ESSURE
Report
- Report Number
- 2951250-2023-01992
- Event Type
- Injury
- Date Received
- May 16, 2023
- Date of Event
- March 1, 2018
- Report Date
- January 28, 2024
- 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("METALLIC DEVICE IS FOCALLY EMBEDDED WITHIN THE MYOMETRIUM OF THE LEFT CORNU AND DEEPLY EMBEDDED WITHIN THE RIGHT CORNU AND EXTENDS INTO THE LEFT AND RIGHT FALLOPIAN TUBE") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 731602) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PELVIC PAIN FEMALE, RECTOCELE, CYSTOCELE, FOREIGN BODY IN UTERUS, ANY PART, HIGH CHOLESTEROL, ALCOHOL USE, SURGERY (ELBOW RIGHT BICEP GALL BLADER REMOVAL 2004), ASTHMA AND VAGINAL BLEEDING (PT STATES THAT SHE HAS HAD VB SINCE (B)(6) 2010 AND IT HASN'T STOPPED; IT IS NOT BRIGHT RED BLEEDING ALL THE TIME, AND IT HAS DECREASED IN AMOUNT, BUT SHE IS STILL HAVING A BIT OF VB/DARK RED BLOOD. PATIENT STOPPED BREASTFEEDING APPROXIMATELY AT THE TIME OF OUR LAST VISIT AND STARLED ON ? YAZ FOR 1 MONTH. IS CONCERNED ABOUT IT BEING A PROBLEM FOR HER TUBAL LIGATION VIS ESSURE.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: YAZ, HYDROCHLOROTHIAZIDE AND FOLIC ACID. THE PATIENT HAD A FAMILY HISTORY OF HYPERTENSION AND HEART DISEASE, UNSPECIFIED. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, ANTERIOR AND POSTERIOR COLPORRHAPHY). ESSURE WAS REMOVED ON (B)(6) 2018. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY NOTED REMOVAL DATE OF DRUG UPDATED TO (B)(6) 2018 FROM (B)(6) 2018 00:00. DISCREPANCY NOTED INSERTION DATE OF DRUG UPDATED TO (B)(6) 2010 FROM (B)(6) 2010 00:00 DISCREPANCY NOTED REMOVAL DATE IS (B)(6) 2018 AND SURGICAL PATHOLOGY TEST DATE IS RECORDED AS (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] ON (B)(6) 2010: LAST PAP SMEAR DATE, 6/10 NEG PAP. +1[RHPV ABNORMAL PAP SMEAR, 2002, POSITIVE HIGH RISK. HPV W/ COLPO-- RE-PAPS: WNL, LMP, (B)(6) 2010: BIRTH CONTROL, NONE. [PATHOLOGY TEST] ON (B)(6) 2018: SPECIMEN (S): UTERUS AND ADNEXA - UTERUS, CERVIX, BILATERAL TUBES. FINAL DIAGNOSIS UTERUS, CERVIX, BILATERAL TUBES. UTERUS AND BILATERAL PALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: NO SIGNIFICANT ABNORMALITY. ENDOMETRIUM: SECRETORY PATTERN. MYOMETRIUM: FOCAL ADENOMYOSIS. SEROSA: NO SIGNIFICANT ABNORMALITY. BILATERAL FALLOPIAN TUBES: NO SIGNIFICANT ABNORMALITY; UTERUS AND ADNEXA; UTERUS, CERVIX, BILATERAL TUBES. SECTIONS OF THE FALLOPIAN TUBES SHOW NO SIGNIFICANT ABNORMALITIES. GROSS DESCRIPTION: UTERUS AND ADNEXA; UTERUS, CERVIX, BILATERAL TUBES. MYOMETRIUM: THE MYOMETRIUM IS TRABECULAR, PINK-TAN, 2.0 CM IN THICKNESS. DEEPLY EMBEDDED WITHIN THE RIGHT CORNU AND EXTENDING INTO THE RIGHT FALLOPIAN TUBE IS A TIGHTLY COILED METALLIC DEVICE. A SIMILAR METALLIC DEVICE IS FOCALLY EMBEDDED WITHIN THE MYOMETRIUM OF THE LEFT CORNU AND EXTENDS INTO THE LEFT FALLOPIAN TUBE. NO PERFORATIONS ARE IDENTIFIED. THE COILS ARE CONSISTENT WITH AN ESSURE IMPLANT. NO INTRAMURAL NODULES OR FOCAL LESIONS ARE IDENTIFIED. FALLOPIAN TUBES: PROXIMALLY, EACH FALLOPIAN TUBE CONTAINS A TIGHTLY COILED METALLIC DEVICE, NO PERFORATIONS ARE IDENTIFIED. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-NOV-2023: MEDICAL RECORD RECEIVED. MEDICAL HISTORY AND LAB DATA ADDED INCLUDING PATHOLOGY TEST. REPORTER INFORMATION ADDED. LOT NUMBER AND EXPIRY DATE ADDED. NON DRUG TREATMENT UPDATED. INDICATION ADDED. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("METALLIC DEVICE IS FOCALLY EMBEDDED WITHIN THE MYOMETRIUM OF THE LEFT CORNU AND DEEPLY EMBEDDED WITHIN THE RIGHT CORNU AND EXTENDS INTO THE LEFT AND RIGHT FALLOPIAN TUBE") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 731602) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PELVIC PAIN FEMALE, RECTOCELE, CYSTOCELE, FOREIGN BODY IN UTERUS, ANY PART, HIGH CHOLESTEROL, ALCOHOL USE, SURGERY (ELBOW RIGHT BICEP GALL BLADER REMOVAL 2004), ASTHMA AND VAGINAL BLEEDING (PT STATES THAT SHE HAS HAD VB SINCE (B)(6) 2010 AND IT HASN'T STOPPED; IT IS NOT BRIGHT RED BLEEDING ALL THE TIME, AND IT HAS DECREASED IN AMOUNT, BUT SHE IS STILL HAVING A BIT OF VB/DARK RED BLOOD. PATIENT STOPPED BREASTFEEDING APPROXIMATELY AT THE TIME OF OUR LAST VISIT AND STARLED ON ? YAZ FOR 1 MONTH. IS CONCERNED ABOUT IT BEING A PROBLEM FOR HER TUBAL LIGATION VIS ESSURE.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: YAZ, HYDROCHLOROTHIAZIDE AND FOLIC ACID. THE PATIENT HAD A FAMILY HISTORY OF HYPERTENSION AND HEART DISEASE, UNSPECIFIED. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2018. ON UNKNOWN DATE SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, ANTERIOR AND POSTERIOR COLPORRHAPHY). THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY NOTED REMOVAL DATE OF DRUG UPDATED TO (B)(6) 2018 FROM (B)(6) 2018 00:00 DISCREPANCY NOTED INSERTION DATE OF DRUG UPDATED TO (B)(6) 2010 FROM (B)(6) 2010 00:00 DISCREPANCY NOTED - REMOVAL DATE IS (B)(6) 2018 AND SURGICAL PATHOLOGY TEST DATE IS RECORDED AS (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] ON (B)(6) 2010: LAST PAP SMEAR DATE, 6/10 NEG PAP. +1[RHPV ABNORMAL PAP SMEAR, 2002, POSITIVE HIGH RISK ; HPV W/ COLPO-- RE-PAPS : WNL LMP, (B)(6) 2010 BIRTH CONTROL, NONE [PATHOLOGY TEST] ON (B)(6) 2018: SPECIMEN (S) : UTERUS AND ADNEXA - UTERUS, CERVIX, BILATERAL TUBES FINAL DIAGNOSIS UTERUS, CERVIX, BILATERAL TUBES UTERUS AND BILATERAL PALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CERVIX: NO SIGNIFICANT ABNORMALITY. ENDOMETRIUM: SECRETORY PATTERN. MYOMETRIUM: FOCAL ADENOMYOSIS. SEROSA: NO SIGNIFICANT ABNORMALITY. BILATERAL FALLOPIAN TUBES: NO SIGNIFICANT ABNORMALITY UTERUS AND ADNEXA UTERUS, CERVIX, BILATERAL TUBES SECTIONS OF THE FALLOPIAN TUBES SHOW NO SIGNIFICANT ABNORMALITIES. GROSS DESCRIPTION: UTERUS AND ADNEXA UTERUS, CERVIX, BILATERAL TUBES MYOMETRIUM: THE MYOMETRIUM IS TRABECULAR, PINK-TAN, 2.0 CM IN THICKNESS. DEEPLY EMBEDDED WITHIN THE RIGHT CORNU AND EXTENDING INTO THE RIGHT FALLOPIAN TUBE IS A TIGHTLY COILED METALLIC DEVICE. A SIMILAR METALLIC DEVICE IS FOCALLY EMBEDDED WITHIN THE MYOMETRIUM OF THE LEFT CORNU AND EXTENDS INTO THE LEFT FALLOPIAN TUBE. NO PERFORATIONS ARE IDENTIFIED. THE COILS ARE CONSISTENT WITH AN ESSURE IMPLANT. NO INTRAMURAL NODULES OR FOCAL LESIONS ARE IDENTIFIED. FALLOPIAN TUBES: PROXIMALLY, EACH FALLOPIAN TUBE CONTAINS A TIGHTLY COILED METALLIC DEVICE, NO PERFORATIONS ARE IDENTIFIED. DISCREPANCY NOTED IN EXPIRATION DATE :AUG-2013 AND 30-APR-2013. 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: 26-JAN-2024: UPDATED QUALITY-SAFETY EVALUATION OF PTC. 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 MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 2981 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 22-MAY-2023: QUALITY SAFETY EVALUATION OF PTC. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 2981 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2196455 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 731602 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention |