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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 Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Inflammation (1932); Pain (1994); Tinnitus (2103); Tingling (2171); Cramp(s) (2193); Anxiety (2328); Arthralgia (2355); Depression (2361); Numbness (2415); Confusion/ Disorientation (2553); Weight Changes (2607)
Event Date 06/30/2008
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2016, the patient experienced fibromyalgia ("fibromyalgia").In 2016, the patient experienced tinnitus ("tinnitus").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain"), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), back pain ("lower back pain"), menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation"), inflammation ("severe inflammation of hands and feet"), arthralgia ("severe joint pain"), pain ("general body aches"), mood swings ("mood swings"), feeling abnormal ("brain fog"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), migraine ("migraines"), headache ("headaches"), depression ("depression"), anxiety ("anxiety"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain") and menstrual disorder ("abnormal menstruation").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, dysmenorrhoea, abdominal pain lower, back pain, menorrhagia, inflammation, arthralgia, pain, mood swings, feeling abnormal, hypoaesthesia, paraesthesia, migraine, headache, depression, anxiety, alopecia, fatigue, weight increased, fibromyalgia, tinnitus and menstrual disorder outcome was unknown.The reporter considered abdominal pain lower, alopecia, anxiety, arthralgia, back pain, depression, dysmenorrhoea, fatigue, feeling abnormal, fibromyalgia, headache, hypoaesthesia, inflammation, menorrhagia, menstrual disorder, migraine, mood swings, pain, paraesthesia, pelvic pain, tinnitus and weight increased to be related to essure.The reporter commented: she underwent a total hysterectomy and bilateral, during which her cervix, uterus, and both fallopian tubes were all removed.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 ("severe pelvic pain/pain") in a 32-year-old female patient who had essure (batch no.627444) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not done".The patient's concurrent conditions included obesity, osteoarthritis and paratubal cyst.Concomitant products included eugynon (aviane) from 1-dec-2008 to 28-mar-2016 for birth control and bleeding menstrual heavy as well as duloxetine hydrochloride (cymbalta), fluoxetine hydrochloride (prozac) and topiramate (topamax).On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2008, 6 months 12 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2009, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain"), migraine ("migraines"), headache ("headaches"), depression ("depression"), anxiety ("anxiety") and dyspareunia ("dyspareunia (painful sexual intercourse)").On 30-jun-2009, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation/ abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In 2010, the patient experienced weight increased ("weight gain") and weight decreased ("weight loss").In july 2015, the patient experienced fatigue ("chronic fatigue").On (b)(6) 2015, the patient experienced inflammation ("severe inflammation of hands and feet"), mood swings ("mood swings"), alopecia ("hair loss"), fibromyalgia ("fibromyalgia"), tinnitus ("tinnitus") and carpal tunnel syndrome ("carpal tunnel syndrome").On an unknown date, the patient experienced abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), back pain ("lower back pain"), arthralgia ("severe joint pain"), pain ("general body aches"), feeling abnormal ("brain fog"), hypoaesthesia ("numbness"), paraesthesia ("tingling") and menstrual disorder ("abnormal menstruation").The patient was treated with surgery (robotic total laparoscopic hysterectomy with bilateral salpingectomy (removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, inflammation, mood swings, feeling abnormal, migraine, headache, depression, anxiety, alopecia, weight increased, fibromyalgia, tinnitus, vaginal haemorrhage, dyspareunia, carpal tunnel syndrome and weight decreased had resolved, the abdominal pain lower, back pain, arthralgia, pain, hypoaesthesia, paraesthesia and menstrual disorder outcome was unknown and the fatigue had not resolved.The reporter considered abdominal pain lower, alopecia, anxiety, arthralgia, back pain, carpal tunnel syndrome, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, headache, hypoaesthesia, inflammation, menorrhagia, menstrual disorder, migraine, mood swings, pain, paraesthesia, pelvic pain, tinnitus, vaginal haemorrhage, weight decreased and weight increased to be related to essure.The reporter commented: she underwent a total hysterectomy and bilateral, during which her cervix, uterus, and both fallopian tubes were all removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.6 kg/sqm.