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 Problem Pain (1994)

Event Date 02/01/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain'), myocardial infarction ('heart attack') and cerebrovascular accident ('stroke') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), headache ("headache"), groin pain ("groin pain"), pain in extremity ("leg and foot pain"), fatigue ("fatigue"), muscular weakness ("muscle weakness"), swelling ("swelling"), genital haemorrhage ("abnormal bleeding"), menstrual cycle abnormal ("menstrual cycle changes"), dysmenorrhoea ("severe menstrual cramps"), autoimmune disorder ("autoimmune disease"), bladder disorder ("bladder problems"), urinary tract infection ("urinary tract infection"), dyspareunia ("dyspareunia (painful intercourse)"), loss of libido ("loss of libido"), alopecia ("hair loss"), nail disorder ("weakening of nails"), tooth disorder ("weakening of teeth"), depression ("depression"), diabetes mellitus ("diabetes"), hypertension ("high blood pressure"), hepatic steatosis ("fatty liver") and menstruation abnormal ("menstruation with blood clots") and was found to have weight increased ("weight gain") and hormone level abnormal ("hormonal problems").In 2019, the patient experienced myocardial infarction (seriousness criterion hospitalization) and cerebrovascular accident (seriousness criteria hospitalization and disability) with blindness, gait inability, deafness, hemiplegia and dysstasia.On an unknown date, the patient experienced multiple sclerosis ("multiple sclerosis") and pain ("severe pain").The patient was treated with surgery (bilateral salpingectomy in (b)(6) 2020).Essure was removed in (b)(6) 2020.At the time of the report, the pelvic pain, dysmenorrhoea, alopecia and nail disorder had resolved, the headache, groin pain, pain in extremity, fatigue, muscular weakness, swelling, weight increased, genital haemorrhage, menstrual cycle abnormal, autoimmune disorder, bladder disorder, urinary tract infection, dyspareunia, loss of libido, hormone level abnormal, tooth disorder, depression, diabetes mellitus, hypertension, hepatic steatosis, menstruation abnormal, myocardial infarction and cerebrovascular accident was resolving and the multiple sclerosis outcome was unknown.The reporter considered alopecia, autoimmune disorder, bladder disorder, cerebrovascular accident, depression, diabetes mellitus, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, groin pain, headache, hepatic steatosis, hormone level abnormal, hypertension, loss of libido, menstrual cycle abnormal, multiple sclerosis, muscular weakness, myocardial infarction, nail disorder, pain, pain in extremity, pelvic pain, swelling, tooth disorder, urinary tract infection, weight increased and menstruation abnormal to be related to essure.The reporter commented: she has been able to walk without a wheelchair, but only with limitations.She has not regained her right-sided hearing or vision.She was discharged and retired due to inability to work.Pain was so severe that she stopped going out and stayed mainly at home.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-feb-2022: patient's dob, essure removal date and event onset date and outcome were added.Essure insertion date was updated.All events were 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 ('chronic pelvic pain'), myocardial infarction ('heart attack') and cerebrovascular accident ('stroke') in a 32-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), headache ("headache"), groin pain ("groin pain"), pain in extremity ("leg and foot pain"), fatigue ("fatigue"), muscular weakness ("muscle weakness"), swelling ("swelling"), genital haemorrhage ("abnormal bleeding"), menstrual cycle abnormal ("menstrual cycle changes"), dysmenorrhoea ("severe menstrual cramps"), autoimmune disorder ("autoimmune disease"), bladder disorder ("bladder problems"), urinary tract infection ("urinary tract infection"), dyspareunia ("dyspareunia (painful intercourse)"), loss of libido ("loss of libido"), alopecia ("hair loss"), nail disorder ("weakening of nails"), tooth disorder ("weakening of teeth"), depression ("depression"), diabetes mellitus ("diabetes"), hypertension ("high blood pressure"), hepatic steatosis ("fatty liver") and menstruation abnormal ("menstruation with blood clots") and was found to have weight increased ("weight gain") and hormone level abnormal ("hormonal problems").In 2019, the patient experienced myocardial infarction (seriousness criterion hospitalization) and cerebrovascular accident (seriousness criteria hospitalization and disability) with blindness, gait inability, deafness, hemiplegia and dysstasia.On an unknown date, the patient experienced multiple sclerosis ("multiple sclerosis") and pain ("severe pain").The patient was treated with surgery (bilateral salpingectomy in (b)(6) 2020).Essure was removed in (b)(6) 2020.At the time of the report, the pelvic pain, dysmenorrhoea, alopecia and nail disorder had resolved, the headache, groin pain, pain in extremity, fatigue, muscular weakness, swelling, weight increased, genital haemorrhage, menstrual cycle abnormal, autoimmune disorder, bladder disorder, urinary tract infection, dyspareunia, loss of libido, hormone level abnormal, tooth disorder, depression, diabetes mellitus, hypertension, hepatic steatosis, menstruation abnormal, myocardial infarction and cerebrovascular accident was resolving and the multiple sclerosis outcome was unknown.The reporter considered alopecia, autoimmune disorder, bladder disorder, cerebrovascular accident, depression, diabetes mellitus, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, groin pain, headache, hepatic steatosis, hormone level abnormal, hypertension, loss of libido, menstrual cycle abnormal, multiple sclerosis, muscular weakness, myocardial infarction, nail disorder, pain, pain in extremity, pelvic pain, swelling, tooth disorder, urinary tract infection, weight increased and menstruation abnormal to be related to essure.The reporter commented: she has been able to walk without a wheelchair, but only with limitations.She has not regained her right-sided hearing or vision.She was discharged and retired due to inability to work.Pain was so severe that she stopped going out and stayed mainly at home.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 15-mar-2022: 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13744814
• MDR Text Key: 289759315
• Report Number: 2951250-2022-00208
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female