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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problems Biocompatibility (2886); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/01/2014
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ("due to symptoms related to her essure, plaintiff underwent essure device removal") in an adult female patient who had essure inserted for female sterilization.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (total hysterectomy).Essure was removed in (b)(6) 2014.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ("due to symptoms related to her essure, plaintiff underwent essure device removal") in an adult female patient who had essure inserted for female sterilization.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (total hysterectomy).Essure was removed in (b)(6) 2014.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2018: quality-safety evaluation of product technical complaint.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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain'), systemic lupus erythematosus ('lupus') and sjogren's syndrome ('sjogren's syndrome') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), systemic lupus erythematosus (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), menorrhagia ("menorrhagia(heavy mesntrual bleeding)"), dysmenorrhoea ("dysmenorrhea(cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), abdominal pain ("abdominal pain"), allergy to metals ("nickel allergy"), psychological trauma ("psych injury") and vaginal discharge ("vaginal discharge") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, dyspareunia and abdominal pain had resolved and the sjogren's syndrome, allergy to metals, psychological trauma, vaginal discharge and hormone level abnormal outcome was unknown.The reporter considered abdominal pain, allergy to metals, dysmenorrhoea, dyspareunia, hormone level abnormal, menorrhagia, pelvic pain, psychological trauma, sjogren's syndrome, systemic lupus erythematosus and vaginal discharge to be related to essure.The reporter commented: discrepancy noted in insertion date -(b)(6) 2012 and explant date -(b)(6) 2013.Patient received treatment for- dysmenorrhea(cramping), dyspareunia(painful sexual intercourse), pelvic pain, abdominal pain, menorrhagia(heavy menstrual bleeding), nickel allergy, sjogren's syndrome, lupus, vaginal discharge, hormonal changes and psych injury.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-oct-2019: pfs received- new events dysmenorrhea(cramping), dyspareunia(painful sexual intercourse), pelvic pain, abdominal pain, menorrhagia(heavy menstrual bleeding), nickel allergy, allergic reaction nos, sjogren's syndrome, lupus, vaginal discharge, hormonal changes and psych injury were added.Reporter and patient demography added.Lab data was added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 ('pelvic pain'), systemic lupus erythematosus ('autoimmune disorder type of disorder: lupus') and sjogren's syndrome ('sjogren's syndrome/ autoimmune disorder type of disorder: sjogren's') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included body mass index normal.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), systemic lupus erythematosus (seriousness criterion medically significant), sjogren's syndrome (seriousness criterion medically significant), genital haemorrhage ("abnormal bleeding (general)"), menorrhagia ("menorrhagia(heavy mesntrual bleeding) / abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea(cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), abdominal pain ("abdominal pain"), allergy to metals ("nickel allergy"), psychological trauma ("psych injury"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), hypersensitivity ("allergic or hypersensitivity reaction"), cystitis ("infection (bladder/ urinary tract/vaginal)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal)"), vaginal infection ("infection (bladder/ urinary tract/vaginal)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), mental disorder ("psychological or psychiatric problems"), dermatitis allergic ("rashes or skin conditions"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), nausea ("nausea"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition"), abdominal pain upper ("stomach pain") and back pain ("lower back pain") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, dyspareunia and abdominal pain had resolved and the sjogren's syndrome, genital haemorrhage, allergy to metals, psychological trauma, vaginal discharge, hormone level abnormal, vaginal haemorrhage, hypersensitivity, cystitis, urinary tract infection, vaginal infection, female sexual dysfunction, mental disorder, dermatitis allergic, bladder disorder, urinary tract disorder, migraine, nausea, fatigue, gastrointestinal disorder, weight increased, abdominal pain upper and back pain outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, allergy to metals, back pain, bladder disorder, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, hormone level abnormal, hypersensitivity, menorrhagia, mental disorder, migraine, nausea, pelvic pain, psychological trauma, sjogren's syndrome, systemic lupus erythematosus, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: discrepancy noted in insertion date -(b)(6) 2012 and explant date -(b)(6) 2013.Patient received treatment for- dysmenorrhea(cramping), dyspareunia(painful sexual intercourse), pelvic pain, abdominal pain, menorrhagia(heavy menstrual bleeding), nickel allergy, sjogren's syndrome, lupus, vaginal discharge, hormonal changes and psych injury.Current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-mar-2020: plaintiff fact sheet received.Events added from pfs- abnormal bleeding (general), abnormal bleeding (vaginal), allergic or hypersensitivity reaction, infection (bladder/ urinary tract/vaginal), apareunia (inability to have sexual intercourse), psychological or psychiatric problems, rashes or skin conditions, bladder or urinary problems or changes, migraines / headaches, nausea, fatigue, gastrointestinal or digestive system condition, weight gain / loss (specify which one) weight gain, stomach pain, lower back pain.Aka name, medical history were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included body mass index normal.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), systemic lupus erythematosus ("autoimmune disorder type of disorder: lupus"), sjogren's syndrome ("sjogren's syndrome/ autoimmune disorder type of disorder: sjogren's"), genital haemorrhage ("abnormal bleeding (general)"), menorrhagia ("menorrhagia(heavy mesntrual bleeding) / abnormal bleeding (menorrhagia)"), dysmenorrhoea ("dysmenorrhea(cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), abdominal pain ("abdominal pain"), allergy to metals ("nickel allergy"), psychological trauma ("psych injury"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), hypersensitivity ("allergic or hypersensitivity reaction"), cystitis ("infection (bladder/ urinary tract/vaginal)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal)"), vaginal infection ("infection (bladder/ urinary tract/vaginal)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), mental disorder ("psychological or psychiatric problems"), dermatitis allergic ("rashes or skin conditions"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), nausea ("nausea"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition"), abdominal pain upper ("stomach pain") and back pain ("lower back pain") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").The patient was treated with surgery (hysterectomy(full)).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, menorrhagia, dysmenorrhoea, dyspareunia and abdominal pain had resolved and the sjogren's syndrome, genital haemorrhage, allergy to metals, psychological trauma, vaginal discharge, hormone level abnormal, vaginal haemorrhage, hypersensitivity, cystitis, urinary tract infection, vaginal infection, female sexual dysfunction, mental disorder, dermatitis allergic, bladder disorder, urinary tract disorder, migraine, nausea, fatigue, gastrointestinal disorder, weight increased, abdominal pain upper and back pain outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, allergy to metals, back pain, bladder disorder, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, hormone level abnormal, hypersensitivity, menorrhagia, mental disorder, migraine, nausea, pelvic pain, psychological trauma, sjogren's syndrome, systemic lupus erythematosus, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: discrepancy noted in insertion date -(b)(6) 2012 and explant date -(b)(6) 2013.Patient received treatment for- dysmenorrhea(cramping), dyspareunia(painful sexual intercourse), pelvic pain, abdominal pain, menorrhagia(heavy menstrual bleeding), nickel allergy, sjogren's syndrome, lupus, vaginal discharge, hormonal changes and psych injury.Current weight 200 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-mar-2020: quality safety evaluation.(product technical complaint) on 1-apr-2020: quality safety evaluation of ptc (product technical complaint) based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
 
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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 Key7637006
MDR Text Key112282367
Report Number2951250-2018-02800
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESS305
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age29 YR
Patient Weight66
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