Laparoscopic Management of Hysteroscopic Essure Sterilization Complications: Report of 3 Cases Hye-Chun Hur, MD,* Suketu M. Mansuria, MD, Beatrice A. Chen, MD, and Ted T. Lee, MD From the Department of Obstetrics and Gynecology, Beth Israel Medical Center, Harvard Medical School, Boston, Massachusetts (Dr. Hur) and Magee-Womens Hospital, University of Pittsburgh Medical School, Pittsburgh, Pennsylvania (Drs. Mansuria, Chen, and Lee).
ABSTRACT Hysteroscopic Essure sterilizations offer women and physicians another option for contraception. Overall, the procedure is simple to perform and highly efficacious, and as a result, has gained popularity among practicing gynecologists. Unfortunately, complications occur with any type of surgery. We report 3 cases of hysteroscopic Essure sterilization complications where the Essure microinsert was noted to be misplaced or where patients had persistent postprocedure pain in the setting of appropriately placed microinserts. In all 3 cases, the microinserts were successfully removed laparoscopically. Journal of Minimally Invasive Gynecology (2008) 15, 362–365 © 2008 AAGL. All rights reserved. Keywords:
Hysteroscopic sterilization; Complications; Laparoscopy; Hysteroscopy; Permanent sterilization
Many advantages of the hysteroscopic Essure sterilization procedure (Essure; Conceptus Inc., San Carlos, CA) have made this technique popular among gynecologists. The benefits of this minimally invasive technique are that it precludes abdominal incisions, avoids general anesthesia, requires less surgical time, entails shorter recovery, and has highly effective contraceptive success compared with wellknown laparoscopic sterilization techniques [1,7]. Studies have also shown that hysteroscopic sterilizations allow for greater institutional cost savings when compared with laparoscopic tubal ligations [5,6]. Formal training in hysteroscopic sterilizations has helped decrease the failure rate from 15% to 2%, enabling more gynecologists to be successful with this technique [2,3]. Growing familiarity with this technique is evidenced with decreased average length of procedure from 14 to 18 minutes to 8 minutes [1– 4]. The replacement of the braided catheter delivery system to the coil catheter also helped improve the successful bilateral microinsert placement rates from 92% to 98% [3,4].
The authors have no commercial, proprietary, or financial interest in the products or companies described in this article. Corresponding author: Hye-Chun Hur, MD, Beth Israel Deaconess Medical Center, Department of Obstetrics and Gynecology, KS-319, 330 Brookline Avenue, Boston, MA 02215. E-mail:
[email protected] Submitted May 16, 2007. Accepted for publication October 29, 2007. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ -see front matter © 2008 AAGL. All rights reserved. doi:10.1016/j.jmig.2007.10.008
Even with these advances, factors such as limited visibility during the procedure, hysteroscopic equipment malfunction, and uterine perforation can contribute to failed procedures. Fortunately, many of these limitations can be optimized with good surgical technique and understanding of the hysteroscopic equipment. Nonetheless, a 2% failure rate persists as a result of unavoidable factors that make coil placement impossible regardless of technique, such as tubal stenosis, occlusion, tortuosity, or spasm [3]. The disadvantages of hysteroscopic sterilization include its irreversibility, risk of tubal perforation, 3-month postprocedure hysterosalpingogram (HSG) used to confirm correct coil placement, reported cases of persistent postoperative pain, and failure of microinsert placement during the initial procedure as a result of unavoidable factors. Regardless of the many advantages of a hysteroscopic approach for sterilization, postoperative complications with any surgical procedure exist. We report 3 cases of hysteroscopic sterilization complications that were referred to our minimally invasive gynecologic surgical service and successfully managed laparoscopically. These cases are described below.
Case 1 A 34-year-old nulliparous woman who underwent an uncomplicated hysteroscopic sterilization procedure had a 3-month follow-up HSG notable for a displaced left tubal
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Fig. 1. Hysterosalpingogram 3 months after hysteroscopic sterilization showing displaced left microinsert.
microinsert with an appropriately placed right tubal microinsert (Fig. 1). The patient was asymptomatic at the time of this finding. The patient’s medical and surgical history was significant for idiopathic gastroparesis for which she had a gastric pacer. After the patient was counseled as to her treatment options, she elected to undergo laparoscopic removal of the misplaced microinsert with bilateral tubal ligation. The patient’s reoperation took place approximately 4 months after the initial hysteroscopic sterilization procedure. Intraoperatively, the misplaced microinsert was discovered in the right posterior cul-de-sac, adherent to the peritoneum with a small amount of adhesions to overlying bowel epiploica (Fig. 2). The adhesions were easily lysed with a combination of blunt and sharp dissection using the laparoscopic scissors. Monopolar energy was not applied because of the gastric pacer. Approximately 3 cm of the isthmic portion of the fallopian tube was coagulated with the bipolar forceps during the bilateral tubal ligation, especially near the cornual region where the microinsert was initially placed. The patient tolerated the procedure well and had an uncomplicated postoperative course.
