7 These advantages must compound libraries be counterbalanced by the increased risk for pregnancy, including ectopic pregnancy, with the Adiana device; 1 patient required operative treatment of ectopic pregnancy in the clinical trials.2 As seen in the CREST study, the use of bipolar energy for tubal occlusion resulted in increasing the risk for failure over a 10-year period. Uncertainty exists as to whether the Adiana method for sterilization will have a similar clinical course.18 Another concern with Adiana is that fewer than half of women with patent tubes at 3 months (42% [19/45]) will actually occlude by 6 months. This is more troublesome when considering that a high proportion of women do not obtain recommended HSG follow-up.12 As commercial use data become available, further information concerning risks and advantages of this procedure will increase.
Although Essure and Adiana may be similar procedures for physicians to perform, they represent very divergent technologies for sterilization. Each of these devices achieves the endpoint of sterilization in a unique manner and thus they have divergent efficacy for preventing pregnancy. Fortunately, both the Essure and Adiana procedures offer distinct advantages over laparoscopic sterilization, with reduced need for anesthesia and decreased risk for injury to intraabdominal organs. Although no procedure is perfect, physicians must appropriately weigh the risks and benefits of all available options for permanent sterilization to best treat their patients. Main Points Six hundred forty-three of 664 women (96.
8%) with bilateral placement were instructed to rely on the Essure devices for pregnancy prevention. In the subsequent 9 years since initiation of the study, no reports of pregnancy have been documented. Five hundred seventy of 611 women (93.3%) with bilateral placement were instructed to rely on Adiana procedure for pregnancy prevention. Interestingly, the study protocol included ultrasound evaluation of silicone implants at both 1 week and 3 months. In the subsequent 5 years of data collection, 12 pregnancies have been documented. As the Essure insert is visible on radiographic imaging, certain clinical decisions and actions can be made when a tubal patency is encountered. With Adiana, due to the inability to visualize the insert on radiographic imaging, a clinician is unable to determine the exact cause of patency.
In the clinical trials for Essure, there were no reports of misread hysterosalpingograms, as no pregnancies were reported. Conversely, as a result of the 12 pregnancies after performance of the Adiana procedure, reviews of the HSG findings were undertaken in a systematic review to determine the cause of the pregnancy. After review, it was determined that 3 of the 12 pregnancies were Brefeldin_A related to a misread HSG, although there is no published information to determine what was insufficient. The cost per patient for each system is essentially equal.