BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4510408 · Received February 12, 2015

    Report

    Report Number
    2951250-2015-00080
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    June 1, 2012
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A (B)(6) FEMALE CONSUMER/PLAINTIFF IN (B)(6) ON (B)(4) 2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012 FOR STERILISATION WITH LOT NUMBER 910509. FOLLOW-UP INFORMATION WAS RECEIVED ON 15-JAN-215, WHEN THE CASE COMPLETED ALL CRITERIA TO BECOME A CASE FOR CENTRAL. THIS IS A POTENTIAL LEGAL CASE. IT WAS REPORTED THAT THE CONSUMER DEVELOPED POST PROCEDURE PAIN AND BLEEDING. BY (B)(6) 2012 THE PAIN WAS SEVERE AND SHE WAS VOMITING. SHE WAS ALSO STILL BLEEDING HEAVILY. THE PAIN WAS SO SEVERE THAT SHE SUFFERED SEVERAL EPILEPTIC SEIZURES. SHE WAS SO CONCERNED THAT SHE CONTACTED THE GYNECOLOGY DEPARTMENT AND WAS ADVISE TO GO STRAIGHT TO EMERGENCY. THE EMERGENCY CARE ASSESSMENT DOCUMENTATION FOR THAT ATTENDANCE STATED PAINFUL PROCEDURE FOLLOWING DAY 5 FITS DUE TO PAIN. SINCE THEN PV BLEEDING. INITIAL PAIN WAS AT RIF (RIGHT ILIAC FOSSA) BUT NOW THROUGHOUT LOWER ABDOMEN. THE CONSUMER'S SYMPTOMS FAILED TO IMPROVE AND SHE THEREFORE VISITED HER PHYSICIAN ON (B)(6) 2012. THE CLINICAL NOTES STATED SHE HAD ESSURE STERILIZATION AND HAD FOUND PROCEDURE VERY PAINFUL. LOTS OF POST-OPERATIVE BLEEDING AND RIF DISCOMFORT. PASSING CLOTS ++ AND FEELING UNWELL. PAIN WAS NOT WELL CONTROLLED ON DISCHARGE. SHE HAD STRUGGLED TO CONTINUE NORMAL ACTIVITY. SHE WAS SAW BY PHYSICIAN 4 D AGO (IN (B)(6) 2012) AND EXAMS WERE NORMAL. SHE CONTACTED THE GYNECOLOGY DEPARTMENT AND WAS ADVISED TO START ON AUGMENTIN AND NORETHISTERONE FOR BLEEDING THE BLEEDING AND PAIN CONTINUED. SHE THEREFORE CONTACTED HER PHYSICIAN AGAIN ON (B)(6) 2012 AND THE DECISION WAS MADE TO REFER HER TO EMERGENCY FOR ASSESSMENT BY THE GYNECOLOGY TEAM WHERE SHE WAS TREATED WITH DICLOFENAC AND ANTIBIOTICS. DESPITE THIS TREATMENT HER PAIN CONTINUED. BY (B)(4) 2012 (REPORTED AS 2011) THE CLAIMANT HAD CONTACTED HER DOCTOR SURGERY AGAIN. THE CLINICAL NOTES FOR THIS ATTENDANCE STATED PERSISTENT PAIN AND BLEEDING WITH NO IMPROVEMENT WITH MEDICATION. THE LETTER WRITTEN TO HOSPITAL STATED THAT WHEN PHYSICIAN INITIALLY REVIEWED HER ONE WEEK AFTER THE PROCEDURE SHE WAS PASSING A LOT OF CLOTS AND WAS TENDER IN THE RIGHT ILIAC FOSSA. SHE WAS PRESCRIBED WITH SOME TRAMADOL AND ON AUGMENTIN AND NORETHISTERONE. UNFORTUNATELY HER PAIN BECAME WORSE AND SHE WAS REFERRED TO GYNECOLOGIST FOR REVIEW. EXAMINATION SWABS AT THIS POINT WERE NORMAL AND SHE WAS GIVEN AN INCREASED DOSE OF NORETHISTERONE, AS THE PAIN AND BLEEDING WERE NOT GETTING BETTER. THE CONSUMER WAS THEREFORE ADMITTED TO THE WARD WHERE HER PAIN AND BLEEDING WERE NOTED. SHE UNDERWENT A CT SCAN THE FOLLOWING DAY AND WAS DISCHARGED HOME. SHE REMAINED IN TERRIBLE PAIN AND DISCOMFORT. ON (B)(6) 2012, SHE CONTACTED HER GYNECOLOGIST. THE RECORDS FROM THAT DATE STATED PAIN IN RIF, MUCH MORE SEVERE AGAIN, NOT CONTROLLED WITH ORAL ANALGESIA AND BLEEDING HAD STARTED AGAIN - HEAVIER THAN NORMAL PERIODS. SHE WAS URGENTLY REFERRED BACK TO HOSPITAL WHERE SHE UNDERWENT DIAGNOSTIC LAPAROSCOPY, DIAGNOSTIC HYSTEROSCOPY/LAPAROSCOPIC ADHESIOLYSIS. IN A LETTER FROM THE HOSPITAL TO THE CONSUMER'S PHYSICIAN DATED (B)(4) 2012, THE FOLLOWING WAS STATED: DURING THE LAPAROSCOPY THE LEFT TUBE WAS SCARRED AND ADHERED TO THE LEFT SIDE WALL AND THIS WAS DISSECTED SO THEREFORE THE PAIN WAS MOST PROBABLY DUE TO THIS, THE LEFT SIDED PAIN MAY BE DUE TO THAT. CONSUMER WAS OBVIOUSLY VERY ANGRY REGARDING THE PAIN SHE WAS EXPERIENCING POST OPERATIVELY AND SHE WISHED THAT THIS HAD BEEN EXPLAINED TO HER AT THE TIME. ON (B)(6) 2012, SHE WAS ADMITTED TO HOSPITAL BY AMBULANCE. THE AMBULANCE RECORDS FOR THAT DATE STATED THAT SHE WAS LYING ON THE FLOOR, DISTRESSED. THE HOSPITAL RECORDS FOR THAT DATE STATED SHE PRESENTED WITH SUDDEN