AI Article Synopsis

  • The Essure device was created to help women who wanted to prevent pregnancy in a less painful way, but some women had problems like pain after using it.
  • After issues were reported, the device was no longer sold in the U.S. by late 2018, and there was a study to look into the problems experienced by patients who had the device.
  • The study found that out of 137 patients, many complained of pelvic pain, and some had serious issues like inflammation in their body where the device was placed.

Article Abstract

The introduction of the Essure (Bayer AG, Leverkusen, Germany) device made possible a less invasive approach for patients desiring sterilization. Following FDA approval in 2002, problems were reported in some patients with these devices including most commonly pain. Labeling changes were mandated in 2016, and as of late 2018, the devices are no longer being sold in the United States. A comprehensive description of Pathologic findings in patients with these devices has not been reported. This study characterizes pathologic findings in patients undergoing surgery who had Essure in place, regardless of the indication for surgery. 137 cases were found, 126 of which had submitted tissue, 121 of which had fallopian tube(s) submitted. Duration for coils being in place was available for 104/137 patients (mean 48 months; median 43 months, range 0-166 months). Cases ranged from 2009 to 19, with a peak in cases noted in 2016. A chief complaint relating to the phrase "pelvic pain" was the most common, noted in 72/137 cases. Obliteration, defined as loss of the fallopian tube epithelium with filling of the lumen with fibrotic material, was noted in 33/121 cases. Inflammation was noted in 59/126 cases, 31/59 showed with giant cells, chronic inflammation (lymphocytes and/or plasma cells) in 37/59 cases, and acute inflammation 19/59 cases, with 14/19 showing eosinophils. Acute inflammation was noted in those with a shorter duration of coil implantation, while chronic inflammation, including giant cells, were noted across the span. This study has expanded knowledge of patients with removal of Essure coil devices.

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Source
http://dx.doi.org/10.1016/j.anndiagpath.2020.151508DOI Listing

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