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

Model Number ESS305

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

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Urinary Tract Infection (2120); Cramp(s) (2193); Urinary Frequency (2275); Anxiety (2328); Arthralgia (2355); Depression (2361); Fungal Infection (2419); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pelvic inflammatory disease') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: a.If yes, on what date? (b)(6) 2008 (b)(6).B.Type of test: hysterosalpingogram (hsg).In (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), uterine infection ("infection (bladder/ urinary tract/vaginal) type: uterine infection/ ureter"), urinary tract infection ("infection (other) describe: uti"), vulvovaginal mycotic infection ("yeast infection"), migraine ("migraines / headaches"), allergy to metals ("allergic or hypersensitivity reaction : nickel allergy"), pelvic pain ("pain"), mood swings ("psychological or psychiatric problems condition: mood swings"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("anxiety"), urticaria ("rashes or skin conditions type: hives"), rash ("rash"), endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), alopecia ("hair loss"), abdominal pain ("abdominal pain"), back pain ("back pain"), arthralgia ("joint pain"), pain ("aches pain"), dysgeusia ("metallic taste") and dyspareunia ("dyspareunia (painful sexual intercourse)") and was found to have weight increased ("weight gain/ loss (which one specify) weight gain").At the time of the report, the pelvic inflammatory disease, vaginal haemorrhage, menorrhagia, bladder disorder, urinary tract disorder, tooth disorder, dysmenorrhoea, uterine infection, urinary tract infection, vulvovaginal mycotic infection, migraine, allergy to metals, pelvic pain, mood swings, depression, anxiety, urticaria, rash, endometriosis, abdominal distension, alopecia, weight increased, abdominal pain, back pain, arthralgia, pain, dysgeusia and dyspareunia outcome was unknown.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, migraine, mood swings, pain, pelvic inflammatory disease, pelvic pain, rash, tooth disorder, urinary tract disorder, urinary tract infection, urticaria, uterine infection, vaginal haemorrhage, vulvovaginal mycotic infection and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Pelvic inflammatory disease, abnormal bleeding (vaginal), menorrhagia, bladder or urinary problems or changes, dental problems, dysmenorrhea (cramping), infection (bladder/ urinary tract/vaginal) type: uterine infection/ ureter, infection (other) describe: uti, yeast infection, migraines / headaches, allergic or hypersensitivity reaction : nickel allergy, pain, psychological or psychiatric problems condition: mood swings, psychological or psychiatric problems condition: depression, anxiety, rashes or skin conditions type: hives, rash, reproductive system disorder or condition type of disorder or condition: endometriosis, gastrointestinal or digestive system condition type: bloating, hair loss, weight gain/ loss (which one specify) weight gain, abdominal pain, back pain, joint pain, metallic taste, dyspareunia (painful sexual intercourse) were 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 information become available from our investigation, this will be and other non-conformances data; should any new and reportable provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pelvic inflammatory disease') and uterine infection ('infection (bladder/ urinary tract/vaginal) type: uterine infection/ ureter') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), uterine infection (seriousness criteria medically significant and intervention required), pelvic pain ("pain/pain- pelvic"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), allergy to metals ("allergic or hypersensitivity reaction : nickel allergy"), vaginal hemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia/bleeding- menorrhagia (heavy menstrual bleeding)"), rash ("rash"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), vaginal infection ("bladder/urinary problems- uti, vag.Infect"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), urinary tract infection ("infection (other) describe: uti/bladder/urinary problems- uti"), vulvovaginal mycotic infection ("yeast infection"), migraine ("migraines / headaches"), mood swings ("psychological or psychiatric problems condition: mood swings"), depression ("psychological or psychiatric problems condition: depression/psych injury"), anxiety ("anxiety/psych injury"), urticaria ("rashes or skin conditions type: hives"), endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), alopecia ("hair loss"), arthralgia ("joint pain"), pain ("aches pain") and dysgeusia ("metallic taste") and was found to have weight increased ("weight gain/ loss (which one specify) weight gain").The patient was treated with surgery (hyst.(full), salping.(bilateral)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic inflammatory disease, uterine infection, vaginal haemorrhage, rash, abdominal distension, bladder disorder, urinary tract disorder, tooth disorder, vulvovaginal mycotic infection, mood swings, depression, anxiety, urticaria, endometriosis, alopecia, weight increased, arthralgia, pain and dysgeusia outcome was unknown and the pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, allergy to metals, menorrhagia, vaginal infection, urinary tract infection and migraine had resolved.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, menorrhagia, migraine, mood swings, pain, pelvic inflammatory disease, pelvic pain, rash, tooth disorder, urinary tract disorder, urinary tract infection, urticaria, uterine infection, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: plaintiff received treatment for pain, bleeding, nickel allergy, bladder/urinary problems, other injuries/symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: was done in (b)(6) 2008 (b)(6) or (b)(6).Results not reported.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-sep-2019: pfs received : event vaginal infection was added.Event outcome was added for the event:vaginal infection.Event outcome was updated for the events: pain- pelvic/abdominal, dysmenorrhea, dyspareunia, back pain, menorrhagia, nickel allergy, uti, vaginal infection, migraine.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 inflammatory disease ('pelvic inflammatory disease') and uterine infection ('infection (bladder/ urinary tract/vaginal) type: uterine infection/ ureter') 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 concurrent conditions included obesity.