ESSURE
Report
- Report Number
- 2951250-2019-06041
- Event Type
- Injury
- Date Received
- September 11, 2019
- Date of Event
- April 1, 2012
- Report Date
- February 21, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922810) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ANEMIA, LOBAR PNEUMONIA, COLONIC POLYP, INTERNAL HEMORRHOIDS, LEFT LOWER QUADRANT PAIN, OVARIAN CYST, CHOLECYSTECTOMY, MULTIPAROUS, ENDOMETRIOSIS AND CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED FOLIC ACID, LEVOTHYROXINE, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("PAIN: BACK"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND DYSPAREUNIA ("DYSPAREUNIA((PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, GENITAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DEPRESSION, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS " PAIN - PELVIC/ABDOMINAL, CHRONIC, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BACK, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), ABNORMAL BLEEDING (GENERAL), PSYCH INJURY". COIL COUNT: RIGHT ¿ 5, LEFT - 8. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) - BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: FOLLOW UP 3 AND 4 PROCESSED TOGETHER. LOT NUMBER RECEIVED. MEDICAL RECORDS RECEIVED. PATIENT'S MEDICAL HISTORY WAS ADDED. ON (B)(6) 2020: PFS RECEIVED. NEW EVENTS VAGINAL BLEEDING, DEPRESSION AND ANXIETY WERE ADDED (PREVIOUSLY REPORTED AS PSYCH INJURY).FOLLOW UP 3 AND 4 PROCESSED TOGETHER. 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 ('PAIN: PELVIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922810-NOTVALID.) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPOTHYROIDISM, ANEMIA IRON DEFICIENCY, LOBAR PNEUMONIA, COLONIC POLYP, INTERNAL HEMORRHOIDS, LEFT LOWER QUADRANT PAIN, OVARIAN CYST, CHOLECYSTECTOMY, MULTIPAROUS, ENDOMETRIOSIS AND CHRONIC CERVICITIS. CONCOMITANT PRODUCTS INCLUDED FOLIC ACID, LEVOTHYROXINE, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("PAIN: BACK"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND DYSPAREUNIA ("DYSPAREUNIA((PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, GENITAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DEPRESSION, DYSPAREUNIA, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS " PAIN - PELVIC/ABDOMINAL, CHRONIC, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BACK, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), ABNORMAL BLEEDING (GENERAL), PSYCH INJURY". COIL COUNT: RIGHT ¿ 5, LEFT - 8. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) - BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN: ABDOMINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("PAIN: BACK"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND DYSPAREUNIA ("DYSPAREUNIA((PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, GENITAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS " PAIN - PELVIC/ABDOMINAL, CHRONIC, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BACK, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), ABNORMAL BLEEDING (GENERAL), PSYCH INJURY". DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) - BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. THE CASE IS NOW INCIDENT. PREVIOUSLY REPORTED EVENT ¿INJURY TO HERSELF¿ WAS UPDATED TO MORE SPECIFIED EVENT¿ PAIN: PELVIC, PAIN: ABDOMINAL, DYSMENORRHEA (CRAMPING), PAIN: BACK, ABNORMAL BLEEDING (GENERAL), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND PSYCH INJURY¿. REPORTER, DEMOGRAPHICS; LAB DATA, ESSURE INDICATION (AMENDED), ESSURE REMOVAL DATE WERE ADDED NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789012 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922810-NOTVALID. | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| FOLIC ACID| FOLIC ACID| LEVOTHYROXINE| LEVOTHYROXINE |