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trasound findings were within normal limits. After extensive counseling regarding all treatment options, the patient requested laparoscopic removal of both microinserts without any further surgical sterilization techniques. She declined a tubal ligation or salpingectomy at the time of surgery even though she was counseled regarding her increased risks of ectopic pregnancy and our inability to guarantee continued sterilization without further contraceptive measures. The laparoscopic surgery took place approximately 8 months after the hysteroscopic sterilization. Intraoperatively, both fallopian tubes appeared within normal limits with no evidence of tubal perforation or erosion. There was no evidence of any pelvic pathology, such as endometriosis, which could explain her symptomatology. Each microinsert was laparoscopically palpated with the grasping forceps and noted to be appropriately placed at the uterotubal junction and isthmic portions of the fallopian tubes. Dilute vasopressin was injected on the antimesenteric border of the tubal isthmus and a linear salpingostomy was made at this site with the monopolar endoshears. The exposed microinserts were retrieved from the fibrosed endosalpinges of the fallopian tubes with minimal force (Fig. 3). There were no intraoperative complications and the patient recovered well postoperatively. A 3-month follow-up HSG revealed bilateral tubal occlusion and the patient’s pelvic pain and abnormal vaginal bleeding resolved. Case 3 A 31-year-old gravida 7, para 1-1-5-2 woman reported persistent right lower quadrant pain 3 months after a hysteroscopic sterilization procedure that was complicated by placement of 2 microinserts in the right fallopian tube. Her gynecologic history included an ectopic pregnancy for which she underwent a laparoscopic salpingostomy. The patient could not recall whether the ectopic involved the
Case 2 A 31-year-old gravida 2, para 2 woman had an HSG revealing correctly placed bilateral microinserts 3 months after an uncomplicated hysteroscopic sterilization procedure. She complained of bilateral lower abdominal and pelvic pain along with irregular vaginal bleeding. On examination, the patient had bilateral adnexal tenderness. Ul-
Fig. 2. Adhesions from peritoneum and bowel epiploica surrounding the misplaced microinsert.
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Fig. 3. Appearance of fallopian tubes after laparoscopic removal of bilateral microinserts.
right or left tube. She also had a history of cervical dysplasia managed by 2 loop electrosurgical excision procedures. Her obstetric history included her 1 ectopic pregnancy, 4 prior spontaneous abortions, a full-term vaginal delivery, and a preterm vaginal delivery secondary to preterm labor and preterm premature rupture of the membranes. Her medical and surgical history was otherwise insignificant. During the hysteroscopic sterilization procedure, the surgeon had difficulty deploying the right microinsert from the catheter. The Essure catheter was threaded through the right tubal ostia without difficulty to the appropriate level where the black positioning marker reaches the fallopian tube ostium. When rotating the thumbwheel back, the instrument did not withdraw the protective sheath in the usual fashion to expose the orange release catheter. The button to deploy the device was pressed, and the sheath still did not retract. The surgeon concluded there was an instrument failure and replaced the original catheter with another device. A second device was used to successfully deploy the microinsert into the right tubal ostia. Finally, a third device was used to place a microinsert into the left ostia. At the end of the case, 4 coils from the right ostia and 8 coils from the left ostia were visualized. Postoperatively, the patient was admitted overnight for pain control. She had abdominal and pelvic pain not relieved with intravenous morphine or ketoralac. A computed tomography scan of the abdomen and pelvis revealed 2 microinserts located within the right tube and one in the left. Free fluid was noted in the dependent portions of the pelvis and no other abnormalities were seen. A diagnostic laparoscopy was performed on postoperative day 1 to rule out a tubal perforation. Inspection of the abdomen and pelvis revealed no evidence of tubal perforation, a normal appendix, and no other pathology to explain the patient’s symptoms. The patient was transitioned to oral pain drugs and discharged home. Three days after her initial surgery, the patient came to the emergency department with persistent
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pain. Abdominal radiograph series revealed no evidence of free air. The patient was discharged home with pain drugs and precautions. At the 3-month follow-up HSG, the patient continued to have persistent pain, both at rest and during intercourse. Because the scout films for the HSG showed 2 coils that appeared abnormally positioned on the right and 1 correctly positioned coil on the left, the HSG was not performed. Given the patient’s persistent symptoms, the patient returned to the operating department approximately 4 months after the initial hysteroscopic sterilization for laparoscopic removal of the right microinserts and right salpingectomy. Laparoscopic findings revealed normal-appearing tubes bilaterally without evidence of any tubal abnormalities, perforation, or erosion. The 2 microinserts within the right fallopian tube were palpated laparoscopically and noted to be lying end to end in succession without overlap. A portion of the right fallopian tube between the ends of the 2 microinserts was incised to expose the tips of each microinsert. The distal and proximal microinserts were visualized and pulled out of the tube without difficulty (Fig. 4). Although the inserts were noted to be fibrosed within the endosalpinx, the level of fibrosis did not require significant force to retrieve the inserts from the fallopian tube. A right salpingectomy was then performed, removing the entire length of the right fallopian tube. Chromotubation was performed and there was no extravasation of dye from the left fallopian tube or right cornua (uterotubal junction). The patient tolerated the procedure well and was discharged home in stable condition that same day. Discussion Permanent sterilization techniques have evolved tremendously during the past several decades. The search for an ideal sterilization technique has been under way for more than a century. With the Food and Drug Administration’s approval of the Essure microinsert hysteroscopic sterilization system in November 2002, gynecologists have been armed with a noninvasive form of permanent sterilization that appears to be safe and effective [1– 4]. As with any surgical procedure, postoperative complications exist. The data on the incidence and types of complications associated with the hysteroscopic sterilization pro-
Fig. 4. Left, Removed Essure microinsert from right fallopian tube. Right, Essure microinsert in pieces after laparoscopic removal.
