GALAFLEX

Additional Manufacturer Narrative

BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS LIKE CAPSULAR CONTRACTURE, WOUND DEHISCENCE, SEROMA, HEMATOMA, INFECTION, AND NECROSIS. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS THAT WERE CAUSED OR CONTRIBUTED BY THE USE OF GALAFLEX. INFECTION, SEROMA, WOUND DEHISCENCE, HEMATOMA 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-2008) 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.

Description of Event or Problem

PER JOURNAL ARTICLE: "A COMPARISON OF CAPSULAR CONTRACTURE RATES AFTER IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION USING BIOLOGIC VERSUS SYNTHETIC MESH." A TOTAL OF 772 BREASTS UNDERGOING IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION BETWEEN 2008 AND 2023 WERE RETROSPECTIVELY ANALYZED TO COMPARE RATES OF CLINICALLY SIGNIFICANT CAPSULAR CONTRACTURE (BAKER GRADE III OR IV) BETWEEN BIOLOGIC MESH (689 BREASTS; 89.2%) AND SYNTHETIC MESH (83 BREASTS; 10.8%). IN THE BIOLOGIC MESH COHORT, 2 PATIENTS RECEIVED THE GALAFLEX P4HB SCAFFOLD. THE MESH WAS USED ACCORDING TO STANDARD RECONSTRUCTIVE INDICATIONS AND WERE INCORPORATED INTO THE STUDY¿S COMPARATIVE ASSESSMENT OF POSTOPERATIVE OUTCOMES. ACROSS ALL MESH TYPES, THE STUDY METICULOUSLY TRACKED COMPLICATIONS AND CAPSULAR CONTRACTURE TO EVALUATE WHETHER BIOLOGIC OR SYNTHETIC SCAFFOLDS DEMONSTRATED DIFFERENTIAL PERFORMANCE PROFILES. THE INCIDENCE OF CAPSULAR CONTRACTURE WAS LOW IN BOTH MESH CATEGORIES, WITH BIOLOGIC MESHES SHOWING A 2.2% RATE AND SYNTHETIC MESHES SHOWING 3.6%, A DIFFERENCE THAT WAS NOT STATISTICALLY SIGNIFICANT (P = 0.430). OVERALL COMPLICATION INCLUDES WOUND DEHISCENCE, SEROMA, HEMATOMA, INFECTION REQUIRING ADMISSION OR IV ANTIBIOTICS, AND NECROSIS. MULTIVARIATE ANALYSIS CONFIRMED THAT MESH TYPE WAS NOT A RISK FACTOR FOR THE DEVELOPMENT OF CAPSULAR CONTRACTURE (P = 0.351), AND PATIENT SPECIFIC FACTORS SUCH AS AGE, BMI, DIABETES, SMOKING STATUS, IMPLANT VOLUME, CHEMOTHERAPY, AND IMPLANT SURFACE ALSO DID NOT PREDICT INCREASED RISK. THE STUDY DEMONSTRATES THAT THE GALAFLEX P4HB SCAFFOLD PERFORM SAFELY AND EFFECTIVELY WHEN USED FOR INTERNAL SUPPORT IN IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION. NEITHER MESH TYPE INCREASED THE LIKELIHOOD OF POSTOPERATIVE COMPLICATIONS OR CAPSULAR CONTRACTURE, AND THEIR OUTCOMES WERE CONSISTENT WITH THE PERFORMANCE OF THEIR BROADER BIOLOGIC OR SYNTHETIC CATEGORIES. THESE FINDINGS SUPPORT CONTINUED CLINICAL USE OF GALAFLEX AS RELIABLE REINFORCEMENT OPTIONS, ALLOWING SURGEONS TO BASE MESH SELECTION ON PATIENT NEEDS, SURGICAL PREFERENCE, AND RECONSTRUCTIVE GOALS RATHER THAN CONCERNS ABOUT LONG TERM SAFETY OR CONTRACTURE RISK. 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 MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.