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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); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Sensitivity of Teeth (2427); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Dysuria (2684)
Event Date 06/01/2014
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("chronic abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), rash ("rash/skin condition"), hypersensitivity ("hypersensitivity"), allergy to metals ("nickel allergy"), psychological trauma ("plaintiff claiming psych injury related to essure?: yes"), vaginal discharge ("bladder/urinary problems: vaginal discharge"), tooth disorder ("dental probs"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions"), alopecia ("hair loss"), abdominal distension ("swelling of abdomen"), skin disorder ("skin condition"), urinary tract disorder ("bladder/urinary problems: vaginal discharge") and bladder disorder ("bladder/urinary problems: vaginal discharge") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy) (full), salpingectomy) (bilateral)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, menorrhagia, tooth disorder, fatigue, gastrointestinal disorder, alopecia, weight increased and abdominal distension had resolved and the rash, hypersensitivity, allergy to metals, psychological trauma, vaginal discharge, skin disorder, urinary tract disorder and bladder disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, back pain, bladder disorder, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, hypersensitivity, menorrhagia, pelvic pain, psychological trauma, rash, skin disorder, tooth disorder, urinary tract disorder, vaginal discharge and weight increased to be related to essure.The reporter commented: pelvic pain, abdominal pain, back pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), menorrhagia (heavy menstrual bleeding), rash/skin condition, hypersensitivity, plaintiff claiming psych injury related to essure?: yes, vaginal discharge, dental probs., fatigue, gi conditions, hair loss, weight gain, swelling of abdomen.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure on (b)(6) 2014: essure confirmation test(unspecified) results: unknown.Most recent follow-up information incorporated above includes: on 6-sep-2019: plaintiff fact sheet received.Reporter information updated.Patient demographic information updated.Product indication female sterilization updated.Essure start date and stop date updated.Lab data updated.Events: pelvic pain, abdominal pain, back pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), menorrhagia (heavy menstrual bleeding), rash/skin condition, hypersensitivity, plaintiff claiming psych injury related to essure?: yes, vaginal discharge, dental probs., fatigue, gi conditions, hair loss, weight gain, swelling of abdomen were newly added.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 and other non-conformances 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 ('chronic pelvic pain') and menorrhagia ('menorrhagia (heavy menstrual bleeding)') in a 35-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included breast cancer from 2014 to 2015, uterine bleeding and follicular cyst of ovary.Current weight 175 lbs.Concomitant products included celecoxib (celebrex) since 2015 and levonorgestrel (mirena) from 2005 to 2014.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("bladder/urinary problems: vaginal discharge"), urinary tract disorder ("bladder/urinary problems: vaginal discharge"), bladder disorder ("bladder/urinary problems: vaginal discharge"), vaginal hemorrhage ("bleeding (vaginal)"), migraine ("migraines / headaches") and nausea ("nausea").In august 2014, the patient experienced diarrhoea ("constant diarrhea").In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and depression ("plaintiff claiming psych injury related to essure?: yes/depression") and was found to have weight increased ("weight gain").In 2016, the patient experienced rash ("rash/skin condition/rashes or skin conditions"), hypersensitivity ("hypersensitivity"), fatigue ("fatigue") and menopause ("menopause").In (b)(6) 2017, the patient experienced abdominal distension ("swelling of abdomen/bloating").In 2017, the patient experienced allergy to metals ("nickel allergy").In (b)(6) 2017, the patient experienced tooth disorder ("dental probs") and tooth infection ("dental infection (other)").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("chronic abdominal pain"), back pain ("back pain"), gastrointestinal disorder ("gi conditions"), alopecia ("hair loss"), skin disorder ("skin condition"), abdominal pain upper ("stomach pain"), pain in extremity ("arm pain"), headache ("head pain") and genital pain ("genitals pain").The patient was treated with surgery (ablation and hysterectomy) (full), salpingectomy) (bilateral).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menorrhagia, abdominal pain, back pain, dysmenorrhoea, dyspareunia, tooth disorder, fatigue, gastrointestinal disorder, alopecia, weight increased, abdominal distension, vaginal hemorrhage, tooth infection and abdominal pain upper had resolved, the rash, hypersensitivity, allergy to metals, depression, vaginal discharge, skin disorder, urinary tract disorder, bladder disorder, menopause, nausea, diarrhoea, pain in extremity and genital pain outcome was unknown and the migraine and headache was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital pain, headache, hypersensitivity, menopause, menorrhagia, migraine, nausea, pain in extremity, pelvic pain, rash, skin disorder, tooth disorder, tooth infection, urinary tract disorder, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: pelvic pain, abdominal pain, back pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), menorrhagia (heavy menstrual bleeding), rash/skin condition, hypersensitivity, plaintiff claiming psych injury related to essure?: yes, vaginal discharge, dental probs., fatigue, gi conditions, hair loss, weight gain, swelling of abdomen.