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Fig. 5. Essure microinsert. (Reprinted with permission from Conceptus Inc., San Carlos, CA.)
cedure are limited. To our knowledge, this is the first publication to report successful laparoscopic removal of microinserts from complicated hysteroscopic Essure sterilizations beyond the 12-week postoperative period. There is one other case report that describes removal of the microinserts within 5 to 6 weeks of initial placement [8]. Typically, the Essure device is believed to induce an inflammatory response that causes fibrosis and complete tubal occlusion within 12 weeks of insertion [9]. In the past, the Conceptus Inc. web site (www.essure.com) stated “a cornual resection of the proximal fallopian tube will be required if the microinsert is properly located across the uterotubal junction.” However, we performed a linear salpingostomy and removed the microinserts laparoscopically without tubal bleeding and avoided a cornual resection altogether. Although the microinserts did induce fibrosis within the endosalpinx, the amount of fibrosis was limited such that the microinserts could be dissected and removed with minimal force applied. The microinserts were removed laparoscopically as far as 8 months postoperatively from the date of initial microinsert placement. For the patient in the first case report where the microinsert was located in the right posterior cul-de-sac with adhesions attached to the surrounding bowel epiploica and peritoneum, these adhesions were easily lysed laparoscopically with only a small amount of fibrosis noted around the displaced microinsert. To ensure successful removal of the microinsert, it is important to note that the microinsert comes with several parts (Fig. 5). Careful attention must be paid to remove the entire specimen (both the outer coil and the inner shaft) intact if possible. On its removal, the microinsert should be carefully inspected to ensure that all its parts have been removed. It is also worthy for the gynecologic surgeon inserting the hysteroscopic microinsert to familiarize oneself with the appearance of the Essure device after deployment. If there is any question regarding possible malfunction of the device, one may consider an intraoperative pelvic radiograph to assess coil placement before inserting another device. As in the third case report, the microinsert may be inserted too deep into the tubal ostium without visible coils,
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misleading the gynecologist to think the microinsert did not deploy. It is also interesting to note that the patient in case 2 had persistent bilateral tubal occlusion at her HSG after laparoscopic removal of both microinserts. These finding suggest fibrosis of the endosalpinges resulting in tubal occlusion may persist even after removal of these devices. Even with this finding, we recommend the use of an alternative mode of contraception after microinsert removal given the lack of data. Furthermore, although the devices can be removed laparoscopically, the persistent fibrosis indicated by the bilateral tubal occlusion supports the idea that hysteroscopic Essure sterilization procedures are irreversible and should be considered permanent. We suspect more hysteroscopic sterilization complications (both displaced microinserts and postprocedure pain) will occur as the number of hysteroscopic sterilizations performed continues to grow. From our experience, we believe a laparoscopic approach to remove Essure microinserts followed by a tubal ligation or bilateral salpingectomy is a safe and feasible minimally invasive option that can help avoid more extensive surgery and provide permanent sterilization for the patient. References 1. Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicenter phase II study. Hum Reprod. 2003;18:1223–1230. 2. Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust N Z J Obstet Gynecol. 2001;41:364 – 370. 3. Kerin JF, Munday DN, Ritossa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc. 2004;11:388 –393. 4. Cooper JM, Carnigan CS, Cher D, Kerin JF. Micro-insert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102:59 – 67. 5. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis. J Minim Invasive Gynecol. 2005;12:318 –322. 6. Hopkins MR, Creedon DJ, Wagie AE, Williams AR, Famuyide AO. Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation. J Minim Invasive Gynecol. 2007;14:97–102. 7. Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, et al. Female sterilization: a cohort controlled comparative study of Essure versus laparoscopic sterilization. Br J Obstet Gynaecol. 2005;112: 1522–1528. 8. Lannon BM, Lee SY. Techniques for removal of the Essure hysteroscopic tubal occlusion device. Fertil Steril. 2007;88:497e13– 497e14. 9. Valle RF, Carigan CS, Wright TC, STOP Prehysterectomy Investigation Group. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril. 2001;76:974 –980.
