What Are Pellets?
Our hormone pellets are small sterile cylinders of estradiol or testosterone, compressed under great pressure. They are produced in a certified, federally inspected outsourcing pharmacy facility in Colorado. After the proper dose is calculated by a computer, the pellets are then implanted in the subcutaneous fat in the upper outer buttock area, where hormones are released gradually as the pellet is absorbed. Dr. Mauldin, was trained in the use of hormone pellets in 2012, initially by the SottoPelle organization, and subsequently BioTE.
In use in this country for over thirty years, the pellet method of hormone administration involves the subcutaneous implantation of bioidentical estrogen and testosterone (for women) or testosterone only (for men) that have been compressed into cylindrical pellets and sterilized. It is a systematic approach, involving computer-calculated dosing and post-dose monitoring of specific laboratory parameters in order to minimize risk and maximize benefit to the patient. Instead of being processed through the G.I. tract, which includes a trip through the liver, pellet hormones go directly into your bloodstream through the capillary circulation. For women, administering estrogen in this way is safer than oral therapy as it does not activate blood clotting factors and gives more consistent levels of hormones in the blood. Pellet therapy provides a more constant level of hormones than other therapies. The hormone pellets are prepared in a federally inspected and certified regional compounding pharmacy.
Q. I’ve been taking estrogen for years since menopause. How is this different?
Estrogen helps hot flashes, but many women still don’t feel “right” on estrogen alone. Some are prescribed sleeping pills and antidepressants for sleeplessness, moodiness, anxiety, and depressive symptoms. This is especially seen in patients who have had their ovaries removed. One cause of these symptoms is testosterone deficiency. Testosterone is a very important hormone for women as well as men. Traditional providers don’t pay attention to testosterone deficiency because there is no effective FDA-approved testosterone product for use in women. Most patients report that testosterone therapy makes them feel “whole” again. Our goal is to balance estrogen and testosterone to increase well-being.
Q. How do I know if I’m a candidate for this therapy?
A panel of twelve blood tests will be done to determine your hormone levels and assess other measures of health. An office consultation appointment will then be scheduled to discuss your symptoms, history, and lifestyle, and review your lab tests. If it is determined that pellet therapy is appropriate for you, we will schedule an appointment for administration. Other prescription options are available and will be discussed.
Q. Do I have blood work done before each treatment?
No, only initially and 6-8 weeks later to determine your peak levels for dosage verification. You will have levels checked again if there are significant changes or persistent symptoms, otherwise, labs will be repeated yearly.
Q. How long will a pellet dose last?
The typical dose interval is 16-18 weeks, but ranges from 13-26 weeks. The dose given varies depending on an age- and weight-influenced calculation. Individual physiology influences the timing of re-dosing, and high levels of stress or physical activity may speed absorption. When symptoms begin to recur, it is time to re-dose.
Q. Is the therapy FDA approved?
Estradiol and testosterone are FDA approved and regulated, the process of making pellets is regulated by the State Pharmacy Board, and the distribution is regulated by the DEA and respective State Pharmacy Boards. The use of compounded pellets and their subcutaneous administration in this manner is not FDA approved. It is considered “off-label” use of the hormones and therefore not covered by insurance. . Please note that this office utilizes high quality compounded pellets prepared, sterilized, and quality tested in an FDA registered and inspected 503B outsourcing facility.
Q. How are they administered?
After a local anesthetic is given, the pellets are implanted in the subcutaneous fat of the posterior hip area. A small incision is made and the pellets are pushed into place with a hollow cannula. No stitch is required.
Q. Are there any special instructions or downtime after insertion?
You will be given instructions that clearly explain how to handle the bandage that covers the incision. Though you may shower, you may not soak in a bathtub until three or four days after the procedure. You also should not engage in exercises such as running, leg presses, squats, elliptical, or rowing for 3 to 4 days after the procedure.
Q. Are there any side effects?
The most common issues are acne, increased hair growth, some fluid retention, and/or a few pounds of weight gain. All are either self-limited or treatable.
Q. What if I’m already on HRT of some sort like creams, patches, pills?
You will be able to stop other hormone therapies within 4-5 days in most cases.
Q. What if I’ve had breast cancer?
Those with a history of breast cancer may still be a candidate for testosterone-only therapy, possibly with an estrogen blocker added.
Q. How do I get started and how much does it cost?
- An initial office consultation at the Center for Balance and Wellness is $125. As we do not file insurance or Medicare, this may be paid in cash, or with a check or credit card. The purpose of this visit is to review your history, discuss lifestyle factors, and determine if pellet therapy is appropriate for you.
- A panel of lab tests (including hormone levels and other indicators of health status) will be ordered prior to your visit. A consultation appointment will then be scheduled to review your symptoms, history, lab results, lifestyle, and discuss options for treatment if indicated. Pellet therapy is only one of several options available to women.
- If pellet therapy is indicated, an appointment will be scheduled for administration. Testosterone pellet therapy for women is $340 (lasting approximately six months). Payment is required in advance.
- Please note that this therapy utilizes high quality compounded pellets prepared, sterilized, and quality tested in a certified compounding pharmacy. Although testosterone itself is an FDA approved drug, its use in this fashion is “off-label” (not FDA approved), and therefore not covered by insurance. You will be given a receipt for your payment that you may file with your insurance company if you choose to do so. Some patients pay for their pellet therapy from their Health Savings Account (HSA). We will not file insurance for you, and cannot file with Medicare.
Please note that the use of estradiol and testosterone in pellet form is considered “off-label” by the FDA. All patients will continue to see their regular physician for checkups and routine care, seeing Dr. Mauldin for hormone management only.