Risks of Hysteroscopy Adverse events or side effects were reported on the day of procedure in 3% of the initial Essure™ patients. These consisted of vasovagal responses, cramping, nausea, and vaginal spotting (297). Possible but uncommon risks of the hysteroscopic tubal sterilization methods include perforation by the device at insertion and expulsion of the device. In the initial clinical trials tubal perforation was reported in 1% of Essure™ placements. None were reported with Adiana™. There is theoretical risk of mutagenic or carcinogenic effect to the fetus from nickel alloy in Essure™ should pregnancy occur, although no such injury was reported (297). Other potential combinations with transcervical sterilization are related to the hysteroscopy procedure, not the tubal occlusion process. These include hypervolemia, injury to surrounding organs, bleeding, and infection and occur in less than 1% of cases. Excessive ﬂuid absorbance leading to hypervolemia is more of a concern with Adiana™ and the nonionic solution that must be used to distend the uterine cavity because of the electrical energy applied. With Essure™ the distending medium is normal saline (293,294). An extensive 2009 review of the first 6 years of Essure™ use reported in publications, industry sources and the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the FDA, found 20 reports of pelvic pain, which in some cases responded to hysteroscopy or laparoscopic removal of the device. An additional 20 women had second-look hysteroscopy because of persistent abnormal vaginal bleeding. During this time period more than 172,000 Essure™ devices were shipped, so such problems are quite rare (298).
Sterilization Failure with Hysteroscopic Methods
The Essure™ microinsert was successfully placed in 86% of patients after the first procedure, which increased to 90% after a second procedure using the initial insertion catheter. (298). Reasons for failure of insertion were tubal obstruction, stenosis, or difficulty in accessing the tubal ostia. Correct placement was confirmed at 3 months in 96%, and complete bilateral occlusion occurred in 92%. Of those patients with complete occlusion, there were no pregnancies in 5,305 woman-months of use. A subsequent study of an improved catheter design in 2004 reported a 98% successful placement rate (299). The Adiana™ trials reported a 94% successful placement rate with the first procedure, which increased to 95% after a second procedure (301).
As of October 2008, 258 Essure™-related pregnancies were reported to the manufacturer. Most can be attributed to patient or clinician noncompliance with the manufacturer’s instructions, failure to use contraception during the 3-month wait for a HSG, failure to return for the HSG, physician error in interpreting the HSG, and some luteal phase pregnancies. No known pregnancies occurred in the clinical trials when the subjects met the criteria to rely on Essure™ (297).
In patients with documented occlusion in the Adiana™ trials, a 1.1% failure rate was reported in the first year of use and a 1.8% failure rate at 2 years (297). Longer-term data are not yet available for Adiana™, but it appears that Essure™ will have a lower long-term pregnancy rate than Adiana™.