% vs. 52% over 72 months).

A decision analysis by Messinger et al found that tubal reanastomosis was more cost-effective for women younger than age 41, whereas IVF was more cost-effective for women aged 41 and older.

Essure reversal is also assumed to be less advantageous for older women. 

Essure reversal with tubouterine anastomosis is technically and functionally a different procedure from tubal reversal with end-to-end anastomosis of the fallopian tube. The greater extent of tubal damage following Essure sterilization is very likely to result in lower success rates than other tubal reversal procedures. While laparoscopic Essure reversal can restore tubal patency, it is currently unknown if it can result in a normal pregnancy. Nevertheless, the opportunity to remove a device associated with symptoms may prompt younger women with Essure regret to attempt reversal despite presumably low success rates.

The authors report no potential conflicts of interest with regard to this article.

Bayer. Essure permanent birth control. http://www.essure.com/what-is-essure. Accessed August 15, 2018.

Walter JR, Ghobadi CW, Hayman E, Xu S. Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance. Obstet Gynecol. 2017;129(1):10-19.

Mohan N. Bayer to stop selling Essure in the U.S. Wall Street Journal. July 20th, 2018.

Kamencic H, Thiel L, Karreman E, Thiel J. Does Essure cause significant de novo pain? a retrospective review of indications for second surgeries after Essure placement. J Minim Invasive Gynecol. 2016;23(7):1158-1162.

Clark NV, Rademaker D, Mushinski AA, Ajao MO, Cohen SL, Einarsson JI. Essure removal for the treatment of device-attributed symptoms: an expanded case series and follow-up survey. J Minim Invasive Gynecol. 2017;24(6):971-976.

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Arora P, Arora RS, Cahill D. Essure® for management of hydrosalpinx prior to in vitro fertilization-a systematic review and pooled analysis. BJOG. 2014;121:527–536.

Kerin JF, Cattanach S. Successful pregnancy outcome with the use of the in vitro fertilization after Essure hysteroscopic sterilization. Fertil Steril. 2007;87:1212.e1-4.

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De Silva PM, Chu JJ, Gallos ID, Vidyasagar AT, Robinson L, Coomarasamy A. Fallopian tube catheterization in the treatment of proximal tubal occlusion: a systematic review and meta-analysis. Hum Reprod. 2017;32(4):836-852.

Turck RC. Hysterosalpingostomy. NY Med J. 1909;89:1193-1196.

Williams GF. Tubo-uterine implantation with special reference to reversal of sterilization. Lancet. 1969;1(7599):825-827.

Green-Armytage VG. Tubo-uterine implantation. J Obstet Gynaecol Br Emp. 1957;64:47.

Diamond E. A comparison of gross and microsurgical techniques for repair of cornual occlusion in infertility: a retrospective study, 1968–1978. Fertil Steril. 1979;32:370-376.

Montieth CW, Berger GS, Zerden ML. pregnancy success after hysteroscopic sterilization reversal. Obstet Gynecol. 2014;124(6):1183-1189.

Tubal Reversal A Personal Choice. https://www.tubal-reversal.net/. Accessed August 15, 2018.

Trussel J, Guilbert E, Hedley A. Sterilization failure, sterilization reversal, and pregnancy after sterilization reversal in Quebec. Obstet Gynecol. 2003;101(4):677.

Boeckxstaens A, Devroey P, Collins J, Tournaye H. Getting pregnant after tubal sterilization: surgical reversal or IVF? Hum Reprod. 2007;22(10):2660.

Messinger LB, Alford CE, Csokmay JM, Henne MB, Mumford SL, Segars JH, Armstrong AY. Cost and efficacy comparison of in vitro fertilization and tubal anastomosis for women after tubal ligation. Fertil Steril. 2015;104(10):32-38. 

With the impending withdrawal of Essure from the US market, ob/gyns should know how to remove the device. The authors describe the traditional technique and their new approach.

Nisse V. Clark, MD, MPH

Articles

Laparoscopic abdominal cerclage

Video: Essure Removal Tips

Laparoscopic Essure tubal reversal: How we do it