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

Model Number ESS205

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Lupus (1956); Menstrual Irregularities (1959); Pain (1994); Hot Flashes/Flushes (2153); Sensitivity of Teeth (2427); Abdominal Distention (2601); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 08/12/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and systemic lupus erythematosus ('systemic lupus') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "appears to be an iud within the uterus".Medical conditions: plaintiff is (b)(6) years old.Concomitant products included anesthetics.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2013, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced pelvic pain (seriousness criterion medically significant), dysfunctional uterine bleeding ("dysfunctional uterine bleeding") and menstruation irregular ("irregular periods"), 9 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced autoimmune disorder ("autoimmune like symptoms"), menorrhagia ("menorrhagia"), abdominal pain ("abdominal pain"), dyspareunia ("dyspareunia"), hot flush ("hot flashes"), arthralgia ("joint pain"), alopecia ("hair loss"), fatigue ("fatigue"), tooth disorder ("weak teeth"), abdominal distension ("bloating"), migraine ("migraine headache"), genital haemorrhage ("genital bleeding") and hypersensitivity ("hypersensitivity").Essure (ess205) treatment was not changed.At the time of the report, the pelvic pain, dysfunctional uterine bleeding, autoimmune disorder, systemic lupus erythematosus, menorrhagia, abdominal pain, dyspareunia, hot flush, arthralgia, alopecia, fatigue, tooth disorder, abdominal distension and menstruation irregular had not resolved and the migraine, genital haemorrhage and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain, alopecia, arthralgia, autoimmune disorder, dysfunctional uterine bleeding, dyspareunia, fatigue, genital haemorrhage, hot flush, hypersensitivity, menorrhagia, menstruation irregular, migraine, pelvic pain, systemic lupus erythematosus and tooth disorder to be related to essure (ess205).The reporter commented: patient menstrual periods were monthly, lasting 5 days with moderate bleeding.Patient began treatment for hot flashes in 2013.Essure devices remain implanted in patient.She began treatment for hot flashes in 2013 diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2015: results: normal with no masses in the uterus/ovary; on (b)(6) 2016: results: normal; on (b)(6) 2016: results: normal.Diagnostic results: on (b)(6) 2013 patient had lumbar spine mri in which appeared iud within uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received.Event: abnormal bleeding, migraine headache and hypersensitivity were added.Fu 4 and 5 processed together.On (b)(6) 2020: fu 4 and 5 processed together.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') and systemic lupus erythematosus ('systemic lupus') in a 44-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "appears to be an iud within the uterus".Medical conditions: plaintiff is forty-seven (47) years old.Concomitant products included anesthetics.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2013, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced pelvic pain (seriousness criterion medically significant), abnormal uterine bleeding ("dysfunctional uterine bleeding") and menstruation irregular ("irregular periods"), 9 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced autoimmune disorder ("autoimmune like symptoms"), heavy menstrual bleeding ("menorrhagia"), abdominal pain ("abdominal pain"), dyspareunia ("dyspareunia"), hot flush ("hot flashes"), arthralgia ("joint pain"), alopecia ("hair loss"), fatigue ("fatigue"), tooth disorder ("weak teeth"), abdominal distension ("bloating"), migraine ("migraine headache"), genital haemorrhage ("genital bleeding") and hypersensitivity ("hypersensitivity").Essure (ess205) treatment was not changed.At the time of the report, the pelvic pain, abnormal uterine bleeding, autoimmune disorder, systemic lupus erythematosus, heavy menstrual bleeding, abdominal pain, dyspareunia, hot flush, arthralgia, alopecia, fatigue, tooth disorder, abdominal distension and menstruation irregular had not resolved and the migraine, genital haemorrhage and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain, abnormal uterine bleeding, alopecia, arthralgia, autoimmune disorder, dyspareunia, fatigue, genital haemorrhage, heavy menstrual bleeding, hot flush, hypersensitivity, menstruation irregular, migraine, pelvic pain, systemic lupus erythematosus and tooth disorder to be related to essure (ess205).The reporter commented: patient menstrual periods were monthly, lasting 5 days with moderate bleeding.Patient began treatment for hot flashes in 2013.Essure devices remain implanted in patient.She began treatment for hot flashes in 2013.Both ostia were visualized and felt to be amenable to cannulization with the essure device.1.Coil trailing in left tubal ostia.3 coils noted in right ostia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2015: results: normal with no masses in the uterus/ovary; on (b)(6) 2016: results: normal; on (b)(6) 2016: results: normal.Diagnostic results: on (b)(6) 2013 patient had lumbar spine mri in which appeard iud within uterus.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 24-jul-2021: 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 pelvic pain ('pelvic pain') and systemic lupus erythematosus ('systemic lupus') in a 44-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "appears to be an iud within the uterus".Medical conditions: plaintiff is forty-seven (47) years old.Concomitant products included anesthetics.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2013, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced pelvic pain (seriousness criterion medically significant), abnormal uterine bleeding ("dysfunctional uterine bleeding") and menstruation irregular ("irregular periods"), 9 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced autoimmune disorder ("autoimmune like symptoms"), heavy menstrual bleeding ("menorrhagia"), abdominal pain ("abdominal pain"), dyspareunia ("dyspareunia"), hot flush ("hot flashes"), arthralgia ("joint pain"), alopecia ("hair loss"), fatigue ("fatigue"), tooth disorder ("weak teeth"), abdominal distension ("bloating"), migraine ("migraine headache"), genital haemorrhage ("genital bleeding") and hypersensitivity ("hypersensitivity").Essure (ess205) treatment was not changed.At the time of the report, the pelvic pain, abnormal uterine bleeding, autoimmune disorder, systemic lupus erythematosus, heavy menstrual bleeding, abdominal pain, dyspareunia, hot flush, arthralgia, alopecia, fatigue, tooth disorder, abdominal distension and menstruation irregular had not resolved and the migraine, genital haemorrhage and hypersensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain, abnormal uterine bleeding, alopecia, arthralgia, autoimmune disorder, dyspareunia, fatigue, genital haemorrhage, heavy menstrual bleeding, hot flush, hypersensitivity, menstruation irregular, migraine, pelvic pain, systemic lupus erythematosus and tooth disorder to be related to essure (ess205).The reporter commented: patient menstrual periods were monthly, lasting 5 days with moderate bleeding.Patient began treatment for hot flashes in 2013.Essure devices remain implanted in patient.She began treatment for hot flashes in 2013.Both ostia were visualized and felt to be amenable to cannulization with the essure device.1 coil trailing in left tubal ostia.3 coils noted in right ostia.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2015: results: normal with no masses in the uterus/ovary; on (b)(6) 2016: results: normal; on (b)(6) 2016: results: normal.Diagnostic results: on (b)(6) 2013 patient had lumbar spine mri in which appeard iud within uterus.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-jul-2021: mr received : reporter information, date of birth added and rcc updated.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: 10517880
• MDR Text Key: 206496987
• Report Number: 2951250-2020-14121
• 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: 07/26/2021

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: ESS205
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 07/16/2021; 07/24/2021
• Supplement Dates FDA Received: 07/22/2021; 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANESTHETICS; ANESTHETICS; ANESTHETICS
• Patient Outcome(s): Other
• Patient Age: 44 YR