ESSURE
Report
- Report Number
- 2951250-2017-05770
- Event Type
- Injury
- Date Received
- October 30, 2017
- Date of Event
- December 1, 2011
- Report Date
- May 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191, 904747) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MIGRAINE, SEIZURE, HEADACHE AND C-SECTION (IN 2008) IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BENADRYL, TORADOL, PENICILLIN AND COMPAZINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH BENADRYL, COMPAZINE, PENICILLIN AND TORADOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED.IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL),"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITH A DEVICE REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 3 COILS VISIBLE FROM EACH SIDE. THE PROCEDURE WAS THEN DISCONTINUED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2018: NEW PFS RECEIVED- NEW EVENTS ADDED: PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191, 904747) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST.". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MIGRAINE, SEIZURE, HEADACHE AND C-SECTION (IN 2008) IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BENADRYL, TORADOL, PENICILLIN AND COMPAZINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH BENADRYL, COMPAZINE, PENICILLIN AND TORADOL. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL),"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITH A DEVICE REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 3 COILS VISIBLE FROM EACH SIDE. THE PROCEDURE WAS THEN DISCONTINUED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-MAY-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: NEW REPORTERS AND REPORTERS DETAILS ADDED. CONCOMITTANT AND HISTORICAL CONDITIONS ADDED. LOT NO ADDED. PRODUCT INDICATION UPDATED.EVENT ADDED AS SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST, VAGINAL HAEMORRHAGE, MENORRHAGIA. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191, 904747) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MIGRAINE, SEIZURE, HEADACHE AND C-SECTION (IN 2008) IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BENADRYL, TORADOL, PENICILLIN AND COMPAZINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH BENADRYL, COMPAZINE, PENICILLIN AND TORADOL. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL),"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITH A DEVICE REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 3 COILS VISIBLE FROM EACH SIDE. THE PROCEDURE WAS THEN DISCONTINUED. LOT NUMBER: 882191, MANUFACTURE DATE: 2004-04, EXPIRATION DATE: 2005-09. LOT NUMBER 904747: MANUFACTURE DATE: 2004-06 EXPIRATION DATE: 2005-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') AND ABORTION SPONTANEOUS ('MISCARRIAGE / PREGNANCY (STILBIRTH OR MISCARRIAGE)') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191, 904747) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST." AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED C-SECTION (IN 2008) IN 2008, MIGRAINE, SEIZURE AND HEADACHE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BENADRYL, TORADOL, PENICILLIN AND COMPAZINE. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED DRUG HYPERSENSITIVITY WITH BENADRYL, COMPAZINE, PENICILLIN AND TORADOL. CONCOMITANT PRODUCTS INCLUDED NAPROXEN22-(B)(6) 2011 TO(B)(6) 2012, NSAID'S FROM (B)(6) 2012 TO (B)(6) 2014 AND PARACETAMOL (ACETAMINOPHEN) SINCE 2002 TO (B)(6) 2014. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN SEPTEMBER 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL),"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH,"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") AND EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), GENITAL HAEMORRHAGE ("GENITAL BLEEDING") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITH A DEVICE REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE 3 COILS VISIBLE FROM EACH SIDE. THE PROCEDURE WAS THEN DISCONTINUED. LOT NUMBER: 882191 MANUFACTURE DATE: 2004-04 EXPIRATION DATE: 2005-09 . LOT NUMBER 904747: MANUFACTURE DATE: 2004-06 EXPIRATION DATE: 2005-11 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED. NEW EVENTS: GENITAL BLEEDING, POST PROCEDURAL COMPLICATION ADDED. OUTCOME FOR PAIN AND BLEEDING ADDED. SERIOUSNESS CRITERIA REMOVED FOR PREGNANCY WITH CONTRACEPTIVE DEVICE. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), ABORTION SPONTANEOUS ("MISCARRIAGE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY WITH A DEVICE REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, PREGNANCY WITH CONTRACEPTIVE DEVICE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, MENSTRUAL DISORDER, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767252 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191, 904747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ACETAMINOPHEN| NAPROXEN| NSAID'S |