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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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Cramp(s) (2193); Heavier Menses (2666)
Event Date 03/01/2012
Event Type  Injury  
Event Description
This case was initially received via regulatory authority food and drug administration (reference number: mw5035863) on 02-jun-2014.The most recent information was received on 14-sep-2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("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) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine spasm ("intense uterine cramping"), dysmenorrhoea ("periods have become more painful with each cycle"), menorrhagia ("passing very large blood clots, much heavier flow/heavy periods clots"), vulvovaginal pain ("vaginal pain"), uterine cervical pain ("cervix pain"), anaemia ("anemia"), memory impairment ("poor memory"), fatigue ("exhaustion"), tinnitus ("tinnitus"), loss of libido ("loss of libido") and dyspareunia ("dyspareunia").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy).Essure was removed on (b)(6)2017.At the time of the report, the pelvic pain, uterine spasm, dysmenorrhoea, menorrhagia, vulvovaginal pain, uterine cervical pain, anaemia, memory impairment, fatigue, tinnitus, loss of libido and dyspareunia outcome was unknown.The reporter considered anaemia, dyspareunia, fatigue, loss of libido, memory impairment, menorrhagia, pelvic pain, tinnitus, uterine cervical pain and vulvovaginal pain to be related to essure.The reporter provided no causality assessment for dysmenorrhoea and uterine spasm with essure.The reporter commented: she underwent a laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, extensive lysis of adhesions involving uterus and omentum and cauterization of endometriosis implants of the right uterosacral ligament.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: essure coils and full occlusion of both tubes.Most recent follow-up information incorporated above includes: on 14-sep-2017: lawyer added from legal claims.Reporters, product indication added, start date and stop date of product was added.Events heavy periods, clots, vaginal pain, pelvic pain, cervix pain, anemia, poor memory, exhaustion, tinnitus, loss of libido, and dyspareunia were added.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5035863) on (b)(6) 2014.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder") in a 30-year-old female patient who had essure (batch no.919034) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included premature delivery and miscarriage.Previously administered products included for an unreported indication: yaz.Concurrent conditions included obesity, depression, anxiety and insomnia.Concomitant products included gabapentin, hydroxyzine, levonorgestrel (mirena), lisinopril, lorazepam (ativan), metformin, mometasone furoate (asmanex) and venlafaxine.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2012, the patient experienced dysmenorrhoea ("periods have become more painful with each cycle / dysmenorrhea (cramping)") and genital haemorrhage (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced hormone level abnormal ("hormonal changes").In 2013, the patient experienced migraine ("migraines"), headache ("headaches") and autoimmune disorder (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced fatigue ("exhaustion"), blood disorder ("blood disorder") and cardiac disorder ("heart disorder").On an unknown date, the patient experienced uterine spasm ("intense uterine cramping"), menorrhagia ("passing very large blood clots, much heavier flow/heavy periods clots / abnormal bleeding (menorrhagia)"), vulvovaginal pain ("vaginal pain"), uterine cervical pain ("cervix pain"), anaemia ("anemia"), memory impairment ("poor memory"), tinnitus ("tinnitus"), loss of libido ("loss of libido"), the first episode of dyspareunia ("dyspareunia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), mood swings ("mood swings"), irritability ("irritability"), fibromyalgia ("fibromyalgia"), pollakiuria ("urinary frequency"), pelvic adhesions ("lysis of adhesions"), the second episode of dyspareunia ("dyspareunia (painful sexual intercourse)"), endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), abdominal pain ("abdominal pain"), abdominal pain upper ("stomach pain") and back pain ("low back pain").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy) and surgery (on (b)(6) 2016 underwent ablation).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, fatigue, vaginal haemorrhage, pollakiuria, genital haemorrhage, autoimmune disorder, hormone level abnormal and blood disorder had resolved, the uterine spasm, vulvovaginal pain, uterine cervical pain, anaemia, memory impairment, tinnitus, loss of libido, mood swings, irritability, fibromyalgia, headache, pelvic adhesions, the last episode of dyspareunia, endometriosis, adenomyosis, cardiac disorder, abdominal pain, abdominal pain upper and back pain outcome was unknown and the migraine was resolving.The reporter provided no causality assessment for dysmenorrhoea and uterine spasm with essure.The reporter considered abdominal pain, abdominal pain upper, adenomyosis, anaemia, autoimmune disorder, back pain, blood disorder, cardiac disorder, endometriosis, fatigue, fibromyalgia, genital haemorrhage, headache, hormone level abnormal, irritability, loss of libido, memory impairment, menorrhagia, migraine, mood swings, pelvic adhesions, pelvic pain, pollakiuria, tinnitus, uterine cervical pain, vaginal haemorrhage, vulvovaginal pain, the first episode of dyspareunia and the second episode of dyspareunia to be related to essure.The reporter commented: she underwent a laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, extensive lysis of adhesions involving uterus and omentum and cauterization of endometriosis implants of the right uterosacral ligament.Current weight: 185 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: essure coils and full occlusion of both tubes most recent follow-up information incorporated above includes: on (b)(6) 2018: events- "abnormal bleeding (vaginal), mood swings, irritability, fibromyalgia, urinary frequency, migraines, headaches, lysis of adhesions on pelvis, dyspareunia (painful sexual intercourse), endometriosis, adenomyosis, abnormal bleeding (general), autoimmune disorder, hormonal changes, blood disorder, heart disorder, abdominal pain, stomach pain, low back pain", lot number, reporter added from pfs.Concomitant drug and condition, historical condition 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
