[188658302]
This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('malposition of essure device location of device: uterus/essure was not located in tubs or cornua of uterus/both devises were misplaced') in a (b)(6) year old female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's concurrent conditions included shoulder operation since (b)(6) 2015. On (b)(6) 2012, the patient had essure inserted. In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pelvic pain"). In (b)(6) 2012, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and was found to have weight increased ("weight gain"). On (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), 9 months 27 days after insertion of essure. In (b)(6) 2018, the patient experienced tooth fracture ("dental problems: tooth unusually fragile,breaking"). On an unknown date, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), complication of device removal ("after surgery he stated there was a lot of scar tissue and stated he was not able to locate either essuredevice and he believes they are still in my uterus. ") and teeth brittle ("fragile teeth"). The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)). Essure treatment was not changed. At the time of the report, the device expulsion, female sexual dysfunction, tooth fracture, dysmenorrhoea, dyspareunia, pelvic pain, weight increased, complication of device removal and teeth brittle outcome was unknown. The reporter considered complication of device removal, device expulsion, dysmenorrhoea, dyspareunia, female sexual dysfunction, pelvic pain, teeth brittle, tooth fracture and weight increased to be related to essure. The reporter commented: after surgery he stated there was a lot of scar tissue and stated he was not able to locate either essure device and he believes they are still in my uterus. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24. 8 kg/sqm. Hysterosalpingogram on (b)(6) 2012: unilateral occlusion (left tube occluded), failure to occlude (close) fallopian tubes. ; on (b)(6) 2013:. Ultrasound scan vagina on (b)(6) 2013: result not provided. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on (b)(6) 2020: injury nos replaced with malposition of essure device location of device: uterus/essure was not located in tubs or cornua of uterus apareunia (inability to have sexual intercourse),dental problems: tooth unusually fragile,breaking, dysmenorrhea (cramping, dyspareunia (painful sexual intercourse), pelvic pain, weight gain and complications from your essure removal procedure. Patient demographic,lab data product information were added on 9-mar-2020: no new information received based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5