Subcutaneous testosterone pellet implant (Testopel) therapy for men with testosterone deficiency syndrome: a single-site retrospective safety analysis.

INTRODUCTION: Long-acting subcutaneous testosterone pellets provide sustained and steady testosterone levels for 3 to 6 months. Testopel subcutaneous crystalline testosterone pellets are U.S.-approved for the treatment of men with testosterone deficiency syndrome. Published experience with testosterone pellets manufactured by Organon has noted relatively high rates of pellet extrusion and infection. AIM: To report safety and limited efficacy data from our patients treated for testosterone deficiency syndrome with Testopel subcutaneous testosterone pellets. MAIN OUTCOME MEASURES: Infection with or without pellet extrusion, as determined by longitudinal follow-up.
METHODS: Single-site, retrospective analysis of medical records from December 2003 through April 2008.
RESULTS: A total of 80 men met inclusion and exclusion criteria. In the 292 implant procedures performed, four adverse events were reported including one implantation site infection. No spontaneous pellet extrusions were reported. Total and free testosterone concentrations were significantly higher at follow-up than at baseline for all patients. Eighty-six percent of patients were satisfied with this treatment modality based on symptom improvement or having subsequent implant procedures.
CONCLUSIONS: Testosterone replacement with long-acting Testopel pellets had a lower rate of infection (0.3%, 1/292 procedures) as compared with historical data from the Organon testosterone pellet (1.4-6.8%). Additionally, the rate of pellet extrusion was substantially lower (0.3%, 1/292 procedures) as compared with historical data (8.5-12%). None of the patients who complied with post-implant procedure instructions experienced infection or pellet extrusion. Patient satisfaction was high and serum hormone values were improved. The low infection and extrusion rates observed may have been the result of the manufacturing process, which results in small, smooth-surfaced pellets; the absence of foreign material within the pellet packaging; and/or differences in the surgical implantation technique used. Though Testopel pellets have been used in the United States for several decades, more research is needed to document their safety and efficacy.