ESSURE
Report
- Report Number
- 2951250-2019-03141
- Event Type
- Injury
- Date Received
- June 28, 2019
- Date of Event
- August 1, 2012
- Report Date
- May 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, PSORIASIS, ANEMIA AND LASIK EYE SURGERY. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LA VH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2014: UTERUS, OVARIES AND FALLOPIAN TUBES: HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY: 1- UTERUS WITH ENDOMETRIOSIS NEAR SEROSAL SURFACE. 2- BENIGN SECRETORY PHASE ENDOMETRIUM. 3- BENIGN CERVIX WITH CHRONIC CERVICITIS. 4- ENDOMETRIOSIS IDENTIFIED ON BOTH OVARIES. 5- RIGHT FALLOPIAN TUBE WITH A BENIGN PARATUBAL CYST; LEFT FALLOPIAN TUBE WITHOUT SIGNIFICANT PATHOLOGIC ABNORMALITIES. LOT NUMBER:841532, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. ADDED OUTCOME FOR EVENT PAIN PELVIC AND ABNORMAL BLEEDING TO RECOVERED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, PSORIASIS, ANEMIA AND LASIK EYE SURGERY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LA VH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2014: UTERUS, OVARIES AND FALLOPIAN TUBES: HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY: UTERUS WITH ENDOMETRIOSIS NEAR SEROSAL SURFACE. BENIGN SECRETORY PHASE ENDOMETRIUM. BENIGN CERVIX WITH CHRONIC CERVICITIS. ENDOMETRIOSIS IDENTIFIED ON BOTH OVARIES. RIGHT FALLOPIAN TUBE WITH A BENIGN PARATUBAL CYST; LEFT FALLOPIAN TUBE WITHOUT SIGNIFICANT PATHOLOGIC ABNORMALITIES. LOT NUMBER:841532 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUL-2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: 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 ('PHYSICAL PAIN') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841532) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVARIAN CYST, PSORIASIS, ANEMIA AND LASIK EYE SURGERY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"), 5 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) - LA VH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2014: UTERUS, OVARIES AND FALLOPIAN TUBES: HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY: UTERUS WITH ENDOMETRIOSIS NEAR SEROSAL SURFACE. BENIGN SECRETORY PHASE ENDOMETRIUM. BENIGN CERVIX WITH CHRONIC CERVICITIS. ENDOMETRIOSIS IDENTIFIED ON BOTH OVARIES. RIGHT FALLOPIAN TUBE WITH A BENIGN PARATUBAL CYST; LEFT FALLOPIAN TUBE WITHOUT SIGNIFICANT PATHOLOGIC ABNORMALITIES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2019: PFS RECEIVED LOT NUMBER WAS ADDED. EVENTS "ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, CRAMPING" WERE ADDED. OUTCOME OF EVENT " PAIN" WAS UPDATED AS RECOVERING AND CRAMPING WAS UPDATED AS RECOVERED. MEDICAL HISTORY AND LAB DATA WERE ADDED. REPORTER, PATIENT AND PRODUCT INFORMATION WERE ADDED. PATIENT AKA NAME WAS ADDED. INCIDENT: 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537294 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841532 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | ACETAMINOPHEN |