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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Rash (2033); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191); Cancer (3262)
Event Date 01/01/2009
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of neoplasm malignant ("cancer"), autoimmune disorder ("autoimmune disorder"), liver disorder ("surgery liver resection x2"), pelvic infection ("pelvic infection"), device dislocation ("migration of essure device"), genital haemorrhage ("abnormal bleeding (general)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("menorrhagia") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not underwent essure confirmation test".The patient's past medical history included herpes simplex virus test positive.Concomitant products included diphenhydramine hydrochloride (benadryl), duloxetine, medroxyprogesterone (depo provera) since (b)(6) 2017, nsaid's, prednisone and sulfasalazine.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced neoplasm malignant (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), liver disorder (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage (seriousness criterion medically significant), menorrhagia (seriousness criteria medically significant and intervention required), mental disorder ("psychological or psychiatric problems"), hormone level abnormal ("hormonal changes"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), alopecia ("hair loss"), weight decreased ("weight loss"), weight increased ("weight gain"), nervous system disorder ("neurological conditions or problems"), eye disorder ("vision/eye problems"), visual impairment ("vision/eye problems"), neoplasm ("tumor"), teratoma ("teratoma"), bladder disorder ("bladder problems"), cystitis ("bladder infection"), urinary tract disorder ("urinary problems"), urinary tract infection ("urinary tract infection"), tooth disorder ("dental problems"), gastrointestinal disorder ("gastrointestinal or digestive system condition"), skin disorder ("skin conditions"), nausea ("nausea"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal infection ("vaginal infection"), hypersensitivity ("allergic or hypersensitivity reaction"), allergy to metals ("nickel allergy"), rash ("rashes") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (ablation novasure).Essure treatment was not changed.At the time of the report, the neoplasm malignant, autoimmune disorder, liver disorder, pelvic infection, device dislocation, genital haemorrhage, vaginal haemorrhage, menorrhagia, mental disorder, hormone level abnormal, female sexual dysfunction, alopecia, weight decreased, weight increased, nervous system disorder, eye disorder, visual impairment, neoplasm, teratoma, bladder disorder, cystitis, urinary tract disorder, urinary tract infection, tooth disorder, gastrointestinal disorder, skin disorder, nausea, fatigue, migraine, headache, dysmenorrhoea, dyspareunia, vaginal infection, hypersensitivity, allergy to metals, rash and vaginal discharge outcome was unknown.The reporter considered allergy to metals, alopecia, autoimmune disorder, bladder disorder, cystitis, device dislocation, dysmenorrhoea, dyspareunia, eye disorder, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hypersensitivity, liver disorder, menorrhagia, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic infection, rash, skin disorder, teratoma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment, weight decreased and weight increased to be related to essure.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet- events hormonal changes, abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), allergic or hypersensitivity reaction, infection (bladder/ urinary tract/vaginal), apareunia (inability to have sexualintercourse), infection (other)(pelvic), psychological or psychiatric problems, autoimmune disorder, rashes or skin conditions, bladder or urinary problems or changes, migraines / headaches, migration of essure device, nausea, dental problems, neurological conditions or problems, nickel allergy, dysmenorrhea (cramping), surgery liver resection x2, dyspareunia (painful sexual intercourse), tumor /teratoma / cancer, pain, vaginal discharge, vision/eye problems, fatigue, weight gain / loss, gastrointestinal or digestive system condition and hair loss were added and event severe physical injuries was deleted.Case became valid.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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
Ntaneous case was reported by a lawyer and describes the occurrence of neoplasm malignant ("cancer"), autoimmune disorder ("autoimmune disorder"), hepatectomy ("surgery liver resection x2"), pelvic infection ("pelvic infection"), device dislocation ("migration of essure device"), genital haemorrhage ("abnormal bleeding (general)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("menorrhagia") in an adult female patient who had essure 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 "she did not underwent essure confirmation test".The patient's past medical history included herpes simplex virus test positive.Concurrent conditions included dysfunctional uterine bleeding and body mass index normal.Concomitant products included diphenhydramine hydrochloride (benadryl), duloxetine, medroxyprogesterone (depo provera) since (b)(6) 2017, nsaid's, prednisone and sulfasalazine.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage (seriousness criterion medically significant), menorrhagia (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), nausea ("nausea"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), mood swings ("mood swings"), sinusitis ("sinus infection"), gingival bleeding ("dental problems bleeding gums") and diarrhoea ("diarrhea").In 2010, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), weight increased ("weight gain"), eye disorder ("vision/eye problems"), urinary tract infection ("urinary tract infection") and rash ("rashes / rash in my face and arms").In 2012, the patient experienced allergy to metals ("nickel allergy").In 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced neoplasm malignant (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), hepatectomy (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), the first episode of mental disorder ("psychological or psychiatric problems"), hormone level abnormal ("hormonal changes"), weight decreased ("weight loss"), nervous system disorder ("neurological conditions or problems"), visual impairment ("vision/eye problems"), neoplasm ("tumor"), teratoma ("teratoma"), bladder disorder ("bladder problems"), cystitis ("bladder infection"), urinary tract disorder ("urinary problems"), tooth disorder ("dental problems"), gastrointestinal disorder ("gastrointestinal or digestive system condition"), skin disorder ("skin conditions"), vaginal infection ("vaginal infection"), hypersensitivity ("allergic or hypersensitivity reaction"), the second episode of mental disorder ("psychological or psychiatric problems-condition-") and constipation ("constipation").The patient was treated with surgery (ablation novasure).Essure treatment was not changed.At the time of the report, the neoplasm