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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Abdominal Pain (1685); Anemia (1706); Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Inflammation (1932); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Thyroid Problems (2102); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Myalgia (2238); Arthralgia (2355); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Constipation (3274)

Event Date 01/24/2018

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("migration of essure device location of device: myometrium at right cornu"), autoimmune disorder ("autoimmune disease reaction"), uterine haemorrhage ("uterine menstrual hemorrhaging") and haemorrhagic anaemia ("anemia (extreme bleeding worsened it)") in a (b)(6) female patient who had essure (batch no.915882) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included abdominal pain, epigastric pain, abdominal pain lower, adnexa uteri pain, memory disturbance, weight gain, hypothyroidism, cold intolerance, constipation, myalgia and chronic rhinitis.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("severe pelvic pain, pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge") and alopecia ("hair loss").On (b)(6) 2015, 3 years 8 months after insertion of essure, the patient experienced antinuclear antibody positive ("autoimmune disorder type of disorder: +ana").On (b)(6) 2018, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), haemorrhagic anaemia (seriousness criterion medically significant), fatigue ("fatigue"), arthralgia ("joint pain, pain") and pain in extremity ("legs pain, pain").The patient was treated with vitamins and surgery (total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, autoimmune disorder, haemorrhagic anaemia, antinuclear antibody positive, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue and alopecia outcome was unknown and the uterine haemorrhage, pelvic pain, menorrhagia, vaginal haemorrhage, arthralgia and pain in extremity had resolved.The reporter considered alopecia, antinuclear antibody positive, arthralgia, autoimmune disorder, dysmenorrhoea, dyspareunia, embedded device, fatigue, haemorrhagic anaemia, menorrhagia, pain in extremity, pelvic pain, uterine haemorrhage, vaginal discharge and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood thyroid stimulating hormone - on an unknown date: 6.65 hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: dyspareunia, alopecia, arthralgia, pelvic pain, autoimmune disorder.Most recent follow-up information incorporated above includes: on 7-may-2018: pfs and mr received: case became incident.New reporters, patient demographic information, product indication, onset and removal dates updated, lot no, treatment medications, concomitant disease, new events embedded device, menorrhagia, vaginal haemorrhage, antinuclear antibody positive, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, alopecia, haemorrhagic anemia, arthralgia and pain in extremity added.Outcome for the events uterine haemorrhage, menorrhagia, vaginal haemorrhage, pelvic pain, arthralgia and pain in extremity added as recovered / resolved.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available, it will be provided in a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("migration of essure device location of device: myometrium at right cornu"), autoimmune disorder ("autoimmune disease reaction"), uterine haemorrhage ("uterine menstrual hemorrhaging") and haemorrhagic anaemia ("anemia (extreme bleeding worsened it)") in a 41-year-old female patient who had essure (batch no.915882) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included abdominal pain, epigastric pain, abdominal pain lower, adnexa uteri pain, memory disturbance, weight gain, hypothyroidism, cold intolerance, constipation, myalgia and chronic rhinitis.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("severe pelvic pain, pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish").On (b)(6) 2015, 3 years 8 months after insertion of essure, the patient experienced antinuclear antibody positive ("autoimmune disorder type of disorder: +ana").On (b)(6) 2018, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), haemorrhagic anaemia (seriousness criterion medically significant), arthralgia ("joint pain, pain") and pain in extremity ("legs pain, pain").The patient was treated with vitamins and surgery (total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, autoimmune disorder, haemorrhagic anaemia, antinuclear antibody positive, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, alopecia, depression and anxiety outcome was unknown and the uterine haemorrhage, pelvic pain, menorrhagia, vaginal haemorrhage, arthralgia and pain in extremity had resolved.The reporter considered alopecia, antinuclear antibody positive, anxiety, arthralgia, autoimmune disorder, depression, dysmenorrhoea, dyspareunia, embedded device, fatigue, haemorrhagic anaemia, menorrhagia, pain in extremity, pelvic pain, uterine haemorrhage, vaginal discharge and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood thyroid stimulating hormone - on an unknown date: 6.65 hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: dyspareunia, alopecia, arthralgia, pelvic pain, autoimmune disorder.Most recent follow-up information incorporated above includes: on 18-jul-2018: new pfs received- new events psychological or psychiatric problems condition: depression and mental anguish were added.New reporter was added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available, it will be provided in a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("migration of essure device location of device: myometrium at right cornu"), autoimmune disorder ("autoimmune disease reaction"), uterine haemorrhage ("uterine menstrual hemorrhaging") and haemorrhagic anaemia ("anemia (extreme bleeding worsened it)") in a 41-year-old female patient who had essure (batch no.915882) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included abdominal pain, epigastric pain, abdominal pain lower, adnexa uteri pain, memory disturbance, weight gain, hypothyroidism, cold intolerance, constipation, myalgia and chronic rhinitis.On (b)(6) 2011, the patient had essure inserted.In january 2012, the patient experienced pelvic pain ("severe pelvic pain, pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish").On (b)(6) 2015, 3 years 8 months after insertion of essure, the patient experienced antinuclear antibody positive ("autoimmune disorder type of disorder: +ana").On (b)(6) 2018, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), haemorrhagic anaemia (seriousness criterion medically significant), arthralgia ("joint pain, pain") and pain in extremity ("legs pain, pain").The patient was treated with vitamins and surgery (total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, autoimmune disorder, haemorrhagic anaemia, antinuclear antibody positive, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, alopecia, depression and anxiety outcome was unknown and the uterine haemorrhage, pelvic pain, menorrhagia, vaginal haemorrhage, arthralgia and pain in extremity had resolved.The reporter considered alopecia, antinuclear antibody positive, anxiety, arthralgia, autoimmune disorder, depression, dysmenorrhoea, dyspareunia, embedded device, fatigue, haemorrhagic anaemia, menorrhagia, pain in extremity, pelvic pain, uterine haemorrhage, vaginal discharge and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood thyroid stimulating hormone - on an unknown date: 6.65 hysterosalpingogram - on 1-feb-2012: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: dyspareunia, alopecia, arthralgia, pelvic pain, autoimmune disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-aug-2018: quality safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available, it will be provided in a supplemental report.