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Events per pfs: abnormal bleeding (vaginal), dyspareunia (painful sexual intercourse), weight loss, carpal tunnel syndrome and essure confirmation test not done.On (b)(6) 2018: reporter, concomittant condition and drug added from medical record.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
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/pain") in a 33-year-old female patient who had essure (batch no.627444) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not done".The patient's concurrent conditions included obesity, osteoarthritis and paratubal cyst.Concomitant products included eugynon (aviane) from 1-dec-2008 to 28-mar-2016 for birth control and bleeding menstrual heavy as well as bupropion (wellbutrin), duloxetine hydrochloride (cymbalta), fluoxetine hydrochloride (prozac), ibuprofen, para-seltzer (excedrin), topiramate (topamax) and vicodin (norco).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, 3 months 12 days after insertion of essure, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/dysmenorrhoea(cramping)"), feeling abnormal ("brain fog"), migraine ("migraines"), headache ("headaches"), depression ("depression"), anxiety ("anxiety"), alopecia ("hair loss"), dyspareunia ("dyspareunia (painful sexual intercourse)") and affective disorder ("mood disorder").On (b)(6) 2009, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation/ abnormal bleeding (menorrhagia)/heavy and longer periods"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menstruation irregular ("irregular cycle").In 2010, the patient experienced weight increased ("weight gain") and weight decreased ("weight loss").In 2015, the patient experienced cystitis ("infection(bladder/ urinary tract/ vaginal)"), urinary tract infection ("infection(bladder/ urinary tract/ vaginal)") and vaginal infection ("infection(bladder/ urinary tract/ vaginal)").In july 2015, the patient experienced fatigue ("chronic fatigue/fatigue").On 30-jul-2015, the patient experienced fibromyalgia ("fibromyalgia").On (b)(6) 2015, the patient experienced inflammation ("severe inflammation of hands and feet/ unexplained inflammation"), mood swings ("mood swings"), tinnitus ("tinnitus"), carpal tunnel syndrome ("carpal tunnel syndrome") and burning sensation ("burning in feet").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), back pain ("lower back pain/back pain"), arthralgia ("severe joint pain/ joint pain") and arthritis ("arthritis").On an unknown date, the patient experienced pain ("general body aches"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), menstrual disorder ("abnormal menstruation"), cervicitis ("infection (bladder/urinary tract/vaginal) type: chronic cervicitis") and abdominal pain ("abdominal pain").The patient was treated with vitamins and surgery (robotic total laparoscopic hysterectomy with bilateral salpingectomy (removal of fallopian tubes)).Essure was removed on 28-mar-2016.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, inflammation, mood swings, feeling abnormal, migraine, headache, depression, anxiety, alopecia, weight increased, fibromyalgia, tinnitus, vaginal haemorrhage, dyspareunia, carpal tunnel syndrome, weight decreased and abdominal pain had resolved, the abdominal pain lower, back pain, arthralgia, pain, hypoaesthesia, paraesthesia, menstrual disorder, cervicitis, burning sensation, arthritis, affective disorder, menstruation irregular, cystitis, urinary tract infection and vaginal infection outcome was unknown and the fatigue had not resolved.The reporter considered abdominal pain, abdominal pain lower, affective disorder, alopecia, anxiety, arthralgia, arthritis, back pain, burning sensation, carpal tunnel syndrome, cervicitis, cystitis, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, headache, hypoaesthesia, inflammation, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, pain, paraesthesia, pelvic pain, tinnitus, urinary tract infection, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: she underwent a total hysterectomy and bilateral, during which her cervix, uterus, and both fallopian tubes were all removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.6 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-sep-2018: plaintiff fact sheet received.Event added: bladder infection, urinary tract infection, vaginal infection.