ESSURE
Report
- Report Number
- 2951250-2022-00557
- Event Type
- Injury
- Date Received
- May 27, 2022
- Date of Event
- January 1, 2012
- Report Date
- June 6, 2022
- 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
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE),") AND ABORTION SPONTANEOUS ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 20214172) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST") AND DEVICE INEFFECTIVE ("PREGNANCY"). THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3 AND MULTIGRAVIDA. CONCURRENT CONDITIONS WERE LISTED AS UTERINE FIBROID, PELVIC ADHESIONS, ENDOMETRIOSIS AND PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) SINCE 2009 AND LOESTRIN (ETHINYLESTRADIOL;NORETHISTERONE ACETATE) FROM 2007 TO 2009. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010 SHE EXPERIENCED CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). IN 2011 SHE EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND KIDNEY INFECTION ("KIDNEY INFECTION"). IN 2012 SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN 2013 SHE EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ESSURE WAS REMOVED ON (B)(6) 2020. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE KIDNEY INFECTION HAD NOT RESOLVED. THE OUTCOMES FOR PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 3, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT'S TREATMENT DATES SUGGEST POTENTIAL FETAL EXPOSURE TO ESSURE DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HEAVY MENSTRUAL BLEEDING, KIDNEY INFECTION, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY IN DATE OF INSERTION: (B)(6) 2010. TRAILING COILS: 4 ON BOTH THE SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): RESULTS: TOTAL BILATERAL OCCLUSION [PREGNANCY TEST] (DATE UNKNOWN): RESULTS: NEGATIVE. LOT NUMBER: 20214172. MANUFACTURE DATE: 2009/09. EXPIRATION DATE: 2012/09. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-JUN-2022: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE),") AND ABORTION SPONTANEOUS ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 20214172) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED ("DID NOT UNDERGO AN ESSURE CONFIRMATION TEST") AND DEVICE INEFFECTIVE ("PREGNANCY"). THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3 AND MULTIGRAVIDA. CONCURRENT CONDITIONS WERE LISTED AS UTERINE FIBROID, PELVIC ADHESIONS, ENDOMETRIOSIS AND PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) SINCE 2009 AND LOESTRIN (ETHINYLESTRADIOL;NORETHISTERONE ACETATE) FROM 2007 TO 2009. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010 SHE EXPERIENCED CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). IN 2011 SHE EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND KIDNEY INFECTION ("KIDNEY INFECTION"). IN 2012 SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN 2013 SHE EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ESSURE WAS REMOVED ON (B)(6) 2020. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("VAGINAL INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY.). AT THE TIME OF THE REPORT, THE KIDNEY INFECTION HAD NOT RESOLVED. THE OUTCOMES FOR PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 3, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT'S TREATMENT DATES SUGGEST POTENTIAL FETAL EXPOSURE TO ESSURE DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HEAVY MENSTRUAL BLEEDING, KIDNEY INFECTION, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY IN DATE OF INSERTION: (B)(6) 2010. TRAILING COILS: 4 ON BOTH THE SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): RESULTS: TOTAL BILATERAL OCCLUSION [PREGNANCY TEST] (DATE UNKNOWN): RESULTS: NEGATIVE QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 04-NOV-2020: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION, RCC, MEDICAL HISTORY AND INFORMATION ABOUT REMOVAL WERE ADDED. EVENT DEVICE INEFFECTIVE WAS ADDED. THIS CASE IS BEING SUBMITTED RETROSPECTIVELY FOLLOWING AN INTERNAL REVIEW WE RECEIVED A LOT NUMBER AND SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2639262 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 20214172 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention| O | DEPO-PROVERA| DEPO-PROVERA| LOESTRIN| LOESTRIN |