ESSURE
Report
- Report Number
- 2951250-2017-01140
- Event Type
- Injury
- Date Received
- March 29, 2017
- Date of Event
- February 25, 2013
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CHRONIC SALPINGITIS AND PELVIC ADHESIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) "). ON (B)(6) 2014, 1 YEAR 4 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BOTH FALLOPIAN TUBES WERE REMOVED TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER, PROCEDURAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME SLIGHT OBSTRUCTION ON THE PATIENT¿S LEFT; IT DID NOT GO IN AS WELL, BUT THERE WAS ADEQUATE SPRING IN THE TUBAL OS FOR SCARRING AND THERE WAS NO BLEEDING. DISCRIPANCY NOTED IN ESSURE INSERTIN DATE. TWO DATES WERE REPORTED. (B)(6) 2013. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC INFLAMMATORY DISEASE & LOWER ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES CANNOT BE EVALUATED. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAR-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS PELVIC INFLAMMATORY DISEASE ,ABNORMAL BLEEDING, VAGINAL BLEEDING, MENORRHAGIA, DYSMENORRHEA ARE ADDED. LOT NUMBER ADDED. PATIENT , REPORTER & PRODUCT INFORMATION UPDATED. 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 PAIN ("SEVERE PELVIC PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CHRONIC SALPINGITIS AND PELVIC ADHESIONS. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) "). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 1 YEAR 4 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER, PROCEDURAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME SLIGHT OBSTRUCTION ON THE PATIENT¿S LEFT; IT DID NOT GO IN AS WELL, BUT THERE WAS ADEQUATE SPRING IN THE TUBAL OS FOR SCARRING AND THERE WAS NO BLEEDING. DISCRIPANCY NOTED IN ESSURE INSERTIN DATE. TWO DATES WERE REPORTED. (B)(6) 2013 & (B)(6) 2013. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC INFLAMMATORY DISEASE & LOWER ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 ("SEVERE PELVIC PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CHRONIC SALPINGITIS AND PELVIC ADHESIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) "). ON (B)(6) 2014, 1 YEAR 4 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014 AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER, PROCEDURAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME SLIGHT OBSTRUCTION ON THE PATIENT¿S LEFT; IT DID NOT GO IN AS WELL, BUT THERE WAS ADEQUATE SPRING IN THE TUBAL OS FOR SCARRING AND THERE WAS NO BLEEDING. DISCRIPANCY NOTED IN ESSURE INSERTIN DATE. TWO DATES WERE REPORTED. (B)(6) 2013. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC INFLAMMATORY DISEASE & LOWER ABDOMINAL PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAY-2018: PFS RECEIVED. OUTCOME OF THE EVENT PELVIC PAIN WAS UPDATED TO RECOVERING/RESOLVING. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CHRONIC SALPINGITIS AND PELVIC ADHESIONS. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) "). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, 1 YEAR 4 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014) AND SURGERY (DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER, PROCEDURAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME SLIGHT OBSTRUCTION ON THE PATIENT¿S LEFT; IT DID NOT GO IN AS WELL, BUT THERE WAS ADEQUATE SPRING IN THE TUBAL OS FOR SCARRING AND THERE WAS NO BLEEDING. DISCRIPANCY NOTED IN ESSURE INSERTIN DATE. TWO DATES WERE REPORTED. (B)(6) 2013 & (B)(6) 2013. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC INFLAMMATORY DISEASE & LOWER ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: PFS RECEIVED: ADDED EVENTS DEPRESSION,MENTAL ANGUISH. UPDATED ONSET DATE AND OUTCOME OF EVENT PELVIC PAIN. 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 ('SEVERE PELVIC PAIN') AND PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CHRONIC SALPINGITIS, PELVIC ADHESIONS AND THYROID DISORDER. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE, NSAIDS AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014 AND DIAGNOSTIC LAPAROSCOPY BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER, PROCEDURAL PAIN, DYSMENORRHOEA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME SLIGHT OBSTRUCTION ON THE PATIENT¿S LEFT; IT DID NOT GO IN AS WELL, BUT THERE WAS ADEQUATE SPRING IN THE TUBAL OS FOR SCARRING AND THERE WAS NO BLEEDING. DISCRIPANCY NOTED IN ESSURE INSERTIN DATE. TWO DATES WERE REPORTED. (B)(6) 2013 & (B)(6) 2013. PATIENT RECEIVED TREATMENT FOR PAIN. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC INFLAMMATORY DISEASE & LOWER ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: EVENT OUTCOME OF VAGINAL HEMORRHAGE, GENITAL BLEEDING, MENORRHAGIA WERE UPDATED AS RECOVERED/RESOLVED. RCC NOTE ADDED. 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES CANNOT BE EVALUATED. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE, NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2017: QUALITY-SAFETY EVALUATION OF PTC (PTC GLOBAL NUMBER (B)(4)). COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED SEVERE PELVIC PAIN. A BILATERAL SALPINGECTOMY TO REMOVE ESSURE WAS PERFORMED AROUND ONE YEAR AFTER PLACEMENT. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS PRESENT CASE, AFTER THE IMPLANT PROCEDURE, CONSUMER EXPERIENCED SEVERE PELVIC PAIN. CONSIDERING THE NATURE OF THE EVENT AND ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT STARTED ESSURE. ON (B)(6) 2014, 490 DAYS AFTER STARTING ESSURE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("FOLLOWING THE REMOVAL, PLAINTIFF UNDERWENT A PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("ISSUES WITH MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (BOTH FALLOPIAN TUBES WERE REMOVED TO REMOVE THE ESSURE DEVICE ON (B)(6) 2014). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUAL DISORDER AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN, MENSTRUAL DISORDER AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED SEVERE PELVIC PAIN. A BILATERAL SALPINGECTOMY TO REMOVE ESSURE WAS PERFORMED AROUND ONE YEAR AFTER PLACEMENT. THE REPORTED EVENT IS SERIOUS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS PRESENT CASE, AFTER THE IMPLANT PROCEDURE, CONSUMER EXPERIENCED SEVERE PELVIC PAIN. CONSIDERING THE NATURE OF THE EVENT AND ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS HAS BEEN SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226850 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | ACETAMINOPHEN| LEVOTHYROXINE| NSAIDS |