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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fatigue (1849); Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Urinary Tract Infection (2120); Visual Impairment (2138); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Date 01/01/2012

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6) 2018.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("heavy menstrual bleeding with clotted blood"), the first episode of subcutaneous abscess ("furuncles and abscesses in the inguinal and gluteal skinfolds"), the second episode of subcutaneous abscess ("furuncles and abscesses in gluteal skinfolds"), furuncle ("furuncles and abscesses in the inguinal and gluteal skinfolds"), urinary tract infection ("urinary tract infection and inflammation"), pyelonephritis ("recurrent pyelonephritis with no identified cause"), sjogren's syndrome ("sicca syndrome with corneal involvement in the left eye with infiltration of autoimmune origin") and urinary tract inflammation ("urinary tract inflammation") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2012, the patient experienced menorrhagia (seriousness criterion medically significant), the first episode of subcutaneous abscess (seriousness criterion medically significant), the second episode of subcutaneous abscess (seriousness criterion medically significant), furuncle (seriousness criterion medically significant), urinary tract infection (seriousness criterion medically significant), pyelonephritis (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), urinary tract inflammation (seriousness criterion medically significant), pain ("incapacitating pain"), dyshidrotic eczema ("palmar and plantar dyshidrotic eczema"), ovulation pain ("pain during ovulation"), fatigue ("chronic fatigue"), migraine with aura ("incapacitating migraine with aura"), fibromyalgia ("fibromyalgia"), visual impairment ("visual disturbance"), disturbance in attention ("difficulty concentrating"), amnesia ("memory loss"), tinnitus ("tinnitus"), back pain ("muscle pain predominating on left lumbar spine radiating to the leg"), sciatica ("chronic sciatica - the pain gradually spread all over my body"), dry mouth ("very bothersome lack of saliva") and restless legs syndrome ("restless leg syndrome").The patient was treated with corticosteroid nos and surgery (sometimes requiring surgical incision and gauze packing, relentlessly).At the time of the report, the menorrhagia, the last episode of subcutaneous abscess, furuncle, urinary tract infection, pyelonephritis, sjogren's syndrome, urinary tract inflammation, pain, dyshidrotic eczema, ovulation pain, fatigue, migraine with aura, fibromyalgia, visual impairment, disturbance in attention, amnesia, tinnitus, back pain, sciatica, dry mouth and restless legs syndrome outcome was unknown.The reporter provided no causality assessment for amnesia, back pain, disturbance in attention, dry mouth, dyshidrotic eczema, fatigue, fibromyalgia, furuncle, menorrhagia, migraine with aura, ovulation pain, pain, pyelonephritis, restless legs syndrome, sciatica, sjogren's syndrome, tinnitus, urinary tract infection, urinary tract inflammation, visual impairment, the first episode of subcutaneous abscess and the second episode of subcutaneous abscess with essure.The reporter commented: after placement of the essure inserts, she developed various health problems that i did not have prior to placement of the inserts.Topical corticosteroids was applied to treat palmar and plantar dyshidrotic eczema, which she can no longer stop without relapsing (no allergy tests were performed prior to placement of essure).She also had blood tests which found nothing abnormal apart from tearless eyes requiring eye drops several times a day and ikervis, an immunosuppressant.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 (b)(6) 2018 for the following meddra preferred term: menorrhagia ¿ analysis in the global safety database revealed 638 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.Most recent follow-up information incorporated above includes: on 14-may-2019: the case will be deleted from bayer pv database.Nullification reason: as per information received from the french health authorities, this case was identified as a duplicate of case 2017-021541.All case information from (b)(4) has been transferred to case (b)(4).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: 8610606
• MDR Text Key: 145087264
• Report Number: 2951250-2019-01916
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 05/14/2019
• 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