ESSURE
Report
- Report Number
- 2951250-2017-04889
- Event Type
- Injury
- Date Received
- October 18, 2017
- Date of Event
- June 3, 2009
- Report Date
- July 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION: COURNA/ MIGRATION OF ESSURE DEVICE: UTERUS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN CONSTANT"). ON (B)(6) 2009, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VULVOVAGINITIS ("VULVOVAGINITIS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("VAGINITIS INFECTIONS") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY WITH INCISION INTO LLQ, ESSURE LEFT TUBAL FULGARATION), AND SURGERY ((B)(6) 2013, ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, VAGINAL INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINITIS, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA WAS RESOLVING AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINITIS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. ON (B)(6) 2009, PATIENT HAD CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2018: PFS RECEIVED. EVENTS ADDED: DYSMENORRHOEA, DYSPAREUNIA, EVENT OUTCOME ADDED FOR EVENT ABNORMAL BLEEDING AND INFECTIONS. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), UTERINE PERFORATION ("PERFORATION: COURNA") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED VULVOVAGINITIS ("VULVOVAGINITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL INFECTION ("VAGINITIS INFECTIONS") WITH VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGOOOPHERECTOMY - DIAGNOSTIC LAPAROSCOPY WITH INCISION INTO LLQ) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, MENORRHAGIA, VAGINAL INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINITIS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINITIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 170 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. ON (B)(6) 2009, PATIENT HAD CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-APR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. ESSURE INSERTION DATE UPDATED TO (B)(6) 2009 AND REMOVAL DATE ((B)(6) 2009) ADDED. EVENTS ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), VULVOVAGINITIS, VAGINITIS, PERFORATION: COURNA AND ABDOMINAL PAIN ADDED. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION: COURNA/ MIGRATION OF ESSURE DEVICE: UTERUS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN CONSTANT"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2009, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VULVOVAGINITIS ("VULVOVAGINITIS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL INFECTION ("VAGINITIS INFECTIONS") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY WITH INCISION INTO LLQ, ESSURE LEFT TUBAL FULGARATION), SURGERY (DIAGNOSTIC LAPAROSCOPY WITH INCISION INTO LLQ, ESSURE LEFT TUBAL FULGARATION) AND SURGERY ((B)(6) 2013, ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, VAGINAL INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINITIS, DYSMENORRHOEA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN, THE MENORRHAGIA WAS RESOLVING AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINITIS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. ON (B)(6) 2009, PATIENT HAD CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: PLAINTIFF FACT SHEET RECEIVED: DEPRESSION AND MENTAL ANGUISH EVENTS WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('FALLOPIAN TUBE PERFORATION'), UTERINE PERFORATION ('PERFORATION: COURNA/ MIGRATION OF ESSURE DEVICE: UTERUS'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN CONSTANT"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 26 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VULVOVAGINITIS ("VULVOVAGINITIS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("VAGINITIS INFECTIONS") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2013, ENDOMETRIAL ABLATION AND SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, VULVOVAGINITIS, DYSMENORRHOEA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, ABDOMINAL PAIN, VAGINAL INFECTION AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINITIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PERFORATION, MIGRATION, URINARY / BLADDER PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2009: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 FALLOPIAN TUBE PERFORATION ('FALLOPIAN TUBE PERFORATION'), UTERINE PERFORATION ('PERFORATION: COURNA/ MIGRATION OF ESSURE DEVICE: UTERUS'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN CONSTANT"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 26 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VULVOVAGINITIS ("VULVOVAGINITIS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("VAGINITIS INFECTIONS") WITH VAGINAL DISCHARGE. THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2013, ENDOMETRIAL ABLATION AND SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, VULVOVAGINITIS, DYSMENORRHOEA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, ABDOMINAL PAIN, VAGINAL INFECTION AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINITIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PERFORATION, MIGRATION, URINARY / BLADDER PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.7 KG/SQM. ON (B)(6) 2009, PATIENT HAD CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: EVENT FALLOPIAN TUBE PERFORATION ADDED. EVENT OUTCOME OF PELVIC PAIN, MENORRHAGIA, VAGINAL HEMORRHAGE, VAGINAL INFECTION WERE UPDATED AS RECOVERED/RESOLVED. 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 DEVICE DISLOCATION ("MIGRATION OF IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND VAGINAL INFECTION ("VAGINITIS INFECTIONS"). THE PATIENT WAS TREATED WITH SURGERY (ON UNSPECIFIED DATE, PATIENT HAD UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVIC). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON (B)(6) 2009, PATIENT HAD CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED ON THE RIGHT SIDE BUT NOT THE LEFT SIDE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 738762 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA |