ESSURE
Report
- Report Number
- 2951250-2018-01396
- Event Type
- Injury
- Date Received
- April 2, 2018
- Report Date
- November 28, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901333) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CROHN'S DISEASE, ESOPHAGEAL REFLUX, IRRITABLE COLON, BENIGN OVARIAN CYST, VAGINAL DISCHARGE, UTERINE LEIOMYOMA AND IRON DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED AZATHIOPRINE SODIUM (IMURAN), CITALOPRAM, IRON AND SUMATRIPTAN (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("HORMONAL CHANGES DESCRIBE: MENSTRUAL MIGRAINES"), 1 MONTH 21 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED GRANULOMA ANNULARE ("RASHES OR SKIN CONDITIONS TYPE: ANULARA; GRANULOMA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASHES ON ARMS AND LEGS"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE BACK PAIN, ABDOMINAL PAIN, MIGRAINE, RASH, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, DEPRESSION, GRANULOMA ANNULARE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, GRANULOMA ANNULARE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN RIGHT FALLOPIAN TUBE (AS INTERPRETED FROM PROCEDURE) NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 4. ON OPPOSITE SIDE THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS- PELVIC PAIN, MENSTRUAL MIGRAINE, ANXIETY, DYSMENORRHOEA, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-NOV-2019: NEW PFS RECEIVED- EVENT HEADACHE WAS ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901333) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHRONIC DISEASE, ESOPHAGEAL REFLUX, IRRITABLE COLON, BENIGN OVARIAN CYST, VAGINAL DISCHARGE, UTERINE LEIOMYOMA AND IRON DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED AZATHIOPRINE SODIUM (IMURAN), CITALOPRAM, IRON AND SUMATRIPTAN (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("HORMONAL CHANGES DESCRIBE: MENSTRUAL MIGRAINES"), 1 MONTH 21 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASHES ON ARMS AND LEGS"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND GRANULOMA ANNULARE ("RASHES OR SKIN CONDITIONS TYPE: ANULARA; GRANULOMA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE BACK PAIN, ABDOMINAL PAIN, MIGRAINE, RASH, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, DEPRESSION AND GRANULOMA ANNULARE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, GRANULOMA ANNULARE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN RIGHT FALLOPIAN TUBE (AS INTERPRETED FROM PROCEDURE) NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 4. ON OPPOSITE SIDE THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENSTRUAL MIGRAINE, ANXIETY, DYSMENORRHOEA, MENORRHAGIA. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-DEC-2018: PFS AND MR RECEIVED, REPORTER ADDED, AKA ADDED, PATIENT DEMOGRAPHIC UPDATED, LOT NUMBER ADDED, PRODUCT INDICATION ADDED, EVENT ADDED: GRANULOMA ANNULARE. EVENTS ONSET DATE, OUTCOME AND SEVERITY ADDED. PATIENTS MEDICAL HISTORY AND CONCOMITANT DRUG ADDED, LAB DATA ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901333) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CROHN'S DISEASE, ESOPHAGEAL REFLUX, IRRITABLE COLON, BENIGN OVARIAN CYST, VAGINAL DISCHARGE, UTERINE LEIOMYOMA AND IRON DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED AZATHIOPRINE SODIUM (IMURAN), CITALOPRAM, IRON AND SUMATRIPTAN (IMITREX). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("HORMONAL CHANGES DESCRIBE: MENSTRUAL MIGRAINES"), 1 MONTH 21 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASHES ON ARMS AND LEGS"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND GRANULOMA ANNULARE ("RASHES OR SKIN CONDITIONS TYPE: ANULARA; GRANULOMA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE BACK PAIN, ABDOMINAL PAIN, MIGRAINE, RASH, DYSMENORRHOEA, MENORRHAGIA, ANXIETY, DEPRESSION AND GRANULOMA ANNULARE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, GRANULOMA ANNULARE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN RIGHT FALLOPIAN TUBE (AS INTERPRETED FROM PROCEDURE) NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 4. ON OPPOSITE SIDE THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS- PELVIC PAIN, MENSTRUAL MIGRAINE, ANXIETY, DYSMENORRHOEA, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-2019: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINES"), RASH ("RASHES ON ARMS AND LEGS"), DYSMENORRHOEA ("DYSMENORRHEA"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH REMOVAL OF THE ESSURE DEVICES). ESSURE WAS REMOVED IN DECEMBER 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, MIGRAINE, RASH, DYSMENORRHOEA, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND RASH TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT WAS NOT PROVIDED. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 230756 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | CITALOPRAM| CITALOPRAM| CITALOPRAM| IMITREX [SUMATRIPTAN]| IMITREX [SUMATRIPTAN]| IMITREX [SUMATRIPTAN]| IMURAN [AZATHIOPRINE SODIUM]| IMURAN [AZATHIOPRINE SODIUM]| IMURAN [AZATHIOPRINE SODIUM]| IRON| IRON| IRON |