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/pain") in a 33-year-old female patient who had essure (batch no.627444) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not done".The patient's concurrent conditions included obesity, osteoarthritis and paratubal cyst.Concomitant products included eugynon (aviane) from 1-dec-2008 to 28-mar-2016 for birth control and bleeding menstrual heavy as well as bupropion (wellbutrin), duloxetine hydrochloride (cymbalta), fluoxetine hydrochloride (prozac), ibuprofen, para-seltzer (excedrin), topiramate (topamax) and vicodin (norco).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, 3 months 12 days after insertion of essure, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/dysmenorrhoea(cramping)"), feeling abnormal ("brain fog"), migraine ("migraines"), headache ("headaches"), depression ("depression"), anxiety ("anxiety"), dyspareunia ("dyspareunia (painful sexual intercourse)") and affective disorder ("mood disorder").On (b)(6) 2009, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation/ abnormal bleeding (menorrhagia)/heavy and longer periods"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menstruation irregular ("irregular cycle").In 2010, the patient experienced weight increased ("weight gain") and weight decreased ("weight loss").In july 2015, the patient experienced fatigue ("chronic fatigue/fatigue").On (b)(6) 2015, the patient experienced fibromyalgia ("fibromyalgia").On 31-jul-2015, the patient experienced inflammation ("severe inflammation of hands and feet"), mood swings ("mood swings"), alopecia ("hair loss"), tinnitus ("tinnitus") and carpal tunnel syndrome ("carpal tunnel syndrome").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), back pain ("lower back pain/back pain"), arthralgia ("severe joint pain/ joint pain") and arthritis ("arthritis").On an unknown date, the patient experienced pain ("general body aches"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), menstrual disorder ("abnormal menstruation"), cervicitis ("infection (bladder/urinary tract/vaginal) type: chronic cervicitis"), burning sensation ("burning in feet") and abdominal pain ("abdominal pain").The patient was treated with surgery (robotic total laparoscopic hysterectomy with bilateral salpingectomy (removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, inflammation, mood swings, feeling abnormal, migraine, headache, depression, anxiety, alopecia, weight increased, fibromyalgia, tinnitus, vaginal haemorrhage, dyspareunia, carpal tunnel syndrome, weight decreased and abdominal pain had resolved, the abdominal pain lower, back pain, arthralgia, pain, hypoaesthesia, paraesthesia, menstrual disorder, cervicitis, burning sensation, arthritis, affective disorder and menstruation irregular outcome was unknown and the fatigue had not resolved.The reporter considered abdominal pain, abdominal pain lower, affective disorder, alopecia, anxiety, arthralgia, arthritis, back pain, burning sensation, carpal tunnel syndrome, cervicitis, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, headache, hypoaesthesia, inflammation, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, pain, paraesthesia, pelvic pain, tinnitus, vaginal haemorrhage, weight decreased and weight increased to be related to essure.The reporter commented: she underwent a total hysterectomy and bilateral, during which her cervix, uterus, and both fallopian tubes were all removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.6 kg/sqm.Most recent follow-up information incorporated above includes: on 11-jun-2018: pfs received.Reporter's information was updated.Events added: chronic cervicitis, mood disorder, burning in feet, arthritis, abdominal pain, irregular cycle.Outcome of event abdominal pain was updated to recovered/resolved.Concomitant drugs were added.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
