ESSURE
Report
- Report Number
- 2951250-2017-09675
- Event Type
- Injury
- Date Received
- December 4, 2017
- Report Date
- July 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND SEIZURE ("SEIZURES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), HEADACHE ("HEADACHES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY DISORDER") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, NAUSEA, FATIGUE, WEIGHT FLUCTUATION, VAGINAL INFECTION, URINARY TRACT INFECTION, CYSTITIS, BLADDER DISORDER, URINARY TRACT DISORDER AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS NOT PROVIDED CURRENT WEIGHT 190 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: PLAINTIFF FACT SHEET RECEIVED: REPORTERS, PATIENT DEMOGRAPHIC, ESSURE LOT NUMBER 922613, EVENTS (ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HYSTERECTOMY (PARTIAL), INFECTION (BLADDER/ URINARY TRACT/VAGINAL), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, NAUSEA, SEIZURES, NICKEL ALLERGY, TUBAL LIGATION, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN / LOSS) WERE ADDED. INCIDENT AT THE TIME OF REPORTING, 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND SEIZURE ("SEIZURES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), HEADACHE ("HEADACHES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), NAUSEA ("NAUSEA"), ALLERGY TO METALS ("NICKEL ALLERGY"), FATIGUE ("FATIGUE"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY DISORDER") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (B)(6)2016 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HEADACHE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, NAUSEA, FATIGUE, WEIGHT FLUCTUATION, VAGINAL INFECTION, URINARY TRACT INFECTION, CYSTITIS, BLADDER DISORDER, URINARY TRACT DISORDER AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2014: RESULTS NOT PROVIDED . CURRENT WEIGHT 190 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), KIDNEY INFECTION ("KIDNEY INFECTION") AND SEIZURE ("SEIZURES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR MENSTRUAL CYCLE, MENOMETRORRHAGIA, RIGHT UPPER QUADRANT PAIN, IRRITABLE BOWEL SYNDROME AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED BUPIVACAINE, ESZOPICLONE (LUNESTA) SINCE (B)(6) 2018, LORAZEPAM (ATIVAN), NORTRIPTYLINE SINCE (B)(6) 2018, SERTRALINE (ZOLOFT) SINCE (B)(6) 2018 AND SUMATRIPTAN (IMITREX) SINCE FEBRUARY 2018. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA/ DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN 2016, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM") AND URINARY TRACT DISORDER ("URINARY DISORDER"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, KIDNEY INFECTION, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, VAGINAL INFECTION, URINARY TRACT INFECTION, CYSTITIS, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, NAUSEA AND ABDOMINAL PAIN HAD RESOLVED AND THE HEADACHE AND MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: SUCCESSFUL FALLOPIAN TUBE OCCLUSION CURRENT WEIGHT 190 LBS. ON (B)(6) 2016 MRI OF BRAIN AND ECG WAS PERFORMED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS- ABDOMINAL PAIN. SEIZURES, NAUSEA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. NEW EVENT KIDNEY INFECTION WAS ADDED. WEIGHT FLUCTUATION WAS UPDATED TO WEIGHT GAIN. OUTCOME OF EVENTS ABDOMINAL PAIN, VAGINAL DISCHARGE, ABNORMAL BLEEDING, DYSPAREUNIA, NAUSEA UPDATED FROM UNKNOWN TO RECOVERED AND OUTCOME OF EVENTS MIGRAINE AND HEADACHE UPDATED TO RECOVERING. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), KIDNEY INFECTION ('KIDNEY INFECTION') AND SEIZURE ('SEIZURES') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA, BIRTH CONTROL PILL AND NUVARING. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR MENSTRUAL CYCLE, MENOMETRORRHAGIA, RIGHT UPPER QUADRANT PAIN, IRRITABLE BOWEL SYNDROME, PARATUBAL CYST AND DVT. CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS, BUPIVACAINE, ESZOPICLONE (LUNESTA) SINCE (B)(6) 2018, LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NORTRIPTYLINE SINCE (B)(6) 2018, SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2018 AND SUMATRIPTAN (IMITREX) SINCE (B)(6) 2018. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA/ DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN 2016, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM") AND URINARY TRACT DISORDER ("URINARY DISORDER"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, KIDNEY INFECTION, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, VAGINAL INFECTION, URINARY TRACT INFECTION, CYSTITIS, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, NAUSEA AND ABDOMINAL PAIN HAD RESOLVED AND THE HEADACHE AND MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DISCREPANCY NOTED: DATE OF EXPLANT :(B)(6) 2016 LEGACY DEVICE REPORT NUM 2951250-2020-11086 MEDWATCH 3500A MFR NUMBER DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: SUCCESSFUL FALLOPIAN TUBE OCCLUSION; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: CURRENT WEIGHT 190 LBS. ON (B)(6) 2016 MRI OF BRAIN AND ECG WAS PERFORMED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS- ABDOMINAL PAIN. SEIZURES, NAUSEA, PELVIC PAIN". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS RECORD WAS DETECTED TO BE A DUPLICATE TO RECORD (B)(4) WHICH WILL BE DELETED FROM BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS RECORD (B)(4) WHICH WILL BE RETAINED. FROM DELETION CASE (B)(4) DATE OF REMOVAL WERE UPDATED.SERIOUSNESS CRITERIA FOR EVENT GENITAL HEMORRHAGE UPDATED TO NON SERIOUS. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), KIDNEY INFECTION ('KIDNEY INFECTION') AND SEIZURE ('SEIZURES') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA, BIRTH CONTROL PILL AND NUVARING. CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, IRREGULAR MENSTRUAL CYCLE, MENOMETRORRHAGIA, RIGHT UPPER QUADRANT PAIN, IRRITABLE BOWEL SYNDROME, PARATUBAL CYST AND DVT. CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS, BUPIVACAINE, ESZOPICLONE (LUNESTA) SINCE (B)(6) 2018, LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), NORTRIPTYLINE SINCE (B)(6) 2018, SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2018 AND SUMATRIPTAN (IMITREX) SINCE (B)(6) 2018. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA/ DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). IN 2016, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), CYSTITIS ("BLADDER INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM") AND URINARY TRACT DISORDER ("URINARY DISORDER"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016 SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, KIDNEY INFECTION, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED, VAGINAL INFECTION, URINARY TRACT INFECTION, CYSTITIS, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, NAUSEA AND ABDOMINAL PAIN HAD RESOLVED AND THE HEADACHE AND MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. DISCREPANCY NOTED: DATE OF EXPLANT :(B)(6) 2016. LEGACY DEVICE REPORT NUM 2951250-2020-11086 MEDWATCH 3500A MFR NUMBER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: SUCCESSFUL FALLOPIAN TUBE OCCLUSION; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: CURRENT WEIGHT 190 LBS. ON (B)(6) 2016 MRI OF BRAIN AND ECG WAS PERFORMED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS- ABDOMINAL PAIN. SEIZURES, NAUSEA, PELVIC PAIN". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2020: QUALITY-SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860645 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ANTIBIOTICS| ANTIBIOTICS| ATIVAN| ATIVAN| ATIVAN| BUPIVACAINE| BUPIVACAINE| BUPIVACAINE| DEPO-PROVERA| DEPO-PROVERA| IMITREX| IMITREX [SUMATRIPTAN]| IMITREX [SUMATRIPTAN]| LUNESTA| LUNESTA| LUNESTA| NORTRIPTYLINE| NORTRIPTYLINE| NORTRIPTYLINE| ZOLOFT| ZOLOFT| ZOLOFT |