ESSURE
Report
- Report Number
- 2951250-2021-00854
- Event Type
- Injury
- Date Received
- March 18, 2021
- Date of Event
- January 1, 2013
- Report Date
- April 19, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS, NO CONCOMITANT DRUGS USED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERIORBITAL SWELLING ("PUFFY EYES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"), MYALGIA ("MUSCLE PAIN") AND LOSS OF LIBIDO ("LIBIDO LOSS OF"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVULATION PAIN ("OVULATION PAIN") AND MOOD SWINGS ("MOOD SWINGS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, VAGINAL DISCHARGE, PERIORBITAL SWELLING AND OVULATION PAIN HAD RESOLVED WITH SEQUELAE AND THE INCONTINENCE, MYALGIA, LOSS OF LIBIDO AND MOOD SWINGS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INCONTINENCE, LOSS OF LIBIDO, MOOD SWINGS, MYALGIA, OVULATION PAIN, PERFORATION, PERIORBITAL SWELLING AND VAGINAL DISCHARGE WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMS PUFFY EYES, INCONTINENCE, MUSCLE PAIN WERE NOT TREATED. LOT NUMBER: 810877, MANUFACTURING DATE: 2010/12, EXPIRATION DATE: 2013/12. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: WITH FOLLOW UP RECEIVED FROM CONSUMER (LAST NAME AMENDED, TAKES LEGAL ACTIONS), THIS RECORD WAS DETECTED TO BE A DUPLICATE TO RECORD # NL-BAYER-2021-120934 (MEDWATCH 3500A MFR NUMBER 2951250-2021-01167) WHICH WILL BE DELETED IN BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS RECORD NL-BAYER-2021-105925 WHICH WILL BE RETAINED. NEW: ESSURE INSERTION DATE WAS AMENDED TO (B)(6) 2011 (PREVIOUSLY: (B)(6) 2011) DUE TO INTERNAL REVIEW THE EVENT 'MEDICAL DEVICE REMOVAL' WAS DELETED, IT WAS ADDED AS SURGICAL TREATMENT FOR THE (PREVIOUSLY REPORTED EVENT:) PERFORATION. 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 REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS, NO CONCOMITANT DRUGS USED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERIORBITAL SWELLING ("PUFFY EYES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"), MYALGIA ("MUSCLE PAIN") AND LOSS OF LIBIDO ("LIBIDO LOSS OF"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVULATION PAIN ("OVULATION PAIN") AND MOOD SWINGS ("MOOD SWINGS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, VAGINAL DISCHARGE, PERIORBITAL SWELLING AND OVULATION PAIN HAD RESOLVED WITH SEQUELAE AND THE INCONTINENCE, MYALGIA, LOSS OF LIBIDO AND MOOD SWINGS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INCONTINENCE, LOSS OF LIBIDO, MOOD SWINGS, MYALGIA, OVULATION PAIN, PERFORATION, PERIORBITAL SWELLING AND VAGINAL DISCHARGE WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMS PUFFY EYES, INCONTINENCE, MUSCLE PAIN WERE NOT TREATED LOT NUMBER: 810877, MANUFACTURING DATE: 2010/12, EXPIRATION DATE: 2013/12. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2021: QUALITY SAFETY EVALUATION OF PTC. 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 REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ACCORDING TO THE REPORTER, THE PATIENT HAD NO RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERFORATION ("PERFORATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERIORBITAL SWELLING ("PUFFY EYES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"), MYALGIA ("MUSCLE PAIN") AND LOSS OF LIBIDO ("LIBIDO LOSS OF"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVULATION PAIN ("OVULATION PAIN") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2016, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 1 MONTH AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN, THE PERFORATION, VAGINAL DISCHARGE, PERIORBITAL SWELLING AND OVULATION PAIN HAD RESOLVED WITH SEQUELAE AND THE INCONTINENCE, MYALGIA, LOSS OF LIBIDO AND MOOD SWINGS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INCONTINENCE, LOSS OF LIBIDO, MEDICAL DEVICE REMOVAL, MOOD SWINGS, MYALGIA, OVULATION PAIN, PERFORATION, PERIORBITAL SWELLING AND VAGINAL DISCHARGE WITH ESSURE. LOT NUMBER: 810877, MANUFACTURING DATE: 2010/12, & EXPIRATION DATE: 2013/12 . QUALITY SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2021: QUALITY SAFETY EVALUATION OF PTC. 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 REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ACCORDING TO THE REPORTER, THE PATIENT HAD NO RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERFORATION ("PERFORATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PERIORBITAL SWELLING ("PUFFY EYES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED INCONTINENCE ("INCONTINENCE"), MYALGIA ("MUSCLE PAIN") AND LOSS OF LIBIDO ("LIBIDO LOSS OF"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OVULATION PAIN ("OVULATION PAIN") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2016, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 1 MONTH AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN, THE PERFORATION, VAGINAL DISCHARGE, PERIORBITAL SWELLING AND OVULATION PAIN HAD RESOLVED WITH SEQUELAE AND THE INCONTINENCE, MYALGIA, LOSS OF LIBIDO AND MOOD SWINGS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR INCONTINENCE, LOSS OF LIBIDO, MEDICAL DEVICE REMOVAL, MOOD SWINGS, MYALGIA, OVULATION PAIN, PERFORATION, PERIORBITAL SWELLING AND VAGINAL DISCHARGE WITH ESSURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411604 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810877 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other| R |