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: other (please describe) unknown.Imaging procedure - on (b)(6) 2014: essure confirmation test(unspecified) results: unknown.Pathology test - on (b)(6) 2018: cervix ,uterus , right and left fallopian tubes: benign cervix.Benign endometrium.Adenomyosis.Unremarkable bilateral fallopian tubes.Essure coil identified.Most recent follow-up information incorporated above includes: on 5-dec-2019: pfs and mr received: new events were added: menopause, bleeding (vaginal), dental infection (other), migraines / headaches, nausea, constant diarrhea, stomach pain, arm pain, head pain, genitals pain, event onset date and event outcome were added.Reporter information were updated.Patient history, lab data and concomitant drugs were added.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 and other non-conformances 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 ('chronic pelvic pain') and menorrhagia ('menorrhagia (heavy menstrual bleeding)') in a 35-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included breast cancer from 2014 to 2015, uterine bleeding and follicular cyst of ovary.Current weight 175 lbs.Concomitant products included celecoxib (celebrex) since 2015 and levonorgestrel (mirena) from 2005 to 2014.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("bladder/urinary problems: vaginal discharge"), urinary tract disorder ("bladder/urinary problems: vaginal discharge"), bladder disorder ("bladder/urinary problems: vaginal discharge"), vaginal haemorrhage ("bleeding (vaginal)"), migraine ("migraines / headaches") and nausea ("nausea").In (b)(6) 2014, the patient experienced diarrhoea ("constant diarrhea").In 2015, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and depression ("plaintiff claiming psych injury related to essure?: yes/depression") and was found to have weight increased ("weight gain").In 2016, the patient experienced rash ("rash/skin condition/rashes or skin conditions"), hypersensitivity ("hypersensitivity"), fatigue ("fatigue") and menopause ("menopause").In (b)(6) 2017, the patient experienced abdominal distension ("swelling of abdomen/bloating").In 2017, the patient experienced allergy to metals ("nickel allergy").In (b)(6) 2017, the patient experienced tooth disorder ("dental probs") and tooth infection ("dental infection (other)").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("chronic abdominal pain"), back pain ("back pain"), gastrointestinal disorder ("gi conditions"), alopecia ("hair loss"), skin disorder ("skin condition"), abdominal pain upper ("stomach pain"), pain in extremity ("arm pain"), headache ("head pain") and genital pain ("genitals pain") and was found to have breast cancer ("breast cancer").The patient was treated with surgery (ablation and hysterectomy) (full), salpingectomy) (bilateral)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menorrhagia, abdominal pain, back pain, dysmenorrhoea, dyspareunia, tooth disorder, fatigue, gastrointestinal disorder, alopecia, weight increased, abdominal distension, vaginal haemorrhage, tooth infection and abdominal pain upper had resolved, the rash, hypersensitivity, allergy to metals, depression, vaginal discharge, skin disorder, urinary tract disorder, bladder disorder, menopause, nausea, diarrhoea, pain in extremity, genital pain and breast cancer outcome was unknown and the migraine and headache was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, allergy to metals, alopecia, back pain, bladder disorder, breast cancer, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital pain, headache, hypersensitivity, menopause, menorrhagia, migraine, nausea, pain in extremity, pelvic pain, rash, skin disorder, tooth disorder, tooth infection, urinary tract disorder, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: pelvic pain, abdominal pain, back pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), menorrhagia (heavy menstrual bleeding), rash/skin condition, hypersensitivity, plaintiff claiming psych injury related to essure?: yes, vaginal discharge, dental probs., fatigue, gi conditions, hair loss, weight gain, swelling of abdomen.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: other (please describe) unknown.Imaging procedure - on (b)(6) 2014: essure confirmation test(unspecified) results: unknown.Pathology test - on (b)(6) 2018: cervix ,uterus , right and left fallopian tubes: benign cervix, benign endometrium, adenomyosis, unremarkable bilateral fallopian tubes, essure coil identified.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received.Event breast cancer added.New reporter added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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 Key9097713
MDR Text Key163817362
Report Number2951250-2019-07535
Device Sequence Number1
Product Code HHS
UDI-Device Identifier10888853003051
UDI-Public(01)10888853003051
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
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESS305
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CELEBREX; CELEBREX; MIRENA; MIRENA
Patient Outcome(s) Other; Required Intervention;
Patient Age35 YR
Patient Weight68
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