ESSURE
Report
- Report Number
- 2951250-2017-07766
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- December 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM 15-AUG-2003 TO 23-JUN-2006 FOR FEMALE STERILISATION AS WELL AS OPTIMAX SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. HISTORICAL CONDITION WERE ADDED. NEW REPORTERS AND REPORTER INFORMATION ADDED. PLAINTIFF DEMOGRAPHY ADDED. LOT NO. RECEIVED. PRODUCT INDICATION ADDED AND IMPLANTED DATE UPDATED. FOLLOWING EVENT: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM AND ABDOMEN PAIN WERE ADDED. LAB DATA 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 PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM (B)(6) 2003 TO (B)(6) 2006 FOR FEMALE STERILISATION AS WELL AS OPTIMAX SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE AND THEY WERE IN PLACE AND IN THE PROPER POSITION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM." THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM (B)(6) 2003 TO (B)(6) 2006 FOR FEMALE STERILISATION AS WELL AS OPTIMAX SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE AND THEY WERE IN PLACE AND IN THE PROPER POSITION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-OCT-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: NO VALID 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM (B)(6) 2003 TO (B)(6) 2006 FOR FEMALE STERILISATION AS WELL AS OPTIMAX SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE AND THEY WERE IN PLACE AND IN THE PROPER POSITION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-OCT-2018: PFS RECEIVED, EVENT CRAMPING 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69-NOT VALID, 12238869) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM". THE PATIENT'S MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM (B)(6) 2003 TO (B)(6) 2006 FOR FEMALE STERILISATION AS WELL AS IRBESARTAN (OPTIMA) SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN"), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE AND THEY WERE IN PLACE AND IN THE PROPER POSITION THIS LOT NUMBER I2238/69 IS NOT VALID. LOT NUMBER: 12238869 MANUFACTURING DATE: 2003/06 EXPIRATION DATE: 2004/02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-DEC-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 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 ('PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. I2238/69-NOT VALID, 12238869) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WAS ENCOUNTERED INSERTING THE DELIVERY SYSTEM". THE PATIENT'S MEDICAL HISTORY INCLUDED MITRAL VALVE PROLAPSE AND BACK INJURY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELLBUTRIN AND ALBUTEROL INHALER. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YASMIN) FROM (B)(6) 2003 TO (B)(6) 2006 FOR FEMALE STERILISATION AS WELL AS IRBESARTAN (OPTIMA) SINCE 1998. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING/ABNORMAL BLEEDING (GENERAL)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("LOCATION OF PAIN: ABDOMEN") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED AND THE ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE OUTER COIL OF THE MICRO-INSERT WAS OBSERVED TO EXPAND AND UNWIND. AFTER WAITING APPROXIMATELY 10 SECONDS FOR THE OUTER COILS TO EXPAND. THE TRAILING COILS WERE COUNTED AND 4 TRAILING COILS WERE NOTED OUTSIDE THE LEFT FALLOPIAN TUBE OSTIUM. THERE WERE B COILS OUTSIDE OF THE RIGHT FALLOPIAN TUBE OSTIUM. DIAGNOSTIC RESULTS: IN 2003, ESSURE CONFIRMATION TEST DONE AND THEY WERE IN PLACE AND IN THE PROPER POSITION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-DEC-2020: MR RECEIVED: LOT NUMBER WAS UPDATED. PATIENT MIDDLE NAME WAS ADDED. EVENT GENITAL HAEMORRHAGE SERIOUSNESS CRITERIA UPDATED AS NON-SERIOUS. 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 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 ("PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2006. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). 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 |
|---|---|---|---|---|---|---|---|
| 835585 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | I2238/69-NOT VALID, 12238869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | OPTIMA| OPTIMA| OPTIMAX| OPTIMAX| OPTIMAX| OPTIMAX| YASMIN| YASMIN| YASMIN| YASMIN| YASMIN| YASMIN |