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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain female") and device breakage ("essure broken and that it was already like that when it was put on") in a 37 year-old female patient who had essure inserted (lot no.C61994) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of covid-19, morbid obesity, gestational diabetes, tonsillectomy and parity 2.Previously administered products included: iud nos.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the day of essure insertion, she experienced presyncope ("vasovagal syndrome") and procedural pain ("essures technically well inserted but more pain during the insertion.").On (b)(6) 2015 she experienced back pain ("acute low back pain").On (b)(6) 2016 she experienced abdominal pain ("abdominal pain").On (b)(6) 2019 she experienced dysmenorrhoea ("dysmenorrhea"), heavy menstrual bleeding ("excessive menstruation / intense period") and intermenstrual bleeding ("metrorrhagia ").Essure was removed on (b)(6) 2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), device breakage (seriousness criterion intervention required), ovulation pain ("ovulation pain") and coital bleeding ("intermittent genital spotting with intercourse").The patient was treated with surgery (hysterectomy + salpingectomy was performed by laparoscopy).At the time of the report, the dysmenorrhoea had resolved and the back pain and abdominal pain had not resolved.The outcome of presyncope was unknown.The reporter considered abdominal pain, back pain, coital bleeding, device breakage, dysmenorrhoea, heavy menstrual bleeding, intermenstrual bleeding, ovulation pain, pelvic pain, presyncope and procedural pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 12.541 kg/sqm.[full blood count] on (b)(6) 2021: glucose (b)(6) 2021 111 mg/dl urea (b)(6) 2021 40 mg/dl total cholesterol/hdl 2.1 mg/dl cholesterol ratio 2.1 mg/dl ferritin 5 ng/ml transferrin 365 mg/dl leukocytes 4.280 10^3/ l hemoglobin 11.8 g/dl [pathology test] on (b)(6) 2021: fallopian tubes, bilateral salpingectomy.Device removal.Essure type intrafallopian tubes.Chronic pelvic pain in an essure device carrier.Fallopian tubes with congestive changes and mild chronic inflammation: non-specific findings.Macroscopic description: two fallopian tubes measuring 6.5 and 5.4 cm, with diameters of 7 and 6 mm respectively, are received in the same package.In both cases, a protrusion is observed at the non-frimbined end of an essure type device.It is extracted with expansion and photographed according to the established protocol.Once extracted and deformed, the devices measure 23 and 15 cm.The devices are stored and guarded according to the current protocol and both fallopian tubes are fully included.[ultrasound scan] (date unknown): normoinserted essures are visualized, with a smaller intramyometral portion on the left, but existing.It is explained that the pain is probably not related to the devices.It is explained that if pain persists or increases in intensity, its withdrawal can be considered.[x-ray] on (b)(6) 2015: retroverted uterus normopositioned essure devices.Both occlude the tubes, preventing the passage of contrast into the pelvic cavity.Bilateral essure devices.Satisfactory localization and occlusion.; on (b)(6) 2021: in which a small radiodense image (metallic density compatible with rest of essure) is identified projected on the lower right sacral rim; (date unknown): in which said radiodense image is no longer visible although there is superimposition of material on the pelvic region and an important gaseous component both at the rectum-colosigmoid level and at the peritoneal level that makes assessment difficul the most recent follow-up information incorporated above includes data received on: 29-nov-2023: plaintiff fact sheet & medical record received.Event injury nos is replaced with abdominal pain, back pain, coital bleeding, dysmenorrhea, heavy menstrual bleeding, intermenstrual bleeding, ovulation pain, pelvic pain, presyncope and procedural pain & device breakage.Lot number, medical history, concomitant condition, lab data & reporter information updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain female") in a 37 year-old female patient who had essure inserted (lot no.C61994) for permanent contraceptive tubal implant.Additional non-serious events are detailed below.Product or product use issues identified: device damaged prior to use ("essure broken and that it was already like that when it was put on").The patient had a medical history of bariatric surgery, cesarean section, covid-19, morbid obesity, gestational diabetes, tonsillectomy and parity 2.Previously administered products included: iud nos.