Manufacturer Narrative

Cutaneous case was reported by a lawyer and describes the occurrence of embedded device ("migration of essure device location of device: myometrium at right cornu"), device expulsion ("migration of essure device location of device: myometrium at right cornu"), autoimmune disorder ("autoimmune disease reaction"), uterine haemorrhage ("uterine menstrual hemorrhaging") and haemorrhagic anaemia ("anemia (extreme bleeding worsened it)") in a 38-year-old female patient who had essure (batch no.915882) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included abdominal pain, epigastric pain, abdominal pain lower, adnexa uteri pain, memory disturbance, weight gain, hypothyroidism, cold intolerance, constipation, myalgia and chronic rhinitis.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2012, 23 days after insertion of essure, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and alopecia ("hair loss").On (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2012, the patient experienced pelvic pain ("severe pelvic pain, pain"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish").On (b)(6) 2015, the patient experienced antinuclear antibody positive ("autoimmune disorder type of disorder: +ana").On (b)(6) 2018, the patient experienced embedded device (seriousness criteria medically significant and intervention required) and device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant).On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), haemorrhagic anaemia (seriousness criterion medically significant), arthralgia ("joint pain, pain") and pain in extremity ("legs pain, pain").The patient was treated with vitamins, surgery (total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, device expulsion, autoimmune disorder, haemorrhagic anaemia, antinuclear antibody positive, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, alopecia, depression and anxiety outcome was unknown and the uterine haemorrhage, pelvic pain, menorrhagia, vaginal haemorrhage, arthralgia and pain in extremity had resolved.The reporter considered alopecia, antinuclear antibody positive, anxiety, arthralgia, autoimmune disorder, depression, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fatigue, haemorrhagic anaemia, menorrhagia, pain in extremity, pelvic pain, uterine haemorrhage, vaginal discharge and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood thyroid stimulating hormone - on an unknown date: 6.65, hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: dyspareunia, alopecia, arthralgia, pelvic pain, autoimmune disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received - event migration of essure device location of device: myometrium at right cornu was added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available, it will be provided in a supplemental 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: 7568776
• MDR Text Key: 110054569
• Report Number: 2951250-2018-02495
• Device Sequence Number: 1
• Product Code: HHS
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: ESS305
• Device Lot Number: 915882
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR