BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 9587476 · Received January 14, 2020

    Report

    Report Number
    1000306051-2019-00136
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    February 13, 2020
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP WITH THE CORRESPONDING AUTHOR REVEALED THERE WERE NO COMPLICATIONS DUE TO THE STRATTICE. TWO PATIENTS WHO EACH HAD STRATTICE IMPLANTED HAD A HEMATOMA. TWO PATIENTS HAD RECURRENT CAPSULAR CONTRACTURE BAKER GRADE III DESPITE THE USE OF STRATTICE. PATIENTS WITH HEMATOMA HAD THE HEMATOMA EVACUATED WITH NO REMOVAL OF STRATTICE. THE TWO PATIENTS WITH RECURRENT CAPSULAR CONTRACTURE WERE FOUND TO HAVE POSITIVE CULTURES AT THE REOPERATION WHERE THE STRATTICE WAS REMOVED IN THE COURSE OF TOTAL CAPSULECTOMY AND IMPLANT EXCHANGE. STRATTICE WAS REPLACED IN BOTH CASES. CORRESPONDING AUTHOR SAID THE STRATTICE WAS NEITHER THE CAUSE NOR A CONTRIBUTOR TO THE COMPLICATIONS.

    Description of Event or Problem · 0

    CAPSULAR CONTRACTURE IS A COMMON COMPLICATION OF BREAST AUGMENTATION SURGERY AND MANY TECHNIQUES TO PREVENT AND TO TREAT CAPSULAR CONTRACTURE HAVE BEEN SUGGESTED WITH INCONSISTENT OR VARIABLY EFFECTIVE RESULTS. THE AUTHORS DESCRIBE A PROTOCOL FOR TREATING ESTABLISHED CAPSULAR CONTRACTURE AFTER BREAST AUGMENTATION WITH A LOW RECURRENCE RATE. FROM (B)(6) 2009 TO (B)(6) 2012, 79 PREVIOUS BILATERAL BREAST AUGMENTATION PATIENTS PRESENTED FOR TREATMENT OF ESTABLISHED CAPSULAR CONTRACTURE. THERE WERE 135 BREASTS WITH CAPSULAR CONTRACTURE: 56 WERE BILATERAL AND 23 WERE UNILATERAL. TEN PATIENTS OPTED FOR NO TREATMENT; TWO PATIENTS OPTED FOR IMPLANT REMOVAL. TWENTY-FOUR WERE TREATED WITH THE ICES (IMPLANT EXCHANGE, CAPSULECTOMY, AND POSSIBLE EXCHANGE OF SITE) PROTOCOL AND 43 WERE TREATED WITH THE SPICES (STRATTICE PLACEMENT IN THE RECONSTRUCTIVE POSITION, IMPLANT EXCHANGE, CAPSULECTOMY, AND POSSIBLE EXCHANGE OF SITE) PROTOCOL. THE 24 PATIENTS TREATED WITH THE ICES PROTOCOL HAD A RECURRENT CAPSULAR CONTRACTURE RATE OF 15%. THE 43 PATIENTS TREATED WITH THE SPICES PROTOCOL HAD A 2.7% RECURRENT CAPSULAR CONTRACTURE INCIDENCE AND AN 2.7% COMPLICATION RATE. CAPSULAR CONTRACTURE AFTER BREAST AUGMENTATION, WHETHER PRIMARY OR RECURRENT, CAN BE SUCCESSFULLY TREATED WITH THE SPICES PROTOCOL.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING REPORTED AS AN INDIVIDUAL EVENT TYPE FOR SERIOUS INJURY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CORRESPONDING AUTHOR FOR ADDITIONAL INFORMATION, INCLUDING RELEVANT LOT NUMBERS. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER REMAINS UNKNOWN; THEREFORE, INTERNAL INVESTIGATION INTO THE EVENT COULD NOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, A RELATIONSHIP BETWEEN THE EVENT AND STRATTICE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS REPORTED, A FOLLOW UP ADVERSE EVENT REPORT WILL BE SUBMITTED. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CAPSULAR CONTRACTURE IS A COMMON COMPLICATION OF BREAST AUGMENTATION SURGERY AND MANY TECHNIQUES TO PREVENT AND TO TREAT CAPSULAR CONTRACTURE HAVE BEEN SUGGESTED WITH INCONSISTENT OR VARIABLY EFFECTIVE RESULTS. THE AUTHORS DESCRIBE A PROTOCOL FOR TREATING ESTABLISHED CAPSULAR CONTRACTURE AFTER BREAST AUGMENTATION WITH A LOW RECURRENCE RATE. FROM JANUARY 2009 TO DECEMBER 2012, 79 PREVIOUS BILATERAL BREAST AUGMENTATION PATIENTS PRESENTED FOR TREATMENT OF ESTABLISHED CAPSULAR CONTRACTURE. THERE WERE 135 BREASTS WITH CAPSULAR CONTRACTURE: 56 WERE BILATERAL AND 23 WERE UNILATERAL. TEN PATIENTS OPTED FOR NO TREATMENT; TWO PATIENTS OPTED FOR IMPLANT REMOVAL. TWENTY-FOUR WERE TREATED WITH THE ICES (IMPLANT EXCHANGE, CAPSULECTOMY, AND POSSIBLE EXCHANGE OF SITE) PROTOCOL AND 43 WERE TREATED WITH THE SPICES (STRATTICE PLACEMENT IN THE RECONSTRUCTIVE POSITION, IMPLANT EXCHANGE, CAPSULECTOMY, AND POSSIBLE EXCHANGE OF SITE) PROTOCOL. THE 24 PATIENTS TREATED WITH THE ICES PROTOCOL HAD A RECURRENT CAPSULAR CONTRACTURE RATE OF 15%. THE 43 PATIENTS TREATED WITH THE SPICES PROTOCOL HAD A 2.7% RECURRENT CAPSULAR CONTRACTURE INCIDENCE AND AN 2.7% COMPLICATION RATE. CAPSULAR CONTRACTURE AFTER BREAST AUGMENTATION, WHETHER PRIMARY OR RECURRENT, CAN BE SUCCESSFULLY TREATED WITH THE SPICES PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50836 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention BREAST IMPLANTS.| BREAST IMPLANTS