GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT DEVELOPED SEVERE BILATERAL BREAST INFECTIONS POST SEVERAL WEEKS OF MASTOPEXY SURGERY WITH GALAFLEX. THE INFORMATION PROVIDED IS LIMITED, MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER, THERE HAS BEEN NO RESPONSE. BASED ON THE INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE GALAFLEX MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE BILATERAL BREAST INFECTIONS. INFECTION IS LISTED AS POSSIBLE COMPLICATIONS IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. REGARDING INFECTION THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (24-JUN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. THIS EMDR REPRESENTS THE GALAFLEX (DEVICE 2). ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE OTHER GALAFLEX (DEVICE 1). 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 DEVELOPED SEVERE BILATERAL BREAST INFECTIONS SEVERAL WEEKS FOLLOWING MASTOPEXY SURGERY WITH GALAFLEX.

Description of Event or Problem

AS REPORTED, THE PATIENT DEVELOPED SEVERE BILATERAL BREAST INFECTIONS SEVERAL WEEKS FOLLOWING MASTOPEXY SURGERY WITH GALAFLEX.

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT DEVELOPED SEVERE BILATERAL BREAST INFECTIONS POST SEVERAL WEEKS OF MASTOPEXY SURGERY WITH GALAFLEX. THE INFORMATION PROVIDED IS LIMITED, MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER, THERE HAS BEEN NO RESPONSE. BASED ON THE INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE GALAFLEX MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE BILATERAL BREAST INFECTIONS. INFECTION IS LISTED AS POSSIBLE COMPLICATIONS IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. REGARDING INFECTION THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (24-JUN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO CORRECT THE MANUFACTURER NARRATIVE, AS ONLY ONE MDR IS SUBMITTED TO REPORT THE PATIENT'S POST-OPERATIVE ADVERSE EVENTS. UPDATED FIELDS: B4, G3, G6, H2, H11 CORRECTED FIELDS: H10 (MANUFACTURER NARRATIVE) 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.