ESSURE
Report
- Report Number
- 2951250-2017-06009
- Event Type
- Injury
- Date Received
- November 3, 2017
- Date of Event
- June 15, 2011
- Report Date
- July 20, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) 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 NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 DOB: (B)(6) 1998, (B)(6) 1999, (B)(6) 2005, ENDOMETRIOSIS, SINUSITIS, BASAL CELL CARCINOMA, HEPATIC CYST, PALPITATIONS AND CARDIAC ABLATION. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, STRESS URINARY INCONTINENCE, LOWER EXTREMITIES DISCOMFORT, IRRITABLE BOWEL SYNDROME, DYSURIA, URINARY TRACT INFECTION, PELVIC DISCOMFORT, URINARY FREQUENCY, MIGRAINE, SINUS DISORDER, NAUSEA AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED CEPHALOSPORINS AND RELATED SUBSTANCES, METFORMIN, METOPROLOL SUCCINATE SINCE (B)(6) 2011, ORAL CONTRACEPTIVE NOS, SPIRONOLACTONE, SULFADIAZINE AND TOPIRAMATE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), PROCEDURAL PAIN ("SUFFERED A PAINFUL POST-OPERATIVE RECOVERY"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), TOOTHACHE ("TEETH PAIN"), ARTHRALGIA ("JOINTS PAIN"), PAIN IN EXTREMITY ("LEGS PAIN") AND ABDOMINAL PAIN ("PAIN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, FATIGUE, WEIGHT INCREASED, TOOTHACHE, ARTHRALGIA, PAIN IN EXTREMITY AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PAIN IN EXTREMITY, PROCEDURAL PAIN, TOOTHACHE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY HER SYMPTOMS ARE MOSTLY RESOLVED. 1-2 COILS WERE SEEN AT THE LEFT TUBAL OSTIA AND 1-2 COILS WERE SEEN AT THE RIGHT TUBAL OSTIA AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.5 KG/SQM. PREGNANCY TEST WAS NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (DOB: ((B)(6) 1998, (B)(6) 1999, (B)(6) 2005)), ENDOMETRIOSIS, SINUSITIS, BASAL CELL CARCINOMA, HEPATIC CYST, PALPITATIONS, CARDIAC ABLATION, CARDIAC ABLATION IN 2012 AND ROTATOR CUFF REPAIR (RIGHT) IN 2008. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, STRESS URINARY INCONTINENCE, LOWER EXTREMITIES DISCOMFORT, IRRITABLE BOWEL SYNDROME, DYSURIA, URINARY TRACT INFECTION, PELVIC DISCOMFORT, URINARY FREQUENCY, MIGRAINE, SINUS DISORDER, NAUSEA, HEADACHE, UTERINE BLEEDING AND INTERMENSTRUAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED CEPHALOSPORINS AND RELATED SUBSTANCES, METFORMIN, METOPROLOL SUCCINATE SINCE (B)(6) 2011, ORAL CONTRACEPTIVE NOS, SPIRONOLACTONE, SULFADIAZINE AND TOPIRAMATE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), PAIN IN EXTREMITY ("LEGS PAIN/LEG THROBBING/PAIN:LEG") AND JOINT SWELLING ("ANKLE SWELLING"). IN (B)(6) 2011, THE PATIENT EXPERIENCED URTICARIA ("HIVES"), SUPRAVENTRICULAR TACHYCARDIA ("PSVT") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL PROBLEMS/PAIN:TEETH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/PAIN: LOWER ABDOMEN"), PROCEDURAL PAIN ("SUFFERED A PAINFUL POST-OPERATIVE RECOVERY"), ARTHRALGIA ("JOINTS PAIN"), ABDOMINAL PAIN ("PAIN ABDOMEN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ALOPECIA ("HAIR LOSS") AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICE) AND SURGERY (ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, URTICARIA, MIGRAINE, HEADACHE, SUPRAVENTRICULAR TACHYCARDIA, NAUSEA, ALLERGY TO METALS, JOINT SWELLING AND ANAEMIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, FATIGUE, VAGINAL HAEMORRHAGE, TOOTHACHE, ARTHRALGIA, PAIN IN EXTREMITY, DYSMENORRHOEA AND ALOPECIA HAD RESOLVED AND THE PROCEDURAL PAIN, WEIGHT INCREASED AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANAEMIA, ARTHRALGIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, JOINT SWELLING, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PROCEDURAL PAIN, SUPRAVENTRICULAR TACHYCARDIA, TOOTHACHE, URTICARIA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY HER SYMPTOMS ARE MOSTLY RESOLVED. 