GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT EXPERIENCED ERYTHEMA OBSERVED ON THE LEFT BREAST AND ALONG WITH MILD NECROSIS POST IMPLANT OF GALAFLEX LITE. IT WAS ALSO REPORTED THAT THE PATIENT IS CURRENTLY UNDER CLOSE CLINICAL MONITORING AND CONTINUED OBSERVATION. HOWEVER, NO CAUSAL RELATIONSHIP BETWEEN GALAFLEX LITE AND THE REPORTED CLINICAL FINDINGS HAS BEEN IDENTIFIED OR SUSPECTED BY THE TREATING PHYSICIAN. BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE GALAFLEX LITE IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES ERYTHEMA AS POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (22-JAN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. 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, THE PATIENT UNDERWENT LEFT MASTECTOMY RECONSTRUCTION ON (B)(6) 2025 USING GALAFLEX LITE, POST IMPLANT OF THE MESH THE PATIENT EXPERIENCED ERYTHEMA OBSERVED ON THE LEFT BREAST AND ALONG WITH MILD NECROSIS. IT WAS ALSO REPORTED THAT AS PER THE CLINICAL ASSESSMENT, THE FINDING IS UNLIKELY TO BE RELATED TO THE USE OF GALAFLEX LITE. THE PATIENT IS CURRENTLY UNDER CLOSE CLINICAL MONITORING AND CONTINUED OBSERVATION. ADDITIONALLY, THE ERYTHEMA IS ABSENT WHEN THE PATIENT IS IN A SUPINE POSITION.