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

Abstract

BackgroundThe risk-benefit of contraception with Essure® is being readdressed due to an increase of reports of adverse effects with this device. Our aim was to proceed to an internal quality evaluation and to identify opportunities for protocol improvement.We proceeded to a one-center, retrospective consecutive case series of women admitted for Essure® placement, from 1 January 2012 until 31 December 2016 (5 years).ResultsIn a total of 274 women, technical difficulties were mainly unilateral, with no acute or short-term severe complications. The procedure was brief (median 3.2 min, IQR 2.5–5.2) and moderately painful (median of 4 in a 0–10 scale; IQR 3–5). At 3 months, the failure rate was 2%, with no pregnancies. Second surgery indication (< 1%) resumed to a case of nickel hypersensitivity. At 1 year, pregnancy rate was 1%. Ninety-eight percent of the patients would recommend the method.ConclusionsWe identified high patient satisfaction and low failure rates, both at short and long term. Investigation about whether some women still have patent tubes at the 3-month follow-up could lead to protocol improvement. It is important that clinicians look for second causes for adverse effects related to Essure® and avoid the erroneous indication for implant removal. Long follow-up allowed for both internal quality evaluation and clarification of misconception; it could possibly also have contributed to patient satisfaction.

Factors Associated with Negative Patient Experiences with Essure Sterilization

“…Within our study population, the satisfaction rate was 61.9%, lower than previously reported 88%-99% satisfaction rates. 5,6,[17][18][19][20][21][22] This difference may be explained by the fact that our duration of follow-up is relatively long (mean 6.1 Ϯ 2.5 y after Essure placement versus 1 to 5 y in prior studies). There is also the opportunity for response bias given less than 50% response rate or the possibility that the nature of the survey questions introduced negative bias against the device.…”