ESSURE
Report
- Report Number
- 2951250-2018-02939
- Event Type
- Injury
- Date Received
- July 2, 2018
- Date of Event
- May 8, 2018
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS 46-YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6) ) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 915889) INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: LAST MENSTRUAL CYCLE BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012, ESSURE INSERTED ON CYCLE DAY 14. NO VASOCONSTRICTIVE AGENT USED DURING THE REMOVAL. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYNE) SINCE (B)(6) 2012 FOR PROCEDURAL PAIN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON THE SAME DAY, THE SUBJECT EXPERIENCED PROCEDURAL VOMITING ("VOMITING"). ON (B)(6) 2018, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (ESSURE DEVICES WERE REMOVED BY HYSTEROSCOPY/ LAPAROSCOPY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. ON (B)(6) 2012, THE PROCEDURAL VOMITING HAD RESOLVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PROCEDURAL VOMITING TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBES WERE VISUALIZED. SUCCESSFUL PLACEMENT ON BOTH SIDES. PHYSICIAN STATED THAT LYSIS OF SYNECHIAE WAS PERFORMED AT THE SAME TIME OF PROCEDURE. DEVICE REMOVAL WAS INTENDED BY SUBJECT'S REQUEST. LIGASURE WAS USED. ULTRASOUND AND X-RAY WERE USED TO LOCALIZE INSERTS PRIOR TO REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. GYNECOLOGICAL EXAMINATION- ESSURE MICRO-INSERT PLACEMENT PROCEDURE ON (B)(6) 2018 (BILATERAL SUCCESSFUL PLACEMENT). ESSURE INSERTED ON CYCLE DAY 14 OF MENSTRUAL CYCLE. NO HORMONE TREATMENT RECEIVED TO PROMOTE ATROPHIC OR PROLIFERATIVE ENDOMETRIUM BEFORE INSERTION. NAPROSYNE 500MG GIVEN. HYSTEROSCOPE INSERTED AT 10:20HRS. RIGHT AND LEFT OSTIAE VISUALIZED. HYSTEROSCOPE REMOVED AT 10:26HRS. LEFT AND RIGHT TUBE TRAILING LENGTHS: 2 COILS (BOTH LOT NUMBERS 915889). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-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 IN A SUPPLEMENTAL REPORT.
THIS 46-YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: 08-009) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 915889) INSERTED. THIS CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESURE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: LAST MENSTRUAL CYCLE BEFORE ESSURE INSERTION STARTED ON (B)(6) 2012, ESSURE INSERTED ON CYCLE DAY 14. NO VASOCONSTRICTIVE AGENT USED DURING THE REMOVAL. CONCURRENT CONDITIONS INCLUDED DYSMENORRHOEA SINCE (B)(6) 2018 AND NUMBNESS IN LEG SINCE (B)(6) 2018. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYNE) SINCE (B)(6) 2012 FOR PROCEDURAL PAIN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, THE SUBJECT EXPERIENCED PROCEDURAL VOMITING ("VOMITING"). ON (B)(6) 2018, THE SUBJECT EXPERIENCED HYPOAESTHESIA ("LEG NUMBNESS") AND DYSMENORRHOEA ("PAINFULL MENSES"). ON AN UNKNOWN DATE, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (ESSURE DEVICES WERE REMOVED BY HYSTEROSCOPY / LAPAROSCOPY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. ON (B)(6) 2012, THE PROCEDURAL VOMITING HAD RESOLVED. ON (B)(6) 2018, THE HYPOAESTHESIA AND DYSMENORRHOEA HAD RESOLVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED DYSMENORRHOEA, HYPOAESTHESIA AND PROCEDURAL VOMITING TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBES WERE VISUALIZED. SUCCESSFUL PLACEMENT ON BOTH SIDES. PHYSICIAN STATED THAT LYSIS OF SYNECHIAE WAS PERFORMED AT THE SAME TIME OF PROCEDURE. DEVICE REMOVAL WAS PERFORMED DUE TO SUBJECT'S REQUEST. LIGASURE WAS USED. ULTRASOUND AND X-RAY WERE USED TO LOCALIZE INSERTS PRIOR TO REMOVAL. INVESTIGATOR ANSWERED TO THE QUESTION IF HE CONSIDERED THAT ESSURE CAUSED OR CONTRIBUTED TO THE OCCURRENCE OF THE EVENT(S) THAT THAT WAS HARD TO SAY, ACCORDING TO THE PATIENT THE ANSWER WAS "YES". ON (B)(6) 2018, AT LAST CONTACT WITH PATIENT ALL COMPLAINTS HAD DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2012: RESULTS: NEGATIVE. GYNECOLOGICAL EXAMINATION- ESSURE MICRO-INSERT PLACEMENT PROCEDURE ON (B)(6) 2018 (BILATERAL SUCCESSFUL PLACEMENT). ESSURE INSERTED ON CYCLE DAY 14 OF MENSTRUAL CYCLE. NO HORMONE TREATMENT RECEIVED TO PROMOTE ATROPHIC OR PROLIFERATIVE ENDOMETRIUM BEFORE INSERTION. NAPROSYNE 500MG GIVEN. HYSTEROSCOPE INSERTED AT 10:20HRS. RIGHT AND LEFT OSTIAE VISUALIZED. HYSTEROSCOPE REMOVED AT 10:26HRS. LEFT AND RIGHT TUBE TRAILING LENGTHS: 2 COILS (BOTH LOT NUMBERS 915889) . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-NOV-2018: LEG NUMBNESS ((B)(6) 2018) AND PAINFULL MENSES ((B)(6) 2018) WERE ADDED AS EVENT. 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 IN A SUPPLEMENTAL REPORT.
