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

Model Number ESS305

Device Problems Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Pelvic Inflammatory Disease (2000); Urinary Tract Infection (2120); Uterine Perforation (2121); Heavier Menses (2666); Genital Bleeding (4507)

Event Date 08/31/2012

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("essure protruding through right cornuea"), pelvic inflammatory disease ("pelvic inflammatory disease") and genital haemorrhage ("frequent and irregular bleeding") in a (b)(6) female patient who received essure.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient started essure at.On (b)(6) 2012, 339 days after starting essure, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and clinically significant/intervention required) and abdominal pain upper ("epigastric pain").On (b)(6) 2013, the patient experienced menorrhagia ("menorrhagia, heavy bleeding") and dysmenorrhoea ("dysmenorrhea").On (b)(6) 2013, the patient experienced cystitis ("acute cystitis").On (b)(6) 2014, the patient experienced nausea ("nausea") and dyspareunia ("dyspareunia").On (b)(6) 2014, the patient experienced urinary tract infection ("urinary tract infection") and back pain ("lower back pain").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and clinically significant/intervention required) with pelvic pain and abdominal pain.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and clinically significant/intervention required).The patient was treated with surgery (on (b)(6) 2016, robotic hysterectomy and bilateral salpingectomy).Essure was withdrawn.At the time of the report, the uterine perforation, pelvic inflammatory disease, genital haemorrhage, urinary tract infection, cystitis, abdominal pain upper, nausea, back pain, menorrhagia, dysmenorrhoea and dyspareunia had resolved.The reporter considered uterine perforation, pelvic inflammatory disease, genital haemorrhage, urinary tract infection, cystitis, abdominal pain upper, nausea, back pain, menorrhagia, dysmenorrhoea and dyspareunia to be related to essure.The reporter commented: after years of suffering, her symptoms resolved after she had her essure removed via hysterectomy and bilateral salpingectomy.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2012: hysterosalpingogram result was bilateral tubal occlusion.On (b)(6) 2012: abdominal x-ray result was essure coils seen.On (b)(6) 2013: ultrasound scan vagina result was acute cystitis.On (b)(6) 2014: ultrasound scan result was normal (normal).On (b)(6) 2016: laparoscopy result was essure protruding through r cornua.Company causality comment: this spontaneous case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced uterine perforation ("essure protruding through right cornuea"), pelvic inflammatory disease ("pelvic inflammatory disease") and genital haemorrhage ("frequent and irregular bleeding").A hysterectomy and bilateral salpingectomy were performed.Additionally, non-serious events were reported.Uterine perforation, pelvic inflammatory disease and genital bleeding are anticipated according to reference safety information for essure.Uterine perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine perforation with essure may occur, most often during insertion.In this particular case, the exact time point and mechanism of perforation was not reported.Upper genital tract infections, also referred to as pelvic inflammatory diseases (pids), occur when microorganisms ascend from the lower genital tract, infecting the uterus, fallopian tubes and ovaries.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In this particular case, consumer presented pelvic inflammation during essure use.Changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Given these events' nature and essure's safety profile, the causality cannot be excluded.This case was regarded as incident since device removal was required.A product technical analysis has been sought.Further information will be obtained through the litigation process.

Manufacturer Narrative

Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 29-mar-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced uterine perforation ("essure protruding through right cornuea"), pelvic inflammatory disease ("pelvic inflammatory disease") and genital haemorrhage ("frequent and irregular bleeding").A hysterectomy and bilateral salpingectomy were performed.Additionally, non-serious events were reported.Uterine perforation, pelvic inflammatory disease and genital bleeding are anticipated according to reference safety information for essure.Uterine perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine perforation with essure may occur, most often during insertion.In this particular case, the exact time point and mechanism of perforation was not reported.Upper genital tract infections, also referred to as pelvic inflammatory diseases (pids), occur when microorganisms ascend from the lower genital tract, infecting the uterus, fallopian tubes and ovaries.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In this particular case, consumer presented pelvic inflammation during essure use.Changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Given these events' nature and essure's safety profile, the causality cannot be excluded.This case was regarded as incident since device removal was required.A product quality defect could not be confirmed but is considered plausible.Further information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('essure protruding through right cornuea'), pelvic inflammatory disease ('pelvic inflammatory disease') and genital haemorrhage ('frequent and irregular bleeding') in a 26-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included vaginal bleeding, pelvic pain female, grand multiparity and menses irregular with excessive bleeding.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2012, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required) and abdominal pain upper ("epigastric pain"), 11 months 5 days after insertion of essure.On (b)(6) 2013, the patient experienced heavy menstrual bleeding ("menorrhagia, heavy bleeding") and dysmenorrhoea ("dysmenorrhea").On (b)(6) 2013, the patient experienced cystitis ("acute cystitis").On (b)(6) 2014, the patient experienced nausea ("nausea") and dyspareunia ("dyspareunia").On (b)(6) 2014, the patient experienced urinary tract infection ("urinary tract infection") and back pain ("lower back pain").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).The patient was treated with surgery (on (b)(6) 2016, robotic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, pelvic inflammatory disease, genital haemorrhage, urinary tract infection, cystitis, abdominal pain upper, nausea, back pain, heavy menstrual bleeding, dysmenorrhoea and dyspareunia had resolved.The reporter considered abdominal pain upper, back pain, cystitis, dysmenorrhoea, dyspareunia, genital haemorrhage, heavy menstrual bleeding, nausea, pelvic inflammatory disease, urinary tract infection and uterine perforation to be related to essure.The reporter commented: after years of suffering, her symptoms resolved after she had her essure removed via hysterectomy and bilateral salpingectomy.Discrepancy noted in date of removal (b)(6) 2016 (as per mr).Diagnostic results (normal ranges are provided in parenthesis if available): abdominal x-ray - on (b)(6) 2012: results: essure coils seen.Hysterosalpingogram - on (b)(6) 2012: results: bilateral tubal occlusion.Laparoscopy - on (b)(6) 2016: results: essure protruding through r cornua.Ultrasound scan - on (b)(6) 2014: assessment: normal results: normal.Ultrasound scan vagina - on (b)(6) 2013: results: acute cystitis.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 3-jun-2021: medical record received: medical history, patient's date of birth, reporter information were added.Rcc was updated.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: 6431303
• MDR Text Key: 70771050
• Report Number: 2951250-2017-01042
• 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: 06/09/2021

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: 02/28/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; 06/03/2021
• Supplement Dates FDA Received: 04/24/2017; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26 YR