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

Model Number ESS305

Device Problems Difficult to Remove (1528); Biocompatibility (2886); Material Protrusion/Extrusion (2979)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Rheumatoid Arthritis (1724); Hair Loss (1877); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Rash (2033); Uterine Perforation (2121); Arthralgia (2355); Abdominal Cramps (2543); Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("coils were embedded and not able to be removed/bilateral essure coils seen, both protruding well into the uterine cavity") and rheumatoid arthritis ("rheumatoid arthritis in foot") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "unsuccessful attempt to remove the coils/ coils were embedded and not able to be removed" on (b)(6) 2016.The patient's past medical history included general anesthesia (she underwent the essure procedure under general anesthesia) in 2007.In 2007, the patient had essure inserted.In 2007, the patient experienced dysfunctional uterine bleeding ("dysfunctional uterine bleeding/ heavy bleeding with menses which included the passage of blood clots") and abdominal pain lower ("severe cramping").In 2009, the patient experienced allergy to metals ("nickel allergy") with rash.In (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) with arthralgia.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced complication of device removal ("coils were embedded and not able to be removed/unsuccessful attempt to remove the coils"), menorrhagia ("heavy bleeding with her menses/passage of blood clots"), dysmenorrhoea ("dysmenorrhea"), bacterial vaginosis ("chronic recurrent bacterial vaginosis"), alopecia ("hair loss"), feeling abnormal ("brain fog") and abdominal pain ("abdominal pain").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, complication of device removal, menorrhagia and abdominal pain outcome was unknown, the rheumatoid arthritis had not resolved and the dysfunctional uterine bleeding, abdominal pain lower, dysmenorrhoea, bacterial vaginosis, allergy to metals, alopecia and feeling abnormal had resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, bacterial vaginosis, complication of device removal, dysfunctional uterine bleeding, dysmenorrhoea, embedded device, feeling abnormal, menorrhagia and rheumatoid arthritis to be related to essure.The reporter commented: most of plaintiff's symptoms have resolved since the removal of the essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: white line in the endometrium like a foreign body.Diagnostic hysteroscopy due to recurrent bacterial vaginosis, abdominal pain and abnormal ultrasound findings - on (b)(6) 2016: normal hysteroscopic evaluation with the exception of bilateral essure coils seen, both protruding well into the uterine cavity.On the left, 5 coils were seen and on the right greater then 10 coils were seen extending well into the uterus almost to the cervix/ coils were embedded and not able to be removed.Incident no lot number or sample available for investigation.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 embedded device ("coils were embedded and not able to be removed/bilateral essure coils seen, both protruding well into the uterine cavity") and rheumatoid arthritis ("rheumatoid arthritis in foot") in a 51-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "unsuccessful attempt to remove the coils/ coils were embedded and not able to be removed" on (b)(6) 2016.The patient's past medical history included general anesthesia (she underwent the essure procedure under general anesthesia) in 2007.In 2007, the patient had essure inserted.In 2007, the patient experienced dysfunctional uterine bleeding ("dysfunctional uterine bleeding/ heavy bleeding with menses which included the passage of blood clots") and abdominal pain lower ("severe cramping").In 2009, the patient experienced allergy to metals ("nickel allergy") with rash.In (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) with arthralgia.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced complication of device removal ("coils were embedded and not able to be removed/unsuccessful attempt to remove the coils"), menorrhagia ("heavy bleeding with her menses/passage of blood clots"), dysmenorrhoea ("dysmenorrhea"), bacterial vaginosis ("chronic recurrent bacterial vaginosis"), alopecia ("hair loss"), feeling abnormal ("brain fog") and abdominal pain ("abdominal pain").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, complication of device removal, menorrhagia and abdominal pain outcome was unknown, the rheumatoid arthritis had not resolved and the dysfunctional uterine bleeding, abdominal pain lower, dysmenorrhoea, bacterial vaginosis, allergy to metals, alopecia and feeling abnormal had resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, bacterial vaginosis, complication of device removal, dysfunctional uterine bleeding, dysmenorrhoea, embedded device, feeling abnormal, menorrhagia and rheumatoid arthritis to be related to essure.The reporter commented: most of plaintiff's symptoms have resolved since the removal of the essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: white line in the endometrium like a foreign body.Diagnostic hysteroscopy due to recurrent bacterial vaginosis, abdominal pain and abnormal ultrasound findings - on (b)(6) 2016: normal hysteroscopic evaluation with the exception of bilateral essure coils seen, both protruding well into the uterine cavity.On the left, 5 coils were seen and on the right greater then 10 coils were seen extending well into the uterus almost to the cervix/ coils were embedded and not able to be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-nov-2018: quality safety evaluation of product technical complaint.Incident: no lot number or sample available for investigation.