THIS ADULT FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO VASOCONSTRICTIVE AGENT USED DURING THE REMOVAL. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, THE SUBJECT EXPERIENCED PROCEDURAL VOMITING ("VOMITING"). ON (B)(6) 2018, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (ESSURE DEVICES WERE REMOVED BY HYSTEROSCOPY/ LAPAROSCOPY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. ON (B)(6) 2012, THE PROCEDURAL VOMITING HAD RESOLVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PROCEDURAL VOMITING TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBES WERE VISUALIZED. SUCCESSFUL PLACEMENT ON BOTH SIDES. PHYSICIAN STATED THAT LYSIS OF SYNECCHIE WAS PERFORMED AT THE SAME TIME OF PROCEDURE. DEVICE REMOVAL WAS INTENDED BY SUBJECT'S REQUEST. LIGASURE WAS USED. ULTRASOUND AND X-RAY WERE USED TO LOCALIZE INSERTS PRIOR TO REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE . THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 854 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: INSERTION DATE AND DETAIL. IT WAS REPORTED THAT VOMITING OCCURRED DURING INSERTION PROCEDURE (EVENT WAS RECODED TO PROCEDURAL VOMITING). 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.
YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 915889, 915889) INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: LAST MENSTRUAL CYCLE BEFORE ESSURE INSERTION STARTED ON(B)(6) 2012, ESSURE INSERTED ON CYCLE DAY 14. NO VASOCONSTRICTIVE AGENT USED DURING THE REMOVAL. CONCOMITANT PRODUCTS INCLUDED NAPROXEN (NAPROSYNE) SINCE (B)(6) 2012 FOR PROCEDURAL PAIN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON THE SAME DAY, THE SUBJECT EXPERIENCED PROCEDURAL VOMITING ("VOMITING"). ON (B)(6) 2018, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (ESSURE DEVICES WERE REMOVED BY HYSTEROSCOPY/ LAPAROSCOPY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. ON (B)(6) 2012, THE PROCEDURAL VOMITING HAD RESOLVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PROCEDURAL VOMITING TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBES WERE VISUALIZED. SUCCESSFUL PLACEMENT ON BOTH SIDES. PHYSICIAN STATED THAT LYSIS OF SYNECHIAE WAS PERFORMED AT THE SAME TIME OF PROCEDURE. DEVICE REMOVAL WAS INTENDED BY SUBJECT'S REQUEST. LIGASURE WAS USED. ULTRASOUND AND X-RAY WERE USED TO LOCALIZE INSERTS PRIOR TO REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE GYNECOLOGICAL EXAMINATION- ESSURE MICRO-INSERT PLACEMENT PROCEDURE ON (B)(6) 2018 (BILATERAL SUCCESSFUL PLACEMENT). ESSURE INSERTED ON CYCLE DAY 14 OF MENSTRUAL CYCLE. NO HORMONE TREATMENT RECEIVED TO PROMOTE ATROPHIC OR PROLIFERATIVE ENDOMETRIUM BEFORE INSERTION. NAPROSYNE 500MG GIVEN. HYSTEROSCOPE INSERTED AT 10:20HRS. RIGHT AND LEFT OSTIAE VISUALIZED. HYSTEROSCOPE REMOVED AT 10:26HRS. LEFT AND RIGHT TUBE TRAILING LENGTHS: 2 COILS (BOTH LOT NUMBERS 915889) THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM (PT). IN THIS PARTICULAR CASE A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PT (EXCLUDING THIS CASE): MEDICAL DEVICE REMOVAL: 865 CASES WERE IDENTIFIED. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6) 2018: ESSURE MICRO-INSERT PLACEMENT PROCEDURE FORM WAS RECEIVED. LAST MENSTRUAL CYCLE BEFORE ESSURE INSERTION STARTED ON(B)(6) 2012. ESSURE INSERTED ON CYCLE DAY 14. NO HORMONE TREATMENT RECEIVED TO PROMOTE ATROPHIC OR PROLIFERATIVE ENDOMETRIUM BEFORE INSERTION. NAPROSYNE 500MG GIVEN. HYSTEROSCOPE INSERTED AT 10:20HRS. RIGHT AND LEFT OSTIAE VISUALIZED. HYSTEROSCOPE REMOVED AT 10:26HRS. LEFT AND RIGHT TUBE TRAILING LENGTHS: 2 COILS (BOTH LOT NUMBERS 915889) 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 IN A SUPPLEMENTAL REPORT.
THIS ADULT FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL:(B)(4)). THE SUBJECT (PATIENT ID: (B)(4)) HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO VASOCONSTRICTIVE AGENT USED DURING THE REMOVAL. ON AN UNKNOWN DATE, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, THE SUBJECT EXPERIENCED VOMITING ("VOMITING"). ON (B)(6) 2018, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (ESSURE DEVICES WERE REMOVED BY HYSTEROSCOPY/ LAPAROSCOPY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. ON (B)(6) 2012, THE VOMITING HAD RESOLVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED VOMITING TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: DEVICE REMOVAL WAS INTENDED BY SUBJECT'S REQUEST. LIGASURE WAS USED. ULTRASOUND AND X-RAY WERE USED TO LOCALIZE INSERTS PRIOR TO REMOVAL. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 851 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. 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 |
|---|---|---|---|---|---|---|---|
| 496230 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 915889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | NAPROSYNE| NAPROSYNE| NAPROSYNE| NAPROSYNE| NAPROSYNE |