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

Natalie Shammas, MD

Angela Qu, DO

Katherine Woodburn, MD

Elizabeth Brunn, MD

Vadim Morozov, MD

James Robinson, MD

Cheryl B. Iglesia, MD

Nicolas D. Hazen, MD

The authors review adverse outcomes of tubal occlusion devices and data on how and when to remove them

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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.

The evaluation and management of chronic pelvic pain in patients with a history of Essure device (Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey) insertion have posed many challenges for both clinicians and patients. The availability of high-quality, evidence-based clinical guidance has been limited. We have reviewed the currently available published data, and here provide an overview of takeaways, as well as share our perspective and approach on evaluating and managing chronic pelvic pain in this unique patient population.

The device

The Essure microinsert is a hysteroscopically placed device that facilitates permanent sterilization by occluding the bilateral proximal fallopian tubes. The microinsert has an inner and outer nitinol coil that attaches the device to the proximal fallopian tube to ensure retention. The inner coil releases polyethylene terephthalate fibers that cause tubal fiber proliferation to occlude the lumen of the fallopian tube and achieve sterilization.

The device was first approved by the US Food and Drug Administration (FDA) in 2002. In subsequent years, the device was well received and widely used, with approximately 750,000 women worldwide undergoing Essure placement.^1,2 Shortly after approval, many adverse events (AEs), including pelvic pain and abnormal uterine bleeding, were reported, resulting in a public meeting of the FDA Obstetrics and Gynecology Devices Panel in September 2015. A postmarket surveillance study on the device ensued to assess complication rates including unplanned pregnancy, pelvic pain, and surgery for removal. In February 2016, the FDA issued a black box warning and a patient decision checklist.^3,4 In December 2018, Bayer stopped selling and distributing Essure in the United States.⁵ A 4-year follow-up surveillance study on Essure was submitted to the FDA in March 2020.

Adverse outcomes

Common AEs related to the Essure device include heavy uterine bleeding, pelvic pain, and other quality-of-life symptoms such as fatigue and weight gain.^6-8 The main safety endpoints for the mandated FDA postmarket 522 surveillance studies were chronic lower abdominal and pelvic pain; abnormal uterine bleeding; hypersensitivity; allergic reaction, as well as autoimmune disorders incorporating inflammatory markers and human leukocyte antigen; and gynecologic surgery for device removal.⁹ Postmarket surveillence has shown that most AEs are related to placement complications or pelvic pain after Essure insertion. However, there have been several reports of autoimmune diseases categorized as serious AEs, such as new-onset systemic lupus erythematosus, rheumatoid arthritis, and worsening ulcerative colitis, after Essure insertion.⁵

Evaluation of symptoms

Prevalence of pelvic pain following device placement

We conducted a PubMed and MEDLINE search from January 2000 to May 2020, which identified 43 studies citing AEs related to device placement, including pelvic or abdominal pain, abnormal uterine bleeding, hypersensitivity, and autoimmune disorders. A particularly debilitating and frequently cited AE was new-onset pelvic pain or worsening of preexisting pelvic pain. Perforation of the uterus or fallopian tube, resulting in displacement of the device into the peritoneal cavity, or fragmentation of the microinsert was reported as a serious AE that occurred after device placement. However, due to the complexity of chronic pelvic pain pathogenesis, the effect of the insert on patients with existing chronic pelvic pain remains unknown.

Authors of a large retrospective study found that approximately 2.7% of 1,430 patients developed new-onset or worsening pelvic pain after device placement. New-onset pelvic pain in 1% of patients was thought to be secondary to device placement, without a coexisting pathology or diagnosis.¹⁰

In a retrospective study by Clark and colleagues, 22 of 50 women (44%) with pelvic pain after microinsert placement were found to have at least one other cause of pelvic pain. The most common alternative diagnoses were endometriosis, adenomyosis, salpingitis, and adhesive disease. Nine of the 50 patients (18%) were found to have endometriosis upon surgical removal of the microinsert.⁷

Another case series examined outcomes in 29 patients undergoing laparoscopic device removal due to new-onset pelvic pain. Intraoperative findings included endometriosis in 5 patients (17.2%) and pelvic adhesions in 3 (10.3%).² Chronic pelvic pain secondary to endometriosis may be exacerbated with Essure insertion due to discontinuation of hormonal birth control after device placement,⁷ and this diagnosis along with adenomyosis should be strongly considered in patients whose pelvic pain began when hormonal contraception was discontinued after placement of the device.

Continue to: Risk factors...

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.

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

References

The device

Adverse outcomes

Evaluation of symptoms

Prevalence of pelvic pain following device placement

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