GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, THE ALLEGATION IS ADVERSE OUTCOMES ASSOCIATED WITH GALAFLEX LITE USED TO TREAT THE PATIENT, INCLUDING DISABILITY, INFLAMMATION, PHYSICAL ASYMMETRY AND NEURALGIA. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHAT IF ANY EXTENT THE DEVICE CAUSED OR CONTRIBUTED TO POST OPERATIVE COURSE. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST INFLAMMATION AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (15-SEP-2025) BASED ON THE DATE OF AWARENESS. 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.

Description of Event or Problem

AS REPORTED, THE PATIENT WAS IMPLANTED WITH GALAFLEX LITE ON (B)(6) 2025. IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED SEVERE STABBING, BURNING, AND RUBBING PAIN IN THE BREASTS, BREAST DEFLATION, SAGGING, BREAST IMPLANT ILLNESS, WEIGHT LOSS, EMOTIONAL DISTRESS AND FATIGUE. THE PATIENT ALSO HAD SEVERE SYSTEMIC ILLNESS AND PHYSICAL DECLINE, LOSS OF STRENGTH AND FUNCTIONAL CAPACITY AND WAS UNABLE TO PERFORM NORMAL DAILY TASKS.