Clinical Review

Best practices for evaluating pelvic pain in patients with Essure tubal occlusion devices

OBG Manag. 2022 July;34(7):33-36, 38-39 | doi: 10.12788/obgm.0209

References

Connor VF. Essure: a review six years later. J Minim Invasive Gynecol. 2009;16:282-290. doi:10.1016/j.jmig.2009.02.009.
Casey J, Aguirre F, Yunker A. Outcomes of laparoscopic removal of the Essure sterilization device for pelvic pain: a case series. Contraception. 2016;94:190-192. doi:10.1016/j.contraception.2016.03.017.
Jackson I. Essure device removed entirely from market, with 99% of unused birth control implants retrieved: FDA. AboutLawsuits.com. January 13, 2020. https://www.aboutlawsuits.com/Essure-removal-update-166509. Accessed June 7, 2022.
US Food and Drug Administration. Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization. October 31, 2016. https://www.fda.gov/media/96315/download. Accessed June 7, 2022.
US Food and Drug Administration. FDA activities related to Essure. March 14, 2022. https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure. Accessed June 8, 2022.
Arjona Berral JE, Rodríguez Jiménez B, Velasco Sánchez E, et al. Essure and chronic pelvic pain: a population-based cohort. J Obstet Gynaecol. 2014;34:712-713. doi:10.3109/01443615.2014.92075.
Clark NV, Rademaker D, Mushinski AA, et al. Essure removal for the treatment of device-attributed symptoms: an expanded case series and follow-up survey. J Minim Invasive Gynecol. 2017;24:971-976. doi:10.1016/j.jmig.2017.05.015.
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.
Administration USF and D. 522 Postmarket Surveillance Studies. Center for Devices and Radiological Health; 2020.
Kamencic H, Thiel L, Karreman E, et al. Does Essure cause significant de novo pain? A retrospective review of indications for second surgeries after Essure placement. J Minim Invasive Gynecol. 2016;23:1158-1162. doi:10.1016/j.jmig.2016.08.823.
Yunker AC, Ritch JM, Robinson EF, et al. Incidence and risk factors for chronic pelvic pain after hysteroscopic sterilization. J Minim Invasive Gynecol. 2015;22:390-994. doi:10.1016/j.jmig.2014.06.007.
Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011;25:141-154. doi:10.1016/j.berh.2011.02.005.
van Limburg Stirum EVJ, Clark NV, Lindsey A, et al. Factors associated with negative patient experiences with Essure sterilization. JSLS. 2020;24(1):e2019.00065. doi:10.4293/JSLS.2019.00065.
Brito LG, Cohen SL, Goggins ER, et al. Essure surgical removal and subsequent symptom resolution: case series and follow-up survey. J Minim Invasive Gynecol. 2015;22:910-913. doi:10.1016/j.jmig.2015.03.018.
Maassen LW, van Gastel DM, Haveman I, et al. Removal of Essure sterilization devices: a retrospective cohort study in the Netherlands. J Minim Invasive Gynecol. 2019;26:1056-1062. doi:10.1016/j.jmig.2018.10.009.
Sills ES, Palermo GD. Surgical excision of Essure devices with ESHRE class IIb uterine malformation: sequential hysteroscopic-laparoscopic approach to the septate uterus. Facts Views Vis Obgyn. 2016;8:49-52.
Ricci G, Restaino S, Di Lorenzo G, et al. Risk of Essure microinsert abdominal migration: case report and review of literature. Ther Clin Risk Manag. 2014;10:963-968. doi:10.2147/TCRM.S65634.
Borley J, Shabajee N, Tan TL. A kink is not always a perforation: assessing Essure hysteroscopic sterilization placement. Fertil Steril. 2011;95:2429.e15-7. doi:10.1016/j.fertnstert.2011.02.006.
Djeffal H, Blouet M, Pizzoferato AC, et al. Imaging findings in Essure-related complications: a pictorial review.7Br J Radiol. 2018;91(1090):20170686. doi:10.1259/bjr.20170686.
Lora Alcantara I, Rezai S, Kirby C, et al. Essure surgical removal and subsequent resolution of chronic pelvic pain: a case report and review of the literature. Case Rep Obstet Gynecol. 2016;2016:6961202. doi:10.1155/2016/6961202.
Mahmoud MS, Fridman D, Merhi ZO. Subserosal misplacement of Essure device manifested by late-onset acute pelvic pain. Fertil Steril. 2009;92:2038.e1-3. doi:10.1016/j.fertnstert.2009.07.1677.
Tissot M, Petry S, Lecointre L, et al. Two surgical techniques for Essure device ablation: the hysteroscopic way and the laparoscopic way by salpingectomy with tubal interstitial resection. J Minim Invasive Gynecol. 2019;26(4):603. doi:10.1016/j.jmig.2018.07.017.
Chene G, Cerruto E, Moret S, et al. Quality of life after laparoscopic removal of Essure sterilization devices. Eur J Obstet Gynecol Reprod Biol X. 2019;3:100054. doi:10.1016/j.eurox.2019.100054.
Thiel L, Rattray D, Thiel J. Laparoscopic cornuectomy as a technique for removal of Essure microinserts. J Minim Invasive Gynecol. 2017;24(1):10. doi:10.1016/j.jmig.2016.07.004.
Charavil A, Agostini A, Rambeaud C, et al. Vaginal hysterectomy with salpingectomy for Essure insert removal. J Minim Invasive Gynecol. 2019;2:695-701. doi:10.1016/j.jmig.2018.07.019.
Howard DL, Christenson PJ, Strickland JL. Use of intraoperative fluoroscopy during laparotomy to identify fragments of retained Essure microinserts: case report. J Minim Invasive Gynecol. 2012;19:667-670. doi:10.1016/j.jmig.2012.04.007.
Miquel L, Crochet P, Francini S, et al. Laparoscopic Essure device removal by en bloc salpingectomy-cornuectomy with intraoperative x-ray checking: a retrospective cohort study. J Minim Invasive Gynecol. 2020;27:697-703. doi:10.1016/j. jmig.2019.06.006.

