SAFETY AND EFFECTIVENESS OF A NEW SALINE FILLED TESTICULAR PROSTHESIS

Abstract

Testicular prostheses have been used for 50 years to replace missing or removed testes. In 1995 the manufacture of the silicone gel filled testis prosthesis in the United States was discontinued because of concern about the safety profiles of other implants. We assessed the safety and effectiveness of a new, saline filled implant for testicular replacement. This open label, multicenter, prospective, case controlled clinical trial was done at 18 American tertiary referral centers. Adult and pediatric male patients missing 1 or 2 testes and without evidence of active malignancy or rheumatological disease were enrolled. All patients underwent formal rheumatological and urological evaluation prior to and after prosthesis placement. Main outcome measures were prosthesis safety assessed by adverse events and effectiveness assessed by changes in testis dimension. Secondary outcome measures were quality of life assessments with 3 validated instruments. All patients were followed a minimum of 1 year in this 5-year study. Postoperative adverse events observed in 19% of 149 patients included device related discomfort or pain in 3%, scrotal edema in 1.3%, infection in 1.3%, extrusion in 2.6%, deflation in 0.7% and pulmonary emboli in 0.7%. No patient reported rheumatological symptoms at 1 year. Testis dimensions were significantly increased in patients missing a testis at baseline (p <0.001). Subjective assessment of testicular appearance was significantly improved (p <0.001) and scores were stable or significantly improved in 2 of 3 quality of life instruments. At short-term followup a new, saline filled testis prosthesis appears safe and well tolerated. Importantly validated self-esteem measures also suggest improvement in quality of life after prosthesis placement.