ESSURE
Report
- Report Number
- 2951250-2017-02167
- Event Type
- Injury
- Date Received
- June 15, 2017
- Report Date
- July 31, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED LYMPHEDEMA, DVT IN 1993, HEMORRHOIDS, GASTRIC BYPASS, CHOLECYSTECTOMY, MULTIGRAVIDA, PARITY 4, HYPOTHYROIDISM, BIPOLAR DISORDER, THROMBOPHLEBITIS SUPERFICIAL AND ANGIOPLASTY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DILANTIN AND PHENOBARB. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILANTIN AND PHENOBARB. CONCURRENT CONDITIONS INCLUDED OSTEOPENIA, HYPERTENSION, MYXEDEMA, LIVER ENZYME ABNORMAL, MALABSORPTION, HYPERALBUMINEMIA, MENORRHAGIA, SMOKER (SHE SMOKES EVERY DAY), UTERINE FIBROID AND MENOMETRORRHAGIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENTRUAL CYCLE"), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, PLANTIFF UNDERWENT A HYSTERECTOMY AND REMOVAL OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: REPORTER INFORMATION WAS UPDATED. THIS CASE CONCERNS ADULT PATIENT. HER HISTORICAL CONDITION, HISTORICAL MEDICATION AND CONCURRENT CONDITION WERE ADDED. ESSURE INDICATION WAS AMENDED. ESSURE LOT NUMBER WAS 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 ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED LYMPHEDEMA, DVT IN 1993, HEMORRHOIDS, GASTRIC BYPASS, CHOLECYSTECTOMY, MULTIGRAVIDA, PARITY 4, HYPOTHYROIDISM, BIPOLAR DISORDER, THROMBOPHLEBITIS SUPERFICIAL AND ANGIOPLASTY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DILANTIN AND PHENOBARB. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILANTIN AND PHENOBARB. CONCURRENT CONDITIONS INCLUDED OSTEOPENIA, HYPERTENSION, MYXEDEMA, LIVER ENZYME ABNORMAL, MALABSORPTION, HYPERALBUMINEMIA, MENORRHAGIA, SMOKER (SHE SMOKES EVERY DAY), UTERINE FIBROID AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM AUGUST 2012 TO NOVEMBER 2012 FOR BIRTH CONTROL AS WELL AS IBUPROFEN FROM 2012 TO 2016 AND TRAMADOL FROM 2012 TO 2016. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN AUGUST 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). IN SEPTEMBER 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN OCTOBER 2015, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENTRUAL CYCLE") AND DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6)2015, PLANTIFF UNDERWENT A HYSTERECTOMY(FULL)AND REMOVAL OF ESSURE DEVICE, SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: IT WAS REPORTED THAT HEATING PADS & PAIN MEDS NEEDED LESS OFTEN AS TREATMENT OF PAIN. ON (B)(6)2015 VIA ABDOMINAL XRAY. FALLOPIAN TUBE INSERTS C/W ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED. REPORTERS WERE ADDED. PATIENT DETAILS, CONCOMITANT DRUGS AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ABDOMINAL PAIN AND MENOMETRORRHAGIA WERE ADDED AS EVENTS. START DATE OF ESSURE WAS CHANGED. 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 ("SEVERE PELVIC PAIN / PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED LYMPHEDEMA, DVT IN 1993, HEMORRHOIDS, GASTRIC BYPASS, CHOLECYSTECTOMY, MULTIGRAVIDA, PARITY 4, HYPOTHYROIDISM, BIPOLAR DISORDER, THROMBOSIS VENOUS SUPERFICIAL AND ANGIOPLASTY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DILANTIN AND PHENOBARB. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH DILANTIN AND PHENOBARB. CONCURRENT CONDITIONS INCLUDED OSTEOPENIA, HYPERTENSION, MYXEDEMA, LIVER ENZYME ABNORMAL, MALABSORPTION, HYPERALBUMINEMIA, MENORRHAGIA, SMOKER (SHE SMOKES EVERY DAY), UTERINE FIBROID AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012 FOR BIRTH CONTROL AS WELL AS IBUPROFEN FROM 2012 TO 2016 AND TRAMADOL FROM 2012 TO 2016. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENTRUAL CYCLE") AND DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, PLANTIFF UNDERWENT A HYSTERECTOMY(FULL)AND REMOVAL OF ESSURE DEVICE, SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, FATIGUE, ABDOMINAL PAIN, BACK PAIN, MENSTRUAL DISORDER, DYSMENORRHOEA, VAGINAL DISCHARGE AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: IT WAS REPORTED THAT HEATING PADS & PAIN MEDS NEEDED LESS OFTEN AS TREATMENT OF PAIN. ON (B)(6) 2015 VIA ABDOMINAL XRAY. FALLOPIAN TUBE INSERTS C/W ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUL-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 ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENTRUAL CYCLE"), DYSPAREUNIA ("DYSPAREUNIA"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, PLAINTIFF UNDERWENT A HYSTERECTOMY AND REMOVAL OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENSTRUAL DISORDER, DYSPAREUNIA, BACK PAIN, ABDOMINAL PAIN, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 425479 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| IBUPROFEN| IBUPROFEN| TRAMADOL| TRAMADOL |