AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT BREAST CANCER. MANUFACTURER?S REFERENCE NUMBER: (B)(4).
D
Patient 1
IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING JOINT PAIN, CHEST PAIN, BACK PAIN, HEADACHES, BURNING SENSATION, AND RIGHT BREAST PAIN. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT?S SYMPTOMS IS UNCLEAR. IN ADDITION, A MAMMOGRAM PERFORMED ON (B)(6) 2020 CONFIRMED INVASIVE DUCTAL CARCINOMA (STAGE 2 CANCER) ON THE RIGHT BREAST. THE PATIENT UNDERWENT A BIOPSY AND LUMPECTOMY ON (B)(6) 2020. THE PATIENT REPORTED THAT SHE WOULD START CHEMOTHERAPY ON (B)(6) 2020 AND IS PLANNING TO HAVE A DOUBLE MASTECTOMY WITH RECONSTRUCTION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT?S RIGHT BREAST PROSTHESIS.