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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Heavier Menses (2666); Foreign Body In Patient (2687); Pregnancy (3193)

Event Date 01/01/2009

Event Type  Injury  

Event Description

This is a spontaneous case report received from an attorney in the united states, on behalf of a plaintiff in united states on 28-sep-2016 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) on (b)(6) 2015 for permanent birth control.Following the essure procedure, the plaintiff began suffering from severe pelvic pain, severe back and leg pain, and menorrhagia.She sought medical attention for her symptoms and discovered that one of the coils was displaced and as result she had become pregnant.On or about 2013 (discrepant information reported), she underwent a surgery for tubal ligation and removal of the remaining coil.During this surgery, her healthcare providers were unable to locate the displaced coil.Company causality comment: this case report was received from a lawyer on behalf of a female plaintiff who had essure (fallopian tube occlusion insert) inserted and had severe pelvic pain.On unknown date, she discovered that one of the coils was displaced and as a result she became pregnant.Later, she underwent a surgery for tubal ligation and removal of the remaining coils, however, her physician was unable to locate the displaced coil.Pelvic pain, pregnancy and device dislocation are listed in the reference safety information for essure and may occur during device wearing.Despite of lack of information whether confirmation test was performed or not and its results and events' order of time of occurrence, causality cannot be excluded.This case was regarded as incident, since a surgical intervention was required.Additionally, non serious events were reported.A product technical analysis is being sought.Further information will be obtained through the litigation process.

Manufacturer Narrative

This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device dislocation ("one of the coils was displaced/unable to locate the displaced coil") and pregnancy with contraceptive device ("pregnant") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe back pain"), menorrhagia ("menorrhagia"), device dislocation (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant) and pain in extremity ("severe back and leg pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery.At the time of the report, the pelvic pain, back pain, menorrhagia, device dislocation, pregnancy with contraceptive device and pain in extremity outcome was unknown.The pregnancy outcome was not reported.The reporter considered back pain, device dislocation, menorrhagia, pain in extremity, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: patient sought medical attention for her symptoms and discovered that one of the coils was displaced and as result she had become pregnant.On or about 2013 (discrepant information reported), she underwent a surgery for tubal ligation and removal of the remaining coil.During this surgery, her healthcare providers were unable to locate the displaced coil.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality safety evaluation of product technical complaint.Company causality comment: 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 prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device dislocation ("one of the coils was displaced/unable to locate the displaced coil/ migration of essure device location of device: unknown") and pregnancy with contraceptive device ("pregnant/ pregnancy (no complications)") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In 2009, the patient had essure inserted.In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe back pain"), menorrhagia (""menorrhagia"/ abnormal bleeding (menorrhagia)"), device dislocation (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), pain in extremity ("severe leg pain") and vaginal haemorrhage ("abnormal bleeding (vaginal)").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery.At the time of the report, the pelvic pain, back pain, menorrhagia, device dislocation, pregnancy with contraceptive device, pain in extremity and vaginal haemorrhage outcome was unknown.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered back pain, device dislocation, menorrhagia, pain in extremity, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: patient sought medical attention for her symptoms and discovered that one of the coils was displaced and as result she had become pregnant.On or about 2013 (discrepant information reported), she underwent a surgery for tubal ligation and removal of the remaining coil.During this surgery, her healthcare providers were unable to locate the displaced coil.She had one essure removed when she had her tubal after the birth of her son, the other remains migrated some where.Most recent follow-up information incorporated above includes: on 1-jun-2018: plaintiff fact sheet received.Reporter information, patient¿s demographic information updated.Essure start date updated from (b)(6) 2015 to 2009.Events abnormal bleeding (menorrhagia), pregnancy (no complications), migration of essure device location of device: unknown were clubbed with previously reported events.Events vaginal haemorrhage was newly added.Pregnancy outcome updated.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 device dislocation ('one of the coils was displaced/unable to locate the displaced coil/ migration of essure device location of device: unknown') and pelvic pain ('severe pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In 2009, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe back pain"), menorrhagia (""menorrhagia"/ abnormal bleeding (menorrhagia)"), pain in extremity ("severe leg pain") and vaginal haemorrhage ("abnormal bleeding (vaginal)") and was found to have a pregnancy with contraceptive device ("pregnant/ pregnancy (no complications)").On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced renal failure ("kidney failure").The patient was treated with surgery (hyst.,tubal ligation/ tubal cauterization and removal of essure device on the patient's right side and hysterectomy, tubal ligation).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, pregnancy with contraceptive device, back pain, menorrhagia, pain in extremity, vaginal haemorrhage and renal failure outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered back pain, device dislocation, menorrhagia, pain in extremity, pelvic pain, pregnancy with contraceptive device, renal failure and vaginal haemorrhage to be related to essure.The reporter commented: patient sought medical attention for her symptoms and discovered that one of the coils was displaced and as result she had become pregnant.On or about 2013 (discrepant information reported), she underwent a surgery for tubal ligation and removal of the remaining coil.During this surgery, her healthcare providers were unable to locate the displaced coil.She had one essure removed when she had her tubal after the birth of her son, the other remains migrated some where.If you have not had your essure removed, are you currently planning for essure removal? no.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-apr-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 device dislocation ('one of the coils was displaced/unable to locate the displaced coil/ migration of essure device location of device: unknown') and pelvic pain ('severe pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In 2009, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe back pain"), menorrhagia ("menoragghia/ abnormal bleeding (menorrhagia)"), pain in extremity ("severe leg pain") and vaginal haemorrhage ("abnormal bleeding (vaginal)") and was found to have a pregnancy with contraceptive device ("pregnant/ pregnancy (no complications)").On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced renal failure ("kidney failure").The patient was treated with surgery (hyst.,tubal ligation/ tubal cauterization and removal of essure device on the patient's right side and hysterectomy, tubal ligation).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, pregnancy with contraceptive device, back pain, menorrhagia, pain in extremity, vaginal haemorrhage and renal failure outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a healthy child.The reporter considered back pain, device dislocation, menorrhagia, pain in extremity, pelvic pain, pregnancy with contraceptive device, renal failure and vaginal haemorrhage to be related to essure.The reporter commented: patient sought medical attention for her symptoms and discovered that one of the coils was displaced and as result she had become pregnant.On or about 2013 (discrepant information reported), she underwent a surgery for tubal ligation and removal of the remaining coil.During this surgery, her healthcare providers were unable to locate the displaced coil.She had one essure removed when she had her tubal after the birth of her son, the other remains migrated some where.If you have not had your essure removed, are you currently planning for essure removal? no.Most recent follow-up information incorporated above includes: on 9-mar-2020: social media received.New event kidney failure was added.Reporter was 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, CA 13353 ; GM 13353
• MDR Report Key: 6055053
• MDR Text Key: 58312585
• Report Number: 2951250-2016-02301
• 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: 04/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided; 06/01/2018; 06/01/2018; 03/09/2020
• Supplement Dates FDA Received: 06/28/2017; 06/15/2018; 04/01/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR