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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 Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Pain (1994); Rash (2033); Visual Impairment (2138); Stenosis (2263); Depression (2361); Numbness (2415); Sensitivity of Teeth (2427); Weight Changes (2607); Dyspareunia (4505); Menorrhagia (4508); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/01/2014
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in a (b)(6) year old female patient who had essure (batch no.B93871) 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 "patient did not undergo essure confirmation test".The patient's medical history included leg pain, pain in hip, augmentation mammoplasty, cholecystectomy, gastric operation, augmentation mammoplasty, cervical radiculopathy, brain operation, varicose veins, lumbar radiculopathy, rectal bleeding and abdominal pain.She had no history of suffering from migraines prior to undergoing the implantation of essure.Concurrent conditions included tingling, numbness in leg, depression, headache, nickel sensitivity, shoulder injury, muscle weakness upper limb, neck pain, anemia, anxiety, esophageal reflux, osteoarthritis, obesity, trochanteric bursitis, paronychia, restless legs syndrome, kidney stone, allergic reaction to analgesics, urinary tract infection, chills, dysuria, hematuria, ascariasis and itching.Family history included adenosquamous cell carcinoma (father) and alzheimer's disease (maternal grandmother).Concomitant products included levonorgestrel (mirena) from (b)(6) 2014 to (b)(6) 2014 for contraception as well as celecoxib (celebrex), gabapentin, hydrocodone bitartrate;paracetamol (norco), ibuprofen, lorazepam, macrogol 3350 (miralax), omeprazole and tramadol.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and visual impairment ("vision/eye problem").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal pain"), dysmenorrhoea ("severe menstrual pain"), fatigue ("fatigue") and depression ("psychological or psychiatric problems condition: depression") with depressive symptom.In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse /' dyspareunia (painful sexual intercourse),"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On (b)(6) 2014, the patient experienced migraine ("severe migraines"), 3 months 9 days after insertion of essure.In (b)(6) 2014, the patient experienced headache ("headaches"), alopecia ("hair loss") and hypoaesthesia ("loss of feelings in hands and feet").In (b)(6) 2016, the patient experienced rash ("rashes or skin conditions type: on jawline / on face").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), back pain ("severe back pain"), weight fluctuation ("weight fluctuations"), menstrual cramps ("dysmenorrhea (cramping),"), musculoskeletal pain ("right shoulder pain"), toothache ("dental pain") and mood altered ("emotional changes") and underwent spinal fusion surgery ("spinal fusion").The patient was treated with surgery (essure removal scheduled date on (b)(6) 2020).Essure was removed.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, back pain, fatigue, weight fluctuation, dyspareunia, migraine, vaginal haemorrhage, female sexual dysfunction, depression, rash, headache, tooth disorder, menstrual cramps, visual impairment, alopecia, hypoaesthesia, menorrhagia, musculoskeletal pain, toothache and mood altered outcome was unknown and the spinal fusion surgery had not resolved.The reporter considered abdominal pain, alopecia, back pain, depression, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, mood altered, musculoskeletal pain, pelvic pain, rash, spinal fusion surgery, tooth disorder, toothache, vaginal haemorrhage, visual impairment, weight fluctuation and menstrual cramps to be related to essure.The reporter commented: four trailing coils were noted.The essure tubal sterilization procedure was performed on that side and we noted 3 trailing coils.Discrepancy noted in insertion date: (b)(6) 2014.Diagnostic results: on (b)(6) 2014, surgical pathology report- gross description: mirena iud, rule out actinomyces, contains an intact and t-shaped, tan-white intrauterine device.It measures 3.2 x 3.2 cm.A 1.7 cm long, gray-colored, and double nylon strand is attached to this t-shaped apparatus, intact.On (b)(6) 2015, pregnancy status was negative.On (b)(6) 2015, hcg qual was negative.On (b)(6) 2015, ct cervical spine without contrast- impression: there are chronic changes present in the cervical spine.Previous anterior fusion in the c4- 5 and c5-6 disc spaces is apparent.Somewhat broad calcified annulus bulging into the anterior aspect of the spinal canal is present at c6-7.On (b)(6) 2015, xr cervical spine 3 views-findings: disc spacers have been placed at the c4- c5 and c5-c6 since the prior study with resulting increased disc heights.Anterior fixation clips are in place with no evidence of loosening.Remaining vertebral body and disc heights are stable compared to the previous.Impression: postsurgical changes of c4-c5 and c5- c6 as above.On (b)(6) 2015, mr cervical spine without contrast- impression: since 11 months ago, status post anterior discectomy and fusion at c4-5 and c5-6.Spinal canal stenosis at both levels has resolved, but there is persistent bilateral neural foraminal stenosis due to uncovertebral and facet arthropathy, which is severe on the right and moderate to severe on the left at c4-5, and moderate to severe on the right at c5-6.Persistent left paracentral disc/osteophyte protrusion at c6-7, abutting and mildly compressing the left ventral cord.Cord signal is normal.Lot number: b93871 manufacturing date:2013-11 expiration date: 2016-11.Most recent follow-up information incorporated above includes: on 29-sep-2020: pfs received.Case was upgraded to serious incident.Event emotional changes added.Reporter information added.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant 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 ('pain') in a 47-year-old female patient who had essure (batch no.B93871) 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 "patient did not undergo essure confirmation test".The patient's medical history included leg pain, pain in hip, augmentation mammoplasty, cholecystectomy, gastric operation, augmentation mammoplasty, cervical radiculopathy, brain operation, varicose veins, lumbar radiculopathy, rectal bleeding, abdominal pain, spinal fusion surgery and caesarean section.She had no history of suffering from migraines prior to undergoing the implantation of essure.On (b)(6) 2014, surgical pathology report- gross description: mirena iud, rule out actinomyces, contains an intact and t-shaped, tan-white intrauterine device.It measures 3.2 x 3.2 cm.A 1.7 cm long, gray-colored, and double nylon strand is attached to this t-shaped apparatus, intact.On (b)(6) 2015, pregnancy status was negative.On (b)(6) 2015, hcg qual was negative.On (b)(6) 2015, ct cervical spine without contrast- impression: there are chronic changes present in the cervical spine.Previous anterior fusion in the c4- 5 and c5-6 disc spaces is apparent.Somewhat broad calcified annulus bulging into the anterior aspect of the spinal canal is present at c6-7.On (b)(6) 2015, xr cervical spine 3 views-findings: disc spacers have been placed at the c4- c5 and c5-c6 since the prior study with resulting increased disc heights.Anterior fixation clips are in place with no evidence of loosening.Remaining vertebral body and disc heights are stable compared to the previous.Impression: postsurgical changes of c4-c5 and c5- c6 as above.On (b)(6) 2015, mr cervical spine without contrast- impression: since 11 months ago, status post anterior discectomy and fusion at c4-5 and c5-6.Spinal canal stenosis at both levels has resolved, but there is persistent bilateral neural foraminal stenosis due to uncovertebral and facet arthropathy, which is severe on the right and moderate to severe on the left at c4-5, and moderate to severe on the right at c5-6.Persistent left paracentral disc/osteophyte protrusion at c6-7, abutting and mildly compressing the left ventral cord.Cord signal is normal.Previously administered products included for allergy: vicodin.Concurrent conditions included tingling, numbness in leg, depression, headache, nickel sensitivity, shoulder injury, muscle weakness upper limb, neck pain, anemia, anxiety, esophageal reflux, osteoarthritis, obesity, trochanteric bursitis, paronychia, restless legs syndrome, kidney stone, allergic reaction to analgesics, urinary tract infection, chills, dysuria, hematuria, ascariasis, itching, gallstones, adenomyosis and leiomyoma.Family history included adenosquamous cell carcinoma (father) and alzheimer's disease (maternal grandmother).Concomitant products included levonorgestrel (mirena) from (b)(6) 2014 to (b)(6) 2014 for contraception as well as cefixime (flexeril), celecoxib (celebrex), cyclobenzaprine, ethinylestradiol; levonorgestrel (aviane), gabapentin, hydrocodone bitartrate; paracetamol (norco), hydrocodone bitartrate; paracetamol (vicodin), ibuprofen, levofloxacin, lorazepam, lorazepam (ativan), macrogol 3350 (miralax), omeprazole, paracetamol (acetaminophen) and tramadol.In 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and visual impairment ("vision/eye problem").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal pain"), the first episode of dysmenorrhoea ("severe menstrual pain/ dysmenorrhoea (cramping)"), fatigue ("fatigue") and depression ("psychological or psychiatric problems condition: depression") with depressive symptom.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse /' dyspareunia (painful sexual intercourse),"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").On (b)(6) 2014, the patient experienced migraine ("severe migraines"), 3 months 9 days after insertion of essure.In (b)(6) 2014, the patient experienced headache ("headaches"), alopecia ("hair loss") and hypoaesthesia ("loss of feelings in hands and feet").In (b)(6) 2016, the patient experienced rash ("rashes or skin conditions type: on jawline / on face").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), back pain ("severe back pain"), weight fluctuation ("weight fluctuations"), the second episode of dysmenorrhoea ("dysmenorrhea (cramping),"), arthralgia ("right shoulder pain"), toothache ("dental pain") and mood altered ("emotional changes") and underwent spinal fusion surgery ("spinal fusion").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingo-oophorectomy).Essure was removed.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, fatigue, weight fluctuation, dyspareunia, migraine, vaginal haemorrhage, female sexual dysfunction, depression, rash, headache, tooth disorder, the last episode of dysmenorrhoea, visual impairment, alopecia, hypoaesthesia, heavy menstrual bleeding, arthralgia, toothache and mood altered outcome was unknown and the spinal fusion surgery and back pain had not resolved.The reporter considered abdominal pain, alopecia, arthralgia, back pain, depression, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, heavy menstrual bleeding, hypoaesthesia, migraine, mood altered, pelvic pain, rash, spinal fusion surgery, tooth disorder, toothache, vaginal haemorrhage, visual impairment, weight fluctuation, the first episode of dysmenorrhoea and the second episode of dysmenorrhoea to be related to essure.The reporter commented: four trailing coils were noted.The essure tubal sterilization procedure was performed on that side and we noted 3 trailing coils.Discrepancy noted in insertion date: (b)(6) 2014.As per pfs essure was not removed ( discrepancy noted)- anticipated or scheduled date: 2021, awaiting rescheduling; was scheduled for (b)(6) 2020 surgery but canceled after a change in my health insurance.Lot number: b93871.Manufacturing date: 2013-11.Expiration date: 2016-11.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: depression, tooth disorder, dyspareunia, rash, pelvic pain most recent follow-up information incorporated above includes: on 28-dec-2021: medical record received.Reporter and medical history were added.Surgery name was updated.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant 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 ('pain') in a 47-year-old female patient who had essure (batch no.B93871) 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 "patient did not undergo essure confirmation test".The patient's medical history included leg pain, pain in hip, augmentation mammoplasty, cholecystectomy, gastric operation, augmentation mammoplasty, cervical radiculopathy, brain operation, varicose veins, lumbar radiculopathy, rectal bleeding, abdominal pain, spinal fusion surgery and caesarean section.She had no history of suffering from migraines prior to undergoing the implantation of essure.On (b)(6) 2014, surgical pathology report- gross description: mirena iud, rule out actinomyces, contains an intact and t-shaped, tan-white intrauterine device.It measures 3.2 x 3.2 cm.A 1.7 cm long, gray-colored, and double nylon strand is attached to this t-shaped apparatus, intact.On (b)(6) 2015, pregnancy status was negative.On (b)(6) 2015, hcg qual was negative.On (b)(6) 2015, ct cervical spine without contrast- impression: there are chronic changes present in the cervical spine.Previous anterior fusion in the c4- 5 and c5-6 disc spaces is apparent.Somewhat broad calcified annulus bulging into the anterior aspect of the spinal canal is present at c6-7.On (b)(6) 2015, xr cervical spine 3 views-findings: disc spacers have been placed at the c4- c5 and c5-c6 since the prior study with resulting increased disc heights.Anterior fixation clips are in place with no evidence of loosening.Remaining vertebral body and disc heights are stable compared to the previous.Impression: postsurgical changes of c4-c5 and c5- c6 as above.On (b)(6) 2015, mr cervical spine without contrast- impression: since 11 months ago, status post anterior discectomy and fusion at c4-5 and c5-6.Spinal canal stenosis at both levels has resolved, but there is persistent bilateral neural foraminal stenosis due to uncovertebral and facet arthropathy, which is severe on the right and moderate to severe on the left at c4-5, and moderate to severe on the right at c5-6.Persistent left paracentral disc/osteophyte protrusion at c6-7, abutting and mildly compressing the left ventral cord.Cord signal is normal.Previously administered products included for allergy: vicodin.Concurrent conditions included tingling, numbness in leg, depression, headache, nickel sensitivity, shoulder injury, muscle weakness upper limb, neck pain, anemia, anxiety, esophageal reflux, osteoarthritis, obesity, trochanteric bursitis, paronychia, restless legs syndrome, kidney stone, allergic reaction to analgesics, urinary tract infection, chills, dysuria, hematuria, ascariasis, itching, gallstones, adenomyosis and leiomyoma nos.Family history included adenosquamous cell carcinoma (father) and alzheimer's disease (maternal grandmother).Concomitant products included levonorgestrel (mirena) from (b)(6) 2014 to (b)(6) 2014 for contraception as well as cefixime (flexeril), celecoxib (celebrex), cyclobenzaprine, ethinylestradiol;levonorgestrel (aviane), gabapentin, hydrocodone bitartrate;paracetamol (norco), hydrocodone bitartrate;paracetamol (vicodin), ibuprofen, levofloxacin, lorazepam, lorazepam (ativan), macrogol 3350 (miralax), omeprazole, paracetamol (acetaminophen) and tramadol.In 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and visual impairment ("vision/eye problem").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal pain"), the first episode of dysmenorrhoea ("severe menstrual pain/ dysmenorrhoea (cramping)"), fatigue ("fatigue") and depression ("psychological or psychiatric problems condition: depression") with depressive symptom.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse /' dyspareunia (painful sexual intercourse),"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and heavy menstrual bleeding ("abnormal bleeding (menorrhagia)").On (b)(6) 2014, the patient experienced migraine ("severe migraines"), 3 months 9 days after insertion of essure.In (b)(6) 2014, the patient experienced headache ("headaches"), alopecia ("hair loss") and hypoaesthesia ("loss of feelings in hands and feet").In (b)(6) 2016, the patient experienced rash ("rashes or skin conditions type: on jawline / on face").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), back pain ("severe back pain"), weight fluctuation ("weight fluctuations"), the second episode of dysmenorrhoea ("dysmenorrhea (cramping),"), arthralgia ("right shoulder pain"), toothache ("dental pain") and mood altered ("emotional changes") and underwent spinal fusion surgery ("spinal fusion").The patient was treated with surgery (total laparoscopic hysterectomy with bilateral salpingo-oophorectomy).Essure was removed.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, fatigue, weight fluctuation, dyspareunia, migraine, vaginal haemorrhage, female sexual dysfunction, depression, rash, headache, tooth disorder, the last episode of dysmenorrhoea, visual impairment, alopecia, hypoaesthesia, heavy menstrual bleeding, arthralgia, toothache and mood altered outcome was unknown and the spinal fusion surgery and back pain had not resolved.The reporter considered abdominal pain, alopecia, arthralgia, back pain, depression, dyspareunia, fatigue, female sexual dysfunction, genital haemorrhage, headache, heavy menstrual bleeding, hypoaesthesia, migraine, mood altered, pelvic pain, rash, spinal fusion surgery, tooth disorder, toothache, vaginal haemorrhage, visual impairment, weight fluctuation, the first episode of dysmenorrhoea and the second episode of dysmenorrhoea to be related to essure.The reporter commented: four trailing coils were noted.The essure tubal sterilization procedure was performed on that side and we noted 3 trailing coils.Discrepancy noted in insertion date- (b)(6) 2014 as per pfs essure was not removed ( discrepancy noted)- anticipated or scheduled date: 2021, awaiting rescheduling; was scheduled for (b)(6) 2020 surgery but canceled after a change in my health insurance.Lot number: b93871, manufacturing date: 2013-11, and expiration date: 2016-11.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 7-jan-2022: quality safety evaluation of ptc (product technical complaint).We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, 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
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM   13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd, p.o. box 915
whippany, nj, NJ 07981
MDR Report Key10618447
MDR Text Key213708859
Report Number2951250-2020-14742
Device Sequence Number1
Product Code HHS
UDI-Device Identifier10888853003051
UDI-Public(01)10888853003051
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2016
Device Model NumberESS305
Device Lot NumberB93871
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACETAMINOPHEN; ACETAMINOPHEN; ATIVAN; ATIVAN; AVIANE; AVIANE; CELEBREX; CELEBREX; CELEBREX; CYCLOBENZAPRINE; CYCLOBENZAPRINE; FLEXERIL [CEFIXIME]; FLEXERIL [CEFIXIME]; GABAPENTIN; GABAPENTIN; GABAPENTIN; IBUPROFEN; IBUPROFEN; IBUPROFEN; LEVOFLOXACIN; LEVOFLOXACIN; LORAZEPAM; LORAZEPAM; LORAZEPAM; MIRALAX; MIRALAX; MIRALAX; MIRENA; MIRENA; MIRENA; NORCO; NORCO; NORCO; OMEPRAZOLE; OMEPRAZOLE; OMEPRAZOLE; OTHER THERAPEUTIC PRODUCTS; OTHER THERAPEUTIC PRODUCTS; OTHER THERAPEUTIC PRODUCTS; TRAMADOL; TRAMADOL; TRAMADOL; VICODIN; VICODIN
Patient Outcome(s) Required Intervention; Other;
Patient Age47 YR
Patient SexFemale
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