GalaFlex

Description of Event or Problem

ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREST MASTOPEXY AND PTOSIS ON (B)(6) 2022 WITH IMPLANT OF GALAFLEX MESH (CAT# UNKAA128; LOT# UNKNOWN) IT WAS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL INTERVENTION DUE TO PAIN AND EXPLANTED THE MESH ON (B)(6) 2024. ATTORNEYS ALLEGES THAT THE PATIENT EXPERIENCING ADDITIONAL SURGICAL INTERVENTION, PAIN WHICH HAVE IMPAIRED DAILY ACTIVITIES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR EMOTIONAL DISTRESS INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. 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.