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Uterine Perforations

Discussion in 'Conceptus' started by Anonymous, Mar 28, 2008 at 7:42 PM.

  1. Anonymous

    Anonymous Guest

    A doc who just stopped implanting Essure emailed me this article. Anybody know anything about this?

    Fertility and Sterility Vol. 89, No. 3, March 2008
    Pregnancy after Essure placement: report of two cases
    A. Whitney Moses, B.S., Judith T. Burgis, M.D., Janice L. Bacon, M.D., and Jennifer Risinger, M.D.
    Department of Obstetrics and Gynecology, University of South Carolina School of Medicine, Columbia, South Carolina

    The Essure system (Conceptus Inc., Mountain View, CA) was approved by the U.S. Food and Drug Administration (FDA) in 2002 as a transcervical method of permanent sterilization. The Essure system involves the placement of a micro-insert into the proximal end of each fallopian tube under direct hysteroscopic visualization using a specialized delivery device. The micro-inserts consist of an inner and outer coil; the outer coil is designed to stabilize the insert within the fallopian tube, while the fibers of the inner coil, composed of polyethylene terephthalate fibers, incite a benign proliferative tissue response (1). This response causes a local, occlusive, benign tissue growth which allows tissue ingrowth over the insert (1). This tissue response, which serves as the primary mechanism for permanent tubal occlusion, takes several weeks to completely occlude the lumen. Therefore, interim contraception is necessary for 3 months following the procedure, after which time a hysterosalpingogram (HSG) is performed to confirm the proper positioning of the micro-inserts and bilateral tubal occlusion. In phase 2 and phase 3 clinical trials, the Essure system was 99.8% effective at the 4-year follow-up evaluation and 99.74% effective in preventing pregnancy at the 5-year follow-up evaluation (2). As this nonincisional method of sterilization has gained popularity throughout the United States and worldwide, new clinical questions and previously undocumented situations arise. Two cases are presented below.

    CASE 1
    Pregnancy Carried to Term with an Essure Micro-insert in Place
    A 38-year-old woman, G3 P1111, presented complaining of stress urinary incontinence and desiring permanent sterilization. The patient elected to proceed with surgical treatment for her urinary incontinence and desired Essure hysteroscopic sterilization at the time of her surgery.

    The surgery was performed in the follicular phase of her menstrual cycle, and a urine HCG was negative the day of the procedure. The Essure procedure was performed with the patient under general anesthesia. The uterine cavity was noted to be normal. The devices were placed by one of the authors. The tubal ostia were easily seen, and the device was deployed without difficulty. After placement, visualization confirmed eight coils protruding from the right ostia, and 13 coils protruding from the left ostia.

    At her 1-month postoperative follow-up evaulation, the patient had no complaints. She was advised to use interim contraception, and she was scheduled for a 3-month followup HSG. Due to financial concerns, the patient canceled the HSG and was lost to follow-up. Seven months after Essure placement, the patient reported a positive home pregnancy test. A transvaginal ultrasound revealed an intrauterine pregnancy measuring 5 weeks 2 days. On transvaginal ultrasound, the left micro-insert was noted to be properly placed in the cornu and traversing the myometrium. The right micro-insert could not be visualized.

    Because of the patient’s history of preterm delivery and cervical incompetence, a cerclage was placed at 13-weeks’ gestation. A second trimester ultrasound performed for fetal anatomic survey was normal. During this exam, the left Essure micro-insert was again noted. The right micro-insert could not be visualized. The patient’s pregnancy was uneventful.

    The patient presented to labor and delivery at 37-weeks’ gestation complaining of regular contractions and increased pelvic pressure. A low transverse cesarean section was performed without complications, and a vigorous female infant was born. Despite irrigation, inspection, and palpation of the posterior cul-de-sac and fallopian tube, the right Essuremicro-insert could not be located. The left micro-insert was palpable in the left fallopian tube at the cornu. No portion of the device appeared to protrude into the uterine cavity. A bilateral tubal ligation was performed with ligation of the
    left tube performed distally to the micro-insert.

