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

Model Number ESS205

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Pain (1994); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain"), autoimmune disorder ("autoimmune disorder") and genital haemorrhage ("severe bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2007, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("abdominal pain").The patient was treated with surgery (remove the essure).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic pain, autoimmune disorder, genital haemorrhage and abdominal pain outcome was unknown.The reporter considered abdominal pain, autoimmune disorder, genital haemorrhage and pelvic pain to be related to essure.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain'), autoimmune disorder ('autoimmune disorder') and genital haemorrhage ('severe bleeding') in an adult female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("metorrhagia (bleeding between periods)") and fatigue ("fatigue").The patient was treated with surgery (hysterectomy (full)).Essure (ess205) was removed on (b)(6) 2011.At the time of the report, the pelvic pain, abdominal pain, menorrhagia and metrorrhagia had resolved and the autoimmune disorder, genital haemorrhage and fatigue outcome was unknown.The reporter considered abdominal pain, autoimmune disorder, fatigue, genital haemorrhage, menorrhagia, metrorrhagia and pelvic pain to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2007: essure confirmation test(s) conducted, specify (unspecified).Most recent follow-up information incorporated above includes: on 27-sep-2019: plaintiff fact sheet received.Events per pfs: menorrhagia (heavy menstrual bleeding), metorrhagia (bleeding between periods) and fatigue.Essure implant and explant date were updated.Outcome for event pelvic pain, abdominal pain, menorrhagia (heavy menstrual bleeding) and metorrhagia (bleeding between periods) were resolved.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain'), systemic lupus erythematosus ('autoimmune disorder type of disorder: lupus') and genital haemorrhage ('severe bleeding') in a 34-year-old female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Concomitant products included ibuprofen.On (b)(6) 2006, the patient had essure (ess205) inserted.On (b)(6) 2006, the patient experienced genital haemorrhage (seriousness criterion medically significant), 6 days after insertion of essure (ess205).On (b)(6) 2006, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), fatigue ("fatigue") and rash ("rashes or skin conditions: rash").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("metorrhagia (bleeding between periods)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), tooth disorder ("dental problems") and abdominal pain lower ("lower abdominal pain") and was found to have hormone level abnormal ("hormonal changes") and weight decreased ("weight loss").The patient was treated with surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes)).Essure (ess205) was removed on (b)(6) 2011.At the time of the report, the pelvic pain, abdominal pain, menorrhagia, metrorrhagia and dysmenorrhoea had resolved and the systemic lupus erythematosus, genital haemorrhage, fatigue, hormone level abnormal, vaginal haemorrhage, anxiety, depression, rash, tooth disorder, dyspareunia, weight decreased and abdominal pain lower outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, pelvic pain, rash, systemic lupus erythematosus, tooth disorder, vaginal haemorrhage and weight decreased to be related to essure (ess205).The reporter commented: current weight 140 lbs approximate weight at the time of essure placement 120 lbs diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 16.8 kg/sqm.Imaging procedure - on (b)(6) 2007: essure confirmation test(s) conducted:(unspecified).Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received events "hormonal changes, abnormal bleeding (vaginal), psychological or psychiatric problems condition: anxiety/depression, autoimmune disorder type of disorder: lupus, rashes or skin conditions type: lupus and rash, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, weight loss, lower abdominal pain" were added.Outcome of event " menorrhagia and dysmenorrhea" were updated as recovered.Concomitant drug was added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this 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: 8195059
• MDR Text Key: 131372575
• Report Number: 2951250-2018-05287
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 11/08/2019

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: ESS205
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 09/27/2019; 10/30/2019
• Supplement Dates FDA Received: 10/17/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 54