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); Anemia (1706); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 11/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('gen.Abnormal.Bleeding') and menorrhagia ('menorrhagia (heavy menstrual bleeding/ abnormal bleeding (vaginal, menorrhagia)') 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) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced menorrhagia (seriousness criterion medically significant) and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").In (b)(6) 2012, the patient experienced migraine ("migraines / headaches"), nausea ("nausea") and abdominal distension ("gastrointestinal or digestive system condition type: bloating").In (b)(6) 2016, the patient experienced alopecia ("hair loss").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain ("pelvic/abdominal, pain"), dysmenorrhoea ("dysmennorhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse"), pelvic pain ("pelvic/abdominal, pain"), psychological trauma ("psych injury"), back pain ("back, chronic pain"), cystitis ("bladder infect"), bladder disorder ("bladder probs.,"), urinary tract disorder ("urinary probs"), the first episode of visual impairment ("vision probs"), vaginal discharge ("vag.Discharge"), vaginal infection ("vag.Infect"), fatigue ("fatigue,"), tooth disorder ("dental probs"), the second episode of visual impairment ("vision probs"), headache ("headaches,"), gastrointestinal disorder ("gi conditions"), iron deficiency anaemia ("anemia") and anaemia ("blood or heart disorder/condition type: anemia") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the genital haemorrhage, abdominal pain, dysmenorrhoea, dyspareunia, pelvic pain, psychological trauma, back pain, menorrhagia, cystitis, bladder disorder, urinary tract disorder, vaginal discharge, vaginal infection, fatigue, alopecia, tooth disorder, weight increased, the last episode of visual impairment, headache, gastrointestinal disorder, iron deficiency anaemia, vaginal haemorrhage, migraine, anaemia, nausea and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, alopecia, anaemia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, headache, iron deficiency anaemia, menorrhagia, migraine, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vaginal infection, weight increased, the first episode of visual impairment and the second episode of visual impairment to be related to essure.The reporter commented: she received treatment for dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic/abdominal, back, chronic, menorrhagia (heavy menstrual bleeding), psych injury, adder probs., urinary probs., bladder infect., uti, vag.Infect., vag.Discharge, fatigue, hair loss, dental probs., vision probs, headaches, weight gain.Discrepancy noted in insertion date (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Imaging procedure on (b)(6) 2014: essure confirmation test(s) (unspecified) result:bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-mar-2020: plaintiff fact sheet and medical records received : reporters added.Events added- vaginal haemorrhage, migraine, anaemia, nausea, abdominal distension.Severity of back pain and pelvic pain added.Event onset dates 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 ('pelvic pain'), menorrhagia ('menorrhagia (heavy menstrual bleeding/ abnormal bleeding/ menorrhagia)'), abdominal pain ('abdominal pain'), back pain ('back, chronic pain') and dysmenorrhoea ('dysmenorrhea (cramping)') in a 28-year-old female patient who had essure (batch no.852003) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced menorrhagia and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2012, the patient experienced migraine ("migraines / headaches"), nausea ("nausea") and abdominal distension ("bloating").In (b)(6) 2016, the patient experienced alopecia ("hair loss").On an unknown date, the patient experienced pelvic pain, abdominal pain, back pain, dysmenorrhoea, genital haemorrhage ("gen.Abnormal.Bleeding"), dyspareunia ("dyspareunia (painful sexual intercourse)"), psychological trauma ("psych injury"), cystitis ("bladder infect"), bladder disorder ("bladder probs."), urinary tract disorder ("urinary probs"), visual impairment ("vision probs"), vaginal discharge ("vag.Discharge"), vaginal infection ("vag.Infect"), fatigue ("fatigue"), tooth disorder ("dental probs"), headache ("headaches"), gastrointestinal disorder ("gi conditions") and anaemia ("anemia") and was found to have weight increased ("weight gain").Essure treatment was ongoing at the time of the report.At the time of the report, the pelvic pain, abdominal pain, back pain, dysmenorrhoea, menorrhagia, genital haemorrhage, vaginal haemorrhage, dyspareunia, psychological trauma, cystitis, bladder disorder, urinary tract disorder, visual impairment, vaginal discharge, vaginal infection, fatigue, alopecia, tooth disorder, weight increased, headache, gastrointestinal disorder, anaemia, migraine, nausea and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, alopecia, anaemia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment and weight increased to be related to essure.The reporter commented: patient received treatment for dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic/abdominal, back, chronic, menorrhagia (heavy menstrual bleeding), psych injury, adder probs., urinary probs., bladder infect., uti, vag.Infect., vag.Discharge, fatigue, hair loss, dental probs., vision probs, headaches, weight gain starting on the left, an essure was deployed with 4 coils noted and repeated on the right with 5 coils noted.Discrepancy noted in insertion date - (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: bilateral occlusion, proper position of essure devices and bilateral tubal occlusion.Lot number: 852003 manufacturing date: 2011-04 expiration date: 2014-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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: 9892218
• MDR Text Key: 193012785
• Report Number: 2951250-2020-02782
• 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: 10/30/2020

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: 04/01/2014
• Device Model Number: ESS305
• Device Lot Number: 852003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 67