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

Model Number ESS305

Device Problems Break (1069); Malposition of Device (2616); Expulsion (2933); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Nausea (1970); Neurological Deficit/Dysfunction (1982); Pain (1994); Urinary Tract Infection (2120); Dizziness (2194); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Constipation (3274)

Event Date 06/05/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device location of device"), device breakage ("device breakage"), device expulsion ("expulsion of essure device") and autoimmune disorder ("autoimmune disorder type of disorder") in a female patient who had essure (batch no.20222096) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: ortho tricyclen.Concomitant products included drospirenone w/ethinylestradiol (yaz) from (b)(6) 2010 to (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("menorrhagia"), cystitis ("bladder/ urinary tract/vaginal"), urinary tract infection ("bladder/ urinary tract/vaginal"), vaginal infection ("bladder/ urinary tract/vaginal"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), headache ("migraines / headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight fluctuation ("weight gain / loss specify which one"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), back pain ("back pain"), abdominal pain lower ("cramping in lower abdomen"), pelvic pain ("pelvic pain"), dizziness ("dizziness"), alopecia ("hair loss"), hypertension ("high blood pressure"), stress ("stressed") and constipation ("constipation").The patient was treated with surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, device expulsion, autoimmune disorder, vaginal haemorrhage, menorrhagia, vaginal infection, bladder disorder, urinary tract disorder, migraine, nausea, nervous system disorder, dysmenorrhoea, dyspareunia, weight fluctuation and gastrointestinal disorder outcome was unknown and the headache, fatigue, back pain, abdominal pain lower, pelvic pain, dizziness, alopecia, hypertension, stress and constipation had resolved.The reporter considered abdominal pain lower, alopecia, autoimmune disorder, back pain, bladder disorder, constipation, cystitis, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hypertension, menorrhagia, migraine, nausea, nervous system disorder, pelvic pain, stress, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: failure to occlude (close) fallopian tube(s), essure removal date: (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion.Ultrasound scan vagina - on (b)(6) 2015: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received.Events abdominal pain lower, alopecia, autoimmune disorder, back pain, bladder disorder, constipation, cystitis, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, headache, hypertension, menorrhagia, migraine, nausea, nervous system disorder, pelvic pain, stress, urinary tract disorder, urinary tract infection, vaginal haemorrhage,expulsion of essure vaginal infection and weight fluctuation are added.Lot number added.Lab data updated.Concomitant & historical conditions drugs are added.Product, patient & reporter information updated.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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 on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device location of device"), device breakage ("device breakage"), device expulsion ("expulsion of essure device"), menorrhagia ("menorrhagia"), autoimmune disorder ("autoimmune disorder type of disorder") and complication of device removal ("complication during essure removal procedure") in a 37-year-old female patient who had essure (batch no.20222096) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included obesity.No cervical ovarian or fallopian tube tissue was identified grossly.Previously administered products included for an unreported indication: ortho tricyclen.Concurrent conditions included heartburn, endometrial ablation, headache, cholecystectomy, cesarean delivery on maternal request (she was having 5 cesarean sections.), inflammatory reaction, ovarian cyst, gas evolution in intestine, cytology nos and bacterial vaginosis.Concomitant products included drospirenone w/ethinylestradiol (yaz) in 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2015, 5 years 4 months after insertion of essure, the patient experienced complication of device removal (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), the first episode of cystitis ("bladder/ urinary tract/vaginal"), urinary tract infection ("bladder/ urinary tract/vaginal"), vaginal infection ("bladder/ urinary tract/vaginal"), the second episode of cystitis ("bladder infection "), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), headache ("migraines / headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight fluctuation ("weight gain / loss specify which one"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), back pain ("back pain"), abdominal pain lower ("cramping in lower abdomen"), pelvic pain ("pelvic pain"), dizziness ("dizziness"), alopecia ("hair loss"), hypertension ("high blood pressure"), stress ("stressed"), constipation ("constipation"), hormone level abnormal ("didn't feel like myself and my hormone levels dropped ") and vulvovaginal mycotic infection ("yeast infections").The patient was treated with surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (dilation and curettage; novasure endometrial ablation on (b)(6) 2010) and surgery.Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, device expulsion, menorrhagia, autoimmune disorder, vaginal haemorrhage, complication of device removal, vaginal infection, the last episode of cystitis, urinary tract disorder, migraine, nausea, nervous system disorder, dysmenorrhoea, dyspareunia, weight fluctuation, gastrointestinal disorder, hormone level abnormal and vulvovaginal mycotic infection outcome was unknown and the headache, fatigue, back pain, abdominal pain lower, pelvic pain, dizziness, alopecia, hypertension, stress and constipation had resolved.The reporter considered abdominal pain lower, alopecia, autoimmune disorder, back pain, complication of device removal, constipation, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, hypertension, menorrhagia, migraine, nausea, nervous system disorder, pelvic pain, stress, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection, weight fluctuation, the first episode of cystitis and the second episode of cystitis to be related to essure.The reporter commented: she had understood him to say that the right device broke and patient may have particles in her uterus yet.There were complications during the essure removal procedure on (b)(6) 2015 and physician would have go back in to perform another surgery to finish removing essure device on (b)(6) 2016.The patient took leave from her job twice ((b)(6) 2015 and (b)(6) 2016) due to surgery recovery.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: successful tubal occlusion by essure ultrasound scan vagina - on (b)(6) 2015: total bilateral occlusion specimens- fallopian tube, left and right, bilateral explanted essures final diagnosis- bilateral fallopian tubes, resection- - fallopian tubes without pathologic abnormalities, bilateral explantated essure devices (gross only).Gross description- the specimen is labeled "bilateral explanted essures" with the patient's name and proper identification.The specimen consists of multiple metallic coils measuring 7.5 x 0,1 x 0.1 cm in.Clinical history- pelvic pain and menorrhagia gross- the specimen was received in formalin with the patient's name and proper identification labeled uterus the specimen consists of a 43 g collective weight of more sized uterus measuring 8.3 x 3.7 x 2.1 cm.On section endometrium measures 0.1 cm in thickness surrounded by a myometrial scarring.On section there are metallic coiled embedded within the myometrium, aggregate.Most recent follow-up information incorporated above includes: on 21-may-2018: pfs provided.Hysterectomy was performed on (b)(6) 2016.Dilation & curettage and ablation were added as treatment of menorrhagia.Events ¿complication during essure removal procedure¿, ¿didn't feel like myself and my hormone levels dropped¿ and ¿yeast infections¿ added, event ¿bladder or urinary problems or changes¿ updated to ¿bladder infection¿.Details of essure removal provided.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 on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device location of device"), device breakage ("device breakage"), device expulsion ("expulsion of essure device"), menorrhagia ("menorrhagia"), autoimmune disorder ("autoimmune disorder type of disorder") and complication of device removal ("complication during essure removal procedure") in a 37-year-old female patient who had essure (batch no.20222096) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included obesity.No cervical ovarian or fallopian tube tissue was identified grossly.Previously administered products included for an unreported indication: ortho tricyclen.Concurrent conditions included heartburn, endometrial ablation, headache, cholecystectomy, cesarean delivery on maternal request (she was having 5 cesarean sections.), inflammatory reaction, ovarian cyst, gas evolution in intestine, cytology nos and bacterial vaginosis.Concomitant products included drospirenone w/ethinylestradiol (yaz) in 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2015, 5 years 4 months after insertion of essure, the patient experienced complication of device removal (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), the first episode of cystitis ("bladder/ urinary tract/vaginal"), urinary tract infection ("bladder/ urinary tract/vaginal"), vaginal infection ("bladder/ urinary tract/vaginal"), the second episode of cystitis ("bladder infection "), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), headache ("migraines / headaches"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight fluctuation ("weight gain / loss specify which one"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), back pain ("back pain"), abdominal pain lower ("cramping in lower abdomen"), pelvic pain ("pelvic pain"), dizziness ("dizziness"), alopecia ("hair loss"), hypertension ("high blood pressure"), stress ("stressed"), constipation ("constipation"), hormone level abnormal ("didn't feel like myself and my hormone levels dropped ") and vulvovaginal mycotic infection ("yeast infections").The patient was treated with surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (bilateral salpingectomy, and supracervical hysterectomy (uterus only) performed on (b)(6) 2016), surgery (dilation and curettage; novasure endometrial ablation on (b)(6) 2010) and surgery.Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, device expulsion, menorrhagia, autoimmune disorder, vaginal haemorrhage, complication of device removal, vaginal infection, the last episode of cystitis, urinary tract disorder, migraine, nausea, nervous system disorder, dysmenorrhoea, dyspareunia, weight fluctuation, gastrointestinal disorder, hormone level abnormal and vulvovaginal mycotic infection outcome was unknown and the headache, fatigue, back pain, abdominal pain lower, pelvic pain, dizziness, alopecia, hypertension, stress and constipation had resolved.The reporter considered abdominal pain lower, alopecia, autoimmune disorder, back pain, complication of device removal, constipation, device breakage, device dislocation, device expulsion, dizziness, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, headache, hormone level abnormal, hypertension, menorrhagia, migraine, nausea, nervous system disorder, pelvic pain, stress, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection, weight fluctuation, the first episode of cystitis and the second episode of cystitis to be related to essure.The reporter commented: she had understood him to say that the right device broke and patient may have particles in her uterus yet.There were complications during the essure removal procedure on (b)(6) 2015 and physician would have go back in to perform another surgery to finish removing essure device on (b)(6) 2016.The patient took leave from her job twice ((b)(6) 2015 and (b)(6) 2016) due to surgery recovery.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: successful tubal occlusion by essure.Ultrasound scan vagina - on (b)(6) 2015: total bilateral occlusion.Specimens- fallopian tube, left and right, bilateral explanted essures final diagnosis- bilateral fallopian tubes, resection- - fallopian tubes without pathologic abnormalities, bilateral explantated essure devices (gross only).Gross description- the specimen is labeled "bilateral explanted essures" with the patient's name and proper identification.The specimen consists of multiple metallic coils measuring 7.5 x 0,1 x 0.1 cm in.Clinical history- pelvic pain and menorrhagia gross- the specimen was received in formalin with the patient's name and proper identification labeled uterus the specimen consists of a 43 g collective weight of more sized uterus measuring 8.3 x 3.7 x 2.1 cm.On section endometrium measures 0.1 cm in thickness surrounded by a myometrial scarring.On section there are metallic coiled embedded within the myometrium, aggregate quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jul-2018: quality-safety evaluation of ptc.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 on 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: 7439125
• MDR Text Key: 105763328
• Report Number: 2951250-2018-01867
• 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
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2012
• Device Model Number: ESS305
• Device Lot Number: 20222096
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: YAZ; YAZ; YAZ; YAZ
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR