GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD ISSUE WITH PALPATION OF THE LATERAL ASPECT OF THE MESH ON THE RIGHT BREAST, PAIN AND TENDERNESS IN THIS AREA. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S CLINICAL COURSE. PAIN IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. 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, PATIENT WAS IMPLANTED WITH GALAFLEX MESH BY UNDERGOING BREAST AUGMENTATION MASTOPEXY ON (B)(6)2023. IT WAS REPORTED THAT PATIENT HAD A PERSISTENT ISSUE WITH PALPATION OF THE LATERAL ASPECT OF THE MESH ON THE RIGHT BREAST AND TENDERNESS IN THIS AREA. ON (B)(6)2024, PATIENT REPORTED PAIN DURING HOSPITAL VISIT FOR APPOINTMENT. HENCE, THE SURGEON RECOMMENDED A REVISION SURGICAL PROCEDURE TO REMOVE THE PALPABLE GALAFLEX AND REPLACE WITH GALAFLEX LITE. THE PROCEDURE IS SCHEDULED FOR (B)(6)2025.