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

Model Number ESS205

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Blurred Vision (2137); Dizziness (2194); Stenosis (2263); Anxiety (2328); Discomfort (2330); Abdominal Distention (2601); Heavier Menses (2666); Constipation (3274)

Event Date 01/01/2008

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (ansm - health authorities in france, reference number: r1810598) on 02-jul-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("chronic pain and fatigue of all muscles"), genital haemorrhage ("bleeding and worsening of premenstrual syndrome") and dizziness ("dizziness") in a female patient who had essure (ess205) (batch no.624276) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included levothyroxine sodium (levothyrox).On (b)(6) 2007, the patient had essure (ess205) inserted.On (b)(6) 2008, 1 month 9 days after insertion of essure (ess205), the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscle fatigue ("chronic pain and fatigue of all muscles"), fatigue ("disabling chronic tiredness"), back pain ("back, cervical and lumbar pain"), neck pain ("back, cervical and lumbar pain"), spinal column stenosis ("spinal stenosis with compression of spinal cord (showed on mri)"), spinal cord compression ("spinal stenosis with compression of spinal cord (showed on mri)"), hypothyroidism ("worsening of hypothyroïdism (from 75 to 150 of levothyroxine sodium)"), musculoskeletal stiffness ("flexing legs, fall"), genital haemorrhage (seriousness criterion medically significant), premenstrual syndrome ("bleeding and worsening of premenstrual syndrome"), abdominal pain ("belly pain"), nausea ("nausea"), dizziness (seriousness criterion hospitalization), ear pain ("pain and itching inside the ears and otitis (several ent visits)"), ear pruritus ("pain and itching inside the ears and otitis (several ent visits)"), ear infection ("pain and itching inside the ears and otitis (several ent visits)"), constipation ("constipation"), diarrhoea ("diarrhea"), pruritus ("skin itching"), rash ("skin rash"), head discomfort ("head in vise"), vision blurred ("vision such as blurred"), disturbance in attention ("concentration disorder"), memory impairment ("memory disorder"), alopecia ("hair loss"), tendonitis ("tendinitis"), cough ("cough"), abdominal pain upper ("stomach pain"), abdominal distension ("stomach bloating during food intake"), weight increased ("weight gain of 17 kgs"), blood test abnormal ("deficiencies proven by blood samples, impossible to compensate despite food supplements, iron"), dyspnoea ("breathlessness"), muscle tightness ("tensions in jaw and nape"), feeling abnormal ("unexplained anguish, morbid sensations in the body") and anxiety ("unexplained anguish, morbid sensations in the body").The patient was treated with other nutrients (dietary supplements), iron and surgery (essure removed).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the pelvic pain, muscle fatigue, fatigue, back pain, neck pain, spinal column stenosis, spinal cord compression, hypothyroidism, musculoskeletal stiffness, genital haemorrhage, premenstrual syndrome, abdominal pain, nausea, dizziness, ear pain, ear pruritus, ear infection, constipation, diarrhoea, pruritus, rash, head discomfort, vision blurred, disturbance in attention, memory impairment, alopecia, tendonitis, cough, abdominal pain upper, abdominal distension, weight increased, blood test abnormal, dyspnoea, muscle tightness, feeling abnormal and anxiety outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain upper, alopecia, anxiety, back pain, blood test abnormal, constipation, cough, diarrhoea, disturbance in attention, dizziness, dyspnoea, ear infection, ear pain, ear pruritus, fatigue, feeling abnormal, genital haemorrhage, head discomfort, hypothyroidism, memory impairment, muscle fatigue, muscle tightness, musculoskeletal stiffness, nausea, neck pain, pelvic pain, premenstrual syndrome, pruritus, rash, spinal column stenosis, spinal cord compression, tendonitis, vision blurred and weight increased with essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): nuclear magnetic resonance imaging - on an unknown date: spinal stenosis with compression of spinal cord.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra 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 11.657 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 on a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm - health authorities in france, reference number: (b)(4)) on 02-jul-2018.The most recent information was received on 17-aug-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("chronic pain and fatigue of all muscles"), genital haemorrhage ("bleeding and worsening of premenstrual syndrome") and dizziness ("dizziness") in a female patient who had essure (ess205) (batch no.624276) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included levothyroxine sodium (levothyrox).On (b)(6) 2007, the patient had essure (ess205) inserted.On (b)(6) 2008, 1 month 9 days after insertion of essure (ess205), the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), muscle fatigue ("chronic pain and fatigue of all muscles"), fatigue ("disabling chronic tiredness"), back pain ("back, cervical and lumbar pain"), neck pain ("back, cervical and lumbar pain"), spinal column stenosis ("spinal stenosis with compression of spinal cord (showed on mri)"), spinal cord compression ("spinal stenosis with compression of spinal cord (showed on mri)"), hypothyroidism ("worsening of hypothyroidism (from 75 to 150 of levothyroxine sodium)"), musculoskeletal stiffness ("flexing legs, fall"), genital haemorrhage (seriousness criterion medically significant), premenstrual syndrome ("bleeding and worsening of premenstrual syndrome"), abdominal pain ("belly pain"), nausea ("nausea"), dizziness (seriousness criterion hospitalization), ear pain ("pain and itching inside the ears and otitis (several ent visits)"), ear pruritus ("pain and itching inside the ears and otitis (several ent visits)"), ear infection ("pain and itching inside the ears and otitis (several ent visits)"), constipation ("constipation"), diarrhoea ("diarrhea"), pruritus ("skin itching"), rash ("skin rash"), head discomfort ("head in vise"), vision blurred ("vision such as blurred"), disturbance in attention ("concentration disorder"), memory impairment ("memory disorder"), alopecia ("hair loss"), tendonitis ("tendinitis"), cough ("cough"), abdominal pain upper ("stomach pain"), abdominal distension ("stomach bloating during food intake"), weight increased ("weight gain of 17 kgs"), blood test abnormal ("deficiencies proven by blood samples, impossible to compensate despite food supplements, iron"), dyspnoea ("breathlessness"), muscle tightness ("tensions in jaw and nape"), feeling abnormal ("unexplained anguish, morbid sensations in the body") and anxiety ("unexplained anguish, morbid sensations in the body").The patient was treated with other nutrients (dietary supplements), iron and surgery (essure removed).Essure (ess205) was removed on (b)(6) 2018.At the time of the report, the pelvic pain, muscle fatigue, fatigue, back pain, neck pain, spinal column stenosis, spinal cord compression, hypothyroidism, musculoskeletal stiffness, genital haemorrhage, premenstrual syndrome, abdominal pain, nausea, dizziness, ear pain, ear pruritus, ear infection, constipation, diarrhoea, pruritus, rash, head discomfort, vision blurred, disturbance in attention, memory impairment, alopecia, tendonitis, cough, abdominal pain upper, abdominal distension, weight increased, blood test abnormal, dyspnoea, muscle tightness, feeling abnormal and anxiety outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain upper, alopecia, anxiety, back pain, blood test abnormal, constipation, cough, diarrhoea, disturbance in attention, dizziness, dyspnoea, ear infection, ear pain, ear pruritus, fatigue, feeling abnormal, genital haemorrhage, head discomfort, hypothyroidism, memory impairment, muscle fatigue, muscle tightness, musculoskeletal stiffness, nausea, neck pain, pelvic pain, premenstrual syndrome, pruritus, rash, spinal column stenosis, spinal cord compression, tendonitis, vision blurred and weight increased with essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): nuclear magnetic resonance imaging - on an unknown date: spinal stenosis with compression of spinal cord.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 17-aug-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 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
• MDR Report Key: 7660256
• MDR Text Key: 113160083
• Report Number: 2951250-2018-02954
• 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: 08/17/2018

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: 03/01/2009
• Device Model Number: ESS205
• Device Lot Number: 624276
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVOTHYROX; LEVOTHYROX
• Patient Outcome(s): Hospitalization; Other; Required Intervention