Device removal and patient outcomes

Removal

Several studies that we evaluated included a discussion on the methods for Essure removal. which are divided into 2 general categories: hysteroscopy and laparoscopy.

Hysteroscopic removal is generally used when the device was placed less than 12 weeks prior to removal.^7,19 After 12 weeks, removal is more difficult due to fibrosis within the fallopian tubes. A risk with hysteroscopic removal is failure to remove all fibers, which allows inflammation and fibrosis to continue.⁷ This risk is mitigated via laparoscopic hysterectomy or mini-cornuectomy with bilateral salpingectomy, where the devices can be removed en bloc and without excessive traction.

Laparoscopic Essure removal procedures described in the literature include salpingostomy and traction on the device, salpingectomy, and salpingectomy with mini-cornuectomy. The incision and traction method is typically performed via a 2- to 3-cm incision on the antimesial edge of the fallopian tube along with a circumferential incision to surround the interstitial tubal area. The implant is carefully extracted from the fallopian tube and cornua, and a salpingectomy is then performed.²² The implant is removed prior to the salpingectomy to ensure that the Essure device is removed in its entirety prior to performing a salpingectomy.

A prospective observational study evaluated laparoscopic removal of Essure devices in 80 women with or without cornual excision. Results suggest that the incision and traction method poses more technical difficulties than the cornuectomy approach.²³ Surgeons reported significant difficulty controlling the tensile pressure with traction, whereas use of the cornuectomy approach eliminated this risk and decreased the risk of fragmentation and incomplete removal.^23,24

Charavil and colleagues demonstrated in a prospective observational study that a vaginal hysterectomy with bilateral salpingectomy is a feasible approach to Essure removal. Twenty-six vaginal hysterectomies with bilateral salpingectomy and Essure removal were performed without conversion to laparoscopy or laparotomy. The surgeons performed an en bloc removal of each hemiuterus along with the ipsilateral tube, which ensured complete removal of the Essure device. Each case was confirmed with an x-ray of the surgical specimen.²⁵

If device fragmentation occurs, there are different methods recommended for locating fragments. A case report of bilateral uterine perforation after uncomplicated Essure placement used a preoperative computed tomography (CT) scan to locate the Essure fragments, but no intraoperative imaging was performed to confirm complete fragment removal.²⁶ The patient continued reporting chronic pelvic pain and ultimately underwent exploratory laparotomy with intraoperative fluoroscopy. Using fluoroscopy, investigators identified omental fragments that were missed on preoperative CT imaging. Fluoroscopy is not commonly used intraoperatively, but it may have added benefit for localizing retained fragments.

