Description of Event or Problem · 0
ACCORDING TO PATIENT REPORT, BREAST IMPLANTS PLACED IN 2012 IN STATE OF (B)(6) (HOSPITAL UNKNOWN TO THIS REPORTER). PATIENT PRESENTED TO (B)(6) FOR BILATERAL BREAST IMPLANT REMOVAL WITH TOTAL CAPSULECTOMIES FOR BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA AROUND THE LEFT BREAST IMPLANT. PATIENT UNDERWENT THIS SURGICAL PROCEDURE ON (B)(6) 2026. EXPLANTS RETURNED TO MANUFACTURER FOR PROCESSING AFTER EXAMINATION BY (B)(6) PATHOLOGY. TISSUE SENT TO HEMATOPATHOLOGY; LAB RESULTS NOT YET AVAILABLE AS OF (B)(6), 2026. CLAIM NUMBER PROVIDED BY PATIENT IS (B)(6) PATIENT SAFETY TEAM CONSULTED AND THIS REPORTER DIRECTED TO PROVIDE THIS DOCUMENTATION TO THE FDA. FINAL DIAGNOSIS A) LEFT BREAST IMPLANT, REMOVAL: - GROSS EXAMINATION ONLY. B) RIGHT BREAST IMPLANT, REMOVAL: - GROSS EXAMINATION ONLY. C) LEFT BREAST IMPLANT CAPSULE, EXCISION: - FIBROUS TISSUE CONSISTENT WITH CAPSULE AND INCREASED LYMPHOCYTIC INFILTRATE, SEE COMMENT. - NEGATIVE FOR CARCINOMA. D) RIGHT BREAST IMPLANT CAPSULE, EXCISION: - FIBROUS TISSUE CONSISTENT WITH CAPSULE, NEGATIVE FOR CARCINOMA. E) LEFT BREAST TISSUE, EXCISION: - SKIN AND SUBCUTANEOUS TISSUE, NEGATIVE FOR CARCINOMA. F) RIGHT BREAST TISSUE, EXCISION: - SKIN AND SUBCUTANEOUS TISSUE, NEGATIVE FOR CARCINOMA. COMMENT: PART C WILL BE SENT TO HEMATOPATHOLOGY FOR FURTHER EVALUATION AND WILL BE REPORTED IN AN ADDENDUM. PATIENT CODE: 4549, 1924. DEVICE CODE: 2993. REFERENCE REPORT#MW5183963.