GALAFLEX

Description of Event or Problem

PER JOURNAL ARTICLE: "COMPARATIVE POSTOPERATIVE COMPLICATIONS OF ACELLULAR DERMAL MATRIX AND MESH USE IN PREPECTORAL AND SUBPECTORAL ONE-STAGE DIRECT TO IMPLANT RECONSTRUCTION". THIS RETROSPECTIVE COHORT ANALYSIS BASED ON EVALUATING THE SAFETY PROFILES OF DIFFERENT SCAFFOLDS USED IN ONE STAGE DIRECT TO IMPLANT (DTI) BREAST RECONSTRUCTION. THIS STUDY INVOLVED A TOTAL OF 242 PATIENTS (404 BREASTS) UNDERWENT PREPECTORAL OR SUBPECTORAL IMMEDIATE DTI RECONSTRUCTION WITH VARIOUS MATERIALS, INCLUDING ACELLULAR DERMAL MATRICES (ADMS) AND SYNTHETIC MESHES SUCH AS GALAFLEX. POSTOPERATIVE ADVERSE PATIENT OUTCOMES INCLUDED CAPSULAR CONTRACTURE, CELLULITIS AND INFECTION. THE STUDY COMPARED POSTOPERATIVE OUTCOMES SUCH AS INFECTIONS, WOUND ISSUES, SEROMAS, AND IMPLANT-RELATED COMPLICATIONS ACROSS SCAFFOLD TYPES. AMONG THESE, GALAFLEX WAS USED IN 21 RECONSTRUCTIONS, AND THE KEY FINDING SPECIFIC TO THIS PRODUCT WAS AN INCREASED RATE OF CAPSULAR CONTRACTURE WHEN COMPARED WITH FLEXHD PLIABLE PREFORMED. THIS HIGHLIGHTED THAT ALTHOUGH ALL SCAFFOLDS ARE USED FOR STRUCTURAL SUPPORT IN RECONSTRUCTION, THEIR COMPLICATION PROFILES MAY DIFFER SIGNIFICANTLY. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

Additional Manufacturer Narrative

BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS, INCLUDING CAPSULAR CONTRACTURE, CELLULITIS AND INFECTION. THE STUDY COMPARED POSTOPERATIVE OUTCOMES SUCH AS INFECTIONS, WOUND ISSUES, SEROMAS, AND IMPLANT RELATED COMPLICATIONS ACROSS SCAFFOLD TYPES. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS WERE THAT CAUSED OR CONTRIBUTED TO THE USE OF THE GALAFLEX. INFECTION, SEROMA, WOUND DEHISCENCE ARE KNOWN INHERENT RISK OF THE SURGERY/USE AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2013) IS CONSIDERED TO BE A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.