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.

Risk factors

Authors of a retrospective cohort study found that patients with prior diagnosis of a chronic pain syndrome, low back pain, headaches, or fibromyalgia were 5 to 6 times more likely to report acute and chronic pain after hysteroscopic sterilization with Essure.¹¹ Since chronic pain is often thought to be driven by a hyperalgesic state of the central nervous system, as previously shown in patients with conditions such as vulvodynia, interstitial cystitis, and fibromyalgia,¹² a hyperalgesic state can potentially explain why some patients are more susceptible to developing worsening pain.

Van Limburg and colleagues conducted a retrospective cohort study with prospective follow-up on 284 women who underwent Essure sterilization. Among these patients, 48% reported negative AEs; risk factors included young age at placement, increasing gravidity, and no prior abdominal surgery.¹³

Onset of pain

The timing and onset of pelvic pain vary widely, suggesting there is no particular time frame for this AE after device placement.^2,6,14-18A case series by Arjona and colleagues analyzed the incidence of chronic pelvic pain in 4,274 patients after Essure sterilization. Seven patients (0.16%) reported chronic pelvic pain that necessitated device removal. In 6 of the women, the pelvic pain began within 1 week of device placement. In 3 of the 6 cases, the surgeon reported the removal procedures as “difficult.” In all 6 cases, the level of pelvic pain increased with time and was not alleviated with standard analgesic medications.⁶

In another case series of 26 patients, the authors evaluated patients undergoing laparoscopic removal of Essure secondary to pelvic pain and reported that the time range for symptom presentation was immediate to 85 months. Thirteen of 26 patients (50%) reported pain onset within less than 1 month of device placement, 5 of 26 patients (19.2%) reported pain between 1 and 12 months after device placement, and 8 of 26 patients (30.8%) reported pain onset more than 12 months after microinsert placement.² In this study, 17.2% of operative reports indicated difficulty with device placement. It is unclear whether difficulty with placement was associated with development of subsequent abdominal or pelvic pain; however, the relevance of initial insertion difficulty diminished with longer follow-up.

Workup and evaluation

We found 5 studies that provided some framework for evaluating a patient with new-onset or worsening pelvic pain after microinsert placement. Overall, correct placement and functionality of the device should be confirmed by either hysterosalpingogram (HSG) or transvaginal ultrasonography (TVUS). The gold standard to determine tubal occlusion is the HSG. However, TVUS may be a dependable alternative, and either test can accurately demonstrate Essure location.¹⁹ Patients often prefer TVUS over HSG due to the low cost, minimal discomfort, and short examination time.¹ TVUS is a noninvasive and reasonable test to start the initial assessment. The Essure devices are highly echogenic on pelvic ultrasound and easily identifiable by the proximity of the device to the uterotubal junction and its relationship with the surrounding soft tissue. If the device perforates the peritoneal cavity, then the echogenic bowel can impede adequate visualization of the Essure microinsert. If the Essure insert is not visualized on TVUS, an HSG will not only confirm placement but also test insert functionality. After confirming correct placement of the device, the provider can proceed with standard workup for chronic pelvic pain.

If one or more of the devices are malpositioned, the devices are generally presumed to be the etiology of the new pain. Multiple case reports demonstrate pain due to Essure misconfiguration or perforation with subsequent resolution of symptoms after device removal.^18,20,21 A case study by Alcantara and colleagues described a patient with chronic pelvic pain and an Essure coil that was curved in an elliptical shape, not adhering to the anatomic course of the fallopian tube. The patient reported pain resolution after laparoscopic removal of the device.²⁰ Another case report by Mahmoud et al described a subserosal malpositioned device that caused acute pelvic pain 4 months after sterilization. The patient reported resolution of pain after the microinsert was removed via laparoscopy.²¹ These reports highlight the importance of considering malpositioned devices as the etiology of new pelvic pain after Essure placement.

Continue to: Device removal and patient outcomes...

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

Risk factors

Onset of pain

Workup and evaluation

Pages

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