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), uterine infection (seriousness criteria medically significant and intervention required), pelvic pain ("pain/pain- pelvic"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), allergy to metals ("allergic or hypersensitivity reaction : nickel allergy"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia/bleeding- menorrhagia (heavy menstrual bleeding)"), rash ("rash"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), vaginal infection ("bladder/urinary problems- uti, vag.Infect"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), urinary tract infection ("infection (other) describe: uti/bladder/urinary problems- uti"), vulvovaginal mycotic infection ("yeast infection"), migraine ("migraines / headaches"), mood swings ("psychological or psychiatric problems condition: mood swings"), depression ("psychological or psychiatric problems condition: depression/psych injury"), anxiety ("anxiety/psych injury"), urticaria ("rashes or skin conditions type: hives"), endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), alopecia ("hair loss"), arthralgia ("joint pain"), pain ("aches pain"), dysgeusia ("metallic taste"), genital haemorrhage ("gen.Abnormal bleeding") and post procedural complication ("post removal complications-yes") and was found to have weight increased ("weight gain/ loss (which one specify) weight gain").The patient was treated with surgery (hyst.(full), salping.(bilateral) and hyst.(full), salping.(bilateral)/unilateral oophorectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic inflammatory disease, uterine infection, vaginal haemorrhage, rash, abdominal distension, bladder disorder, urinary tract disorder, tooth disorder, vulvovaginal mycotic infection, mood swings, depression, anxiety, urticaria, endometriosis, alopecia, weight increased, arthralgia, pain, dysgeusia, genital haemorrhage and post procedural complication outcome was unknown and the pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, allergy to metals, menorrhagia, vaginal infection, urinary tract infection and migraine had resolved.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, genital haemorrhage, menorrhagia, migraine, mood swings, pain, pelvic inflammatory disease, pelvic pain, post procedural complication, rash, tooth disorder, urinary tract disorder, urinary tract infection, urticaria, uterine infection, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: plaintiff received treatment for pain, bleeding, nickel allergy, bladder/urinary problems, other injuries/symptoms.Discrepancy noted in removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Hysterosalpingogram - on an unknown date: was done in (b)(6) 2008 april or may.Results not reported.Imaging procedure - on an unknown date: essure confirmation test((unspecified) result: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: ppf received event "gen.Abnormal bleeding and post procedural complication" were added.Reporter information was 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 inflammatory disease ('pelvic inflammatory disease') and uterine infection ('infection (bladder/ urinary tract/vaginal) type: uterine infection/ ureter') 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 concurrent conditions included obesity.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), uterine infection (seriousness criteria medically significant and intervention required), pelvic pain ("pain/pain- pelvic"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), allergy to metals ("allergic or hypersensitivity reaction: nickel allergy"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia/bleeding- menorrhagia (heavy menstrual bleeding)"), rash ("rash"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), vaginal infection ("bladder/urinary problems- uti, vag.Infect"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), urinary tract infection ("infection (other) describe: uti/bladder/urinary problems- uti"), vulvovaginal mycotic infection ("yeast infection"), migraine ("migraines / headaches"), mood swings ("psychological or psychiatric problems condition: mood swings"), depression ("psychological or psychiatric problems condition: depression/psych injury"), anxiety ("anxiety/psych injury"), urticaria ("rashes or skin conditions type: hives"), endometriosis ("reproductive system disorder or condition type of disorder or condition: endometriosis"), alopecia ("hair loss"), arthralgia ("joint pain"), pain ("aches pain"), dysgeusia ("metallic taste"), genital haemorrhage ("gen.Abnormal bleeding") and post procedural complication ("post removal complications-yes") and was found to have weight increased ("weight gain/ loss (which one specify) weight gain").The patient was treated with surgery (hyst.(full), salping.(bilateral) and hyst.(full), salping.(bilateral)/unilateral oophorectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic inflammatory disease, uterine infection, vaginal haemorrhage, rash, abdominal distension, bladder disorder, urinary tract disorder, tooth disorder, vulvovaginal mycotic infection, mood swings, depression, anxiety, urticaria, endometriosis, alopecia, weight increased, arthralgia, pain, dysgeusia, genital haemorrhage and post procedural complication outcome was unknown and the pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, allergy to metals, menorrhagia, vaginal infection, urinary tract infection and migraine had resolved.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, anxiety, arthralgia, back pain, bladder disorder, depression, dysgeusia, dysmenorrhoea, dyspareunia, endometriosis, genital haemorrhage, menorrhagia, migraine, mood swings, pain, pelvic inflammatory disease, pelvic pain, post procedural complication, rash, tooth disorder, urinary tract disorder, urinary tract infection, urticaria, uterine infection, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: plaintiff received treatment for pain, bleeding, nickel allergy, bladder/urinary problems, other injuries/symptoms.Discrepancy noted in removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.9 kg/sqm.Hysterosalpingogram - on an unknown date: was done in (b)(6) 2008 or (b)(6).Results not reported.Imaging procedure - on an unknown date: essure confirmation test((unspecified) result: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-jul-2020: 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
• MDR Report Key: 8792524
• MDR Text Key: 151103125
• Report Number: 2951250-2019-03907
• 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: 07/21/2020

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/04/2019; 05/05/2020; 07/02/2020
• Supplement Dates FDA Received: 09/17/2019; 05/20/2020; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 82