ESSURE
Report
- Report Number
- 2951250-2019-06117
- Event Type
- Injury
- Date Received
- September 11, 2019
- Date of Event
- June 1, 2012
- Report Date
- April 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE HEADACHE, NAUSEA AND UNINTENDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED GESTATIONAL DIABETES, DYSPAREUNIA AND URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN / CHRONIC"), PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("HIP PAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, PAIN IN EXTREMITY, ARTHRALGIA AND BACK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: BILATERAL OCCLUSION. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE HEADACHE, NAUSEA AND UNINTENDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED GESTATIONAL DIABETES, DYSPAREUNIA AND URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN / CHRONIC"), PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("HIP PAIN"), BACK PAIN ("LOWER BACK PAIN") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES).). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, PAIN IN EXTREMITY, ARTHRALGIA AND BACK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: BILATERAL OCCLUSION. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED: EVENT WAS ADDED- MEMORY LOSS .REPORTER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE HEADACHE, NAUSEA AND UNINTENDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED GESTATIONAL DIABETES, DYSPAREUNIA AND URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN / CHRONIC"), PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("HIP PAIN"), BACK PAIN ("LOWER BACK PAIN") AND AMNESIA ("MEMORY LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("GAINED 53IBS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES).). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, PAIN IN EXTREMITY, ARTHRALGIA AND BACK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: BILATERAL OCCLUSION. LOT NUMBER: 822376 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED:-NEW EVENT "GAINED 53IBS" WAS ADDED. REPORTER WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE HEADACHE, NAUSEA AND UNINTENDED PREGNANCY. CONCURRENT CONDITIONS INCLUDED GESTATIONAL DIABETES, DYSPAREUNIA AND URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), FATIGUE ("FATIGUE"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN / CHRONIC"), PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("HIP PAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES).). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, PAIN IN EXTREMITY, ARTHRALGIA AND BACK PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, FATIGUE, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS RECEIVED. LOT NUMBER ,LAB DATA AND CONCOMITANT MEDICATION AND CONDITION ADDED. EVENTS ; ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, DYSMENORRHEA, FATIGUE, INFECTION (BLADDER/URINARY TRACT/VAGINAL): BLADDER/URINARY, LEG PAIN, HIP PAIN, LOWER BACK PAIN WERE 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 / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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), ABDOMINAL PAIN ("ABDOMINAL PAIN / CHRONIC") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(4) 2011: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT APPROXIMATELY/ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED. CASE BECAME INCIDENT. THE PREVIOUSLY REPORTED EVENT INJURY WAS REPLACED WITH EVENTS FROM PFS: PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING). OUTCOME OF PAIN WAS UPDATED. LABORATORY DATA WAS ADDED, ESSURE INSERTION DATE, REMOVAL DATE WITH PROCEDURE WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 789734 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822376 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | ONDANSETRON| ONDANSETRON| ONDANSETRON| ONDANSETRON |