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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Dry Eye(s) (1814); Fatigue (1849); Gastritis (1874); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Myalgia (2238); Arthralgia (2355); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 16-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of dyspareunia ("significant pelvic pain during sexual intercourse") and fatigue ("chronic fatigue") in a (b)(6) female patient who had essure (batch no.20193379) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dyspareunia (seriousness criterion medically significant), fatigue (seriousness criterion disability), back pain ("lumbar pain"), dry eye ("eye dryness"), myalgia ("muscular pain"), arthralgia ("articular pain"), pruritus ("significant itching"), amnesia ("memory loss"), disturbance in attention ("impossible to concentrate"), pain in extremity ("significant pain on legs and feet that prevent from doing the slightest movement"), the first episode of gastrointestinal disorder ("colon problem"), gastric disorder ("stomach problem"), the second episode of gastrointestinal disorder ("belly problem") and abnormal faeces ("stools that could persisted 24 hours").At the time of the report, the dyspareunia, fatigue, back pain, dry eye, myalgia, arthralgia, pruritus, amnesia, disturbance in attention, pain in extremity, gastric disorder, the last episode of gastrointestinal disorder and abnormal faeces outcome was unknown.The reporter provided no causality assessment for abnormal faeces, amnesia, arthralgia, back pain, disturbance in attention, dry eye, dyspareunia, fatigue, gastric disorder, myalgia, pain in extremity, pruritus, the first episode of gastrointestinal disorder and the second episode of gastrointestinal disorder with essure.The reporter commented: following a sick leave of 2 years, the patient was unemployed.Since (b)(6) and in the impossibility to work as the patient was rapidly tired and she was recovering very slowly.She was rather hyperactive before.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 18-aug-2017 for the following meddra preferred term: dyspareunia.The analysis in the global safety database revealed 76 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the regulatory authority is not possible.Incident.At the time of reporting, 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 case was initially received via regulatory authority ansm (reference number: (b)(4)) on 16-aug-2017.The most recent information was received on 06-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of dyspareunia ("significant pelvic pain during sexual intercourse") and fatigue ("chronic fatigue") in a (b)(6) year-old female patient who had essure (batch no.20193379) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dyspareunia (seriousness criterion medically significant), fatigue (seriousness criterion disability), back pain ("lumbar pain"), dry eye ("eye dryness"), myalgia ("muscular pain"), arthralgia ("articular pain"), pruritus ("significant itching"), amnesia ("memory loss"), disturbance in attention ("impossible to concentrate"), pain in extremity ("significant pain on legs and feet that prevent from doing the slightest movement"), the first episode of gastrointestinal disorder ("colon problem"), gastric disorder ("stomach problem"), the second episode of gastrointestinal disorder ("belly problem") and abnormal faeces ("stools that could persisted 24 hours").At the time of the report, the dyspareunia, fatigue, back pain, dry eye, myalgia, arthralgia, pruritus, amnesia, disturbance in attention, pain in extremity, gastric disorder, the last episode of gastrointestinal disorder and abnormal faeces outcome was unknown.The reporter provided no causality assessment for abnormal faeces, amnesia, arthralgia, back pain, disturbance in attention, dry eye, dyspareunia, fatigue, gastric disorder, myalgia, pain in extremity, pruritus, the first episode of gastrointestinal disorder and the second episode of gastrointestinal disorder with essure.The reporter commented: following a sick leave of 2 years, the patient was unemployed.Since october and in the impossibility to work as the patient was rapidly tired and she was recovering very slowly.She was rather hyperactive before.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 06-sep-2017 for the following meddra preferred term: dyspareunia.The analysis in the global safety database revealed 78 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 6-sep-2017: quality-safety evaluation of ptc.Incident: at the time of reporting, 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.

• 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: 6844467
• MDR Text Key: 84958556
• Report Number: 2951250-2017-03346
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

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
• Device Lot Number: 20193379
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 09/29/2017
• 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
• Patient Age: 48 YR
• Patient Weight: 62