This case was initially received via regulatory authority (food and drug administration, reference number: mw5035863) on 02-jun-2014.The most recent information was received on 08-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (genaral)") and autoimmune disorder ("autoimmune disorder") in a 30-year-old female patient who had essure (batch no.919034) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included premature delivery and miscarriage.Previously administered products included for an unreported indication: yaz.Concurrent conditions included obesity, depression, anxiety and insomnia.Concomitant products included gabapentin, hydroxyzine, levonorgestrel (mirena), lisinopril, lorazepam (ativan), metformin, mometasone furoate (asmanex) and venlafaxine.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2012, the patient experienced dysmenorrhoea ("periods have become more painful with each cycle / dysmenorrhea (cramping)") and genital haemorrhage (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced hormone level abnormal ("hormonal changes").In 2013, the patient experienced migraine ("migraines"), headache ("headaches") and autoimmune disorder (seriousness criterion medically significant).In (b)(6) 2015, the patient experienced fatigue ("exhaustion"), blood disorder ("blood disorder") and cardiac disorder ("heart disorder").On an unknown date, the patient experienced uterine spasm ("intense uterine cramping"), menorrhagia ("passing very large blood clots, much heavier flow/heavy periods clots / abnormal bleeding (menorrhagia)"), vulvovaginal pain ("vaginal pain"), uterine cervical pain ("cervix pain"), anaemia ("anemia"), memory impairment ("poor memory"), tinnitus ("tinnitus"), loss of libido ("loss of libido"), the first episode of dyspareunia ("dyspareunia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), mood swings ("mood swings"), irritability ("irritability"), fibromyalgia ("fibromyalgia"), pollakiuria ("urinary frequency"), pelvic adhesions ("lysis of adhesions"), the second episode of dyspareunia ("dyspareunia (painful sexual intercourse)"), endometriosis ("endometriosis"), adenomyosis ("adenomyosis"), abdominal pain ("abdominal pain"), abdominal pain upper ("stomach pain") and back pain ("low back pain").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy) and surgery (on (b)(6) 2016 underwent ablation).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dysmenorrhoea, menorrhagia, fatigue, vaginal haemorrhage, pollakiuria, genital haemorrhage, autoimmune disorder, hormone level abnormal and blood disorder had resolved, the uterine spasm, vulvovaginal pain, uterine cervical pain, anaemia, memory impairment, tinnitus, loss of libido, mood swings, irritability, fibromyalgia, headache, pelvic adhesions, the last episode of dyspareunia, endometriosis, adenomyosis, cardiac disorder, abdominal pain, abdominal pain upper and back pain outcome was unknown and the migraine was resolving.The reporter provided no causality assessment for dysmenorrhoea and uterine spasm with essure.The reporter considered abdominal pain, abdominal pain upper, adenomyosis, anaemia, autoimmune disorder, back pain, blood disorder, cardiac disorder, endometriosis, fatigue, fibromyalgia, genital haemorrhage, headache, hormone level abnormal, irritability, loss of libido, memory impairment, menorrhagia, migraine, mood swings, pelvic adhesions, pelvic pain, pollakiuria, tinnitus, uterine cervical pain, vaginal haemorrhage, vulvovaginal pain, the first episode of dyspareunia and the second episode of dyspareunia to be related to essure.The reporter commented: she underwent a laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, extensive lysis of adhesions involving uterus and omentum and cauterization of endometriosis implants of the right uterosacral ligament.Current weight: 185 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: essure coils and full occlusion of both tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-aug-2018: quality-safety evaluation of ptc update.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 (food and drug administration, reference number: (b)(4) on 02-jun-2014.The most recent information was received on 05-mar-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder") in a 30-year-old female patient who had essure (batch no.919034) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included premature delivery, miscarriage and depression.Previously administered products included for an unreported indication: yaz.Concurrent conditions included obesity, depression, anxiety and insomnia.Concomitant products included acetylsalicylic acid;caffeine;salicylamide (excedrin), ascorbic acid;beta vulgaris root;iron amino acid chelate;rosa canina fruit;rubus idaeus leaf (iron supplement with vit c & herbs), bupropion hydrochloride (wellbutrin), gabapentin, hydroxyzine, ibuprofen, ketorolac tromethamine (toradol), levonorgestrel (mirena), levonorgestrel (mirena), lisinopril, lorazepam (ativan), metformin, methocarbamol (robaxin), mometasone furoate (asmanex), naltrexone hydrochloride (naltrexon), oxycodone hydrochloride;paracetamol (percocet), paracetamol (tylenol), tramadol, venlafaxine and venlafaxine hydrochloride (effexor).In (b)(6)2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6)2012, the patient had essure inserted.In (b)(6)2012, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), dysmenorrhoea ("periods have become more painful with each cycle / dysmenorrhea (cramping)") and the first episode of dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6)2012, the patient experienced mood swings ("mood swings") and irritability ("irritability") and was found to have hormone level abnormal ("hormonal changes").In 2013, the patient experienced autoimmune disorder (seriousness criterion medically significant), migraine ("migraines") and headache ("headaches").In (b)(6)2014, the patient experienced endometriosis ("endometriosis").In (b)(6)2015, the patient experienced anaemia ("anemia"), fatigue ("exhaustion"), blood disorder ("blood disorder") and cardiac disorder ("heart disorder").In (b)(6)2015, the patient experienced depression ("worsened depression").In (b)(6)2015, the patient experienced pollakiuria ("urinary frequency").On (b)(6)2017, the patient experienced pelvic adhesions ("lysis of adhesions") and adenomyosis ("adenomyosis"), 5 years 4 months after insertion of essure.On an unknown date, the patient experienced uterine spasm ("intense uterine cramping"), menorrhagia ("passing very large blood clots, much heavier flow/heavy periods clots / abnormal bleeding (menorrhagia)"), vulvovaginal pain ("vaginal pain"), uterine cervical pain ("cervix pain"), memory impairment ("poor memory"), tinnitus ("tinnitus"), loss of libido ("loss of libido"), the second episode of dyspareunia ("dyspareunia/dyspareunia(female sexual dysfunction)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), fibromyalgia ("fibromyalgia"), abdominal pain ("abdominal pain"), abdominal pain upper ("stomach pain"), back pain ("low back pain") and urinary incontinence ("urinary frequency/incontinence").The patient was treated with surgery (cauterisation surgery, on (b)(6)2016 underwent ablation, removal of endometriosis and laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy).Essure was removed on (b)(6)2017.At the time of the report, the pelvic pain, genital haemorrhage, autoimmune disorder, dysmenorrhoea, menorrhagia, fatigue, vaginal haemorrhage, pollakiuria, hormone level abnormal and blood disorder had resolved, the uterine spasm, vulvovaginal pain, uterine cervical pain, anaemia, memory impairment, tinnitus, loss of libido, the last episode of dyspareunia, mood swings, irritability, fibromyalgia, headache, pelvic adhesions, endometriosis, adenomyosis, cardiac disorder, abdominal pain, abdominal pain upper, back pain, urinary incontinence and depression outcome was unknown and the migraine was resolving.The reporter provided no causality assessment for dysmenorrhoea and uterine spasm with essure.The reporter considered abdominal pain, abdominal pain upper, adenomyosis, anaemia, autoimmune disorder, back pain, blood disorder, cardiac disorder, depression, endometriosis, fatigue, fibromyalgia, genital haemorrhage, headache, hormone level abnormal, irritability, loss of libido, memory impairment, menorrhagia, migraine, mood swings, pelvic adhesions, pelvic pain, pollakiuria, tinnitus, urinary incontinence, uterine cervical pain, vaginal haemorrhage, vulvovaginal pain, the first episode of dyspareunia and the second episode of dyspareunia to be related to essure.The reporter commented: she underwent a laparoscopically assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, extensive lysis of adhesions involving uterus and omentum and cauterization of endometriosis implants of the right uterosacral ligament.Current weight: 185 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 33 kg/sqm.Hysterosalpingogram - on (b)(6)2012: results: essure coils and full occlusion of both tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-mar-2019: pfs received.Reporter information were added.Medical history and concomitant drug were added.Onset date of event were updated.Event verbatim were updated as dyspareunia/ dyspareunia (female sexual dysfunction).Event : worsened depression and urinary frequency/ incontinence were added.Incident: 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 non-conformances data; should any new and reportable information become available as a result, this 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 Key6928048
MDR Text Key89117164
Report Number2951250-2017-04398
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
Report Date 03/11/2019
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 Date11/01/2014
Device Model NumberESS305
Device Lot Number919034
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/14/2017
Initial Date FDA Received10/09/2017
Supplement Dates Manufacturer Received05/10/2018
08/08/2018
03/05/2019
Supplement Dates FDA Received06/05/2018
08/10/2018
03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASMANEX; ASMANEX; ASMANEX; ATIVAN; ATIVAN; ATIVAN; EFFEXOR; EXCEDRIN [CAFFEINE,PARACETAMOL]; GABAPENTIN; GABAPENTIN; GABAPENTIN; HYDROXYZINE; HYDROXYZINE; HYDROXYZINE; IBUPROFEN; IRON SUPPLEMENT WITH VIT C & HERBS; LISINOPRIL; LISINOPRIL; LISINOPRIL; METFORMIN; METFORMIN; METFORMIN; MIRENA; MIRENA; MIRENA; MIRENA; NALTREXON; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; ROBAXIN; TORADOL; TRAMADOL; TYLENOL [PARACETAMOL]; VENLAFAXINE; VENLAFAXINE; VENLAFAXINE; WELLBUTRIN
Patient Outcome(s) Other; Required Intervention;
Patient Age30 YR
Patient Weight86
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