ESSURE
Report
- Report Number
- 2951250-2019-09973
- Event Type
- Injury
- Date Received
- October 17, 2019
- Date of Event
- May 1, 2016
- Report Date
- November 14, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (ABNORMAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 916242-NOT VALID, 915243) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION IN 2011. CONCURRENT CONDITIONS INCLUDED HASHIMOTO'S THYROIDITIS, HYPOTHYROIDISM, UTERINE FIBROID, ARTHRITIS, AUTOIMMUNE THYROIDITIS, HYPOTHYROIDISM AND HERNIATED DISC. CONCOMITANT PRODUCTS INCLUDED ATENOLOL SINCE 2011 AND LEVOTHYROXINE SINCE 2011. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTIS INFECTION (BLADDER/ URINARY TRACT INFECTION)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE DYSPAREUNIA, FATIGUE AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FATIGUE, MENORRHAGIA, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. STATUS POST ESSURE TUBAL CLOSURE DEVICE PLACEMENT WITHOUT FLUOROSCOPIC EVIDENCE OF FALLOPIAN TUBE PATENCY. PATHOLOGY TEST - ON (B)(6) 2016: ENDOCERVICAL CURETTINGS: SCANT ENDOCERVICAL MUCOSA WITH FOCAL SQUAMOUS METAPLASIA. ENDOMETRIUM SUGGESTIVE OF LOWER UTERINE SEGMENT. ENDOMETRIAL CURETTINGS: FRAGMENTS OF DISORDERED PROLIFERATIVE ENDOMETRIUM WITH FOCAL TUBAL METAPLASIA AND FOCAL STROMAL BREAKDOWN; ON (B)(6) 2017: ENDOCERVICAL MUCOSA WITH FOCAL MILD ACUTE AND CHRONIC INFLAMMATION, SQUAMOUS METAPLASIA AND MICROGLANDULAR HYPERPLASIA. BENIGN SUPERFICIAL SQUAMOUS EPITHELIUM. ENDOMETRIAL CURETTINGS: ENDOMETRIAL TISSUE WITH FEATURES OF PROGESTERONE EFFECT. FOCAL ENDOMETRIAL BREAKDOWN. ENDOCERVICAL MUCOSA WITH FOCAL SQUAMOUS METAPLASIA AND MICROGLANDULAR HYPERPLASIA.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-OCT-2019: PFS RECEIVED: EVENT ADDED: UTIS INFECTION (BLADDER/ URINARY TRACT INFECTION), EVENT OUTCOME AND ONSET DATE WERE ADDED, CONCOMITANT DRUG ADDED: ATENOLOL. 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 916242-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HASHIMOTO'S THYROIDITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FATIGUE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 916242) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HASHIMOTO'S THYROIDITIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL ABLATION, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, FATIGUE, MENORRHAGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY" WAS UPDATED TO ABNORMAL BLEEDING (VAGINAL. EVENT S; MENORRHAGIA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), AND FATIGUE WERE ADDED. LAB DATA ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 996384 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 916242-NOT VALID, 915243 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R | ATENOLOL| LEVOTHYROXINE |