GALAFLEX

Description of Event or Problem

PER JOURNAL ARTICLE: "LONG-TERM OUTCOMES OF POLY-4-HYDROXYBUTYRATE (P4HB) IN AESTHETIC BREAST SURGERY". A TOTAL OF 621 FEMALE PATIENTS (WITH MEAN PATIENT AGE OF 38.1 YEARS) WERE ANALYZED FOR LONG-TERM OUTCOMES FOLLOWING AESTHETIC BREAST SURGERY USING THE GALAFLEX P4HB SCAFFOLD. OF THESE, 460 PATIENTS UNDERWENT PRIMARY PROCEDURES INCLUDING AUGMENTATION-MASTOPEXY (253), MASTOPEXY (125), AND BREAST REDUCTION (71). THE REMAINING 161 PATIENTS UNDERWENT REVISION PROCEDURES, PRIMARILY FOR RECURRENT PTOSIS (166), IMPLANT MALPOSITION (64), AND CAPSULAR CONTRACTURE (61). IMPLANTS WERE PLACED IN CONJUNCTION WITH P4HB IN 466 CASES (75%), WHILE 155 PATIENTS (25%) HAD P4HB PLACED DURING REVISION PROCEDURES. DURING THE AVERAGE FOLLOW-UP OF 1.33 YEARS (RANGE: 1¿9.3 YEARS), 23 COMPLICATIONS WERE OBSERVED: 1. DEVICE-RELATED COMPLICATIONS: 5 CASES (0.8%) INCLUDING 4 CASES OF DELAYED WOUND HEALING AND 1 CASE OF ENCAPSULATED P4HB; 2. NON-DEVICE COMPLICATIONS: 18 CASES (2.9%) INCLUDING DELAYED WOUND HEALING (7), HYPERTROPHIC SCARRING (5), HEMATOMA (3), FAT NECROSIS (1), MALPOSITION AND SEROMA (1). CONCLUSION: USE OF THE GALAFLEX P4HB SCAFFOLD IN BOTH PRIMARY AND REVISION AESTHETIC BREAST SURGERIES DOES NOT APPEAR TO INCREASE THE INHERENT COMPLICATION RISK OF COSMETIC BREAST SURGERY, WITH A LOW COMPLICATION RATE AND HIGH PATIENT SATISFACTION. ADDENDUM PER COAUTHOR: "I AM NOT GOING TO BE ABLE TO GIVE YOU A LOT MORE DETAILS. HOWEVER THERE WAS ONLY 1 DEVICE RELATED COMPLICATION IN THAT STUDY. THE DELAYED WOUND HEALING IS A PROCEDURE RELATED COMPLICATION AND HAS NOTHING TO DO WITH THE P4HB. SO JUST 1 SMALL ENCAPSULATED PORTION OF P4HB IN 1 CASE. THIS IS A MINIMAL ISSUE OVERALL." 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 DELAYED WOUND HEALING AND ENCAPSULATION OF P4HB. 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. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2012) 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.