    CASE 2
    Pregnancy after Hysteroscopic Bilateral Sterilization and Evidence of Bilateral Tubal Occlusion
    A 35-year old woman, G3 P2012, patient presented in the 3-month postpartum period desiring permanent sterilization with the Essure system. The surgery was performed in the follicular phase of the patient’s menstrual cycle, and a urine HCG was negative the day of the surgery. The surgery was performed by one of the authors. The procedure was uncomplicated, and the micro-inserts were placed bilaterally. The patient used contraception for the first 3 months after Essure placement. Three months after the procedure, an HSG and a saline infusion sonography were performed. The HSG documented bilateral tubal occlusion, with the Essure devices extending from each tubal ostia (Fig. 1). No extravasation of contrast was noted. The patient discontinued her contraception.

    Fourteen months after undergoing the Essure procedure, the patient reported 2 months of amenorrhea and noted a positive pregnancy test. She carried the pregnancy until 19 weeks without complication, at which time she chose to terminate the pregnancy.With a history of menorrhagia and dysmenorrhea, the patient noted progressively increasing severity of symptoms over the next several months. Following documentation of leiomyomata on pelvic ultrasound, the patient elected to have a total vaginal hysterectomy 6 months after pregnancy termination. Upon removal of the uterus, an Essure micro-insert was noted to protrude through the upper myometrium at the left cornu of the uterus. The location of the micro-insert and perforation through the uterine wall was confirmed on routine pathology dissection. No extrauterine complications of the perforation have been identified. This illustrates again that pregnancy may continue with an Essure insert in place, as the right insert was in proper position. The case also illustrates that an HSG is not foolproof for documenting correct Essure placement.

    A systematic English-language literature review was completed using the Ovid, PubMed, and UpToDate search engines to locate any reports of ongoing pregnancies with one or more Essure micro-inserts in place. There were no documented pregnancies with Essure micro-inserts in place that culminated in the birth of a live-born infant. The manufacturer, Conceptus Incorporated (Mountain View, CA), reports knowledge of several prior pregnancies carried to term with at least one of the coils in place, although none of these cases were documented in the literature. The company reports no adverse events during these pregnancies. A recent case review reports 37 pregnancies in women who have undergone the Essure procedure; however, the pregnancy outcomes were not discussed (3).

    Pregnancies after Essure hysteroscopic sterilization are rare (4). No Essure failures resulting in pregnancy have been documented when adequate interim contraception is used, the Essure inserts are properly positioned, and bilateral tubal occlusion is confirmed by a 3-month HSG. The phase 2 and phase 3 trials for Essure product approval documented no pregnancies after 6015 and 9620 women-months of intercourse exposure, respectively (1, 5). Completion of the 5-year follow-up evaluation of the phase 3 participants is expected in the near future.

    The Essure product information currently states that the risks of the micro-insert to any woman who becomes pregnant, her fetus, or her ability to maintain the pregnancy are unknown (6). Conceptus Incorporated also states in the product information that the effects of the micro-inserts on the success of in vitro fertilization (IVF) are unknown (6). However, a recent study documented progressive tissue encapsulation with micro-insert exclusion from the uterine cavity (7). The phenomenon was documented by noting the number of coils extending into the uterine cavity on repeat hysteroscopy an average of 20 months after initial placement (7). This number was compared with the number of coils noted to be extending into the uterine cavity immediately after placement of the micro-inserts. Based on the study results, the investigator hypothesized that progressive tissue encapsulation of the micro-inserts may prevent them from interfering with implantation following IVF (7).