1-2 COILS WERE SEEN AT THE LEFT TUBAL OSTIA AND 1-2 COILS WERE SEEN AT THE RIGHT TUBAL OSTIA AT THE COMPLETION OF THE PROCEDURE. MEDICAL BACKGROUND CURRENT WEIGHT 127 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.5 KG/SQM. PREGNANCY TEST WAS NEGATIVE. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT: ADENOMYOSIS UTERI; INACTIVE ENDOMETRIUM; FALLOPIAN TUBES WITH LUMINAL STERILIZATION DEVICES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: UTERINE PERFORATION, MENORRHAGIA, PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-2018: REPORTER INFORMATION WAS ADDED. LAB DATA WAS ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENTS: MENORRHAGIA (ABLATION), HIVES, MIGRAINES, HEADACHES, PSVT (PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA), NAUSEA, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), HAIR LOSS, ANKLE SWELLING AND ANEMIA WERE ADDED. SHE HAD RECOVERED FROM EVENTS: PAIN IN LOWER ABDOMEN, LEGS, JOINTS AND TEETH, FATIGUE, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA/GENERAL); CRAMPING AND HAIR LOSS. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) 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 NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (DOB: ((B)(6) 1998, (B)(6) 1999, (B)(6) 2005)), ENDOMETRIOSIS, SINUSITIS, BASAL CELL CARCINOMA, HEPATIC CYST, PALPITATIONS AND CARDIAC ABLATION. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, STRESS URINARY INCONTINENCE, LOWER EXTREMITIES DISCOMFORT, IRRITABLE BOWEL SYNDROME, DYSURIA, URINARY TRACT INFECTION, PELVIC DISCOMFORT, URINARY FREQUENCY, MIGRAINE, SINUS DISORDER, NAUSEA AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED CEPHALOSPORINS AND RELATED SUBSTANCES, METFORMIN, METOPROLOL SUCCINATE SINCE (B)(6) 2011, ORAL CONTRACEPTIVE NOS, SPIRONOLACTONE, SULFADIAZINE AND TOPIRAMATE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), PROCEDURAL PAIN ("SUFFERED A PAINFUL POST-OPERATIVE RECOVERY"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), TOOTHACHE ("TEETH PAIN"), ARTHRALGIA ("JOINTS PAIN"), PAIN IN EXTREMITY ("LEGS PAIN") AND ABDOMINAL PAIN ("PAIN ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, FATIGUE, WEIGHT INCREASED, TOOTHACHE, ARTHRALGIA, PAIN IN EXTREMITY AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PAIN IN EXTREMITY, PROCEDURAL PAIN, TOOTHACHE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY HER SYMPTOMS ARE MOSTLY RESOLVED. 1-2 COILS WERE SEEN AT THE LEFT TUBAL OSTIA AND 1-2 COILS WERE SEEN AT THE RIGHT TUBAL OSTIA AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.5 KG/SQM. PREGNANCY TEST WAS NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-FEB-2018: FU FROM PFS+MR: NEW EVENTS: VAGINAL HEMORRHAGE, MENORRHAGIA, UTERINE PERFORATION, TOOTHACHE, ARTHRALGIA, PAIN IN EXTREMITY, ABDOMINAL PAIN, DEVICE MONITORING PROCEDURE NOT PERFORMED WERE ADDED. LOT NO, PATIENT INFORMATION, OTHER RELEVANT HISTORY 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 ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, 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), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), PROCEDURAL PAIN ("SUFFERED A PAINFUL POST-OPERATIVE RECOVERY"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, PROCEDURAL PAIN, FATIGUE AND WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, FATIGUE, GENITAL HAEMORRHAGE, PELVIC PAIN, PROCEDURAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY HER SYMPTOMS ARE MOSTLY 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779027 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | CEPHALOSPORINS AND RELATED SUBSTANCES| CEPHALOSPORINS AND RELATED SUBSTANCES| CEPHALOSPORINS AND RELATED SUBSTANCES| METFORMIN| METFORMIN| METFORMIN| METOPROLOL SUCCINATE| METOPROLOL SUCCINATE| METOPROLOL SUCCINATE| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| SPIRONOLACTONE| SPIRONOLACTONE| SPIRONOLACTONE| SULFADIAZINE| SULFADIAZINE| SULFADIAZINE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE |