ESSURE
Report
- Report Number
- 2951250-2016-00073
- Event Type
- Injury
- Date Received
- February 8, 2016
- Report Date
- August 9, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), POSTOPERATIVE ADHESION ("COLON SCARRED FROM LAST SURGERY/EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS MOST LIKELY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 619616,623215) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION AND ARTHRALGIA MULTIPLE. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE HYDROCHLORIDE (BUSPAR), CLONAZEPAM, ESCITALOPRAM OXALATE (LEXAPRO), MINOCYCLINE, QUETIAPINE (SEROQUEL), TRAMADOL HYDROCHLORIDE (ULTRAM), TRAZODONE HYDROCHLORIDE (DESYREL), VICODIN AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POSTOPERATIVE ADHESION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MASS AND ARTHROPATHY, ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL"), NAUSEA ("NAUSEA") AND SWELLING ("SWELLING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POSTOPERATIVE ADHESION, SYSTEMIC LUPUS ERYTHEMATOSUS, ALLERGY TO METALS, NAUSEA AND SWELLING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, NAUSEA, PELVIC PAIN, POSTOPERATIVE ADHESION, SWELLING AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS, REPORTER ADDED, PATIENT CONCOMITANT CONDITION ADDED, CONCOMITANT DRUG ADDED, LOT NUMBER RECEIVED, EVENT HYSTERECTOMY REPLACED WITH EVENTS:- PELVIC PAIN, NAUSEA, ALLERGY TO METAL, SWELLING. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY 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 ("PAIN"), POSTOPERATIVE ADHESION ("COLON SCARRED FROM LAST SURGERY/EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS MOST LIKELY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 619616,623215) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION AND ARTHRALGIA MULTIPLE. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE HYDROCHLORIDE (BUSPAR), CLONAZEPAM, ESCITALOPRAM OXALATE (LEXAPRO), MINOCYCLINE, QUETIAPINE (SEROQUEL), TRAMADOL HYDROCHLORIDE (ULTRAM), TRAZODONE HYDROCHLORIDE (DESYREL), VICODIN AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POSTOPERATIVE ADHESION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MASS AND ARTHROPATHY, ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL"), NAUSEA ("NAUSEA"), SWELLING ("SWELLING") AND DYSGEUSIA ("OTHER INJURY(IES) OR COMPLICATION: METAL TASTE IN MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POSTOPERATIVE ADHESION, SYSTEMIC LUPUS ERYTHEMATOSUS, ALLERGY TO METALS, NAUSEA, SWELLING AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, DYSGEUSIA, NAUSEA, PELVIC PAIN, POSTOPERATIVE ADHESION, SWELLING AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS METAL TASTE IN MOUTH. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), POSTOPERATIVE ADHESION ("COLON SCARRED FROM LAST SURGERY/EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS") AND SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS MOST LIKELY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NOS. 619616 AND 623215) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION AND ARTHRALGIA MULTIPLE. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE HYDROCHLORIDE (BUSPAR), CLONAZEPAM, ESCITALOPRAM OXALATE (LEXAPRO), MINOCYCLINE, QUETIAPINE (SEROQUEL), TRAMADOL HYDROCHLORIDE (ULTRAM), TRAZODONE HYDROCHLORIDE (DESYREL), VICODIN AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED AND REMOVED ON (B)(6) 2012. A NEW ESSURE WAS INSERTED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POSTOPERATIVE ADHESION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MASS AND ARTHROPATHY, ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL"), NAUSEA ("NAUSEA"), SWELLING ("SWELLING") AND DYSGEUSIA ("OTHER INJURY(IES) OR COMPLICATION: METAL TASTE IN MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, POSTOPERATIVE ADHESION, SYSTEMIC LUPUS ERYTHEMATOSUS, ALLERGY TO METALS, NAUSEA, SWELLING AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, DYSGEUSIA, NAUSEA, PELVIC PAIN, POSTOPERATIVE ADHESION, SWELLING AND SYSTEMIC LUPUS ERYTHEMATOSUS TO BE RELATED TO ESSURE. LOT NUMBER: 619616 MANUFACTURE DATE:2009/02 EXPIRATION DATE: 2012/02. LOT NUMBER:623215 MANUFACTURE DATE: 2009/03 EXPIRATION DATE: 2012/03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-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.
FOLLOW UP 08-MAR-2016: PTC INVESTIGATION RESULTS WERE PROVIDED. (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS SUBMITTED TO A HYSTERECTOMY. SHE STATED HER COLON SCARRED FROM LAST SURGERY BECAUSE EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS. ADDITIONALLY, SHE REPORTED SHE MOST LIKELY HAVE LUPUS. ONLY HYSTERECTOMY IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. CONSUMER CONTACTED BAYER TO REPORT ADVERSE EVENTS WITH ESSURE AND STATED SHE HAD 2 SURGERIES, ONE OF THEM BEING A HYSTERECTOMY. SHE ALSO REPORTED SCARRING IN HER COLON DUE TO A SURGERY. ALTHOUGH THE EXACT MEDICAL REASON FOR THE HYSTERECTOMY WAS NOT SPECIFIED; A CONTRIBUTORY ROLE OF THE ESSURE IN THIS PROCEDURE CANNOT BE TOTALLY RULE OUT. REGARDING THE REPORTED LUPUS, IT WAS CONSIDERED AS UNRELATED TO ESSURE DUE TO THE SYSTEMIC NATURE OF THIS DISEASE AND BASED ON DEVICE'S LOCAL ACTION IN THE FALLOPIAN TUBE. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (HYSTERECTOMY PERFORMED). ACCORDING TO PRODUCT TECHNICAL ANALYSIS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
FOLLOW-UP RECEIVED ON 04-MAY-2016: INFORMATION RECEIVED STATES THAT PLAINTIFF HAD ESSURE INSERTED FOR PERMANENT STERILIZATION AND SUBSEQUENTLY HAD THE DEVICE REMOVED DUE TO COMPLICATIONS. COMPANY CAUSALITY COMMENT THIS NON-MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS SUBMITTED TO A HYSTERECTOMY. SHE STATED HER COLON SCARRED FROM LAST SURGERY BECAUSE EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS. ADDITIONALLY, SHE REPORTED SHE MOST LIKELY HAVE LUPUS. ACCORDING TO CLAIM RECEIVED, THIS CASE BECAME LEGAL. ONLY HYSTERECTOMY IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. CONSUMER CONTACTED BAYER TO REPORT ADVERSE EVENTS WITH ESSURE AND STATED SHE HAD 2 SURGERIES, ONE OF THEM BEING A HYSTERECTOMY. SHE ALSO REPORTED SCARRING IN HER COLON DUE TO A SURGERY. ALTHOUGH THE EXACT MEDICAL REASON FOR THE HYSTERECTOMY WAS NOT SPECIFIED; A CONTRIBUTORY ROLE OF THE ESSURE IN THIS PROCEDURE CANNOT BE TOTALLY RULE OUT. REGARDING THE REPORTED LUPUS, IT WAS CONSIDERED AS UNRELATED TO ESSURE DUE TO THE SYSTEMIC NATURE OF THIS DISEASE AND BASED ON DEVICE'S LOCAL ACTION IN THE FALLOPIAN TUBE. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (HYSTERECTOMY PERFORMED). ACCORDING TO PRODUCT TECHNICAL ANALYSIS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM AN ADULT FEMALE CONSUMER IN THE UNITED STATES ON 11-JAN-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. SHE SENT A MESSAGE THROUGH A PRIVATE MESSAGE ON THE (B)(6) PAGE. SHE WOULD LIKE TO KNOW WHO TO GET AHOLD OF TO REPORT ADVERSE ISSUES TO ESSURE. SHE HAD TWO SURGERIES, FULL HYSTERECTOMY AT (B)(6), HER COLON SCARRED FROM LAST SURGERY BECAUSE EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS (PER HER DOCTOR), AND RANDOM LUMPS ALL OVER HER BODY, JOINT ISSUES. SHE WAS TOLD LUPUS MOST LIKELY. SHE WAS PERFECTLY HEALTHY, HAD NEVER HAD SURGERY EVER BEFORE THIS AND WAS NOT HAPPY. SHE OBTAINED AN ATTORNEY. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WAS SUBMITTED TO A HYSTERECTOMY. SHE STATED HER COLON SCARRED FROM LAST SURGERY BECAUSE EVERYTHING WAS STUCK TOGETHER DUE TO EXCESSIVE SCARRING FROM PET FIBERS. ADDITIONALLY, SHE REPORTED SHE MOST LIKELY HAVE LUPUS. ONLY HYSTERECTOMY IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. CONSUMER CONTACTED (B)(4) TO REPORT ADVERSE EVENTS WITH ESSURE AND STATED SHE HAD 2 SURGERIES, ONE OF THEM BEING A HYSTERECTOMY. SHE ALSO REPORTED SCARRING IN HER COLON DUE TO A SURGERY. ALTHOUGH THE EXACT MEDICAL REASON FOR THE HYSTERECTOMY WAS NOT SPECIFIED; A CONTRIBUTORY ROLE OF THE ESSURE IN THIS PROCEDURE CANNOT BE TOTALLY RULE OUT. REGARDING THE REPORTED LUPUS, IT WAS CONSIDERED AS UNRELATED TO ESSURE DUE TO THE SYSTEMIC NATURE OF THIS DISEASE AND BASED ON DEVICE'S LOCAL ACTION IN THE FALLOPIAN TUBE. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (HYSTERECTOMY PERFORMED). A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74600 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 619616,623215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | AMBIEN| AMBIEN| AMBIEN| BUSPAR| BUSPAR| BUSPAR| CLONAZEPAM| CLONAZEPAM| CLONAZEPAM| DESYREL| DESYREL| DESYREL| LEXAPRO| LEXAPRO| LEXAPRO| MINOCYCLINE| MINOCYCLINE| MINOCYCLINE| SEROQUEL| SEROQUEL| SEROQUEL| ULTRAM| ULTRAM| ULTRAM| VICODIN| VICODIN| VICODIN |