ESSURE
Report
- Report Number
- 2951250-2019-04160
- Event Type
- Injury
- Date Received
- July 24, 2019
- Date of Event
- August 1, 2013
- Report Date
- September 12, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), EMBEDDED DEVICE ('ESSURE DEVICE THAT HAS ERODED THROUGH THE TUBE, AND A FAIRLY LARGE PORTION OF THE ESSURE DEVICE IS STUCK TO THE TUBE AND THE SEROSA OF THE UTERUS ON THE LEFT FUNDAL PORTION OF THE UTERUS') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11725, B11729) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. 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), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND MIGRAINE ("MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY ABLATION AND SURGICAL REMOVAL OF COIL; DILATION AND CURETTAGE, EXCISION OF RIGHT HIP NEVUS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, MENORRHAGIA, DYSPAREUNIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYSTITIS, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- RECOVERY FROM HYSTERECTOMY ESSURE DEVICE WAS THEN INTRODUCED INTO THE LEFT FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING FOUR COILS VISIBLE IN THE ENDOMETRIAL CAVITY. USING CAUTERY AND A PICKUP, THE ESSURE DEVICE WAS CAREFULLY AND GRADUALLY DISSECTED FROM THE UTERUS AND THE TUBE AND REMOVED FROM THE LEFT FUNDAL PORTION OF THE UTERUS. THIS WAS REMOVED THROUGH THE LOWER TROCAR SITE AND PASSED OFF THE TABLE AS A PORTION OF ESSURE DEVICE. I COULD NOT TELL IF ALL THE ESSURE DEVICE WAS THERE OR JUST A PART OF IT. AT THIS TIME, VISUALIZATION OF THE RIGHT TUBE REVEALED SOME BULGE COMING OFF THE RIGHT TUBE WHERE THE ESSURE DEVICE SHOULD BE REMOVED, AND IT APPEARS TO MOST LIKELY BE IN PLACE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER: B11725 MANUFACTURE DATE: 2013-03 EXPIRATION DATE: 2016-03. LOT NUMBER:B11729 MANUFACTURE DATE:2013-03 EXPIRATION DATE: 2016-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-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'), EMBEDDED DEVICE ('ESSURE DEVICE THAT HAS ERODED THROUGH THE TUBE, AND A FAIRLY LARGE PORTION OF THE ESSURE DEVICE IS STUCK TO THE TUBE AND THE SEROSA OF THE UTERUS ON THE LEFT FUNDAL PORTION OF THE UTERUS') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11725, B11729) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. 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), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND MIGRAINE ("MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY ABLATION AND SURGICAL REMOVAL OF COIL; DILATION AND CURETTAGE, EXCISION OF RIGHT HIP NEVUS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, EMBEDDED DEVICE, MENORRHAGIA, DYSPAREUNIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYSTITIS, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- RECOVERY FROM HYSTERECTOMY ESSURE DEVICE WAS THEN INTRODUCED INTO THE LEFT FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING FOUR COILS VISIBLE IN THE ENDOMETRIAL CAVITY. USING CAUTERY AND A PICKUP, THE ESSURE DEVICE WAS CAREFULLY AND GRADUALLY DISSECTED FROM THE UTERUS AND THE TUBE AND REMOVED FROM THE LEFT FUNDAL PORTION OF THE UTERUS. THIS WAS REMOVED THROUGH THE LOWER TROCAR SITE AND PASSED OFF THE TABLE AS A PORTION OF ESSURE DEVICE. I COULD NOT TELL IF ALL THE ESSURE DEVICE WAS THERE OR JUST A PART OF IT. AT THIS TIME, VISUALIZATION OF THE RIGHT TUBE REVEALED SOME BULGE COMING OFF THE RIGHT TUBE WHERE THE ESSURE DEVICE SHOULD BE REMOVED, AND IT APPEARS TO MOST LIKELY BE IN PLACE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2019: MR RECEIVED. LOT NUMBER ADDED. ESSURE DEVICE THAT HAS ERODED THROUGH THE TUBE, AND A FAIRLY LARGE PORTION OF THE ESSURE DEVICE IS STUCK TO THE TUBE AND THE SEROSA OF THE UTERUS ON THE LEFT FUNDAL PORTION OF THE UTERUS EVENT ADDED. CONCOMITANT CONDITION ADDED. 