Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey

Essure® present controversies and 5 years’ learned lessons: a retrospective study with short- and long-term follow-up

“…A good adherence to the 3-month confirmatory tests and back-up birth control after hysteroscopic sterilization is important to avoid unintended pregnancies. Remarkably, we had no loss to follow-up or pregnancy events at 3 months, with a correct placement confirmed in 99% of the tests which is analogous to previous publications (99.5% [ 7 ] and 99.6% [ 9 ]; even if in these series a lower first control compliance rate is reported 90.8 and 96.8%, respectively). Our 3-month follow-up detected failures were due to contrast leakage or micro-insert expulsion.…”

“…In our experience, the surgeon perceived the procedure as difficult in 11% of the cases (mainly unilateral difficulty), with an unsuccessful micro-insert delivery (either with or without attempt), comparable to the results found in the literature (7.3 versus 1.5% [ 9 ], 2.8% [ 7 ], 8% [ 6 ], 12% [ 10 ]). Systematic use of a non-steroidal anti-inflammatory or a spasmolytic before the procedure (except if contraindicated) could possibly contribute to diminish tubal spasm and subsequent obstruction, but this is yet to be probed.…”

“…However, it may also be hypothesized that some women may produce less or slower reaction to the implant, accounting for cases of migration or expulsion, or even for cases of pregnancy after the 3-month correct follow-up. In agreement with this hypothesis, higher than expected tubal patency at intervals less than 1 year [ 11 ] and cases of pregnancy after the 3-month ideal follow-up have been published [ 2 , 7 ]. Failure rates of all types of sterilization failures are estimated in 0.9% [ 12 ] but there is uncertainty about specific failure rates for Essure® due to either short follow-up studies, discrepancy between study results, or lack of information on follow-up or on accomplished protocol [ 13 , 14 ].…”

“…Considering the case of nickel hypersensitivity, our post-procedure second surgery was 0.4%. We consider that the suspicion of nickel allergy should contraindicate the procedure even if since 2011 this is no longer contraindicated by the Food and Drug Administration and if some authors would recommend further evaluation but nevertheless consider the procedure [ 7 ]. In the manufacturer’s official site, it can be read that no test can reliably predict this adverse effect [ 16 ].…”

“…Several studies have been reported which describe long-term follow-ups (from 1 to 5 years) of patients submitted to sterilization with Essure® [ 5 – 7 ]. In this study, the authors have proceeded to a retrospective consecutive case series analysis of one-center ( two hysteroscopists ), 5 years’ experience with Essure®.…”