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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Weight Changes (2607)

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 sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding/bleeding"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), fatigue ("fatigue"), alopecia ("hair loss"), migraine ("migraine"), nausea ("nausea"), abdominal pain lower ("cramping") and psychological trauma ("psych injury") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain, genital haemorrhage, bladder disorder, urinary tract disorder, fatigue, alopecia, migraine, nausea, weight increased, abdominal pain lower and psychological trauma outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, bladder disorder, fatigue, genital haemorrhage, migraine, nausea, pelvic pain, psychological trauma, urinary tract disorder and weight increased to be related to essure.The reporter commented: previously essure insertion date provided as (b)(6) 2015 patient received treatment for pelvic/ abdominal pain, severe cramping, bleeding, and hair loss.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2019: pfs received- previously reported event "injury" was updated to "pelvic pain", events- "abdominal pain, general abnormal bleeding/bleeding, bladder problems, urinary problems, fatigue, hair loss, migraine, nausea, weight gain and cramping", reporter information was 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 pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight.In (b)(6)2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding/bleeding"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), fatigue ("fatigue"), alopecia ("other injury(ies) or complication please describe:hair loss"), migraine ("migraine/migraines / headaches"), nausea ("nausea"), abdominal pain lower ("cramping"), psychological trauma ("psych injury"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), arthralgia ("hips pain/ other injury(ies) or complication please describe: extreme pain in my hips") and endometriosis ("endometriosis") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6)2018.At the time of the report, the pelvic pain, abdominal pain, genital haemorrhage, bladder disorder, urinary tract disorder, fatigue, alopecia, migraine, nausea, weight increased, abdominal pain lower, psychological trauma, dysmenorrhoea, dyspareunia, vaginal discharge, arthralgia and endometriosis outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, bladder disorder, dysmenorrhoea, dyspareunia, endometriosis, fatigue, genital haemorrhage, migraine, nausea, pelvic pain, psychological trauma, urinary tract disorder, vaginal discharge and weight increased to be related to essure.The reporter commented: previously essure insertion date provided as (b)(6)2015 , (b)(6)2014 patient received treatment for pelvic/ abdominal pain, severe cramping, bleeding, and hair loss.In (b)(6)2014, dye test was performed and the doctor said that everything looked good.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.1 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-sep-2019: pfs received.New events dysmenorrhea, dyspareunia, vaginal discharge, hips pain, endometriosis were added.Date of insertion was updated.Patient demographic details were added.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 pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B61393) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight, uterine bleeding and uterine bleeding.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding/bleeding"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), fatigue ("fatigue"), alopecia ("other injury(ies) or complication please describe:hair loss"), migraine ("migraine/migraines / headaches"), nausea ("nausea"), abdominal pain lower ("cramping"), psychological trauma ("psych injury"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), arthralgia ("hips pain/ other injury(ies) or complication please describe: extreme pain in my hips") and endometriosis ("endometriosis") and was found to have weight increased ("weight gain").The patient was treated with surgery (oopherectomy total laparoscopic hysterectomy,bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain, genital haemorrhage, bladder disorder, urinary tract disorder, fatigue, alopecia, migraine, nausea, weight increased, abdominal pain lower, psychological trauma, dysmenorrhoea, dyspareunia, vaginal discharge, arthralgia and endometriosis outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, bladder disorder, dysmenorrhoea, dyspareunia, endometriosis, fatigue, genital haemorrhage, migraine, nausea, pelvic pain, psychological trauma, urinary tract disorder, vaginal discharge and weight increased to be related to essure.The reporter commented: previously essure insertion date provided as (b)(6) 2015 , (b)(6) 2014 patient received treatment for pelvic/ abdominal pain, severe cramping, bleeding, and hair loss.In (b)(6) 2014, dye test was performed and the doctor said that everything looked good.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.1 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-may-2020: mr received , reporter , lot number and patient relevant information added.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.

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 (batch no.B61393) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight, uterine bleeding and uterine bleeding.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding/bleeding"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), fatigue ("fatigue"), alopecia ("other injury(ies) or complication please describe:hair loss"), migraine ("migraine/migraines / headaches"), nausea ("nausea"), abdominal pain lower ("cramping"), psychological trauma ("psych injury"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), arthralgia ("hips pain/ other injury(ies) or complication please describe: extreme pain in my hips") and endometriosis ("endometriosis") and was found to have weight increased ("weight gain").The patient was treated with surgery (oopherectomy total laparoscopic hysterectomy,bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain, genital haemorrhage, bladder disorder, urinary tract disorder, fatigue, alopecia, migraine, nausea, weight increased, abdominal pain lower, psychological trauma, dysmenorrhoea, dyspareunia, vaginal discharge, arthralgia and endometriosis outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, bladder disorder, dysmenorrhoea, dyspareunia, endometriosis, fatigue, genital haemorrhage, migraine, nausea, pelvic pain, psychological trauma, urinary tract disorder, vaginal discharge and weight increased to be related to essure.The reporter commented: previously essure insertion date provided as (b)(6) 2015 , (b)(6) 2014 patient received treatment for pelvic/ abdominal pain, severe cramping, bleeding, and hair loss.In (b)(6) 2014, dye test was performed and the doctor said that everything looked good.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.1 kg/sqm.Batch no b61393 production date 2013-08-22 expiration date 2016-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jun-2020: quality safety evaluation of ptc.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.

• 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: 8963781
• MDR Text Key: 161192559
• Report Number: 2951250-2019-05381
• 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,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: ESS305
• Device Lot Number: B61393
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 05/28/2020; 06/25/2020
• Supplement Dates FDA Received: 10/08/2019; 06/15/2020; 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 76