Management of Complications Encountered With Essure Hysteroscopic Sterilization: A Systematic Review

Adelman, Marisa R.; Dassel, Mark; Sharp, Howard T.

doi:10.1016/j.jmig.2014.03.019

Cited by 36 publications

(26 citation statements)

References 61 publications

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“…Bleeding was another commonly reported issue during this survey. However, this was not a complaint found in a recent systematic review about Essure complications [11].…”

Section: Discussionmentioning

confidence: 77%

Essure Surgical Removal and Subsequent Symptom Resolution: Case Series and Follow-Up Survey

Brito

Cohen

Goggins

et al. 2015

Journal of Minimally Invasive Gynecology

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“…Bleeding was another commonly reported issue during this survey. However, this was not a complaint found in a recent systematic review about Essure complications [11].…”

Section: Discussionmentioning

confidence: 77%

Essure Surgical Removal and Subsequent Symptom Resolution: Case Series and Follow-Up Survey

Brito

Cohen

Goggins

et al. 2015

Journal of Minimally Invasive Gynecology

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“…73,74 A true understanding of the magnitude of complications associated with Essure is difficult because most adverse events remain unreported. Published case reports detail bowel injury, device migration, nickel allergy, and unintended pregnancy after successful Essure placement.…”

Section: Essurementioning

confidence: 99%

Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

Carey

Nader

Chai

et al. 2017

Clinical Therapeutics

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A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.

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“…There appears to be no clear consensus on how best to manage Essure patients who subsequently develop symptoms associated with HS [17]. While the notion that Essure patients might require further surgery is not entirely new, at least for the population of Essure patients sampled here the reliance on hysterectomy was higher than expected.…”

Section: Discussionmentioning

confidence: 97%

Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences

Sills

Wood

et al. 2017

Obstet Gynecol Sci

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ObjectiveAlthough previous research has suggested that risk for reoperation among hysteroscopic sterilization (HS) patients is more than ten times higher than for patients undergoing standard laparoscopic tubal ligation, little has been reported about these subsequent procedures.MethodsThis descriptive cohort study used a confidential online questionnaire to gather data from women (n=3,803) who volunteered information on HS followed by device removal surgery performed due to new symptoms developing after Essure placement.ResultsIn this sample, mean age was 35.6 years and women undergoing hysterectomy after HS comprised 64.9% (n=2,468). Median interval between HS and hysterectomy was 3.7 (interquartile range, 3.9) years and mean age at hysterectomy was 36.3 years. Some patients (n=1,035) sought removal of HS devices and fallopian tubes only, while other miscellaneous gynecological procedures were also occasionally performed for Essure-associated symptoms. When data from all patients who had any post-Essure surgery besides hysterectomy were aggregated (e.g., device removal + “other” cases, n=1,335) and compared to those cases undergoing hysterectomy, mean age was significantly lower than for the hysterectomy group (34.4 vs. 36.3 years, respectively; P<0.01); uterus-conserving surgeries were also typically performed significantly earlier than hysterectomy (P<0.01).ConclusionThis investigation is the first to characterize specific gynecological operations after Essure, and suggests that the predominant surgical answer to HS complaints is hysterectomy for many women. Dissatisfaction with HS may represent an important indication for hysterectomy and additional study is needed to quantify this phenomenon.

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Management of Complications Encountered With Essure Hysteroscopic Sterilization: A Systematic Review

Cited by 36 publications

References 61 publications

Essure Surgical Removal and Subsequent Symptom Resolution: Case Series and Follow-Up Survey

Essure Surgical Removal and Subsequent Symptom Resolution: Case Series and Follow-Up Survey

Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences

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