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

Model Number ESS305

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

Patient Problems Abdominal Pain (1685); Aneurysm (1708); Bronchitis (1752); Cyst(s) (1800); Dry Eye(s) (1814); Fatigue (1849); Micturition Urgency (1871); Gastritis (1874); Granuloma (1876); Hair Loss (1877); Headache (1880); Hyperplasia (1906); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Itching Sensation (1943); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Swelling (2091); Tinnitus (2103); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Myalgia (2238); Discomfort (2330); Arthralgia (2355); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551); Abdominal Distention (2601); Weight Changes (2607); Vaso-Vagal Response (2661); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on (b)(6) 2017.The most recent information was received on (b)(6) 2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("constant pelvic pain/ pelvic pain every day"), abdominal pain ("constant abdominal pain") and intracranial aneurysm ("frontal aneurysm") in a female patient who had essure (batch no.835437) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On the same day the patient experienced general physical health deterioration ("serious deterioration in health").In 2016, the patient experienced intracranial aneurysm (seriousness criterion medically significant) with migraine, visual impairment, diplopia, and vision blurred, white matter lesion ("destruction of cerebral matter seen on mri/ white patches on brain"), granuloma ("granuloma on right temple") and hyperplasia ("right hyperplasia").On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant, disability), abdominal pain (seriousness criterion medically significant, disability), depression ("serious depression"), amnesia ("memory loss"), dysarthria ("loss of allocution"), disturbance in attention ("difficulty concentrating"), fatigue ("major general fatigue"), musculoskeletal pain ("constant muscle and joint pain"), dizziness ("dizziness/ faintness"), blood pressure fluctuation ("high blood pressure then sudden fall"), tinnitus ("ringing in ears"), bronchitis chronic ("chronic bronchitis"), dysmenorrhoea and polymenorrhagia ("extremely painful and heavy menstrual bleeding every 10 days"), metrorrhagia ("bleeding between periods"), dyspareunia ("pain on sexual intercourse"), loss of libido ("loss of libido"), vaginal discharge ("abundant vaginal discharge"), micturition urgency ("frequent urge to urinate"), urinary incontinence ("major urinary leakage"), vaginal cyst ("vaginal cysts"), abdominal distension abdomen ("constantly swollen"), breast swelling ("breasts constantly swollen"), nausea ("nausea/ urge to vomit with or without food"), abnormal weight gain ("weight gain of 30 kg in 3 or 4 years"), insomnia and poor quality sleep ("insomnia and very restless sleep"), renal pain ("pain in kidneys every day"), back pain ("back pain every day"), muscle fatigue ("muscle fatigue"), spinal column injury ("problem with blocked vertebrae at l4-l5"), paraesthesia ("tingling in extremities of feet and hands"), the second episode of muscle fatigue and limb discomfort ("tiredness and heaviness in legs"), cardiovascular disorder ("very poor blood circulation"), vein rupture ("veins that burst"), burning sensation ("feeling of burning in head"), toothache ("tooth pain"), fibromyalgia ("fibromyalgic pain"), pruritus generalised ("itching all over the body"), presyncope ("vasovagal reactions"), dry eye, eye pruritus, eye irritation and lacrimation increased ("dry eyes that itch, burn and water"), dyspepsia ("gastric burning"), visual impairment ("decompensation of vision with new glasses"), alopecia ("hair loss"), dry skin and pruritus ("dry skin and itching"), skin discolouration ("brown and white spots all over the body"), abdominal pain upper ("stomach pain"), diarrhoea ("diarrhoea"), constipation ("constipation"), ovarian disorder ("fluid in ovaries").At the time of the report, the pelvic pain, abdominal pain, intracranial aneurysm, white matter lesion, granuloma, hyperplasia, general physical health deterioration, depression, amnesia, dysarthria, disturbance in attention, fatigue, musculoskeletal pain, dizziness, blood pressure fluctuation, tinnitus, bronchitis chronic, dysmenorrhoea, polymenorrhagia, metrorrhagia, dyspareunia, loss of libido, vaginal discharge, micturition urgency, urinary incontinence, vaginal cyst, abdominal distension, breast swelling, nausea, abnormal weight gain, insomnia, poor quality sleep, renal pain, back pain, muscle fatigue, spinal column injury, paraesthesia, the second episode of muscle fatigue, limb discomfort, cardiovascular disorder, vein rupture, burning sensation, toothache, fibromyalgia, pruritus generalised, presyncope, dry eye, eye pruritus, eye irritation, lacrimation increased, dyspepsia, visual impairment, alopecia, dry skin, pruritus, skin discolouration, abdominal pain upper, diarrhoea, constipation, and ovarian disorder outcome was unknown.The reporter provided no causality assessment for pelvic pain, abdominal pain, intracranial aneurysm, white matter lesion, granuloma, hyperplasia, general physical health deterioration, depression, amnesia, dysarthria, disturbance in attention, fatigue, musculoskeletal pain, dizziness, blood pressure fluctuation, tinnitus, bronchitis chronic, dysmenorrhoea, polymenorrhagia, metrorrhagia, dyspareunia, loss of libido, vaginal discharge, micturition urgency, urinary incontinence, vaginal cyst, abdominal distension, breast swelling, nausea, abnormal weight gain, insomnia, poor quality sleep, renal pain, back pain, muscle fatigue, spinal column injury, paraesthesia, the second episode of muscle fatigue, limb discomfort, cardiovascular disorder, vein rupture, burning sensation, toothache, fibromyalgia, pruritus generalised, presyncope, dry eye, eye pruritus, eye irritation, lacrimation increased, dyspepsia, visual impairment, alopecia, dry skin, pruritus, skin discolouration, abdominal pain upper, diarrhoea, constipation, and ovarian disorder with essure.The reporter commented: serious deterioration in her health since placement in 2011.She can no longer lean forwards, bend over or sit down since the slightest pressure on her abdomen is very painful and debilitating.She is on long-term disability leave since (b)(6) 2015.Unable to resume working due to health problems that are constantly multiplying.Awaiting removal of the inserts.Visit with gynecologist scheduled for (b)(6) 2017 to take a decision with the doctor.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis/abdomen - on an unknown date: fluid in ovaries.Nuclear magnetic resonance imaging - in 2016: destruction of cerebral matter.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) 2017 for the following meddra preferred terms: pelvic pain.The analysis in the global safety database revealed (b)(4) cases.Abdominal pain.The analysis in the global safety database revealed (b)(4) 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 pts.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 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: 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 07981-0915
• MDR Report Key: 6987044
• MDR Text Key: 90564633
• Report Number: 2951250-2017-05711
• 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: 10/30/2017

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: 835437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/30/2017
• 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; Disability