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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Diarrhea (1811); Fatigue (1849); Flatus (1865); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Skin Inflammation (2443); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Abdominal Distention (2601); Heavier Menses (2666); Constipation (3274)

Event Date 06/01/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 21-dec-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic menstruations") and mental impairment ("difficulty thinking about several things") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 1 month 18 days after insertion of essure, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), erysipelas ("erysipelas"), fatigue ("chronic crushing fatigue"), myalgia ("generalized muscle pain"), arthralgia ("generalized joint pain"), oedema peripheral ("oedema of ankles"), abdominal distension ("swollen abdomen"), loss of libido ("loss of libido"), poor quality sleep ("poor sleep"), insomnia ("insomnia"), back pain ("back pain"), tendon pain ("tendon pain"), headache ("headaches"), anxiety ("anxiety"), mental impairment (seriousness criterion medically significant), amnesia ("memory loss"), speech disorder ("speech difficulty"), dermatitis ("dermatitis"), alopecia ("hair loss"), gastrointestinal pain ("gastrointestinal pain"), diarrhoea ("diarrhea"), constipation ("constipation"), flatulence ("gas"), fibromyalgia ("fibromyalgia pain"), asthenia ("loss of strength") and depression ("depressive state").The patient was treated with surgery (surgery planned to (b)(6) 2018).Essure treatment was ongoing at the time of the report.At the time of the report, the menorrhagia, erysipelas, fatigue, myalgia, arthralgia, oedema peripheral, abdominal distension, loss of libido, poor quality sleep, insomnia, back pain, tendon pain, headache, anxiety, mental impairment, amnesia, speech disorder, dermatitis, alopecia, gastrointestinal pain, diarrhoea, constipation, flatulence, fibromyalgia, asthenia and depression outcome was unknown.The reporter provided no causality assessment for abdominal distension, alopecia, amnesia, anxiety, arthralgia, asthenia, back pain, constipation, depression, dermatitis, diarrhoea, erysipelas, fatigue, fibromyalgia, flatulence, gastrointestinal pain, headache, insomnia, loss of libido, menorrhagia, mental impairment, myalgia, oedema peripheral, poor quality sleep, speech disorder and tendon pain with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 22-dec-2017 for the following meddra preferred term: menorrhagia ¿ analysis in the global safety database revealed 568 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 these meddra pt.Further company follow-up with the regulatory authority is not possible.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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
• MDR Report Key: 7143020
• MDR Text Key: 95692532
• Report Number: 2951250-2017-11067
• 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
• Report Date: 12/22/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 12/22/2017
• 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