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/pain") in a 33-year-old female patient who had essure (batch no.627444) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not done".The patient's concurrent conditions included obesity, osteoarthritis and paratubal cyst.Concomitant products included eugynon (aviane) from 1-dec-2008 to 28-mar-2016 for birth control and bleeding menstrual heavy as well as bupropion (wellbutrin), duloxetine hydrochloride (cymbalta), fluoxetine hydrochloride (prozac), ibuprofen, para-seltzer (excedrin), topiramate (topamax) and vicodin (norco).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, 3 months 12 days after insertion of essure, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/dysmenorrhoea(cramping)"), feeling abnormal ("brain fog"), migraine ("migraines"), headache ("headaches"), depression ("depression"), anxiety ("anxiety"), dyspareunia ("dyspareunia (painful sexual intercourse)") and affective disorder ("mood disorder").On (b)(6) 2009, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/ prolonged menstruation/ abnormal bleeding (menorrhagia)/heavy and longer periods"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menstruation irregular ("irregular cycle").In 2010, the patient experienced weight increased ("weight gain") and weight decreased ("weight loss").In (b)(6) 2015, the patient experienced fatigue ("chronic fatigue/fatigue").On (b)(6) 2015, the patient experienced fibromyalgia ("fibromyalgia").On (b)(6) 2015, the patient experienced inflammation ("severe inflammation of hands and feet"), mood swings ("mood swings"), alopecia ("hair loss"), tinnitus ("tinnitus") and carpal tunnel syndrome ("carpal tunnel syndrome").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe abdominal cramping/ lower abdominal pain"), back pain ("lower back pain/back pain"), arthralgia ("severe joint pain/ joint pain") and arthritis ("arthritis").On an unknown date, the patient experienced pain ("general body aches"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), menstrual disorder ("abnormal menstruation"), cervicitis ("infection (bladder/urinary tract/vaginal) type: chronic cervicitis"), burning sensation ("burning in feet") and abdominal pain ("abdominal pain").The patient was treated with surgery (robotic total laparoscopic hysterectomy with bilateral salpingectomy (removal of fallopian tubes)).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, inflammation, mood swings, feeling abnormal, migraine, headache, depression, anxiety, alopecia, weight increased, fibromyalgia, tinnitus, vaginal haemorrhage, dyspareunia, carpal tunnel syndrome, weight decreased and abdominal pain had resolved, the abdominal pain lower, back pain, arthralgia, pain, hypoaesthesia, paraesthesia, menstrual disorder, cervicitis, burning sensation, arthritis, affective disorder and menstruation irregular outcome was unknown and the fatigue had not resolved.The reporter considered abdominal pain, abdominal pain lower, affective disorder, alopecia, anxiety, arthralgia, arthritis, back pain, burning sensation, carpal tunnel syndrome, cervicitis, depression, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, fibromyalgia, headache, hypoaesthesia, inflammation, menorrhagia, menstrual disorder, menstruation irregular, migraine, mood swings, pain, paraesthesia, pelvic pain, tinnitus, vaginal haemorrhage, weight decreased and weight increased to be related to essure.The reporter commented: she underwent a total hysterectomy and bilateral, during which her cervix, uterus, and both fallopian tubes were all removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.6 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jul-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.
 
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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 Key6947760
MDR Text Key89353982
Report Number2951250-2017-04711
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,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/03/2018
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 Date06/01/2010
Device Model NumberESS305
Device Lot Number627444
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/18/2017
Initial Date FDA Received10/13/2017
Supplement Dates Manufacturer Received02/28/2018
06/11/2018
07/30/2018
09/26/2018
Supplement Dates FDA Received05/02/2018
06/29/2018
08/07/2018
10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AVIANE; AVIANE; AVIANE; AVIANE; CYMBALTA; CYMBALTA; CYMBALTA; CYMBALTA; EXCEDRIN [CAFFEINE,PARACETAMOL]; EXCEDRIN [CAFFEINE,PARACETAMOL]; EXCEDRIN [CAFFEINE,PARACETAMOL]; IBUPROFEN; IBUPROFEN; IBUPROFEN; NORCO; NORCO; NORCO; PROZAC; PROZAC; PROZAC; PROZAC; TOPAMAX; TOPAMAX; TOPAMAX; TOPAMAX; WELLBUTRIN; WELLBUTRIN; WELLBUTRIN
Patient Outcome(s) Other; Required Intervention;
Patient Age33 YR
Patient Weight73
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