    A second English language literature search was performed using Ovid, PubMed, and UpToDate to investigate the frequency and complications of uterine perforation with an Essure micro-insert. The phase 2 clinical trial documented six perforations among 227 women participating in the trial (1). The investigators did not specify the perforation as either tubal or uterine. One incident of inadvertent placement of a micro-insert into the myometrium was reported. This was detected by tubal patency on the 3-month HSG (1). The phase 3 clinical trial documents five cases of perforation at unspecified locations among 507 women in whom micro-insert placement was attempted (5). Two of the cases were attributed to preexisting tubal occlusion, and the other two perforations resulted from difficulty in identifying the ostium (5). The incorrect placement of the micro-inserts was identified before pregnancy or further complications ensued. The literature search revealed no cases of uterine perforation by an Essure micro-insert that mimicked the appearance of bilateral tubal occlusion and proper placement on HSG or saline infusion sonography.

    The patient presented in case 1 had an uncomplicated pregnancy and cesarean delivery with an Essure micro-insert securely in place in the left fallopian tube and ostia. The location of the left micro-insert was confirmed by multiple transvaginal and abdominal ultrasounds, and it was palpated during cesarean section. The right micro-insert was not visualized on any imaging or at the time of delivery. The 5-week and second trimester ultrasounds showed possible progressive exclusion of the left micro-insert from the uterine cavity. No objective measurements on the location of the left microinsert could be made, but this finding is compatible with the hypothesis that progressive exclusion of the micro-insert from the uterine cavity may prevent it from interfering with implantation and pregnancy after Essure failure. This may have implications for in vitro fertilization following Essure.

    The location of the right micro-insert and the exact reason for Essure failure in this case are unknown. Expulsion of the right micro-insert out of the distal end of the fallopian tube is a possibility. A follow-up HSG would have identified the location of the right insert and detected the presumed patency of the right fallopian tube.

    Unlike case 1, the patient in case 2 underwent a follow-up evaluation appropriately at 3 months. Her 3-month HSG appeared to indicate proper placement of the micro-inserts with subsequent bilateral tubal occlusion. The patient and her physician had no reason to question the HSG results, so her pregnancy 8 months later was unanticipated. The discovery of the left micro-insert protruding through the uterine wall at the time of hysterectomy may represent device migration (see Fig. 1), which was unforeseen. On review of the 3-month HSG, there were no indications of the improper placement of either Essure coil.

    As the Essure permanent sterilization procedure gains popularity, it is increasingly important to understand the effects of the micro-inserts on implantation and pregnancy following either IVF or a failed Essure procedure. As other cases of similar pregnancies are documented and the results of the 5-year follow-up evaluation of the phase 3 participants are released, physicians will be able to better assess the risks of such tubal inserts to a developing fetus. Documented pregnancies carried to term without complications may indicate the possibility of IVF in women with the Essure system in place. As alternate methods of confirming proper placement of the Essure inserts and subsequent tubal occlusion are being investigated, it is equally as important to determine which technique will allow the most confidence is assessing the success of the procedure.
  2. Anonymous

    Anonymous Guest

    I don't know about all the studies done on the essure but i can tell you i had the essure procedure done in august of 2009 and it is now October of 2011 and i am having a baby boy in two weeks and my 30 week ultrasound showed the coils were still in place so no one can explain it but i can tell you from personal experience that i have talked to at least five other women who have just had a baby after essure so i am really tired of seeing that pregnancy with essure failure is rare because i can guarantee it is not it just has not been reported properly enough.
  3. Anonymous

    Anonymous Guest

    Did you have a HSG at 3 months?
  4. Anonymous

    Anonymous Guest

    The human body is an amazing machine and much of its function is not well understood. Although tubal ligation is immediately effective at preventing conception and thus pregnancy, nothing is foolproof. The body can sometimes find "work arounds" when there is an obstacle to normal function.

    When I had my tubal ligation 10 years ago, I knew of 5 women who had become pregnant up to 15 years AFTER their tubal ligation. My doctor told me that the body can actually create a new route for the egg. Given that tubal ligation involves physically cutting the tubes, cauterizing with heat to close the tubes AND claimping such that nothing will pass, it does not surprise me AT ALL that women can become pregnant after getting Essure implanted. No one can assure that enough tissue will grow to sufficiently block every or any woman on the planet.

    Good luck to all the surprised Moms out there! Enjoy your sweet blessing or consider adoption.