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the day of essure insertion, she experienced presyncope ("vasovagal syndrome"), procedural pain ("essures technically well inserted but more pain during the insertion.") and abdominal pain ("abdominal pain").On (b)(6) 2015 she experienced back pain ("acute low back pain / right lumbago").On (b)(6) 2016 she experienced coital bleeding ("intermittent genital spotting with intercourse").On (b)(6) 2018 she experienced insomnia ("insomnia"), anxiety ("anxiety") and tension ("tension").On (b)(6) 2019 she experienced dysmenorrhoea ("dysmenorrhea"), heavy menstrual bleeding ("excessive menstruation / intense period/ abundant clots in the period") and intermenstrual bleeding ("metrorrhagia").Essure was removed on (b)(6) 2021.In (b)(6) 2021 she experienced salpingitis ("fallopian tubes with congestive changes and mild chronic inflammation").An unknown time later she experienced pelvic pain (seriousness criterion intervention required), ovulation pain ("ovulation pain"), metaplasia ("metaplasia"), pelvic discomfort ("discomfort at pelvic level"), groin pain ("left inguinal pain"), endometriosis ("endometriosis"), dizziness ("dizziness"), nausea ("nausea"), vomiting ("vomiting"), vaginal haemorrhage (" irregular and abundant vaginal bleeding,"), alopecia ("hair loss"), diarrhoea ("diarrhoea"), candida infection ("candidiasis"), rash ("skiin rashe") and dermatitis ("scalp dermatitis").The patient was treated with surgery (hysterectomy + salpingectomy was performed by laparoscopy).At the time of the report, the dysmenorrhoea had resolved and the back pain and abdominal pain had not resolved.The outcomes for presyncope, metaplasia, pelvic discomfort, salpingitis, groin pain, insomnia, anxiety, tension, endometriosis, dizziness, nausea, vomiting, vaginal haemorrhage, alopecia, diarrhoea, candida infection, rash and dermatitis were unknown.The reporter considered abdominal pain, alopecia, anxiety, back pain, candida infection, coital bleeding, dermatitis, diarrhoea, dizziness, dysmenorrhoea, endometriosis, groin pain, heavy menstrual bleeding, insomnia, intermenstrual bleeding, metaplasia, nausea, ovulation pain, pelvic discomfort, pelvic pain, presyncope, procedural pain, rash, salpingitis, tension, vaginal haemorrhage and vomiting to be related to essure administration.The reporter commented: discrepancy noted in essure insertion date.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 12.541 kg/sqm.[cytology] on (b)(6) 2020: squamous metaplasia [full blood count] on (b)(6) 2021: glucose (b)(6) 2021 111 mg/dl, urea 09-nov-2021 40 mg/dl, total cholesterol/hdl 2.1 mg/dl, cholesterol ratio 2.1 mg/dl, ferritin 5 ng/ml, transferrin 365 mg/dl, leukocytes 4.280 10^3/l, hemoglobin 11.8 g/dl.[hysterosalpingogram] on (b)(6) 2015: bilateral essure devices, localization and satisfactory occlusion [pathology test] on (b)(6) 2021: fallopian tubes, bilateral salpingectomy.Device removal.Essure type intrafallopian tubes.Chronic pelvic pain in an essure device carrier.Fallopian tubes with congestive changes and mild chronic inflammation: non-specific findings.Macroscopic description: two fallopian tubes measuring 6.5 and 5.4 cm, with diameters of 7 and 6 mm respectively, are received in the same package.In both cases, a protrusion is observed at the non-frimbined end of an essure type device.It is extracted with expansion and photographed according to the established protocol.Once extracted and deformed, the devices measure 23 and 15 cm.The devices are stored and guarded according to the current protocol and both fallopian tubes are fully included.[ultrasound scan] on (b)(6) 2021: bilateral adnexal formations suggestive of benignity; (dates unknown): normoinserted essures are visualized, with a smaller intramyometral portion on the left, but existing.It is explained that the pain is probably not related to the devices.It is explained that if pain persists or increases in intensity, its withdrawal can be considered.And possible detection of an ovarian image suggestive of endometrioma in right ovary [x-ray] on (b)(6) 2015: retroverted uterus normopositioned essure devices.Both occlude the tubes, preventing the passage of contrast into the pelvic cavity.Bilateral essure devices.Satisfactory localization and occlusion.; on (b)(6) 2021: in which a small radiodense image (metallic density compatible with rest of essure) is identified projected on the lower right sacral rim; (date unknown): in which said radiodense image is no longer visible although there is superimposition of material on the pelvic region and an important gaseous component both at the rectum-colosigmoid level and at the peritoneal level that makes assessment difficul.The most recent follow-up information incorporated above includes data received on: 09-jan-2024: new events dizziness, nausea, vomiting, irregular and abundant vaginal bleeding, hair loss diarrhea, candidiasis, skin rashes scalp dermatitis added.Reporter information updated.12-jan-2024: medical record received.New events metaplasia, pelvic discomfort, salpingitis, groin pain, insomnia, anxiety, tension endometriosis added.Medical history, historical drugs added.Reporter information updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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