A retrospective cohort study reviewed the use of intraoperative x-ray of the removed specimen to confirm complete Essure removal.²⁷ If an x-ray of the removed specimen showed incomplete removal, an intraoperative pelvic x-ray was performed to locate missing fragments. X-ray of the removed devices confirmed complete removal in 63 of 72 patients (87.5%). Six of 9 women with an unsatisfactory specimen x-ray had no residual fragments identified during pelvic x-ray, and the device removal was deemed adequate. The remaining 3 women had radiologic evidence of incomplete device removal and required additional dissection for complete removal. Overall, use of x-ray or fluoroscopy is a relatively safe and accessible way to ensure complete removal of the Essure device and is worth consideration, especially when retained device fragments are suspected.

Symptom resolution

We reviewed 5 studies that examined pain outcomes after removal of the Essure devices. Casey et al found that 23 of 26 patients (88.5%) reported significant pain relief at the postoperative visit, while 3 of 26 (11.5%) reported persistent pelvic pain.² Two of 3 case series examined other outcomes in addition to postoperative pelvic pain, including sexual function and activities of daily living.^7,14 In the first case series by Brito and colleagues, 8 of 11 patients (72.7%) reported an improvement in pelvic pain, ability to perform daily activities, sexual life, and overall quality of life after Essure removal. For the remaining 3 patients with persistent pelvic pain after surgical removal of the device, 2 patients reported worsening pain symptoms and dyspareunia.¹⁴ In this study, 5 of 11 patients reported a history of chronic pelvic pain at baseline. In a retrospective case series by Clark et al, 28 of 32 women (87.5%) reported some improvement in all domains, with 24 of 32 patients (75%) reporting almost total or complete improvement in quality of life, sexual life, pelvic pain, and scores related to activities of daily living. Pain and quality-of-life scores were similar for women who underwent uterine-preserving surgery and for those who underwent hysterectomy. Ten of 32 women (31.3%) reported persistent or worsening symptoms after the Essure removal surgery. In these patients, the authors recommended consideration of other autoimmune and hypersensitivity etiologies.⁷

In a retrospective cohort study by Kamencic et al from 2002 to 2013 of 1,430 patients who underwent Essure placement with postplacement imaging, 62 patients (4.3%) required a second surgery after Essure placement due to pelvic pain.¹⁰ This study also found that 4 of 62 patients (0.3%) had no other obvious cause for the pelvic pain. All 4 of these women had complete resolution of their pain with removal of the Essure microinsert device. A prospective observational study by Chene et al examined health-related quality-of-life outcomes in 80 women who underwent laparoscopic Essure removal for pelvic pain. This survey study demonstrated significant improvement in the quality of life in both psychological and physical aspects, and these results were maintained at 3- and 6-month follow-up examinations.²³

Summary

Although Essure products were withdrawn from the market in the United States in 2018, many patients still experience significant AEs associated with the device. The goal of the perspectives and data presented here is to assist clinicians in addressing and managing the pain experienced by patients after device insertion. ●

