By Paul Savage, MD, FAARM, ABAARM – Founder and Chief Medical Officer | Power2Practice

 

Testosterone therapy for men is not new. In fact, pellet therapy for men has been around since the 1930s! Hormone replacement therapy by pellet implantation has been used with great success in the United States, Europe and Australia since 1938 and many physicians have discovered the ease and effectiveness of this delivery method for testosterone.

 

Benefits of Testosterone Pellets

Testosterone has been shown to increase muscle mass, bump up energy, relieve depression, increase sense of well-being, relieve anxiety, improve memory and improve concentration.

Testosterone pellets increase lean body mass (muscle strength, bone density) and decrease fat mass. Men need adequate levels of testosterone for optimal mental and physical health and for the prevention of chronic illnesses like Alzheimer’s and Parkinson’s disease, which have been associated with low testosterone levels.

For delivering a consistent dose over the long term, pellets are the best option. Pellets deliver consistent, physiologic levels of hormones and avoid the fluctuations of hormone levels seen with other methods of delivery.

Hormone replacement therapy with testosterone implants is superior to oral and topical (both the patch and gel) hormone replacement therapy for bone density.

 

The Procedure

Pellet implantation is a short, simple and painless. The insertion is a simple in-office procedure and is less painful than drawing blood. It requires just 1 cc lidocaine and an incision in the upper hip area, where the pellet is placed inside. No stitches are necessary and the incision is so small it can be closed up with a piece of tape. Implantation may sound a bit scary, but it is actually a simple procedure that takes only a few minutes.

 

Watch me perform a Pellet implantation procedure in this video:

 

Testosterone Pellets

Testosterone pellets, like Testopel, are small, 3 mm by 9 mm pellets that contain crystalline testosterone. Implanted under the skin, they slowly release testosterone over the course of three to six months. These pellets are a long-acting form of testosterone therapy. They deliver a stable, steady dose of testosterone. Pellets typically provide the needed level of hormone for four months.

Testosterone pellet implants release testosterone at a steady rate of 1.3 mg/200 mg implant/day. (Kelleher, S. Testosterone release rate and duration of action of testosterone pellet implant.) Testosterone pellets provide sustained levels of testosterone for at least 4 months and up to 6 months. Implantation of 600-800 mgs of pellets achieved optimal results with respect to peak mean testosterone level and duration of effect.

Testosterone pellets were generally well tolerated and natural testosterone is viewed as the best androgen for substitution in hypogonadal men. Subcutaneous testosterone implants provide the patient, depending on the dose of implants, with normal plasma testosterone for 3-6 months. Administration of testosterone to young individuals has almost no adverse effects. (Gooren LJ, Androgen replacement therapy: present and future.)

 

Risks

There are few and uncommon risks associated with pellet implantation. The occasional infection can occur, or the pellets can be “extruded” and come out of the skin. Both of these are rare: less than <1% for infection and ~5% percent for cases of extrusion of a single pellet. Extrusions are more common among slim men undertaking vigorous physical activities. (1)

 

What About the Prostate?

Men who are contemplating pellet therapy often ask about the risk of developing prostate cancer. In a landmark study by Dr. Abraham Morgentaler, Harvard Urologist, it was noted that the men with the highest risk of developing prostate cancer when placed on testosterone therapy had a lower rate of developing prostate cancer than those men at high risk who were not placed on testosterone therapy.

Dr. Morgentaler wrote:

“We found that men at high risk for prostate cancer did not seem to suffer any dramatic “explosion” of cancer when treated for a year with testosterone therapy. And when I looked back at my extensive experience of treating men with testosterone therapy, many for ten years or longer, precious few cases of cancer had developed.”

 

And Cardiovascular Risk?

Do you remember the onslaught of media coverage surrounding testosterone therapy and increased risk for cardiovascular disease? Of course—how could we ever forget?

According to a 2015 press release from the American College of Cardiology, two recent studies failed to find a connection between testosterone therapy in men and heart problems, which contradicted research that prompted the FDA to investigate the safety of testosterone therapy.

The first study (2) included a meta-analysis of data from 29 separate studies involving more 122,889 men from a Wisconsin health system. The meta-analysis included data that found a link between testosterone therapy and adverse cardiovascular events and revealed that testosterone therapy does not cause statistically significant adverse cardiovascular events among men.

In the second study (3), researchers at Aurora Health Care, a large community-based health care system in Wisconsin, analyzed demographic and health data from 7,245 men with low testosterone levels from 2011-2014. After obtaining data from the electronic record systems of 15 hospitals and 150 clinics, the researchers looked at the combined cardiovascular event rate of heart attack, stroke and death in men with low testosterone who received testosterone therapy and in those who did not.

They found the event rate at three years was low in both the treated group at 5.5 percent and in the untreated group at 6.7 percent, suggesting a potential cardiovascular benefit of testosterone replacement therapy on initial analysis.

However, after adjusting for baseline differences including age, prior heart attack or stroke, cholesterol levels, smoking status and length of follow-up, researchers found no difference in cardiovascular event rates between the two groups.

Arshad Jahangir, MD, the study’s senior author and director at the Center for Integrative Research on Cardiovascular Aging, Aurora Health Care, stated:

“The reassurance we get from this analysis in the community setting is that testosterone replacement therapy in patients with low serum levels is not causing any harm, even if it is not providing much cardiovascular benefit [in this patient population]. “In the absence of prospective data, I think studies like ours will help ease anxieties around this treatment and provide some information on which physicians can base their prescribing decisions.”

Click here to watch a video presentation by (the aforementioned) Dr. Morgentaler from 2015, where he clarifies the misperceptions of testosterone replacement therapy and heart disease risk.

 

Safety of the Procedure

Safety is the most common concern when it comes to testosterone therapy, which the majority of the public is unfamiliar with. In 2009, the Journal of Sexual Medicine published a study analyzing the data from multiple studies of pellet therapy as far back as December of 2003 through April of 2008. The study focused on male subjects and found that 86 percent of the patients were satisfied with the improvement of their symptoms and the ease of insertion. No patient that followed post-insertion directions experienced any adverse side effects, such as infection or pellet extrusion.

 

Cost of the Procedure

Testosterone pellet therapy is not usually covered by insurance, while the Androderm patch or Androgen gel usually is. However, the patient satisfaction, patient safety and effectiveness of pellets over gels and patches are well documented.

The Testopel 75mg pellet costs around $94 per pellet (with most men requiring 8-10 pellets) and with an additional charge by the physician for the procedure ($150.00). = $1100.00

The patient may opt for compounded testosterone pellets 200mg which are considerably less expensive at $50 per pellet (with most men requiring about 4 pellets) and with an additional charge by the physician for the procedure ($150.00). = $350.00

The lab testing required prior to each implantation can be billed to insurance.

 

Would you like to learn more about Pellet Implant therapy? Watch our webinar lead by Dr. James Mirabile of Sotto Pelle.

 

About the Author:

Power2Practice EMR for Integrative Medicine

Dr. Paul Savage founded Power2Practice in 2011 and is currently serves as the Chief Medical Officer. He graduated from the University of Michigan Medical School in Emergency Medicine and later earned his board certification in Integrative Medicine at George Washington University.

Since 2004, he has practiced integrative medicine exclusively and is considered by many as one of the world’s foremost authorities in the area of integrative metabolic medicine (IMM), including bioidentical hormone therapy.

Dr. Savage is currently Founder and President of Chicago Integrative Care where he practices medicine. He continues to lecture worldwide and frequently provides expert insights on hormone therapy to major news media.

 

References & Online Sources:

  1. Handelsman DJ. Androgen Physiology, Pharmacology and Abuse. [Updated 2013 Jan 1]. In: De Groot LJ, Chrousos G, Dungan K, et al., editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from: http://www.ncbi.nlm.nih.gov/books/NBK279000/
  2. Patel P, Arora B, Molnar J, Khosla S, Arora R. EFFECT OF TESTOSTERONE THERAPY ON ADVERSE CARDIOVASCULAR EVENTS AMONG MEN: A META-ANALYSIS. J Am Coll Cardiol. 2015;65(10_S):. doi:10.1016/S0735-1097(15)61645-X.
  3. Zuber A, Greer D, Shearer R, Gardezi A, Chandel A, Jahangir A. Effects of Testosterone Supplement Therapy on Cardiovascular Outcomes in Men With Low Testosterone. Journal of the American College of Cardiology. 65(10):A1346. March 2015. DOI: 10.1016/S0735-1097(15)61346-8

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