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.

Hormone replacement therapy (HRT) is a type of treatment that involves taking hormones to prevent or treat certain medical conditions and/ or symptoms associated with female menopause and pre-menopause. These symptoms can include hot flashes, insomnia, vaginal atrophy, accelerated skin aging, vaginal dryness, decreased muscle mass, sexual dysfunction, night sweats, fatigue, joint pain, and others. These symptoms are in large part related to diminished levels of sex hormones. Improvement of symptoms is achieved through hormone replacement and optimization. Furthermore, long-term benefits of HRT include reduced risk for bones, heart, brain, and different cancers (1-3).In the United States, 240,000 women developed breast cancer (BC) annually and 40,000 will die from the disease (4). The lifetime risk of developing BC is 1 in 8 (5). HRT for menopause women has been used mostly in western countries, with about 600 million woman-years of use since 1970.

Hormone replacement therapy continues to be a controversial topic in medicine, with certain narratives regarding safety concerns that are not scientifically established in peer-reviewed literature. These negative narratives, specifically undermining the use of testosterone in women, have caused women to remain without any Food and Drug Administration (FDA)-approved testosterone therapies, while more than 30 FDA-approved testosterone therapies are available for men in the United States. This has resulted in millions of women suffering in silence with very common symptoms of perimenopause and menopause that could easily be addressed with the use of testosterone. There is growing evidence to support the use of physiologic doses of testosterone for sexual function, osteoporosis prevention, brain protection, and breast protection. The safety of testosterone use in women has been evaluated for the past 80 years. A recent publication on the complications of subcutaneous hormone-pellet therapy, looking at a large cohort of patients over 7 years, demonstrated long-term safety. In addition, there have been two large long-term peer-reviewed studies showing a significant reduction in the incidence of invasive breast cancer in women on testosterone therapy. Perhaps it is time for the FDA to consider approving products that would benefit testosterone-deficient women.