ESSURE
Report
- Report Number
- 2951250-2019-03712
- Event Type
- Injury
- Date Received
- July 11, 2019
- Date of Event
- March 1, 2015
- Report Date
- September 16, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 001977- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;CALCIUM;CALCIUM LEVOMEFOLATE;CHOLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE (PNV DHA) SINCE (B)(6) 2014, NSAIDS SINCE (B)(6) 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2015:INSERTION DETAILS:- THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. ON (B)(6) 2017: LAPAROSCOPIC BILATERAL SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY FOR IC. DISCREPANCY - PREVIOUSLY MENTIONED AS PLAINTIFF HAD AN HSG TEST DONE, IN FOLLOW-UP PFS AND MR - ESSURE CONFIRMATION TEST(S) NOT DONE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JUL-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 001977- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;CALCIUM;CALCIUM LEVOMEFOLATE;CHOLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;MAGNESIUM;PYRIDOXINE HYDROCHLORIDE (PNV DHA) SINCE (B)(6) 2014, NSAIDS SINCE (B)(6) 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN MARCH 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2015:INSERTION DETAILS:- THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. (B)(6) 2017: LAPAROSCOPIC BILATERAL SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY FOR IC. PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. DISCREPANCY - PREVIOUSLY MENTIONED AS PLAINTIFF HAD AN HSG TEST DONE, IN FOLLOW-UP PFS AND MR - ESSURE CONFIRMATION TEST(S) NOT DONE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED : REPORTERS INFORMATION UPDATED. EVENT: ABDOMINAL PAIN, GENERAL ABNORMAL BLEEDING WERE ADDED. EVENT OUTCOME WERE UPDATED TO RECOVERED: PELVIC PAIN, ABDOMINAL PAIN,GENERAL ABNORMAL BLEEDING. INCIDENT NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S 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 AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 001977) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID; CALCIUM; CALCIUM LEVOMEFOLATE; COLECALCIFEROL; CYANOCOBALAMIN; DL-ALPHA TOCOPHERYL ACETATE; DOCOSAHEXAENOIC ACID; FERROUS FUMARATE; MAGNESIUM; PYRIDOXINE HYDROCHLORIDE (PNV DHA) SINCE (B)(6) 2014, NSAIDS SINCE (B)(6) 2015 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2015: INSERTION DETAILS: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. ON (B)(6) 2017: LAPAROSCOPIC BILATERAL SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY FOR IC. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: NEW PFS AND MR RECEIVED- NEW EVENTS ADDED:ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, PAIN. OUTCOME OF EVENT PELVIC PAIN FROM UNKNOWN TO RECOVERING/RESOLVING WAS UPDATED. LOT NUMBER AND NEW REPORTERS WERE ADDED. CONCOMITANT DRUGS AND CONDITIONS WERE ADDED. WE RECEIVED A LOT NUMBER. 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 |
|---|---|---|---|---|---|---|---|
| 575895 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 001977- NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| NSAIDS| NSAIDS| NSAIDS| PNV DHA| PNV DHA| PNV DHA| ACETAMINOPHEN| NSAIDS| PNV DHA |