ESSURE
Report
- Report Number
- 2951250-2017-09302
- Event Type
- Injury
- Date Received
- November 29, 2017
- Date of Event
- January 1, 2012
- Report Date
- September 5, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 ("CHRONIC PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") AND ENDOMETRIOSIS ("ENDOMETRIOSIS") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSION, ESOPHAGEAL REFLUX, ULCER NOS AND HUMAN PAPILLOMA VIRUS INFECTION. CONCURRENT CONDITIONS INCLUDED VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY, URINARY RETENTION, DIZZINESS, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, GASTRITIS AND PAIN IN JAW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, 3 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), AMNESIA ("MEMORY LOSS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY) AND SURGERY (SURGICAL LAPAROSCOPY, FULGURATION OF ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ENDOMETRIOSIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, MIGRAINE, AMNESIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, ANXIETY, DYSMENORRHOEA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED. PLAINTIFF DEMOGRAPHICS, HISTORICAL CONDITION AND CONCOMITANT DISEASE ADDED. ESSURE STOP DATE ADDED. NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ANXIETY, MIGRAINES /HEADACHES, MEMORY LOSS, DYSMENORRHEA (CRAMPING), ENDOMETRIOSIS WERE ADDED. LAB DATA 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 PELVIC PAIN ("CHRONIC PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") AND ENDOMETRIOSIS ("ENDOMETRIOSIS") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSION, ESOPHAGEAL REFLUX, ULCER NOS AND HUMAN PAPILLOMA VIRUS INFECTION. CONCURRENT CONDITIONS INCLUDED VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY, URINARY RETENTION, DIZZINESS, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, GASTRITIS AND PAIN IN JAW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, 3 YEARS 5 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), AMNESIA ("MEMORY LOSS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY) AND SURGERY (SURGICAL LAPROSCOPY, FULGARATION OF ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ENDOMETRIOSIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, MIGRAINE, AMNESIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, ANXIETY, DYSMENORRHOEA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 ('CHRONIC PELVIC PAIN'), GENITAL HAEMORRHAGE ('HEAVY AND IRREGULAR BLEEDING') AND ENDOMETRIOSIS ('ENDOMETRIOSIS') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT WENT ESSURE CONFIRMATION TEST .". THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, DEPRESSION, ESOPHAGEAL REFLUX, ULCER NOS AND HUMAN PAPILLOMA VIRUS INFECTION. CONCURRENT CONDITIONS INCLUDED VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY, URINARY RETENTION, DIZZINESS, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, GASTRITIS AND PAIN IN JAW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 3 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), AMNESIA ("MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND SURGICAL LAPROSCOPY, FULGARATION OF ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND ABDOMINAL PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, ENDOMETRIOSIS, VAGINAL HAEMORRHAGE, ANXIETY, MIGRAINE, AMNESIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ANXIETY, DYSMENORRHOEA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN, BLEEDING : YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PFS RECEIVED. REPORTER ADDED. EVENT : ABDOMINAL PAIN, SHE DID NOT WENT ESSURE CONFIRMATION TEST WERE ADDED. OUTCOME OF THE EVENT PAIN AND BLEEDING WERE UPDATED. 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 ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, 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 (PELVIC SURGERY ON (B)(6) 2016). 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. 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 |
|---|---|---|---|---|---|---|---|
| 846181 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R |