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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Hair Loss (1877); Headache (1880); Failure of Implant (1924); Nausea (1970); Pain (1994); Visual Impairment (2138); Visual Disturbances (2140); Sensitivity of Teeth (2427); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration'), menorrhagia ('menorrhagia (heavy menstrual bleeding)') and cholecystectomy ('gallbladder removal') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia (seriousness criterion medically significant), iron deficiency anaemia ("bleeding: anemia"), psychological trauma ("psych injury"), fatigue ("fatigue"), gastrointestinal disorder ("gi (gastrointestinal) conditions"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea"), visual impairment ("vision problems") and migraine ("migraines"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have hormone level abnormal ("hormonal changes"), weight increased ("weight gain") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, dysmenorrhoea, dyspareunia, abdominal pain, back pain, menorrhagia, iron deficiency anaemia, cholecystectomy, psychological trauma, fatigue, gastrointestinal disorder, alopecia, tooth disorder, hormone level abnormal, headache, nausea, visual impairment, weight increased, weight decreased and migraine outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, cholecystectomy, device dislocation, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, migraine, nausea, pelvic pain, psychological trauma, tooth disorder, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: per ppf: essure insertion date: (b)(6) 2009 (discrepancy noted).She had not undergone essure removal surgery.She had received treatment for following events"dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic pain, abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), bleeding: anemia, psych injury, fatigue, gi (gastrointestinal) conditions, hair loss, dental problems, hormonal changes, headaches, nausea, vision problems, weight gain and weight loss".Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure on (b)(6) 2009: (unspecified): bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-sep-2019: plaintiff fact sheet received.The case is incident.Previously reported event ¿injury¿ was updated to more specified event¿ migration, pelvic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), bleeding anemia, psych injury, fatigue, gi (gastrointestinal) conditions, hair loss, dental problems, hormonal changes, headaches, nausea, vision problems, weight gain, gallbladder removal and weight loss¿.Reporter¿s information, demographics, lab data, and essure indication (amended) were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration') and cholecystectomy ('gallbladder removal') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), iron deficiency anaemia ("bleeding: anemia"), depression ("severe depression"), fatigue ("fatigue"), gastrointestinal disorder ("gi (gastrointestinal) conditions"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea"), blindness ("vision/eye problems type: sight loss") and migraine ("migraines"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have hormone level abnormal ("hormonal changes"), weight increased ("weight gain") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, dysmenorrhoea, dyspareunia, abdominal pain, back pain, menorrhagia, iron deficiency anaemia, cholecystectomy, depression, fatigue, gastrointestinal disorder, alopecia, tooth disorder, hormone level abnormal, headache, nausea, blindness, weight increased, weight decreased and migraine outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, blindness, cholecystectomy, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, migraine, nausea, pelvic pain, tooth disorder, weight decreased and weight increased to be related to essure.The reporter commented: per ppf: essure insertion date: (b)(6) 2009 (discrepancy noted).She had not undergone essure removal surgery.She had received treatment for following events"dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic pain, abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), bleeding: anemia, psych injury, fatigue, gi (gastrointestinal) conditions, hair loss, dental problems, hormonal changes, headaches, nausea, vision problems, weight gain and weight loss".Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2009: (unspecified): bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-mar-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration') and cholecystectomy ('gallbladder removal') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), iron deficiency anaemia ("bleeding: anemia"), depression ("severe depression"), fatigue ("fatigue"), gastrointestinal disorder ("gi (gastrointestinal) conditions"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea"), blindness ("vision/eye problems type: sight loss") and migraine ("migraines"), underwent cholecystectomy (seriousness criterion medically significant) and was found to have hormone level abnormal ("hormonal changes"), weight increased ("weight gain") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, dysmenorrhoea, dyspareunia, abdominal pain, back pain, menorrhagia, iron deficiency anaemia, cholecystectomy, depression, fatigue, gastrointestinal disorder, alopecia, tooth disorder, hormone level abnormal, headache, nausea, blindness, weight increased, weight decreased and migraine outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, blindness, cholecystectomy, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, migraine, nausea, pelvic pain, tooth disorder, weight decreased and weight increased to be related to essure.The reporter commented: per ppf: essure insertion date: (b)(6) 2009 (discrepancy noted).She had not undergone essure removal surgery.She had received treatment for following events"dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic pain, abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), bleeding: anemia, psych injury, fatigue, gi (gastrointestinal) conditions, hair loss, dental problems, hormonal changes, headaches, nausea, vision problems, weight gain and weight loss".Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2009: (unspecified): bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-feb-2020: pfs received: few events was updated from vision problems to sight loss & psyche injury to severe depression.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.

• 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: 9144097
• MDR Text Key: 167191704
• Report Number: 2951250-2019-09207
• 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,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other