ESSURE
Report
- Report Number
- 2951250-2017-05547
- Event Type
- Injury
- Date Received
- October 27, 2017
- Report Date
- March 13, 2018
- 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 FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S) ERODED THROUGH TUBE"), PELVIC PAIN ("PAIN, PELVIC PAIN(SEVERE)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)HEAVY MENSTRUAL") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE 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 "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2006, (B)(6) 2014), DEPRESSION, TONSILLECTOMY AND HEAVY PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: DEPO PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ADVERSE DRUG REACTION WITH DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY, KIDNEY STONE SINCE (B)(6) 2016 AND SORENESS BREAST SINCE (B)(6) 2016. FAMILY HISTORY INCLUDED STROKE (GRANDMA AND AUNT) AND ENDOMETRIAL ABLATION (MOTHER AND SISTER). CONCOMITANT PRODUCTS INCLUDED ANAESTHETICS (ANESTHESIA), BUPROPION (WELLBUTRIN) SINCE 2016 AND SERTRALINE (ZOLOFT) FROM 2015 TO 2016. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING), PAIN PP MOSTLY WITH MENSTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS TEETH BREAKING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: FELT LIKE ELECTRIC WAVES AND NUMBNESS IN ARMS AND HANDS") AND PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: FELT LIKE ELECTRIC WAVES AND NUMBNESS IN ARMS AND HANDS"). IN NOVEMBER 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ DYSPAREUNIA (MILD)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND BILATERAL SALPINGECTOMY, ESSURE REMOVAL), SURGERY (SURGERY TO REMOVE THE ESSURE) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, TOOTH FRACTURE, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, HYPOAESTHESIA AND PARAESTHESIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, PARAESTHESIA, PELVIC PAIN, TOOTH FRACTURE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.2 KG/SQM. ULTRASOUND PELVIS - ON (B)(6) 2016: NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT SHOWED UTERUS AND BILATERAL FALLOPIAN TUBE-PROLIFERATIVE ENDOMETRIUM, PERVIOUS ENDOMETRIAL ABLATION SITE DISCHARGE, CHRONIC CERVICITIS, UNMARK ABLE FALLOPIAN TUBES AND FIMBRIA. CLINICAL HISTORY- FAILED ENDOMETRIAL ABLATION, MENORRHAGIA. THE UTERUS WITHOUT ADNEXA 97GM AND IR8.7 CM SUPERIOR TO INFERIOR,5.4CM CORNU TO CORNU AND 4.2CM ANTERIOR TO POSTERIOR. THE SERCOSS IS SMOOTH AND SHINY SECTIONS AND POSTERIOR SAC ARE SUBMITTED IN CASSETTE C .THE CERVIX IS AVOID, 3.4CM IN DIAMETER , THE CERVICAL IS 3.8CM IN DIAMETER. SECTION OF ANTERIOR AND POSTERIOR CERVIX IS SUBMITTED IN CASSETTE D. THE ENDOMETRIUM IS FOCALLY HEMORRHAGIC AND FINALLY GRANULAR AND 0.1CM IN THICKNESS. THE MYOMETRIUM IS ALSO FINELY GRANULAR AND IS UP TO 2.3CM IN THICKNESS. SECTIONING REVEALS NO LESION IN NEITHER ANTERIOR NOR POSTERIOR. ONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, DYSMENORRHEA, NUMBNESS OF ARM AND HAND. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-FEB-2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT INDICATION, HISTORICAL DRUG AND CONDITIONS, CONCOMITANT DRUGS AND CONDITIONS, LAB DATA, NEW EVENTS MENORRHAGIA, TOOTH FRACTURE, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE, WEIGHT INCREASED, FALLOPIAN TUBE PERFORATION, HYPOAESTHESIA, PARAESTHESIA, DEVICE MONITORING PROCEDURE NOT PERFORMED ADDED. OUTCOME FOR THE EVENTS PELVIC PAIN, HYPOAESTHESIA AND PARAESTHESIA ADDED AS RECOVERED / RESOLVED. 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 ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT HAD ESSURE 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 (SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED 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. 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 |
|---|---|---|---|---|---|---|---|
| 764954 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ANESTHESIA| WELLBUTRIN| ZOLOFT |