GALAFLEX

Description of Event or Problem

ALLEGED EVENT: ON (B)(6) 2025, PMQA RECEIVED AN EMAIL FROM (B)(6) WITH DR. (B)(6) OFFICE REPORTING ADVERSE EVENTS FOR THE CURRENT SET OF IMPLANTS ((B)(6).) UPON REVIEW THE POST OPERATIVE NOTES FROM (B)(6) 2024 INDICATE: OPERATION PERFORMED: LEFT INFRAMAMMARY FOLD RECONSTRUCTION AND SOFT TISSUE SUPPORT WITH GALAFLEX. (B)(6) 2024: ADDITIONAL NOTES INDICATE: "PT NOTES TENDERNESS ON HER L BREAST RELATED GALAFLEX. IS HAPPY WITH PLACEMENT HOWEVER, IS CONCERNED THAT IF IT DROPS, SHE WILL BE IN THE SAME POSITION WAS IN PREVIOUSLY WITH ASYMMETRY. PT NOTES SHE IS EXPERIENCING SOME TIGHTNESS ON THE R, IS CONCERNED WITH DEVELOPING CAPSULAR CONTRACTURE, SAYS THAT IF SHE INDEED IS DEVELOPING WOULD (LIKE TO DISCUSS CLOSED CAPSULECTOMY IN OFFICE??; (B)(6) 2024: "MILD DISCOMFORT FROM GALAFLEX BUT MANAGEABLE AND WORTH IT FOR RESULTS" EMAIL IS ATTACHED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).