ONSET SEVERE PAIN, SUPRAPUBIC RADIATING TO RIF, LIKE BEING STABBED WITH A KNIFE AND HAVING IT DRAGGED ACROSS HER LOWER ABDOMEN. LASTED THIS SEVERELY FOR APPROXIMATELY 15 MINUTES, THE CONSUMER THOUGHT SHE MAY HAVE BLACKED OUT WITH THE PAIN - PARTNER SAID HE FOUND HER SLUMPED ON THE SOFA, AWOKE WITHIN SECONDS. PAIN EASED A LITTLE BY CURLING LEGS UP AND HOLDING RIF. FOLLOWING THAT ATTENDANCE THE CONSUMER UNDERWENT HYSTERECTOMY TOGETHER WITH HYSTEROSCOPIC REMOVAL OF THE ESSURE. BY (B)(6) 2013, HOWEVER, THE PAIN HAD RETURNED. IT WAS DESCRIBED IN HER PHYSICIAN NOTES ON (B)(6) 2013 AS BEING EXACTLY THE SAME PAIN AS POST STERILIZATION. IT WAS NOTED AT THAT TIME THAT SHE HAD TAKEN TRAMADOL WITHOUT EFFECT. THE CONSUMER HAD SINCE BEEN GIVEN A NUMBER OF GNRH ANALOGUE INJECTIONS. THESE HOWEVER HAD NOT RESULTED IN AN END TO HER PAIN. SHE IS LEFT WITH THE POSSIBILITY THAT SHE WILL HAVE TO UNDERGO FURTHER SURGERY AGAIN. FOLLOW-UP INFORMATION RECEIVED ON 21-JAN-2015: MHRA (ADVERSE INCIDENT CENTER) PROVIDED THEIR REFERENCE NUMBER ((B)(4)). PTC (PRODUCT TECHNICAL COMPLAINT) INVESTIGATION RESULT RECEIVED ON 27-JAN-2015. THE PTC GLOBAL REFERENCE NUMBER FOR THIS REPORT IS (B)(4). FINAL ASSESSMENT: LOT NUMBER 910509 IS VALID. MANUFACTURING DATE: OCT-2011 AND EXPIRATION DATE: OCT-2014. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION AT THIS POINT IN TIME. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO BATCH SIGNAL COULD BE IDENTIFIED. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN MEDDRA. IT INCLUDES RECENT CASES RECEIVED BY BAYER PHARMA AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER PHARMA STANDARDS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(4) 2015 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: ABDOMINAL PAIN LOWER. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 95 CASES. GENITAL HAEMORRHAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 160 CASES. SUPRAPUBIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1 CASE. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM AN LAWYER ON BEHALF OF A (B)(6) FEMALE CONSUMER/PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DEVELOPED POST PROCEDURE BLEEDING WITH CLOTS AND POST PROCEDURE PAIN (INITIALLY ON RIGHT ILIAC FOSSA-RIF, AND LATER THROUGHOUT LOWER ABDOMEN/RIF DISCOMFORT), DUE TO PAIN SHE EXPERIENCED SEVERAL EPILEPTIC SEIZURES. SHE WAS HOSPITALIZED. THE PAIN AND BLEEDING PERSISTED AND SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY. AFTER THIS PROCEDURE, SHE HAD AN EPISODE OF SUDDEN ONSET SEVERE PAIN, SUPRAPUBIC RADIATING TO RIF (SHE BLACKED OUT WITH THIS PAIN) AND WAS HOSPITALIZED AND SUBMITTED TO HYSTERECTOMY WITH ESSURE REMOVAL. ALL REPORTED EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND HOSPITALIZATION. EPILEPTIC SEIZURES AND BLACKED OUT ARE UNLISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION, WHILE THE OTHER EVENTS ARE LISTED. DURING ESSURE MICRO-INSERT THERAPY PAIN AND GENITAL BLEEDING OR SPOTTING MAY OCCUR. IN THIS PARTICULAR CASE, GIVEN THE POSITIVE TEMPORAL RELATIONSHIP BETWEEN ESSURE INSERTION AND THE REPORTED BLEEDING AND PAIN A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING THE REMAINING EVENTS, VASOVAGAL REACTIONS (SYNCOPE) ARE COMMONLY TRIGGERED BY PAIN. IN CASES OF LONG-LASTING CEREBRAL HYPO PERFUSION SEIZURE-LIKE MOVEMENTS ARE OBSERVED IMITATING AN EPILEPTIC SEIZURE. RECOVERY IS SPONTANEOUS, COMPLETE AND LASTS NO LONGER THAN 30 SECONDS. IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED ABOUT CONSUMER'S SEIZURES/BLACK OUT; HOWEVER, SINCE THESE EVENTS WERE RELATED BY CONSUMER TO HER PAIN; CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT DUE TO HOSPITALIZATION AND REQUIRED INTERVENTION FOR ESSURE REMOVAL. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104921 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 910509

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O| R