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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Anxiety (2328); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Genital Bleeding (4507)

Event Date 03/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('bleeding') and pelvic pain ('pelvic pains') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted, specify no".The patient's concurrent conditions included overweight.Concomitant products included bupropion hydrochloride (wellbutrin), diazepam (valium) and ketorolac.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criterion medically significant), migraine ("migraine headaches"), mood swings ("hormonal changes describe: mood swings"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue") and headache ("headache").In 2013, the patient experienced nausea ("nausea"), back pain ("back pain") and breast pain ("breast pain").In 2015, the patient experienced bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge") and alopecia ("hair loss") and was found to have weight increased ("weight gain / loss specify which one: weight gain").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping in her lower abdomen"), rash ("rashes"), dysgeusia ("metal taste in her mouth") and anxiety ("psychological or psychiatric problems condition: anxiety").The patient was treated with ibuprofen (matrix), sumatriptan and surgery (ablation and ablation on 2013).Essure treatment was not changed.At the time of the report, the genital haemorrhage, pelvic pain, abdominal pain lower, rash, migraine and dysgeusia had not resolved and the mood swings, vaginal haemorrhage, menorrhagia, anxiety, bladder disorder, urinary tract disorder, nausea, allergy to metals, dysmenorrhoea, vaginal discharge, fatigue, weight increased, alopecia, headache, back pain and breast pain outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, alopecia, anxiety, back pain, bladder disorder, breast pain, dysgeusia, dysmenorrhoea, fatigue, genital haemorrhage, headache, menorrhagia, migraine, mood swings, nausea, pelvic pain, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: treatment with medical providers.She continues to suffer from and treat for these maladies discrepancy in date of insertion: (b)(6) 2013.Current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)().Most recent follow-up information incorporated above includes: on 24-may-2019: pfs received- pt of mood altered update to mood swings.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 pains') and genital haemorrhage ('bleeding') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted, specify no".The patient's medical history included gravida ii and parity 2.Concurrent conditions included overweight and paratubal cyst.Concomitant products included bupropion hydrochloride (wellbutrin), diazepam (valium) and ketorolac.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), migraine ("migraine headaches"), mood swings ("hormonal changes describe: mood swings"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue") and headache ("headache").In 2013, the patient experienced nausea ("nausea"), back pain ("back pain") and breast pain ("breast pain").In 2015, the patient experienced bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge") and alopecia ("hair loss") and was found to have weight increased ("weight gain / loss specify which one: weight gain").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping in her lower abdomen"), rash ("rashes"), dysgeusia ("metal taste in her mouth") and anxiety ("psychological or psychiatric problems condition: anxiety").The patient was treated with ibuprofen (matrix), sumatriptan and surgery (ablation, ablation on 2013 and robotic assisted total laparoscopic hysterectomy,bilateral salpingectomy).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain and headache had resolved, the genital haemorrhage, abdominal pain lower, rash, migraine and dysgeusia had not resolved and the mood swings, vaginal haemorrhage, heavy menstrual bleeding, anxiety, bladder disorder, urinary tract disorder, nausea, allergy to metals, dysmenorrhoea, vaginal discharge, fatigue, weight increased, alopecia, back pain and breast pain outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, alopecia, anxiety, back pain, bladder disorder, breast pain, dysgeusia, dysmenorrhoea, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, migraine, mood swings, nausea, pelvic pain, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: treatment with medical providers.She continues to suffer from and treat for these maladies.Discrepancy in date of insertion: on (b)(6) 2013, (b)(6) 2013.Current weight 165 lbs.Date(s) of insertion: (b)(6) 2013 (discrepancy noted per pif).Ha resolved since surgery, feeling better overall since hysterectomy and implant removal.Symptoms of headache and pelvic pain, metallic taste is resolved since hysterectomy and essure implant removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.3 kg/sqm.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s media records: headache,pelvic pain, metallic taste.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jul-2021: mr received.Reporter information, other relevant history, explant date, surgery type and reporter causality comment added.Outcome of event pelvic pain and headache updated to recovered/resolved.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: 8662108
• MDR Text Key: 146793587
• Report Number: 2951250-2019-02386
• 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: 07/27/2021

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 Model Number: ESS305
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KETOROLAC; KETOROLAC; VALIUM; VALIUM; WELLBUTRIN; WELLBUTRIN; KETOROLAC; VALIUM; WELLBUTRIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 91