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 embedded device ('coils were embedded and not able to be removed/bilateral essure coils seen, both protruding well into the uterine cavity'), uterine perforation ('perforation') and rheumatoid arthritis ('rheumatoid arthritis in foot') in a 51-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia (she underwent the essure procedure under general anesthesia) in 2007.On (b)(6) 2007, the patient had essure inserted.In 2007, the patient experienced dysfunctional uterine bleeding ("dysfunctional uterine bleeding/ heavy bleeding with menses which included the passage of blood clots") and abdominal pain lower ("severe cramping").In 2009, the patient experienced allergy to metals ("nickel allergy") with rash.In january 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) with arthralgia.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 9 years 6 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), complication of device removal ("coils were embedded and not able to be removed/unsuccessful attempt to remove the coils"), menorrhagia ("heavy bleeding with her menses/passage of blood clots"), dysmenorrhoea ("dysmenorrhea"), bacterial vaginosis ("chronic recurrent bacterial vaginosis"), alopecia ("hair loss"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain / worsenening pain"), migraine ("migraines"), headache ("headaches"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergy symptoms / hypersensitivity") and autoimmune disorder ("autoimmune disorder").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, uterine perforation, complication of device removal, menorrhagia, abdominal pain, migraine, headache, genital haemorrhage, hypersensitivity and autoimmune disorder outcome was unknown, the rheumatoid arthritis had not resolved and the dysfunctional uterine bleeding, abdominal pain lower, dysmenorrhoea, bacterial vaginosis, allergy to metals, alopecia and feeling abnormal had resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, autoimmune disorder, bacterial vaginosis, complication of device removal, dysfunctional uterine bleeding, dysmenorrhoea, embedded device, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, rheumatoid arthritis and uterine perforation to be related to essure.The reporter commented: most of plaintiff's symptoms have resolved since the removal of the essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: white line in the endometrium like a foreign body.Diagnostic results: diagnostic hysteroscopy due to recurrent bacterial vaginosis, abdominal pain and abnormal ultrasound findings - on (b)(6) 2016: normal hysteroscopic evaluation with the exception of bilateral essure coils seen, both protruding well into the uterine cavity.On the left, 5 coils were seen and on the right greater then 10 coils were seen extending well into the uterus almost to the cervix/ coils were embedded and not able to be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received.New events - perforation, migraines, headaches, abnormal bleeding, allergy symptoms, autoimmune disorder were added.Event of device removal failed deleted due to duplication.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 embedded device ('coils were embedded and not able to be removed/bilateral essure coils seen, both protruding well into the uterine cavity'), uterine perforation ('perforation') and rheumatoid arthritis ('rheumatoid arthritis in foot') in a 51-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia (she underwent the essure procedure under general anesthesia) in 2007.On (b)(6) 2007, the patient had essure inserted.In 2007, the patient experienced dysfunctional uterine bleeding ("dysfunctional uterine bleeding/ heavy bleeding with menses which included the passage of blood clots") and abdominal pain lower ("severe cramping").In 2009, the patient experienced allergy to metals ("nickel allergy") with rash.In (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) with arthralgia.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 9 years 6 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), complication of device removal ("coils were embedded and not able to be removed/unsuccessful attempt to remove the coils"), menorrhagia ("heavy bleeding with her menses/passage of blood clots"), dysmenorrhoea ("dysmenorrhea"), bacterial vaginosis ("chronic recurrent bacterial vaginosis"), alopecia ("hair loss"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain / worsenening pain"), migraine ("migraines"), headache ("headaches"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergy symptoms / hypersensitivity") and autoimmune disorder ("autoimmune disorder").