GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, PATIENTS UNDERWENT PRE-PECTORAL BREAST RECONSTRUCTION WITH THE IMPLANT OF GALAFLEX. THE SURGEON MADE A GENERAL OBSERVATION STATING SOME PATIENTS PRESENTED POST IMPLANT WITH UNSATISFACTORY AESTHETIC OUTCOMES WITH INCREASED FIRMNESS, SKIN NECROSIS OR SKIN BREAKDOWN AND INFECTION. BASED ON THE INFORMATION REPORTED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' POSTOPERATIVE COURSE. REVIEW OF MANUFACTURING RECORDS WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. INFECTION IS A KNOWN INHERENT RISK OF SURGERY AND IS INCLUDED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE. REGARDING INFECTION, THE WARNINGS SECTION OF THE IFU STATES: "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." 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

AS REPORTED, PATIENTS UNDERWENT PRE-PECTORAL BREAST RECONSTRUCTION WITH THE IMPLANT OF GALAFLEX. POST IMPLANT PATIENTS SHOWED UNSATISFACTORY AESTHETIC OUTCOMES WITH INCREASED FIRMNESS, SKIN NECROSIS OR SKIN BREAKDOWN AND INFECTION. REPORTEDLY, THE POST OPERATIVE COMPLICATIONS PERSISTED EVEN AFTER ONE YEAR OF IMPLANT.