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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); Erythema (1840); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Rash (2033); Tinnitus (2103); Anxiety (2328); Depression (2361); Sensitivity of Teeth (2427); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
Event Date 03/01/2012
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 sterilization.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain"), back pain ("lower back pain"), menorrhagia ("abnormally heavy menstrual bleeding"), dental caries ("tooth decay"), migraine ("migraines"), headache ("headache"), dyspareunia ("painful intercourse"), depression ("depression"), anxiety ("anxiety"), rash ("rashes"), erythema ("skin redness"), abdominal pain lower ("lower abdominal pain/severe abdominal cramping"), dry skin ("dry skin/ patches of skin resembling burn marks"), pruritus ("itching"), alopecia ("hair loss"), fatigue ("chronic fatigue"), weight increased ("weight gain"), ear infection ("chronic ear infection"), tinnitus ("constant ringing in ears"), ovulation pain ("severe ovulation pain"), skin disorder ("skin bumps") and abdominal distension ("severe bloating").The patient was treated with surgery (underwent a bilateral salpingectomy,during which both of her fallopian tubes were removed).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, dysmenorrhoea, back pain, menorrhagia, dental caries, migraine, headache, dyspareunia, depression, anxiety, rash, erythema, abdominal pain lower, dry skin, pruritus, alopecia, fatigue, weight increased, ear infection, tinnitus, ovulation pain, skin disorder and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, dry skin, dysmenorrhoea, dyspareunia, ear infection, erythema, fatigue, headache, menorrhagia, migraine, ovulation pain, pelvic pain, pruritus, rash, skin disorder, tinnitus and weight increased to be related to essure.The reporter commented: since her removal surgery, plaintiff symptoms have mostly resolved, though some remain.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 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 "essure confirmation test(s) conducted, specify: patient did not undergo an essure confirmation test".Medical conditions: current weight of patient is 120 lbs.Concurrent conditions included obesity, stevens-johnson syndrome since 1997 and allergy to chemicals since 1997.Concomitant products included medroxyprogesterone acetate (depo-provera) since 2007 for female sterilisation as well as paracetamol (tylenol).On (b)(6) 2012, the patient had essure inserted.In march 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("abnormally severe menstrual pain, dysmenorrhea (cramping)"), dyspareunia ("painful intercourse, dyspareunia (painful sexual intercourse)") and fatigue ("chronic fatigue").In august 2012, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding, abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("headaches"), rash ("rashes, rashes or skin conditions"), alopecia ("hair loss"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), nausea ("nausea") and vaginal discharge ("vaginal discharge") and was found to have the first episode of weight increased ("weight gain /loss").In february 2013, the patient experienced tooth disorder ("dental problems").On an unknown date, the patient experienced back pain ("lower back pain"), dental caries ("tooth decay"), depression ("depression"), anxiety ("anxiety"), erythema ("skin redness, rashes or skin conditions type: red and dry patches of skin"), abdominal pain lower ("daily lower abdominal pain/severe abdominal cramping"), dry skin ("dry skin/ patches of skin resembling burn marks, rashes or skin conditions type: red and dry patches of skin"), pruritus ("itching"), ear infection ("chronic ear infection"), tinnitus ("constant ringing in ears"), ovulation pain ("severe ovulation pain"), skin disorder ("skin bumps") and abdominal distension ("severe bloating") and was found to have the second episode of weight increased ("weight gain").The patient was treated with surgery (a bilateral salpingectomy was performed on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, back pain, dental caries, dyspareunia, abdominal pain lower, alopecia, ovulation pain, vaginal haemorrhage, nausea, tooth disorder and vaginal discharge had resolved, the dysmenorrhoea, menorrhagia, headache, depression, anxiety, erythema, pruritus, fatigue, the last episode of weight increased, ear infection, tinnitus, skin disorder and abdominal distension outcome was unknown, the migraine was resolving and the rash and dry skin had not resolved.The reporter considered abdominal distension, abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, dry skin, dysmenorrhoea, dyspareunia, ear infection, erythema, fatigue, headache, menorrhagia, migraine, nausea, ovulation pain, pelvic pain, pruritus, rash, skin disorder, tinnitus, tooth disorder, vaginal discharge, vaginal haemorrhage, the first episode of weight increased and the second episode of weight increased to be related to essure.The reporter commented: since her removal surgery, plaintiff symptoms have mostly resolved, though some remain.Was then deployed and thumb wheeled back again.4 coils were noted.The same was done on the left as was done on the right with 2 coils noted.