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, uterine perforation, complication of device removal, menorrhagia, abdominal pain, migraine, headache, genital haemorrhage, hypersensitivity and autoimmune disorder outcome was unknown, the rheumatoid arthritis had not resolved and the dysfunctional uterine bleeding, abdominal pain lower, dysmenorrhoea, bacterial vaginosis, allergy to metals, alopecia and feeling abnormal had resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, autoimmune disorder, bacterial vaginosis, complication of device removal, dysfunctional uterine bleeding, dysmenorrhoea, embedded device, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, rheumatoid arthritis and uterine perforation to be related to essure.No further causality assessment were provided for the product.The reporter commented: most of plaintiff's symptoms have resolved since the removal of the essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: white line in the endometrium like a foreign body.Diagnostic results: diagnostic hysteroscopy due to recurrent bacterial vaginosis, abdominal pain and abnormal ultrasound findings - on (b)(6) 2016: normal hysteroscopic evaluation with the exception of bilateral essure coils seen, both protruding well into the uterine cavity.On the left, 5 coils were seen and on the right greater then 10 coils were seen extending well into the uterus almost to the cervix/ coils were embedded and not able to be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-sep-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('coils were embedded and not able to be removed/bilateral essure coils seen, both protruding well into the uterine cavity'), uterine perforation ('perforation') and rheumatoid arthritis ('rheumatoid arthritis in foot') in a 51-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia (she underwent the essure procedure under general anesthesia) in 2007.Concurrent conditions included uterine leiomyoma and vaginal discharge.On (b)(6) 2007, the patient had essure inserted.In 2007, the patient experienced abnormal uterine bleeding ("dysfunctional uterine bleeding/ heavy bleeding with menses which included the passage of blood clots") and abdominal pain lower ("severe cramping").In 2009, the patient experienced allergy to metals ("nickel allergy") with rash.In (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant) with arthralgia.On (b)(6) 2016, the patient experienced embedded device (seriousness criteria medically significant and intervention required), 9 years 6 months after insertion of essure.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), complication of device removal ("coils were embedded and not able to be removed/unsuccessful attempt to remove the coils"), heavy menstrual bleeding ("heavy bleeding with her menses/passage of blood clots"), dysmenorrhoea ("dysmenorrhea"), bacterial vaginosis ("chronic recurrent bacterial vaginosis"), alopecia ("hair loss"), feeling abnormal ("brain fog"), abdominal pain ("abdominal pain / worsenening pain"), migraine ("migraines"), headache ("headaches"), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("allergy symptoms / hypersensitivity") and autoimmune disorder ("autoimmune disorder").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, uterine perforation, complication of device removal, heavy menstrual bleeding, abdominal pain, migraine, headache, genital haemorrhage, hypersensitivity and autoimmune disorder outcome was unknown, the rheumatoid arthritis had not resolved and the abnormal uterine bleeding, abdominal pain lower, dysmenorrhoea, bacterial vaginosis, allergy to metals, alopecia and feeling abnormal had resolved.The reporter considered abdominal pain, abdominal pain lower, abnormal uterine bleeding, allergy to metals, alopecia, autoimmune disorder, bacterial vaginosis, complication of device removal, dysmenorrhoea, embedded device, feeling abnormal, genital haemorrhage, headache, heavy menstrual bleeding, hypersensitivity, migraine, rheumatoid arthritis and uterine perforation to be related to essure.The reporter commented: most of plaintiff's symptoms have resolved since the removal of the essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2016: results: white line in the endometrium like a foreign body.Diagnostic results: diagnostic hysteroscopy due to recurrent bacterial vaginosis, abdominal pain and abnormal ultrasound findings - on (b)(6) 2016: normal hysteroscopic evaluation with the exception of bilateral essure coils seen, both protruding well into the uterine cavity.On the left, 5 coils were seen and on the right greater then 10 coils were seen extending well into the uterus almost to the cervix/ coils were embedded and not able to be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-jun-2021: medical record received.Reporters information and medical history were 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.

• 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: 7637007
• MDR Text Key: 112284581
• Report Number: 2951250-2018-02804
• 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,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR