ESSURE
Report
- Report Number
- 2951250-2017-09875
- Event Type
- Injury
- Date Received
- December 5, 2017
- Report Date
- August 9, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ("INFECTION (OTHER): PELVIC") AND PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852006) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4, ENDOMETRIOSIS, VAGINITIS, CHOLECYSTECTOMY, UTI, CESAREAN SECTION, HYPERTENSION, OBESITY, URINATION PAIN AND BLOOD TRANSFUSION. CONCURRENT CONDITIONS INCLUDED NAUSEA (POSTOPERATIVE), VOMITING (POSTOPERATIVE), BLADDER INFECTION, ANXIETY, DEPRESSION AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION AND PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT/LEFT OOPHORECTOMY, LYSIS OF ADHESIONS, D & C) AND SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT/LEFT OOPHORECTOMY, LYSIS OF ADHESIONS, D & C). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFECTION, PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MR: PROCEDURE: THE HYSTEROSCOPE WAS INSERTED NOTING BOTH OSTIA. THE LEFT OSTIA WERE VISUALIZED, AND THE COIL WAS INSERTED WITH THREE TRAILING COILS. THE RIGHT OSTIA WERE THEN VISUALIZED AND THE COIL INSERTED WITH ONE TRAILING COIL. THE NUVARING WAS REPLACED IN THE PATIENT'S VAGINA, HAD BEEN REMOVED PRIOR TO SURGERY. DIAGNOSTIC RESULTS: (B)(6) 2014 - US PELVIC (NON OB) COMPLETE - NEGATIVE PELVIC ULTRA SONOGRAPHIC ANALYSIS . ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: THIS CASE IS MEDICALLY CONFIRMED. REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS ADULT PATIENT. HER HISTORICAL/CONCURRENT CONDITIONS WERE ADDED. ESSURE INSERTION AND REMOVAL DATE WAS ADDED. ESSURE LOT NUMBER WAS ADDED. ESSURE INDICATION WAS ADDED. FOLLOWING EVENTS: INFECTION (OTHER): PELVIC ABNORMAL BLEEDING AND (MENORRHAGIA/VAGINA) 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ("INFECTION (OTHER): PELVIC") AND PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852006) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4, ENDOMETRIOSIS, VAGINITIS, CHOLECYSTECTOMY, UTI, CESAREAN SECTION, HYPERTENSION, OBESITY, URINATION PAIN AND BLOOD TRANSFUSION. CONCURRENT CONDITIONS INCLUDED NAUSEA (POSTOPERATIVE), VOMITING (POSTOPERATIVE), BLADDER INFECTION, ANXIETY, DEPRESSION AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT/LEFT OOPHORECTOMY, LYSIS OF ADHESIONS, D & C). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFECTION, PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC INFECTION, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MR: PROCEDURE: THE HYSTEROSCOPE WAS INSERTED NOTING BOTH OSTIA. THE LEFT OSTIA WERE VISUALIZED, AND THE COIL WAS INSERTED WITH THREE TRAILING COILS. THE RIGHT OSTIA WERE THEN VISUALIZED AND THE COIL INSERTED WITH ONE TRAILING COIL. THE NUVARING WAS REPLACED IN THE PATIENT'S VAGINA, HAD BEEN REMOVED PRIOR TO SURGERY. DIAGNOSTIC RESULTS: (B)(6) 2014 - US PELVIC (NON OB) COMPLETE - NEGATIVE PELVIC ULTRA SONOGRAPHIC ANALYSIS . ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFECTION ('INFECTION (OTHER): PELVIC') AND PELVIC PAIN ('PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852006) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 4), PARITY 4, ENDOMETRIOSIS, VAGINITIS, CHOLECYSTECTOMY, UTI, CESAREAN SECTION, HYPERTENSION, OBESITY, URINATION PAIN AND BLOOD TRANSFUSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: NUVARING FROM (B)(6) 2011 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED NAUSEA (POSTOPERATIVE), VOMITING (POSTOPERATIVE), BLADDER INFECTION, ANXIETY, DEPRESSION AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED AMLODIPINE FROM (B)(6) 2015 TO (B)(6) 2017 AND HYDROCHLOROTHIAZIDE FROM (B)(6) 2015 TO (B)(6) 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("PAIN VAGINALLY INTERNALLY / VAGINA PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: RECURRENT UTI'S"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT/LEFT OOPHORECTOMY, LYSIS OF ADHESIONS, D & C). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC INFECTION, URINARY TRACT INFECTION AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED MENORRHAGIA, PELVIC INFECTION, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MR: PROCEDURE: THE HYSTEROSCOPE WAS INSERTED NOTING BOTH OSTIA. THE LEFT OSTIA WERE VISUALIZED, AND THE COIL WAS INSERTED WITH THREE TRAILING COILS. THE RIGHT OSTIA WERE THEN VISUALIZED AND THE COIL INSERTED WITH ONE TRAILING COIL. THE NUVARING WAS REPLACED IN THE PATIENT'S VAGINA, HAD BEEN REMOVED PRIOR TO SURGERY. DISCREPANCY NOTED IN DATE OF REMOVAL (B)(6) 2014 AND (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION. DIAGNOSTIC RESULTS: (B)(6) 2014 - US PELVIC (NON OB) COMPLETE - NEGATIVE PELVIC ULTRA SONOGRAPHIC ANALYSIS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-AUG-2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: RECURRENT UTI'S, PAIN VAGINALLY INTERNALLY. OUTCOME OF EVENT PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE WAS UPDATED. DATE OF REMOVAL WAS UPDATED FROM (B)(6) 2014 TO (B)(6) 2017. CONCOMITANT DRUG, LAB DATA WERE 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 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 ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 864345 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | AMLODIPINE| HYDROCHLOROTHIAZIDE |