ESSURE
Report
- Report Number
- 2951250-2019-02036
- Event Type
- Injury
- Date Received
- May 21, 2019
- Date of Event
- August 1, 2008
- Report Date
- March 31, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4); (B)(4). ON (B)(6) 2019. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('PAINFUL MENSTRUAL CYCLE') AND POLYMENORRHAGIA ('INCREASED FREQUENCY OF PERIODS AND HAEMORRHAGE') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYMENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MYALGIA ("MUSCLE PAIN"), DEPRESSION ("DEPRESSED"), DEAFNESS ("DECREASED HEARING - DEAFNESS"), TINNITUS ("TINNITUS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINE"), 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED TENDON DISORDER ("TENDINOPATHY"), VERTIGO ("VERTIGO"), GASTROINTESTINAL MOTILITY DISORDER ("TRANSIT AND BLADDER PROBLEMS") AND BLADDER DISORDER ("TRANSIT AND BLADDER PROBLEMS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, POLYMENORRHAGIA, MYALGIA, TENDON DISORDER, DEPRESSION, DEAFNESS, TINNITUS, VERTIGO, FATIGUE, MIGRAINE, GASTROINTESTINAL MOTILITY DISORDER AND BLADDER DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BLADDER DISORDER, DEAFNESS, DEPRESSION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, MIGRAINE, MYALGIA, POLYMENORRHAGIA, TENDON DISORDER, TINNITUS AND VERTIGO WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: NEW INFORMATION FROM HA: CASE 2020-040231 (MEDWATCH REFERENCE NUMBER 2951250-2020-02153) WAS FOUND TO BE A DUPLICATE OF THIS CASE 2019-099844. CASE 2020-040231 WAS DELETED AND ITS INFORMATION WAS TRANSFERRED FOR THIS CURRENT CASE. NEW EVENTS ADDED: TENDINOPATHY, TRANSIT AND BLADDER PROBLEMS, VERTIGO. THE EVENT "FREQUENT HEMORRHAGE DURING MENSTRUATION" WAS UPDATED TO "INCREASED FREQUENCY OF PERIODS AND HAEMORRHAGE" AND THE EVENT "DECREASED HEARING" WAS UPDATED TO "DEAFNESS". INSERTION DATE WAS UPDATED TO (B)(6) 2008. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON 20-MAY-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 4-NOV-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC, INTER-CYCLE PELVIC PAIN') AND POLYMENORRHAGIA ('INCREASED FREQUENCY OF PERIODS AND HAEMORRHAGE') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED POLYMENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE, SECONDARY DYSMENORRHOEA"), MYALGIA ("MUSCLE PAIN"), DEPRESSION ("DEPRESSED"), DEAFNESS ("DECREASED HEARING - DEAFNESS"), TINNITUS ("TINNITUS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINE"), 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVULATION PAIN ("CHRONIC, INTER-CYCLE ABDOMINAL PAIN"), TENDON DISORDER ("TENDINOPATHY"), VERTIGO ("VERTIGO"), GASTROINTESTINAL MOTILITY DISORDER ("TRANSIT AND BLADDER PROBLEMS"), BLADDER DISORDER ("TRANSIT AND BLADDER PROBLEMS") AND LOSS OF LIBIDO ("DISAPPEARANCE OF HER LIBIDO"). THE PATIENT WAS TREATED WITH SURGERY (SUBTOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POLYMENORRHAGIA, OVULATION PAIN, DYSMENORRHOEA, MYALGIA, TENDON DISORDER, DEPRESSION, DEAFNESS, TINNITUS, VERTIGO, FATIGUE, MIGRAINE, GASTROINTESTINAL MOTILITY DISORDER, BLADDER DISORDER AND LOSS OF LIBIDO OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BLADDER DISORDER, DEAFNESS, DEPRESSION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, LOSS OF LIBIDO, MIGRAINE, MYALGIA, OVULATION PAIN, PELVIC PAIN, POLYMENORRHAGIA, TENDON DISORDER, TINNITUS AND VERTIGO WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 48 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, REGULATORY AUTHORITY OR PHARMACIST IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-NOV-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON (B)(6) 2019. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC, INTER-CYCLE PELVIC PAIN') AND POLYMENORRHAGIA ('INCREASED FREQUENCY OF PERIODS AND HAEMORRHAGE') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED POLYMENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE, SECONDARY DYSMENORRHOEA"), MYALGIA ("MUSCLE PAIN"), DEPRESSION ("DEPRESSED"), DEAFNESS ("DECREASED HEARING - DEAFNESS"), TINNITUS ("TINNITUS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINE"), 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CHRONIC, INTER-CYCLE ABDOMINAL PAIN"), TENDON DISORDER ("TENDINOPATHY"), VERTIGO ("VERTIGO"), GASTROINTESTINAL MOTILITY DISORDER ("TRANSIT AND BLADDER PROBLEMS"), BLADDER DISORDER ("TRANSIT AND BLADDER PROBLEMS") AND LOSS OF LIBIDO ("DISAPPEARANCE OF HER LIBIDO"). THE PATIENT WAS TREATED WITH SURGERY (SUBTOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POLYMENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, MYALGIA, TENDON DISORDER, DEPRESSION, DEAFNESS, TINNITUS, VERTIGO, FATIGUE, MIGRAINE, GASTROINTESTINAL MOTILITY DISORDER, BLADDER DISORDER AND LOSS OF LIBIDO OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, BLADDER DISORDER, DEAFNESS, DEPRESSION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, LOSS OF LIBIDO, MIGRAINE, MYALGIA, PELVIC PAIN, POLYMENORRHAGIA, TENDON DISORDER, TINNITUS AND VERTIGO WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 48 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, REGULATORY AUTHORITY OR PHARMACIST IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2020: HEALTH AUTHORITY IN FRANCE REPORTED THAT THIS RECORD WAS A DUPLICATE TO RECORD # (B)(4) WHICH WILL BE DELETED IN BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS DUPLICATE RECORD # (B)(4) WHICH WILL BE RETAINED. NEW: NEW REPORTER ADDED: PHARMACIST. BODY WEIGHT: 48KG. NEW EVENTS WERE ADDED: PELVIC PAIN (SERIOUS INCIDENT; EVENT DYSMENORRHEA DOWNGRADED TO NON-SERIOUS INCIDENT), ABDOMINAL PAIN, LOSS OF LIBIDO. ESSURE WAS REMOVED ON (B)(6) 2020 BY SUBTOTAL HYSTERECTOMY BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ) ON (B)(6) -2019. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6)-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC, INTER-CYCLE PELVIC PAIN') AND POLYMENORRHAGIA ('INCREASED FREQUENCY OF PERIODS AND HAEMORRHAGE') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)-2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)-2008, THE PATIENT EXPERIENCED POLYMENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE, SECONDARY DYSMENORRHOEA"), MYALGIA ("MUSCLE PAIN"), DEPRESSION ("DEPRESSED"), DEAFNESS ("DECREASED HEARING - DEAFNESS"), TINNITUS ("TINNITUS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINE"), 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVULATION PAIN ("CHRONIC, INTER-CYCLE ABDOMINAL PAIN"), TENDON DISORDER ("TENDINOPATHY"), VERTIGO ("VERTIGO"), GASTROINTESTINAL MOTILITY DISORDER ("TRANSIT AND BLADDER PROBLEMS"), BLADDER DISORDER ("TRANSIT AND BLADDER PROBLEMS") AND LOSS OF LIBIDO ("DISAPPEARANCE OF HER LIBIDO"). THE PATIENT WAS TREATED WITH SURGERY (SUBTOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)-2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POLYMENORRHAGIA, OVULATION PAIN, DYSMENORRHOEA, MYALGIA, TENDON DISORDER, DEPRESSION, DEAFNESS, TINNITUS, VERTIGO, FATIGUE, MIGRAINE, GASTROINTESTINAL MOTILITY DISORDER, BLADDER DISORDER AND LOSS OF LIBIDO OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BLADDER DISORDER, DEAFNESS, DEPRESSION, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, LOSS OF LIBIDO, MIGRAINE, MYALGIA, OVULATION PAIN, PELVIC PAIN, POLYMENORRHAGIA, TENDON DISORDER, TINNITUS AND VERTIGO WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 48 KGS. QUALITY-SAFETY EVALUATION OF PTC: THE INVESTIGATION OF THE SAMPLE COULD NOT CONFIRM ANY QUALITY DEFECT. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, REGULATORY AUTHORITY OR PHARMACIST IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)-2021: QUALITY SAFETY EVALUATION OF PTC BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 20-MAY-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('PAINFUL MENSTRUAL CYCLE') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINE"), MYALGIA ("MUSCLE PAIN"), TINNITUS ("TINNITUS"), HYPOACUSIS ("DECREASED HEARING"), MENORRHAGIA ("FREQUENT HEMORRHAGE DURING MENSTRUATION"), FATIGUE ("FATIGUE") AND DEPRESSION ("DEPRESSED"), 7 MONTHS AFTER INSERTION OF ESSURE. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, MIGRAINE, MYALGIA, TINNITUS, HYPOACUSIS, MENORRHAGIA, FATIGUE AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION, DYSMENORRHOEA, FATIGUE, HYPOACUSIS, MENORRHAGIA, MIGRAINE, MYALGIA AND TINNITUS WITH ESSURE. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422193 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R |