ESSURE
Report
- Report Number
- 2951250-2019-05332
- Event Type
- Injury
- Date Received
- September 4, 2019
- Date of Event
- February 1, 2008
- Report Date
- May 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL. BLEEDING') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED COLPOSCOPY IN (B)(6) , CRYOSURGERY IN (B)(6) , BIOPSY IN (B)(6) , TONSILLECTOMY, CONDYLOMA, NAUSEA, VOMITING, UTERINE DILATION AND CURETTAGE AND MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL SINCE (B)(6) , POISON IVY RASH, RASH, ALLERGY, ITCHING, URINARY RETENTION, ENCEPHALITIS BRAIN STEM, FINGER INJURY, DYSPLASIA AND HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION. CONCOMITANT PRODUCTS INCLUDED OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PREDNISONE. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION / PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH / PSYCH INJURY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY (FULL), ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, ABDOMINAL PAIN AND VAGINAL INFECTION HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL( DISCREPANCY NOTED) DISCREPANCY: PLAINTIFF PREVIOUSLY PERFORMED ESSURE CONFIRMATION TEST NOW IT IS REPORTED AS PLAINTIFF DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS : PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED. REPORTER ADDED. EVENTS ABDOMINAL PAIN, GENERAL ABNORMAL. BLEEDING AND VAGINAL INFECTION ADDED. INCIDENT: 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 INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL. BLEEDING') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED COLPOSCOPY IN 2007, CRYOSURGERY IN 2007, BIOPSY IN 2007, TONSILLECTOMY, CONDYLOMA, NAUSEA, VOMITING, UTERINE DILATION AND CURETTAGE AND MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL SINCE 2004, POISON IVY RASH, RASH, ALLERGY, ITCHING, URINARY RETENTION, ENCEPHALITIS BRAIN STEM, FINGER INJURY, DYSPLASIA AND HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PREDNISONE AND TOPIRAMATE (TOPAMAX). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2008, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN FEBRUARY 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION / PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH / PSYCH INJURY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY (FULL), ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL( DISCREPANCY NOTED) DISCREPANCY: PLAINTIFF PREVIOUSLY PERFORMED ESSURE CONFIRMATION TEST NOW IT IS REPORTED AS PLAINTIFF DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS : PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. CONCOMITANT MEDICATION AND EVENT; MIGRAINES / HEADACHES WERE ADDED.. INCIDENT BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') IN A 21-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED COLPOSCOPY IN 2007, CRYOSURGERY IN 2007, BIOPSY IN 2007, TONSILLECTOMY, CONDYLOMA, NAUSEA, VOMITING, UTERINE DILATION AND CURETTAGE AND MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL SINCE 2004, POISON IVY RASH, RASH, ALLERGY, ITCHING, URINARY RETENTION, ENCEPHALITIS BRAIN STEM, FINGER INJURY, DYSPLASIA, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION AND BIPOLAR DISORDER. CONCOMITANT PRODUCTS INCLUDED TOPIRAMATE (TOPAMAX) FOR BIPOLAR DISORDER AS WELL AS CELECOXIB (CELEXA), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PREDNISONE. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION / PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH / PSYCH INJURY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GENERAL ABNORMAL. BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY (FULL-UTERUS AND CERVIX)). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED, THE DEPRESSION, ANXIETY AND MIGRAINE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL( DISCREPANCY NOTED) DISCREPANCY: PLAINTIFF PREVIOUSLY PERFORMED ESSURE CONFIRMATION TEST NOW IT IS REPORTED AS PLAINTIFF DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. SHE RECEIVED TREATMENT FOR EVENTS BLEEDING, PELVIC PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS : PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PLAINTIFF FACT SHEET: RECEIVED. OUTCOME OF EVENTS BLEEDING, PELVIC PAIN UPDATED AS RECOVERED. EVENT OF GENITAL HAEMORRHAGE DOWNGRADED TO NON-SERIOUS. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED COLPOSCOPY IN 2007, CRYOSURGERY IN 2007, BIOPSY IN 2007, TONSILLECTOMY, CONDYLOMA, NAUSEA, VOMITING, UTERINE DILATION AND CURETTAGE AND MISCARRIAGE. CONCURRENT CONDITIONS INCLUDED PAP SMEAR ABNORMAL SINCE 2004, POISON IVY RASH, RASH, ALLERGY, ITCHING, URINARY RETENTION, ENCEPHALITIS BRAIN STEM, FINGER INJURY, DYSPLASIA AND HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION. CONCOMITANT PRODUCTS INCLUDED OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PREDNISONE. IN (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY (FULL), ON (B)(6)2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL( DISCREPANCY NOTED) DISCREPANCY: PLAINTIFF PREVIOUSLY PERFORMED ESSURE CONFIRMATION TEST NOW IT IS REPORTED AS PLAINTIFF DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2019: PFS & MR RECEIVED. NEW EVENTS- "ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), URINARY TRACT INFECTION, DEPRESSION, MENTAL ANGUISH", CONCOMITANT CONDITIONS, CONCOMITANT & TREATMENT DRUGS, REPORTER¿S INFORMATION, PATIENT¿S DEMOGRAPHICS WERE ADDED. INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 753032 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other| R | CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| DEPO PROVERA| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE| TOPAMAX| TOPAMAX |