malignant, autoimmune disorder, hepatectomy, pelvic infection, device dislocation, genital haemorrhage, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, alopecia, weight decreased, weight increased, nervous system disorder, eye disorder, visual impairment, neoplasm, teratoma, bladder disorder, cystitis, urinary tract disorder, urinary tract infection, tooth disorder, gastrointestinal disorder, skin disorder, nausea, fatigue, migraine, headache, dysmenorrhoea, dyspareunia, vaginal infection, hypersensitivity, allergy to metals, rash, vaginal discharge, mood swings, sinusitis, the last episode of mental disorder, gingival bleeding, constipation and diarrhoea outcome was unknown.The reporter considered allergy to metals, alopecia, autoimmune disorder, bladder disorder, constipation, cystitis, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, eye disorder, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, gingival bleeding, headache, hepatectomy, hormone level abnormal, hypersensitivity, menorrhagia, migraine, mood swings, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic infection, rash, sinusitis, skin disorder, teratoma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment, weight decreased, weight increased, the first episode of mental disorder and the second episode of mental disorder to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Concerning the injuries reported in this case, the following one were reported via social media menorrhagia, quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.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 neoplasm malignant ("cancer"), autoimmune disorder ("autoimmune disorder"), hepatectomy ("surgery liver resection x2"), pelvic infection ("pelvic infection"), device dislocation ("migration of essure device"), genital haemorrhage ("abnormal bleeding (general)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("menorrhagia") in an adult female patient who had essure 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 "she did not underwent essure confirmation test".The patient's past medical history included herpes simplex virus test positive.Concurrent conditions included dysfunctional uterine bleeding and body mass index normal.Concomitant products included diphenhydramine hydrochloride (benadryl), duloxetine, medroxyprogesterone (depo provera) since (b)(6) 2017, nsaid's, prednisone and sulfasalazine.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage (seriousness criterion medically significant), menorrhagia (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), nausea ("nausea"), fatigue ("fatigue"), migraine ("migraines"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), mood swings ("mood swings"), sinusitis ("sinus infection"), gingival bleeding ("dental problems bleeding gums") and diarrhoea ("diarrhea").In 2010, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), weight increased ("weight gain"), eye disorder ("vision/eye problems"), urinary tract infection ("urinary tract infection") and rash ("rashes / rash in my face and arms").In 2012, the patient experienced allergy to metals ("nickel allergy").In 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced neoplasm malignant (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), hepatectomy (seriousness criterion medically significant), pelvic infection (seriousness criterion medically significant), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), the first episode of mental disorder ("psychological or psychiatric problems"), hormone level abnormal ("hormonal changes"), weight decreased ("weight loss"), nervous system disorder ("neurological conditions or problems"), visual impairment ("vision/eye problems"), neoplasm ("tumor"), teratoma ("teratoma"), bladder disorder ("bladder problems"), cystitis ("bladder infection"), urinary tract disorder ("urinary problems"), tooth disorder ("dental problems"), gastrointestinal disorder ("gastrointestinal or digestive system condition"), skin disorder ("skin conditions"), vaginal infection ("vaginal infection"), hypersensitivity ("allergic or hypersensitivity reaction"), the second episode of mental disorder ("psychological or psychiatric problems-condition-") and constipation ("constipation").The patient was treated with surgery (ablation novasure).Essure treatment was not changed.At the time of the report, the neoplasm malignant, autoimmune disorder, hepatectomy, pelvic infection, device dislocation, genital haemorrhage, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, alopecia, weight decreased, weight increased, nervous system disorder, eye disorder, visual impairment, neoplasm, teratoma, bladder disorder, cystitis, urinary tract disorder, urinary tract infection, tooth disorder, gastrointestinal disorder, skin disorder, nausea, fatigue, migraine, headache, dysmenorrhoea, dyspareunia, vaginal infection, hypersensitivity, allergy to metals, rash, vaginal discharge, mood swings, sinusitis, the last episode of mental disorder, gingival bleeding, constipation and diarrhoea outcome was unknown.The reporter considered allergy to metals, alopecia, autoimmune disorder, bladder disorder, constipation, cystitis, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, eye disorder, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, gingival bleeding, headache, hepatectomy, hormone level abnormal, hypersensitivity, menorrhagia, migraine, mood swings, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic infection, rash, sinusitis, skin disorder, teratoma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment, weight decreased, weight increased, the first episode of mental disorder and the second episode of mental disorder to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Concerning the injuries reported in this case, the following one were reported via social media menorrhagia.Most recent follow-up information incorporated above includes: on 11-jun-2018: pfs received.Reporter and patient demographics were added.Updated suspect drug indication.Events mood swings, sinus infection, psychological or psychiatric problems-condition-, dental problems bleeding gums, constipation and diarrhea 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.
 
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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 Key7431986
MDR Text Key105516312
Report Number2951250-2018-01816
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
Report Date 07/13/2018
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 Model NumberESS305
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received04/16/2018
Supplement Dates Manufacturer Received06/11/2018
07/05/2018
Supplement Dates FDA Received06/28/2018
07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BENADRYL; BENADRYL; BENADRYL; DEPO PROVERA; DEPO PROVERA; DEPO PROVERA; DULOXETINE; DULOXETINE; DULOXETINE; NSAID'S; NSAID'S; NSAID'S; PREDNISONE; PREDNISONE; PREDNISONE; SULFASALAZINE; SULFASALAZINE; SULFASALAZINE; BENADRYL; DEPO PROVERA; DULOXETINE; NSAID'S; PREDNISONE; SULFASALAZINE
Patient Outcome(s) Other; Required Intervention;
Patient Age23 YR
Patient Weight59
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