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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Fatigue (1849); Headache (1880); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Paralysis (1997); Dizziness (2194); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Cognitive Changes (2551); Confusion/ Disorientation (2553); Constipation (3274)

Event Date 04/01/2010

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 04-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic ligament pain") and paralysis ("right paralysis") in a female patient who had essure (batch no.685779) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 9 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria disability, medically significant and intervention required), paralysis (seriousness criterion medically significant), tendon pain ("achilles tendon pain"), general physical health deterioration ("deterioration of health with loss of autonomy"), pain ("diffuse pain throughout the body"), dysmenorrhoea ("painful menstruations"), presyncope ("vasovagal reaction"), menorrhagia ("hemorrhagic menstruation"), fatigue ("chronic fatigue"), arthralgia ("generalized joint pain / hip pain"), muscle atrophy ("muscular atrophy"), carpal tunnel syndrome ("affected carpal tunnel"), fibromyalgia ("fibromyalgia-like pain"), dry eye ("dry eye"), decreased appetite ("loss of appetite"), eczema ("eczema"), psoriasis ("psoriasis"), pruritus generalised ("itching all over the body"), dry skin ("dry skin"), constipation ("constipation"), dyspepsia ("poorly digested food"), urinary incontinence ("urinary incontinence"), loss of bladder sensation ("loss of sensation of urination"), dizziness ("dizziness"), anxiety ("anxiety"), thinking abnormal ("difficulty thinking about several things"), disturbance in attention ("concentration problems"), memory impairment ("memory problems"), headache ("headaches"), migraine ("migraine"), cognitive disorder ("cognitive problems"), sinusitis noninfective ("inflammation of sinus"), bone pain ("generalized bone pain") and myalgia ("generalized muscle pain").In 2011, the patient experienced muscle disorder ("muscular problems"), torticollis ("torticollis") and the first episode of tendonitis ("tendonitis").In (b)(6) 2012, the patient experienced the second episode of tendonitis ("tendonitis of both achilles tendons").On an unknown date, the patient experienced feeling abnormal ("fog").The patient was treated with surgery (essure removed).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, paralysis, tendon pain, general physical health deterioration, muscle disorder, torticollis, the last episode of tendonitis, pain, dysmenorrhoea, presyncope, menorrhagia, fatigue, arthralgia, muscle atrophy, carpal tunnel syndrome, fibromyalgia, dry eye, decreased appetite, eczema, psoriasis, pruritus generalised, dry skin, constipation, dyspepsia, urinary incontinence, loss of bladder sensation, dizziness, anxiety, thinking abnormal, disturbance in attention, memory impairment, headache, migraine, cognitive disorder, sinusitis noninfective, bone pain, myalgia and feeling abnormal outcome was unknown.The reporter provided no causality assessment for anxiety, arthralgia, bone pain, carpal tunnel syndrome, cognitive disorder, constipation, decreased appetite, disturbance in attention, dizziness, dry eye, dry skin, dysmenorrhoea, dyspepsia, eczema, fatigue, feeling abnormal, fibromyalgia, general physical health deterioration, headache, loss of bladder sensation, memory impairment, menorrhagia, migraine, muscle atrophy, muscle disorder, myalgia, pain, paralysis, pelvic pain, presyncope, pruritus generalised, psoriasis, sinusitis noninfective, tendon pain, thinking abnormal, torticollis, urinary incontinence, the first episode of tendonitis and the second episode of tendonitis with essure.The reporter commented: wheelchair in (b)(6) 2015, loss of social relations and activity.The patient was considered as disable worker 2 in (b)(6) 2015.She had deterioration of health with loss of autonomy: difficulty eating, cooking, dressing, undressing etc.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 (b)(6) 2018 for the following meddra preferred term: pelvic pain - the analysis in the global safety database revealed 11.493 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 in a supplemental report.

Manufacturer Narrative

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) 2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic ligament pain") and paralysis ("right paralysis") in a female patient who had essure (batch no.685779) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 9 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria disability, medically significant and intervention required), paralysis (seriousness criterion medically significant), tendon pain ("achilles tendon pain"), general physical health deterioration ("deterioration of health with loss of autonomy"), pain ("diffuse pain throughout the body"), dysmenorrhoea ("painful menstruations"), presyncope ("vasovagal reaction"), menorrhagia ("hemorrhagic menstruation"), fatigue ("chronic fatigue"), arthralgia ("generalized joint pain / hip pain"), muscle atrophy ("muscular atrophy"), carpal tunnel syndrome ("affected carpal tunnel"), fibromyalgia ("fibromyalgia-like pain"), dry eye ("dry eye"), decreased appetite ("loss of appetite"), eczema ("eczema"), psoriasis ("psoriasis"), pruritus generalised ("itching all over the body"), dry skin ("dry skin"), constipation ("constipation"), dyspepsia ("poorly digested food"), urinary incontinence ("urinary incontinence"), loss of bladder sensation ("loss of sensation of urination"), dizziness ("dizziness"), anxiety ("anxiety"), mental impairment ("difficulty thinking about several things"), disturbance in attention ("concentration problems"), memory impairment ("memory problems"), headache ("headaches"), migraine ("migraine"), cognitive disorder ("cognitive problems"), sinusitis noninfective ("inflammation of sinus"), bone pain ("generalized bone pain") and myalgia ("generalized muscle pain").In 2011, the patient experienced muscle disorder ("muscular problems"), torticollis ("torticollis") and the first episode of tendonitis ("tendonitis").In may 2012, the patient experienced the second episode of tendonitis ("tendonitis of both achilles tendons").On an unknown date, the patient experienced feeling abnormal ("fog").The patient was treated with surgery (essure removed).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, paralysis, tendon pain, general physical health deterioration, muscle disorder, torticollis, the last episode of tendonitis, pain, dysmenorrhoea, presyncope, menorrhagia, fatigue, arthralgia, muscle atrophy, carpal tunnel syndrome, fibromyalgia, dry eye, decreased appetite, eczema, psoriasis, pruritus generalised, dry skin, constipation, dyspepsia, urinary incontinence, loss of bladder sensation, dizziness, anxiety, mental impairment, disturbance in attention, memory impairment, headache, migraine, cognitive disorder, sinusitis noninfective, bone pain, myalgia and feeling abnormal outcome was unknown.The reporter provided no causality assessment for anxiety, arthralgia, bone pain, carpal tunnel syndrome, cognitive disorder, constipation, decreased appetite, disturbance in attention, dizziness, dry eye, dry skin, dysmenorrhoea, dyspepsia, eczema, fatigue, feeling abnormal, fibromyalgia, general physical health deterioration, headache, loss of bladder sensation, memory impairment, menorrhagia, mental impairment, migraine, muscle atrophy, muscle disorder, myalgia, pain, paralysis, pelvic pain, presyncope, pruritus generalised, psoriasis, sinusitis noninfective, tendon pain, torticollis, urinary incontinence, the first episode of tendonitis and the second episode of tendonitis with essure.The reporter commented: wheelchair in (b)(6) 2015, loss of social relations and activity.The patient was considered as disable worker 2 in (b)(6) 2015.She had deterioration of health with loss of autonomy: difficulty eating, cooking, dressing, undressing etc.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 (b)(6) 2018 for the following meddra preferred term: pelvic pain - the analysis in the global safety database revealed 11.654 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 (b)(6) 2018: 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 in 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
• MDR Report Key: 7572581
• MDR Text Key: 110246057
• Report Number: 2951250-2018-02509
• Device Sequence Number: 1
• Product Code: HHS
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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 Expiration Date: 10/15/2012
• Device Model Number: ESS305
• Device Lot Number: 685779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability