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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Asthma (1726); Autoimmune Disorder (1732); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Neurological Deficit/Dysfunction (1982); Pain (1994); Vertigo (2134); Visual Impairment (2138); Weakness (2145); Myalgia (2238); Numbness (2415); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain'), neuromyopathy ('neuromuscular problems') and sjogren's syndrome ('autoimmune-like symptoms other (list): sjogren's syndrome') in an adult female patient who had essure (batch no.626626) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache.Concurrent conditions included sleep disturbance, headache, numbness (right side of head for past few days.), vision abnormal, speech disorder, language disorder, weakness, vertigo, gait disorder, nausea, photophobia, menometrorrhagia, memory loss, celiac disease, myalgia (anterior chest wall tenderness, trapezius muscle tenderness), hypertension, asthma, myofascial pain syndrome and memory loss.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), urinary tract disorder ("urinary problems"), allergy to metals ("nickel sensitivity"), dyspareunia ("dyspareunia"), neuromyopathy (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), raynaud's phenomenon ("raynaud's syndrome"), fibromyalgia ("fibromyalgia"), costochondritis ("costochondritis"), gallbladder disorder ("gallbladder and gallstone issues"), cholelithiasis ("gallbladder and gallstone issues") and migraine ("migraines").The patient was treated with surgery (laparoscopic bilateral salprngostomy).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, genital haemorrhage, urinary tract disorder, allergy to metals, dyspareunia, neuromyopathy, sjogren's syndrome, raynaud's phenomenon, fibromyalgia, costochondritis, gallbladder disorder, cholelithiasis and migraine outcome was unknown.The reporter considered allergy to metals, cholelithiasis, costochondritis, dyspareunia, fibromyalgia, gallbladder disorder, genital haemorrhage, migraine, neuromyopathy, pelvic pain, raynaud's phenomenon, sjogren's syndrome and urinary tract disorder to be related to essure.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain'), neuromyopathy ('neuromuscular problems') and sjogren's syndrome ('autoimmune-like symptoms other (list): sjogren's syndrome') in an adult female patient who had essure (batch no.626626) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included headache.Concurrent conditions included sleep disturbance, headache, numbness (right side of head for past few days.), vision abnormal, speech disorder, language disorder, weakness, vertigo, gait disorder, nausea, photophobia, menometrorrhagia, memory loss, celiac disease, myalgia (anterior chest wall tenderness, trapezius muscle tenderness), hypertension, asthma, myofascial pain syndrome and memory loss.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), urinary tract disorder ("urinary problems"), allergy to metals ("nickel sensitivity"), dyspareunia ("dyspareunia"), neuromyopathy (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), raynaud's phenomenon ("raynaud's syndrome"), fibromyalgia ("fibromyalgia"), costochondritis ("costochondritis"), gallbladder disorder ("gallbladder and gallstone issues"), cholelithiasis ("gallbladder and gallstone issues") and migraine ("migraines").The patient was treated with surgery (laparoscopic bilateral "salpingectomy").Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, genital haemorrhage, urinary tract disorder, allergy to metals, dyspareunia, neuromyopathy, sjogren's syndrome, raynaud's phenomenon, fibromyalgia, costochondritis, gallbladder disorder, cholelithiasis and migraine outcome was unknown.The reporter considered allergy to metals, cholelithiasis, costochondritis, dyspareunia, fibromyalgia, gallbladder disorder, genital haemorrhage, migraine, neuromyopathy, pelvic pain, raynaud's phenomenon, sjogren's syndrome and urinary tract disorder to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-feb-2020: quality safety evaluation of ptc.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary 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: 9573795
• MDR Text Key: 178174385
• Report Number: 2951250-2020-00367
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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: 01/01/2010
• Device Model Number: ESS305
• Device Lot Number: 626626
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention