Essure Sterilization in Patients with History of Pelvic Inflammatory Disease and Hydrosalpinges: An Analysis on Feasibility and Clinical Outcomes

Introduction

In modern industrialized countries, the annual incidence of pelvic inflammatory disease (PID) in women 15–39 years of age is estimated as 10–13/1,000 women, with a peak incidence of ∼20/1,000 women in the 20–24 year age group. Since 1960, an increase in incidence by a factor of 1.6–1.9 has been observed in the 20–29 year age group. The incidence of PID is correlated strongly with the prevalence of sexually transmitted diseases (STDs), although a fraction of the infections might be of endogenous origin. ¹ In the Dallas area, chlamydia, with gonorrhea a close second, is the most frequently reported bacterial STD. ² Even so, cases are under-reported because most people with chlamydia do not have any symptoms. Dallas County STD statistics for 2008 place the chlamydia infection rate at 578.9/100,000 people, with a rate of 217.1/100,000 for gonorrhea. ²

Complementary to this prevalence of PID is the frequency of permanent sterilization. Currently, 700,000 sterilizations are performed annually in the United States, ³ with roughly half of them being laparoscopic in the female population. Sterilization is the most common form of birth control (BC) worldwide (190,000,000 couples/year) and is the number one method of BC in women >35 years of age. ⁴ Statistically, therefore, the two conditions–past history of PID and desire for sterilization–are not unlikely to occur to the same patient. Current United States Food and Drug Administration (FDA) labeling for the Essure hysteroscopic sterilization procedure states current active genital infection as a contraindication to microinsert placement. ⁵ However, past history is not a contraindication. A PubMed search revealed only one prior publication describing the Essure procedure in patients with known hydrosalpinges as pre-treatment for in vitro fertilization (IVF) infertility therapy. ⁶ It was, therefore, decided to investigate the feasibility of Essure bilateral insertion in patients with prior PID with resulting hydrosalpinges. The null hypothesis was that bilateral microinsert placement would be prevented, and/or procedure prolonged, in those with hydrosalpinges versus those without, as hydrosalpinges would be a marker of more severe tubal disease and distortion. That premise was based on the assumption that distal tubal disease would also imply microarchitectual alterations to the tubal lumen proximally, preventing successful cannulation by the Essure microinsert.

Materials and Methods

This is a retrospective case review via the electronic medical record system database of Women's Specialty Center (WSC) in Dallas, an inner-city, community-based single specialty obstetrics and gynecology medical clinic. The study protocol/proposal was presented to and approved by the Ethical Review Board acting on behalf of WSC. This Ethical Review Board is an independent board that functions as an institutional review board (IRB) for WSC, and assures maintenance of ethical standards in recruitment, consent, and treatment as well as safety monitoring. ⁷ The database was queried for the terms hydrosalpinges, pelvic inflammatory disease, salpingitis, and meshed to hysteroscopic tubal occlusion, Essure procedure, and desires permanent sterilization. Database search was from October 2007 to October 2010. It is standard protocol at WSC to follow Centers for Disease Control (CDC) criteria for PID diagnosis (cervical motion tenderness and/or uterine tenderness and/or adnexal tenderness) ⁸ and to perform transvaginal sonography with such a diagnosis to evaluate for possible tubo-ovarian abscess. Those not meeting CDC criteria for PID diagnosis or for whom full documentation was not found, patients with prior tubal surgery, those without pelvic transvaginal ultrasound performed either with or after the PID diagnosis, and those not returning for postprocedure confirmation test, were excluded from the study cohort. All procedures were performed in office with the patient under local paracervical block by Essure certified/trained attending physicians experienced with the procedure.

Primary endpoint was rate comparison of successful bilateral microinsert placement at first attempt between cohorts (hydrosalpinges versus nonhydrosalpinges). Secondary analysis was procedure time (“scope in” to “scope out”) between the two.

Results

Nineteen patients had PID diagnosed and treated at WSC, and subsequently underwent in-office Essure sterilization within the study period. The records of 2 patients failed to document any criteria of PID, and 1 patient did not have pelvic ultrasound performed; these 3 were excluded from evaluation, leaving 16 for final analysis. The shortest interval from original PID diagnosis and treatment to Essure procedure was 7 months; the longest interval was 13 months. Patent characteristics are shown in Table 1. In the hydrosalpinx group, 4/5 were found to have bilateral distal tubal disease on ultrasound, and 1 had isolated left hydrosalpinx (Fig. 1). Breakdown of specific PID diagnoses/criteria per patient was as follows: in the nonhydrosalpinx cohort (n=11), 8 patients (8/11, 73%) met two of the three criteria for PID (cervical motion tenderness and uterine tenderness) whereas 3/11 (27%) possessed all three criteria. In the hydrosalpinx group (n=5) the breakdown was as follows: in the 4 patients with bilateral tubal disease, all 4 (100%) met all three criteria for PID diagnosis. The single patient with unilateral tubal disease possessed cervical motion tenderness and uterine tenderness. All patients underwent outpatient oral medical therapy per CDC treatment guidelines. ⁸

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FIG. 1.

Left hydrosalpinx. Philips (Providian Medical Equipment LLC, Willowick, OH) transvaginal ultrasound (7.5 mH transducer).

No statistically significant differences in initial bilateral placement rates were noted between cohorts (p=0.09). All but 1 patient in the nonhydrosalpinx group had successful bilateral cannulation at first attempt. The 1 patient on whom the attempt was unsuccessful had right-only microinsert placement initially, with the second attempt occurring after 48 hours. Successful microinsert placement was performed then on the left. No patencies were noted in either cohort at the respective 3 month confirmation tests. No significant difference was noted in procedure time between cohorts (p=0.89) (Table 2). No postprocedural infectious morbidities were encountered in either cohort.

Discussion

One sequela of PID is hydrosalpinx formation. With the introduction of hysteroscopic sterilization in 2002, more and more physicians have been adopting this minimally invasive alternative to laparoscopy. ¹⁰ Despite this, there is a paucity of peer-reviewed data regarding the utility of Essure sterilization in patients with past history of PID and/or hydrosalpinges. Although overt distal tubular disease is undisputed with hydrosalpinx, it is unclear if architectural alterations in the proximal interstitial portion would prevent Essure microinsert placement.

The results of this study indicate, and are similar to those of Mijatovic et al., ⁶ that Essure bilateral placement is not affected by the presence of distal tubular disease. Interestingly, the only unsuccessful bilateral attempt was in the nonhydrosalpinx group, likely because of proximal muscular tubal spasm initially. This resolved at the second successful attempt.

This study's main strength lies in this being second only to the Mijatovic et al.'s ⁶ study describing a similar clinical scenario. This study chose to include only those patients initially diagnosed and treated for PID at WSC, and not include those with prior outside diagnosis, in order to have uniform diagnostic criteria and treatment algorithm. As a past diagnosis of PID could not be validated from another source/location, these cases were not included in this study's database search. WSC uses CDC criteria for PID diagnosis (two of three major criteria). This served to strengthen the study design. Additionally, a patient was classified in the hydrosalpinx group even if a unilateral tubal abnormality was noted sonographically, as it was assumed that bilateral initial placement would be hindered in that case as well, despite the actual placement not being bilateral.

Conclusions

It is assumed that this article will provide guidance for the practicing gynecologist when/if presented with this clinical scenario. Within the limits of this preliminary study, it is concluded that hysteroscopic sterilization with the Essure system is not hindered by the presence of hydrosalpinges in patients with a past history of treated pelvic inflammatory disease.