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.4 kg/sqm.Most recent follow-up information incorporated above includes: on 30-nov-2018: pfs received event weight gain was updated.Outcome of event " pain, dental problems, cramping, painful sex, weight gain" was updated as recovered.Incident: 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 information become available from our investigation, this will be and other non-conformances data; should any new and reportable provided in a supplementary report.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/pain") 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 "essure confirmation test(s) conducted, specify: patient did not undergo an essure confirmation test".Medical conditions: current weight of patient is 120 lbs.Concurrent conditions included obesity, stevens-johnson syndrome since 1997 and allergy to chemicals since 1997.Concomitant products included medroxyprogesterone acetate (depo-provera) since 2007 for female sterilisation as well as paracetamol (tylenol).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), dysmenorrhoea ("abnormally severe menstrual pain, dysmenorrhea (cramping)"), dyspareunia ("painful intercourse, dyspareunia (painful sexual intercourse)") and fatigue ("chronic fatigue").In (b)(6) 2012, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding, abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("headaches"), rash ("rashes, rashes or skin conditions"), alopecia ("hair loss"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), nausea ("nausea"), vaginal discharge ("vaginal discharge") and weight fluctuation ("weight gain /loss").In (b)(6) 2013, the patient experienced tooth disorder ("dental problems").On an unknown date, the patient experienced back pain ("lower back pain"), dental caries ("tooth decay"), depression ("depression"), anxiety ("anxiety"), erythema ("skin redness, rashes or skin conditions type: red and dry patches of skin"), abdominal pain lower ("daily lower abdominal pain/severe abdominal cramping"), dry skin ("dry skin/ patches of skin resembling burn marks, rashes or skin conditions type: red and dry patches of skin"), pruritus ("itching"), weight increased ("weight gain"), ear infection ("chronic ear infection"), tinnitus ("constant ringing in ears"), ovulation pain ("severe ovulation pain"), skin disorder ("skin bumps") and abdominal distension ("severe bloating").The patient was treated with surgery (a bilateral salpingectomy was performed on (b)(6)2015).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, dysmenorrhoea, back pain, menorrhagia, dental caries, headache, dyspareunia, depression, anxiety, erythema, abdominal pain lower, pruritus, fatigue, weight increased, ear infection, tinnitus, ovulation pain, skin disorder and abdominal distension outcome was unknown, the migraine was resolving, the rash, dry skin and alopecia had not resolved and the vaginal haemorrhage, nausea, tooth disorder, vaginal discharge and weight fluctuation had resolved.The reporter considered abdominal distension, abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, dry skin, dysmenorrhoea, dyspareunia, ear infection, erythema, fatigue, headache, menorrhagia, migraine, nausea, ovulation pain, pelvic pain, pruritus, rash, skin disorder, tinnitus, tooth disorder, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: since her removal surgery, plaintiff symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.4 kg/sqm.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received: new reporters, patient demographic information, product indication, onset date updated, concomitant drug and disease, new events vaginal haemorrhage, nausea, tooth disorder, vaginal discharge, weight fluctuation and device monitoring procedure not performed added.Outcome for the events alopecia, dry skin, rash, migraine added as not recovered / not resolved and for events vaginal haemorrhage, nausea, tooth disorder, vaginal discharge, weight fluctuation added as recovered / resolved.Reporter and product information was added.Concomitant disease and product was 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 Key7000834
MDR Text Key91060329
Report Number2951250-2017-06110
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 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESS305
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DEPO-PROVERA; DEPO-PROVERA; DEPO-PROVERA; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]
Patient Outcome(s) Other; Required Intervention;
Patient Age32 YR
Patient Weight76
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