Does Essure Cause Significant De Novo Pain? A Retrospective Review of Indications for Second Surgeries After Essure Placement

Kamencic, Huse; Thiel, Luke; Karreman, Erwin; Thiel, John

doi:10.1016/j.jmig.2016.08.823

Cited by 18 publications

(15 citation statements)

References 13 publications

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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%

“…Published case reports detail bowel injury, device migration, nickel allergy, and unintended pregnancy after successful Essure placement. 74–76 Unintended intra-uterine pregnancy remains a significant concern after Essure placement. One postmarketing subgroup analysis on female subjects who reported unintended pregnancy to Conceptus Incorporated after Essure placement revealed poor adherence with 3-month follow-up and misinterpretation of hysterosalpingogram by physicians as leading etiologies of unintended pregnancy.…”

Section: Essurementioning

confidence: 99%

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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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Section: Essurementioning

confidence: 99%

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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“…Resuming hormonal therapy ameliorated the symptoms, avoiding the need for second surgery for implant removal (guaranteeing a more effective contraception). Others have enlightened the importance to clearly evaluate the complaints that patients relate to Essure®, at the risk of removing the implants without improvement [ 2 , 4 ]. With reported second surgery rates of 0.4% [ 7 ] to 4.3% [ 4 ], according to a recent retrospective cohort study, more than half of surgeries post-Essure® placement were related to pain complaints and the majority of them related to subjacent gynecological conditions [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

“…While being a highly satisfactory permanent contraception method, pelvic pain (related or not to menses) and irregular bleeding or heavy menstruation are among the most frequent late complications related to the procedure [ 2 ]. However, these symptoms are not always related to the micro-inserts itself but to other underlying gynecologic conditions (endometriosis, adenomyosis, or others), which could erroneously indicate the implant surgical removal [ 2 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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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.

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“…An estimated 1.1% to 4.3% of women who have undergone Essure sterilization experience long-term adverse effects including pelvic pain, abnormal bleeding, allergic reaction, and other reported symptoms. 1,2 An increasing number of women are now seeking removal of the device, with some also desiring to restore their fertility. Sterilization reversal is uniquely challenging following the Essure procedure as up to 4 cm of the proximal fallopian tube, including the interstitial segment, is permanently scarred by the device.…”

Section: Introductionmentioning

confidence: 99%

A Novel Technique for Essure Reversal

Clark

Einarsson

2019

JSLS

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Background and Objectives: An increasing number of women are seeking removal of the Essure sterilization device due to symptoms including pelvic pain, abnormal bleeding, and allergic reaction. A fraction of these women also desire a future pregnancy and request sterilization reversal at the time of device removal. We present a novel technique for Essure reversal in addition to our experience with three cases. Methods: Simultaneous laparoscopy and hysteroscopy is used to remove the device followed by laparoscopic reimplantation of the distal fallopian tube to the uterine fundus. A video of our method is included and the outcomes of three patients reported. Results: Three women underwent laparoscopic Essure reversal for device-attributed symptoms and desire to restore fertility between 2017 and 2018. All procedures were uncomplicated with restoration of tubal patency in one or both fallopian tubes on follow-up hysterosalpingogram. Over a period of 4 to 10 months of followup, no pregnancies have been reported. Conclusion: Essure reversal is a feasible technique for removing the device and restoring tubal patency; however, more data are needed on pregnancy outcomes following this novel procedure.

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Does Essure Cause Significant De Novo Pain? A Retrospective Review of Indications for Second Surgeries After Essure Placement

Cited by 18 publications

References 13 publications

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

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

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

A Novel Technique for Essure Reversal

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