Low complication rates of testosterone and estradiol implants for androgen and estrogen replacement therapy in over 1 million procedures

Abstract

Background: Testosterone (T) deficiency (TD) in men and women and estrogen (E) deficiency (ED) in women increasingly affects the overall health and quality of life of patients. T implants have seen increased utilization over the past decade. We evaluated continuation rates and adverse events that occurred during T therapy by reviewing practitioner reported data on compressed human-identical T implants for the treatment of TD in both men and women collected over 7 years. Methods: This was a retrospective review of data collected prospectively from men and women from 2012 and 2019. Men who had the clinical syndrome of TD received subcutaneous T implant therapy. Women who presented with symptoms of TD and/or ED underwent T implant and/or estradiol implant therapy. The clinics spanned multiple specialties including obstetrics and gynecology, internal medicine, family practice, and urology. Data were entered into a secure, custom tracking App, using Azure App Services and MS SQL Database integrated with a proprietary dosing site and industry-leading Pharmacy Dispensing software (BioTracker®). Results: Over the 7 years, 1,204,012 subcutaneous implant procedures were performed for 376,254 patients; 85% of the procedures were performed in women. Of the women, 54% of were premenopausal, and 46% were postmenopausal. The overall continuation rate after two insertions was 93%. The overall complication rate was <1%. Most common secondary response reported was pellet extrusion, which was more common in men (<3%) than women (<1%). Conclusions: This study is the largest reported retrospective study to evaluate the continuation and complication rates of T pellet implants. The safety of subcutaneous hormone pellet implants in men and women appears to be better than other routes of administration of bioidentical hormone replacement therapy. Further investigations on short- and long-term benefits of this modality are ongoing and could expand the overall utilization of this method.