MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); No Code Available (3191)

Event Date 03/29/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain"), dyspareunia ("painful intercourse"), uterine haemorrhage ("abnormal uterine bleeding") and device dislocation ("essure coil was protruding from the right hand tube") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for birth control: depo-provera.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced treatment noncompliance ("unable to undergo a hsg test").On (b)(6) 2011, 1 month 12 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant) and abdominal pain ("right-sided abdominal pain").On (b)(6) 2013, the patient experienced the first episode of abdominal pain lower ("pain in her left lower quadrant").On (b)(6) 2013, the patient experienced the second episode of abdominal pain lower ("lower abdominal pain that radiated to the right side of her body/ cramping").On (b)(6) 2013, the patient experienced device dislocation (seriousness criterion medically significant).On an unknown date, the patient experienced menorrhagia ("menorrhagia") and dysmenorrhoea ("dysmenorrhea").The patient was treated with surgery (total vaginal hysterectomy, bilateral hemi-salpingectomy and excision of essure on (b)(6) 2013).Essure was removed on (b)(6) 2013.On (b)(6) 2013, the pelvic pain had resolved.At the time of the report, the dyspareunia, uterine haemorrhage, device dislocation, menorrhagia, dysmenorrhoea, abdominal pain and treatment noncompliance outcome was unknown and the last episode of abdominal pain lower had resolved.The reporter considered abdominal pain, device dislocation, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain, treatment noncompliance, uterine haemorrhage, the first episode of abdominal pain lower and the second episode of abdominal pain lower to be related to essure.Company causality comment: this litigation case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2011 and reported adverse events including chronic pelvic pain, painful intercourse, abnormal uterine bleeding and essure coil was protruding from the right hand tube (seen as device dislocation).On (b)(6) 2013 plaintiff was submitted to total vaginal hysterectomy, bilateral hemi-salpingectomy and excision of essure.Pelvic pain, pain during intercourse and abnormal genital bleeding may occur within consumers under essure use.In this case, besides these complaints the device was found to be dislocated during the surgical procedure, which could have contributed to the occurrence of some of consumer´s symptoms.During essure micro-insert therapy, there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation.In this case the exact date and the mechanism of device dislocation are not known.This case was classified as incident since surgical intervention was required.A product technical analysis is being sought.Follow-up information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain"), dyspareunia ("painful intercourse"), uterine haemorrhage ("abnormal uterine bleeding") and device dislocation ("essure coil was protruding from the right hand tube") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for birth control: depo-provera.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced investigation noncompliance ("unable to undergo a hsg test").On (b)(6) 2011, 1 month 12 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant) and abdominal pain ("right-sided abdominal pain").On (b)(6) 2013, the patient experienced the first episode of abdominal pain lower ("pain in her left lower quadrant").On (b)(6) 2013, the patient experienced the second episode of abdominal pain lower ("lower abdominal pain that radiated to the right side of her body/ cramping").On (b)(6) 2013, the patient experienced device dislocation (seriousness criterion medically significant).On an unknown date, the patient experienced menorrhagia ("menorrhagia") and dysmenorrhoea ("dysmenorrhea").The patient was treated with surgery (total vaginal hysterectomy, bilateral hemi-salpingectomy and excision of essure on (b)(6) 2013).Essure was removed on (b)(6) 2013.On (b)(6) 2013, the pelvic pain had resolved.At the time of the report, the dyspareunia, uterine haemorrhage, device dislocation, menorrhagia, dysmenorrhoea, abdominal pain and investigation noncompliance outcome was unknown and the last episode of abdominal pain lower had resolved.The reporter considered abdominal pain, device dislocation, dysmenorrhoea, dyspareunia, investigation noncompliance, menorrhagia, pelvic pain, uterine haemorrhage, the first episode of abdominal pain lower and the second episode of abdominal pain lower to be related to essure.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.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 1-may-2017: quality-safety evaluation of product technical complaint.Company causality comment: this litigation case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2011 and reported adverse events including chronic pelvic pain, painful intercourse, abnormal uterine bleeding and essure coil was protruding from the right hand tube (seen as device dislocation).On (b)(6) 2013, plaintiff was submitted to total vaginal hysterectomy, bilateral hemi-salpingectomy and excision of essure.Pelvic pain, pain during intercourse and abnormal genital bleeding may occur within consumers under essure use.In this case, besides these complaints the device was found to be dislocated during the surgical procedure, which could have contributed to the occurrence of some of consumer's symptoms.During essure micro-insert therapy, there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation.In this case the exact date and the mechanism of device dislocation are not known.This case was classified as incident since surgical intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Follow-up information will be obtained through the litigation process.

Event Description

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6518421
• MDR Text Key: 73609597
• Report Number: 2951250-2017-01683
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR