MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Biocompatibility (2886); Expulsion (2933)

Patient Problems Abdominal Pain (1685); Anemia (1706); Autoimmune Disorder (1732); Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included anesthesia.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dysfunctional uterine bleeding ("dysfunctional uterine bleeding"), device expulsion ("essure contraceptive device was in her uterus / migration"), menorrhagia ("menorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss"), fatigue ("fatigue"), abdominal pain ("abdominal pain"), anaemia ("anemia") with blood iron decreased, migraine ("migraines"), menometrorrhagia ("menometrorrhagia"), uterine enlargement ("enlarged uterus"), menstruation irregular ("irregular periods"), abdominal pain lower ("abdominal cramping"), cyst ("cyst"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune symptoms") and hypersensitivity ("hypersensitivity") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the pelvic pain, dysfunctional uterine bleeding, device expulsion, menorrhagia, arthralgia, alopecia, weight increased, fatigue, abdominal pain, anaemia, migraine, menometrorrhagia, uterine enlargement, menstruation irregular, abdominal pain lower and cyst had not resolved and the genital haemorrhage, autoimmune disorder and hypersensitivity outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, anaemia, arthralgia, autoimmune disorder, cyst, device expulsion, dysfunctional uterine bleeding, fatigue, genital haemorrhage, hypersensitivity, menometrorrhagia, menorrhagia, menstruation irregular, migraine, pelvic pain, uterine enlargement and weight increased to be related to essure.The reporter commented: she was diagnosed with menorrhagia and discussions were had concerning an endometrial ablation for treatment.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: occlusion was viewed in both fallopian tubes.Ultrasound pelvis - on (b)(6) 2009: results: mildly enlarged uterus but otherwise, unremarkable.Diagnostic results: she subsequent had a transabdominal and endovaginal ultrasound performed on or around (b)(6) 2011 due to irregular periods and abdominal cramping.It is noted that the uterus was somewhat bulky in configuration and there was no discrete fibroid confirmed.A transvaginal ultrasound was performed which showed an enlarged anteverted uterus with a cyst at the cervical vaginal junction measuring 1.5 cm.The report also suggests that an essure contraceptive device was in the her uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received : new events- "genital haemorrhage ,autoimmune disorder , hypersensitivity" added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included anesthesia.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), dysfunctional uterine bleeding ("dysfunctional uterine bleeding"), device expulsion ("essure contraceptive device was in her uterus / migration"), menorrhagia ("menorrhagia"), arthralgia ("joint pain"), alopecia ("hair loss"), fatigue ("fatigue"), abdominal pain ("abdominal pain"), anaemia ("anemia") with blood iron decreased, migraine ("migraines"), menometrorrhagia ("menometrorrhagia"), uterine enlargement ("enlarged uterus"), menstruation irregular ("irregular periods"), abdominal pain lower ("abdominal cramping"), cyst ("cyst"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune symptoms") and hypersensitivity ("hypersensitivity") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the pelvic pain, dysfunctional uterine bleeding, device expulsion, menorrhagia, arthralgia, alopecia, weight increased, fatigue, abdominal pain, anaemia, migraine, menometrorrhagia, uterine enlargement, menstruation irregular, abdominal pain lower and cyst had not resolved and the genital haemorrhage, autoimmune disorder and hypersensitivity outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, anaemia, arthralgia, autoimmune disorder, cyst, device expulsion, dysfunctional uterine bleeding, fatigue, genital haemorrhage, hypersensitivity, menometrorrhagia, menorrhagia, menstruation irregular, migraine, pelvic pain, uterine enlargement and weight increased to be related to essure.The reporter commented: she was diagnosed with menorrhagia and discussions were had concerning an endometrial ablation for treatment.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: occlusion was viewed in both fallopian tubes.Ultrasound pelvis - on (b)(6) 2009: results: mildly enlarged uterus but otherwise, unremarkable.Diagnostic results: she subsequent had a transabdominal and endovaginal ultrasound performed on or around (b)(6) 2011 due to irregular periods and abdominal cramping.It is noted that the uterus was somewhat bulky in configuration and there was no discrete fibroid confirmed.A transvaginal ultrasound was performed which showed an enlarged anteverted uterus with a cyst at the cervical vaginal junction measuring 1.5 cm.The report also suggests that an essure contraceptive device was in the her uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-sep-2020: quality-safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 10523341
• MDR Text Key: 213850690
• Report Number: 2951250-2020-14143
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other