TOROSA SALINE-FILLED TESTICULAR PROSTHESIS

Additional Manufacturer Narrative

ACCORDING TO THE AVAILABLE INFORMATION, THE ARTICLE REPORTED COMPLICATIONS FROM RESEARCH THAT OCCURRED IN THE UNITED SATES. COMPLICATIONS REPORTED WERE RE-SURGERY. THE REPORTED COMPLICATIONS WERE IDENTIFIED IN THE RISK MANAGEMENT DOCUMENT AS POSSIBLE KNOWN HARMS. THE TOROSA INSTRUCTIONS FOR USE INCLUDES GUIDANCE ON FILL VOLUMES. COMPLAINTS WILL BE REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION NO FURTHER INVESTIGATION REQUIRED AT THIS TIME.

Additional Manufacturer Narrative

AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE FOLLOWING WAS PRESENTED VIA ABSTRACT VIDEO AT THE WORLD MEETING ON SEXUAL MEDICINE 2026. TITLE - PERCUTANEOUS ADJUSTMENT OF TESTICULAR IMPLANT IN THE OFFICE (PATIO PROCEDURE) (#001). OBJECTIVE: TO DESCRIBE A NOVEL, MINIMALLY INVASIVE, OFFICE-BASED TECHNIQUE-PERCUTANEOUS ADJUSTMENT OF A TESTICULAR IMPLANT IN THE OFFICE (PATIO)-FOR POSTOPERATIVE VOLUME OPTIMIZATION OF TESTICULAR PROSTHESIS. METHODS: A PATIENT REPORTED DISSATISFACTION DUE TO PERCEIVED UNDERFILLING AFTER STANDARD TESTICULAR PROSTHESIS PLACEMENT. UNDER LOCAL ANESTHESIA IN THE OFFICE, A 23-GAUGE NEEDLE WAS INTRODUCED PERCUTANEOUSLY INTO THE PROSTHESIS PORT. 1.5 CC OF STERILE SALINE WAS ADDED TO ACHIEVE THE DESIRED FIRMNESS AND SYMMETRY. THE PATIENT WAS MONITORED FOR COMPLICATIONS AND SATISFACTION OUTCOMES. RESULTS: THE PROCEDURE WAS WELL TOLERATED, WITH NO PAIN, INFECTION, OR LEAKAGE NOTED. IMMEDIATE IMPROVEMENT IN COSMETIC APPEARANCE AND PATIENT SATISFACTION WAS OBSERVED. CONCLUSIONS: THE PATIO PROCEDURE REPRESENTS A SAFE, EFFECTIVE, AND REPRODUCIBLE OFFICE-BASED TECHNIQUE FOR FINE-TUNING TESTICULAR IMPLANT VOLUME. IT ALLOWS BOTH AUGMENTATION AND REDUCTION OF PROSTHESIS FILL VOLUME WITHOUT REPEAT SURGERY, PROVIDING A PRACTICAL STRATEGY TO ENHANCE POSTOPERATIVE SATISFACTION WITH A TESTICULAR IMPLANT.