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'), EMBEDDED DEVICE ('ESSURE DEVICE THAT HAS ERODED THROUGH THE TUBE, AND A FAIRLY LARGE PORTION OF THE ESSURE DEVICE IS STUCK TO THE TUBE AND THE SEROSA OF THE UTERUS ON THE LEFT FUNDAL PORTION OF THE UTERUS') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11725, B11729) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST. DATE OF COMMUNICATION: (B)(6) 2013. WHAT DID YOUR HEALTHCARE PROVIDER TELL YOU ABOUT YOUR RESULTS? BOTH FALLOPIAN TUBES WERE CLOSED. 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), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND MIGRAINE ("MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL),SALPING. (BILATERAL); DILATION AND CURETTAGE, EXCISION OF RIGHT HIP NEVUS, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND LAPAROSCOPY ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA, URINARY TRACT INFECTION, MIGRAINE AND ABDOMINAL PAIN HAD NOT RESOLVED AND THE EMBEDDED DEVICE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN, CYSTITIS AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYSTITIS, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- RECOVERY FROM HYSTERECTOMY ESSURE DEVICE WAS THEN INTRODUCED INTO THE LEFT FALLOPIAN TUBE AND IT WAS DEPLOYED WITHOUT DIFFICULTY LEAVING FOUR COILS VISIBLE IN THE ENDOMETRIAL CAVITY. USING CAUTERY AND A PICKUP, THE ESSURE DEVICE WAS CAREFULLY AND GRADUALLY DISSECTED FROM THE UTERUS AND THE TUBE AND REMOVED FROM THE LEFT FUNDAL PORTION OF THE UTERUS. THIS WAS REMOVED THROUGH THE LOWER TROCAR SITE AND PASSED OFF THE TABLE AS A PORTION OF ESSURE DEVICE. I COULD NOT TELL IF ALL THE ESSURE DEVICE WAS THERE OR JUST A PART OF IT. AT THIS TIME, VISUALIZATION OF THE RIGHT TUBE REVEALED SOME BULGE COMING OFF THE RIGHT TUBE WHERE THE ESSURE DEVICE SHOULD BE REMOVED, AND IT APPEARS TO MOST LIKELY BE IN PLACE. DISCREPANCY REMOVAL DATE (B)(6) 2016 AND AS PER PFS DATE. (B)(6) 2018. PATIENT RECEIVED TREATMENT FOR DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER: B11725, MANUFACTURE DATE: 2013-03, EXPIRATION DATE: 2016-03. LOT NUMBER:B11729, MANUFACTURE DATE:2013-03, EXPIRATION DATE: 2016-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED EVENT " ABDOMINAL PAIN" WAS ADDED. OUTCOME OF EVENTS" DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), UTI, MIGRAINE" WERE UPDATED AS NOT RECOVERED. REPORTER INFORMATION 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 AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11725) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND MIGRAINE ("MIGRAINES / HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL; DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, VULVOVAGINAL PAIN, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYSTITIS, DYSPAREUNIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- RECOVERY FROM HYSTERECTOMY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2019: PFS RECEIVED- LOT NUMBER WERE ADDED. NEW EVENTS ABNORMAL BLEEDING (MENORRHAGIA), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINES / HEADACHES, PELVIC PAIN, VAGINAL PAIN WERE ADDED. EVENT INJURY UPDATED TO ABNORMAL BLEEDING (VAGINAL). NEW REPORTER, PATIENT INFORMATION, LAB DATA WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617917 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B11725, B11729 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R |