References

Connor VF. Essure: a review six years later. J Minim Invasive Gynecol. 2009;16:282-290. doi:10.1016/j.jmig.2009.02.009.
Casey J, Aguirre F, Yunker A. Outcomes of laparoscopic removal of the Essure sterilization device for pelvic pain: a case series. Contraception. 2016;94:190-192. doi:10.1016/j.contraception.2016.03.017.
Jackson I. Essure device removed entirely from market, with 99% of unused birth control implants retrieved: FDA. AboutLawsuits.com. January 13, 2020. https://www.aboutlawsuits.com/Essure-removal-update-166509. Accessed June 7, 2022.
US Food and Drug Administration. Labeling for permanent hysteroscopically-placed tubal implants intended for sterilization. October 31, 2016. https://www.fda.gov/media/96315/download. Accessed June 7, 2022.
US Food and Drug Administration. FDA activities related to Essure. March 14, 2022. https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure. Accessed June 8, 2022.
Arjona Berral JE, Rodríguez Jiménez B, Velasco Sánchez E, et al. Essure and chronic pelvic pain: a population-based cohort. J Obstet Gynaecol. 2014;34:712-713. doi:10.3109/01443615.2014.92075.
Clark NV, Rademaker D, Mushinski AA, et al. Essure removal for the treatment of device-attributed symptoms: an expanded case series and follow-up survey. J Minim Invasive Gynecol. 2017;24:971-976. doi:10.1016/j.jmig.2017.05.015.
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.
Administration USF and D. 522 Postmarket Surveillance Studies. Center for Devices and Radiological Health; 2020.
Kamencic H, Thiel L, Karreman E, et al. Does Essure cause significant de novo pain? A retrospective review of indications for second surgeries after Essure placement. J Minim Invasive Gynecol. 2016;23:1158-1162. doi:10.1016/j.jmig.2016.08.823.
Yunker AC, Ritch JM, Robinson EF, et al. Incidence and risk factors for chronic pelvic pain after hysteroscopic sterilization. J Minim Invasive Gynecol. 2015;22:390-994. doi:10.1016/j.jmig.2014.06.007.
Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011;25:141-154. doi:10.1016/j.berh.2011.02.005.
van Limburg Stirum EVJ, Clark NV, Lindsey A, et al. Factors associated with negative patient experiences with Essure sterilization. JSLS. 2020;24(1):e2019.00065. doi:10.4293/JSLS.2019.00065.
Brito LG, Cohen SL, Goggins ER, et al. Essure surgical removal and subsequent symptom resolution: case series and follow-up survey. J Minim Invasive Gynecol. 2015;22:910-913. doi:10.1016/j.jmig.2015.03.018.
Maassen LW, van Gastel DM, Haveman I, et al. Removal of Essure sterilization devices: a retrospective cohort study in the Netherlands. J Minim Invasive Gynecol. 2019;26:1056-1062. doi:10.1016/j.jmig.2018.10.009.
Sills ES, Palermo GD. Surgical excision of Essure devices with ESHRE class IIb uterine malformation: sequential hysteroscopic-laparoscopic approach to the septate uterus. Facts Views Vis Obgyn. 2016;8:49-52.
Ricci G, Restaino S, Di Lorenzo G, et al. Risk of Essure microinsert abdominal migration: case report and review of literature. Ther Clin Risk Manag. 2014;10:963-968. doi:10.2147/TCRM.S65634.
Borley J, Shabajee N, Tan TL. A kink is not always a perforation: assessing Essure hysteroscopic sterilization placement. Fertil Steril. 2011;95:2429.e15-7. doi:10.1016/j.fertnstert.2011.02.006.
Djeffal H, Blouet M, Pizzoferato AC, et al. Imaging findings in Essure-related complications: a pictorial review.7Br J Radiol. 2018;91(1090):20170686. doi:10.1259/bjr.20170686.
Lora Alcantara I, Rezai S, Kirby C, et al. Essure surgical removal and subsequent resolution of chronic pelvic pain: a case report and review of the literature. Case Rep Obstet Gynecol. 2016;2016:6961202. doi:10.1155/2016/6961202.
Mahmoud MS, Fridman D, Merhi ZO. Subserosal misplacement of Essure device manifested by late-onset acute pelvic pain. Fertil Steril. 2009;92:2038.e1-3. doi:10.1016/j.fertnstert.2009.07.1677.
Tissot M, Petry S, Lecointre L, et al. Two surgical techniques for Essure device ablation: the hysteroscopic way and the laparoscopic way by salpingectomy with tubal interstitial resection. J Minim Invasive Gynecol. 2019;26(4):603. doi:10.1016/j.jmig.2018.07.017.
Chene G, Cerruto E, Moret S, et al. Quality of life after laparoscopic removal of Essure sterilization devices. Eur J Obstet Gynecol Reprod Biol X. 2019;3:100054. doi:10.1016/j.eurox.2019.100054.
Thiel L, Rattray D, Thiel J. Laparoscopic cornuectomy as a technique for removal of Essure microinserts. J Minim Invasive Gynecol. 2017;24(1):10. doi:10.1016/j.jmig.2016.07.004.
Charavil A, Agostini A, Rambeaud C, et al. Vaginal hysterectomy with salpingectomy for Essure insert removal. J Minim Invasive Gynecol. 2019;2:695-701. doi:10.1016/j.jmig.2018.07.019.
Howard DL, Christenson PJ, Strickland JL. Use of intraoperative fluoroscopy during laparotomy to identify fragments of retained Essure microinserts: case report. J Minim Invasive Gynecol. 2012;19:667-670. doi:10.1016/j.jmig.2012.04.007.
Miquel L, Crochet P, Francini S, et al. Laparoscopic Essure device removal by en bloc salpingectomy-cornuectomy with intraoperative x-ray checking: a retrospective cohort study. J Minim Invasive Gynecol. 2020;27:697-703. doi:10.1016/j. jmig.2019.06.006.

Best practices for evaluating pelvic pain in patients with Essure tubal occlusion devices

References

Device removal and patient outcomes

Removal

Symptom resolution

Summary

Pages

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