ESSURE
Report
- Report Number
- 2951250-2017-00577
- Event Type
- Injury
- Date Received
- February 16, 2017
- Date of Event
- January 1, 2013
- Report Date
- July 30, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN / PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING/ BLOOD LOSS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND HAEMORRHAGE ("OTHER INJURY OR COMPLICATION(S) -BLOOD LOSS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 2 ((B)(6) 2003 AND (B)(6) 2007), NON-TOBACCO USER, ENDOMETRIAL BIOPSY ON (B)(6) 2015, IRREGULAR MENSTRUATION IN (B)(6) 2015, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION IN (B)(6) , WISDOM TEETH REMOVAL IN (B)(6) , CESAREAN SECTION ((B)(6)) IN (B)(6), ABDOMINOPLASTY IN (B)(6) AND TOXEMIA. PATIENTS DENIED ALCOHOL USE. CONCURRENT CONDITIONS INCLUDED OBESITY, UTERINE BLEEDING, CLOTTING DISORDER, PAIN DULL, DRUG ALLERGY, ABDOMINAL ADHESIONS AND ADENOMYOSIS. FAMILY HISTORY INCLUDED UTERINE CANCER (MATERNAL GRANDMOTHER). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6), THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("CRAMPING / MILD CONSTANT PAIN IN LOWER ABDOMEN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION /MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL (VAGINAL) BLEEDING"). IN (B)(6), THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VULVOVAGINAL PAIN ("MILD CONSTANT PAIN IN VAGINAL AREA") AND HAEMOGLOBIN ABNORMAL ("BLOOD/HEMOGLOBIN LEVEL"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IRON AND SURGERY (LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, FATIGUE, ABDOMINAL PAIN LOWER, ALOPECIA AND HAEMOGLOBIN ABNORMAL HAD RESOLVED AND THE HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANAEMIA, DYSMENORRHOEA AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HAEMOGLOBIN ABNORMAL, HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY WAS NOTED IN PRODUCT IMPLANT DATE AS IT WAS GIVEN AS (B)(6) 2012 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY PLACEMENT AND FULL OCCLUSION OF TUBES. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. ON (B)(6) 2012, HYSTEROSALPINGOGRAPHY SHOWED, SCOUT FILM REVEALS COILS IN BOTH FALLOPIAN TUBES. CONTRAST INJECTED INTO ENDOMETRIAL CAVITY. THERE IS NO OPACIFICATION OR VISUALIZATION OF THE TUBES, INDICATING COMPLETE BLOCKAGE BILATERALLY. TOTAL FLUOROSCOPY TIME 0.7 MINUTES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUL-2018: PFS RECEIVED EVENT "BLOOD LOSS" ADDED. CONCOMITANT AND TREATMENT DRUG 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 / PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING/ BLOOD LOSS") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 8821B4) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6) 2003 AND (B)(6) 2007), NON-TOBACCO USER, ENDOMETRIAL BIOPSY ON (B)(6) 2015, IRREGULAR MENSTRUATION IN (B)(6) 2015, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION IN 1997, WISDOM TEETH REMOVAL IN 1998, CESAREAN SECTION (2007) IN 2003 AND ABDOMINOPLASTY IN 2010. PATIENTS DENIED ALCOHOL USE. CONCURRENT CONDITIONS INCLUDED OBESITY, UTERINE BLEEDING, CLOTTING DISORDER, PAIN DULL, DRUG ALLERGY, ABDOMINAL ADHESIONS AND ADENOMYOSIS. FAMILY HISTORY INCLUDED UTERINE CANCER (MATERNAL GRANDMOTHER). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL PAIN LOWER ("CRAMPING / MILD CONSTANT PAIN IN LOWER ABDOMEN"). IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL (VAGINAL) BLEEDING"). IN 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION /MENORRHAGIA"), ANAEMIA ("ANEMIA"), VULVOVAGINAL PAIN ("MILD CONSTANT PAIN IN VAGINAL AREA") AND HAEMOGLOBIN ABNORMAL ("BLOOD/HEMOGLOBIN LEVEL"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, FATIGUE, ABDOMINAL PAIN LOWER, ALOPECIA AND HAEMOGLOBIN ABNORMAL HAD RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, ANAEMIA, DYSMENORRHOEA AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HAEMOGLOBIN ABNORMAL, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY WAS NOTED IN PRODUCT IMPLANT DATE AS IT WAS GIVEN AS (B)(6) 2012 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY PLACEMENT AND FULL OCCLUSION OF TUBES. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE ON (B)(6) 2012, HYSTEROSALPINGOGRAPHY SHOWED, SCOUT FILM REVEALS COILS IN BOTH FALLOPIAN TUBES. CONTRAST INJECTED INTO ENDOMETRIAL CAVITY. THERE IS NO OPACIFICATION OR VISUALIZATION OF THE TUBES, INDICATING COMPLETE BLOCKAGE BILATERALLY. TOTAL FLUOROSCOPY TIME 0.7 MINUTES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2018: PFS RECEIVED - NEW EVENT ¿DYSMENORRHEA, CRAMPING, HAIR LOSS, URINARY TRACT INFECTION, VAGINAL INFECTION, BLOOD LOSS, MILD CONSTANT PAIN IN VAGINAL AREA, ABNORMAL BLEEDING, VAGINAL BLEEDING, ANEMIA, BLOOD/HEMOGLOBIN LEVEL WAS ADDED. PRODUCT IMPLANT DATE WAS UPDATED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. HISTORICAL AND CONCOMITANT CONDITION WERE 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.
QUALITY-SAFETY EVALUATION OF PTC: (B)(4). SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-FEB-2017: QUALITY-SAFETY EVALUATION OF PTC RECEIVED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD CHRONIC PELVIC PAIN. SHE UNDERWENT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY APPROXIMATELY 4 YEARS AFTER INSERTION. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE GYNAECOLOGICAL AND NON-GYNAECOLOGICAL CAUSES. IN THE PRESENT CASE, NO INFORMATION REGARDING CONSUMER´S MEDICAL HISTORY OR CONCURRENT CONDITIONS WAS PROVIDED. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED WITH NEITHER COMPLAINT SAMPLE NOR VALID LOT NUMBER. THUS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE AS IT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY AND ABNORMAL BLEEDING DURING MENSTRUATION") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN, MENORRHAGIA AND FATIGUE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON (B)(6) 2012: HYSTEROSALPINGOGRAM RESULT WAS SATISFACTORY PLACEMENT AND FULL OCCLUSION OF TUBES. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD CHRONIC PELVIC PAIN. SHE UNDERWENT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY APPROXIMATELY 4 YEARS AFTER INSERTION. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE GYNAECOLOGICAL AND NON-GYNAECOLOGICAL CAUSES. IN THE PRESENT CASE, NO INFORMATION REGARDING CONSUMER´S MEDICAL HISTORY OR CONCURRENT CONDITIONS WAS PROVIDED. GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. ~ FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118213 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R |