Introduction

One of the oldest form of Hormone Replacement Therapy that was practiced since the 1940s is Hormone pellets. Testosterone and estradiol were compressed into small cylinders and implanted under the skin by Dr. Greenblatt in Augusta.

Safety and efficiency of Hormone Pellets were documented in many scientific studies.
For decades this method was only used by Dr. Greenblatt and few other practitioners, but recently it gains more popularity due to its effectiveness and convenience to patients.
Pellets are superior to the other delivery methods due to significantly more pronounced effects on mood, energy and especially on sex drive.
Medical scientific data supports that hormone implants effectively treat symptoms in both men and women. Pellets, placed under the skin, steadily release small, physiologic doses of hormones providing optimal therapy without adverse effects.

What are Pellets?

Pellets or implants are made up of hormones that are pressed into very small solid cylinders. These pellets are about a size of a rice grain. In the United States, the majority of pellets are made by compounding pharmacists and delivered in sterile glass vials. There is an ‘FDA approved’ 75 mg testosterone pellet.

Why pellets?

Pellets deliver consistent, healthy levels of hormones for 3-4 months in women and 4-5 months in men. They avoid the ups and downs, of hormone levels seen with every other method of delivery. This is important for optimal health and disease prevention. Pellets do not increase the risk of blood clots like synthetic hormone replacement therapy.

In medical studies, when compared to conventional hormone replacement therapy, pellets have been shown to provide better relief of menopausal symptoms, maintenance of bone density, improvement of sleep patterns and sex drive, sexual response and performance.

Testosterone delivered by a pellet implant, has been used to treat migraine and menstrual headaches. It helps with vaginal dryness, incontinence, urinary urgency and frequency. Testosterone has been shown to increase energy, relieve depression, increase sens of well being, relieve anxiety and improve memory and concentration in both men and women. Testosterone, delivered by pellets, increases lean body mass (muscle strength, bone density) and decreases fat. Men and women 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 are associated with low testosterone levels.

Even patients who have failed other types of hormone therapy have a very high success rate with pellets. There is no other ‘method of hormone delivery’ that is as convenient for the patient as the implants. Implants have been used in both men and women since the late 1930’s. There is
significant data that supports the use of testosterone in women and men.

How and where are pellets inserted?

The insertion of pellets is a simple, relatively painless procedure done under local anesthesia. The pellets are usually inserted in the upper buttocks through a small incision, which is then closed with a skin tape (steri-strip). The experience of the health care professional matters not only in the insertion procedure, but also in determining the correct dosage of hormones to be used.

Are there any side effects or complications from the insertion of the pellets?

Complications from the insertion of pellets include; minor bleeding or bruising, discoloration of the skin, infection, and the possible extrusion of the pellet. Other than slight bruising, or discoloration of the skin, these complications are rare.

Testosterone may cause acne or slight increase in facial hair in some women. Testosterone stimulates the bone marrow and increases the production of red blood cells. A low testosterone level in older men is a cause of anemia. Testosterone, delivered by implants or other methods, can cause an elevation in the red blood cells. If the hemoglobin and hematocrit (blood count) get too high, a unit of blood may be donated.

After the insertion of the implants, vigorous physical activity is avoided for 48 hours in women and up to 5 to 7 days in men. Early physical activity is a cause of ‘extrusion’, which is a pellet working it’s way out. Antibiotics may be prescribed if a patient is diabetic or has had a joint replaced. However, this is a ‘clean procedure’ and antibiotics may not be needed.

Why haven’t I heard about Pellets?

Wonder why you haven’t heard of pellets? Pellets are not patented and have not been marketed in the United States. They are frequently used in Europe and Australia where pharmaceutical companies produce pellets. Most of the research on pellets is out of Europe and Australia. Pellets were frequently used in the United States from about 1940 through the late 70’s when oral patented synthetic estrogens were marketed to the public. In fact, some of the most exciting data on hormone implants in breast cancer patients is out of the United States. Even in United States, there are clinics that specialize in the use of pellet implants for hormone therapy.

Do men need hormone therapy?

Testosterone levels decline 1% a year in men beginning in their early 30’s. Most men maintain adequate levels of testosterone into their mid 40’s to mid 50’s, some into their late 70’s to early 80’s. Men should be tested when they begin to show signs of testosterone deficiency. Even men in their 30’s can be testosterone deficient and show signs of bone loss, fatigue, depression, erectile dysfunction, difficulty sleeping and mental decline. Most men need to be tested around 50 years of age. It is never too late to benefit from hormone therapy.

What if my primary care physician or my gynecologist says that there is ‘no data’ to support the use of pellet implants?

He or she is wrong. There is a big difference between ‘no data’ and not being familiar with the data. It is much easier for busy practitioners to dismiss the patient, than it is to question their beliefs and do the research. It’s about a patient making an informed choice. After testosterone pellets are inserted, patients may notice that they have more energy, sleep better and feel happier. Muscle mass and bone density will increase while fatty tissue decreases. Patients may notice increased strength, co-ordination and physical performance. They may see an improvement in skin tone and hair texture. Concentration and memory may improve as will overall physical and sexual health. There is also data to support the ‘long term’ safety of testosterone delivered by pellet implants.

Do testosterone implants have the same danger of breast cancer as other forms of hormone replacement therapy?

Testosterone, delivered by pellet implantation, has been shown to decrease breast proliferation and lower the risk of breast cancer, even in patients on conventional hormone replacement therapy. Clinical studies show that testosterone balances estrogen and is protective for breast. In the past, testosterone implants have been used to treat patients with advanced breast cancer. In 1940, it was theorized that treating patients with testosterone implants earlier, at the time of diagnosis, would have an even greater benefit, preventing recurrent disease. Androgens have also been shown to enhance the effect of Tamoxifen® therapy in breast cancer patients.

Will hormone therapy with estradiol and testosterone pellets help with hair loss?

Hormone deficiency is a common cause of hair loss and treatment with estradiol and testosterone implants can help to re-grow hair. Hair becomes thicker and less dry with pellet therapy

How long until a patient feels better after pellets are inserted?

Some patients begin to ‘feel better’ within 24-48 hours while others may take a week or two to notice a difference. Diet and lifestyle, along with hormone balance are critical for optimal health. Stress is a major contributor to hormone imbalance and illness. Side effects and adverse drug
events from prescription medications can interfere with the beneficial effects of the testosterone implant.

How long do pellets last?

The pellets usually last between 3-4 months in women and 4-5 months in men. The pellets do not need to be removed. They completely dissolve on their own.

Do patients need progesterone when they use the pellets?

Women who are treated with testosterone implants alone (no estrogen therapy) do not require progestin therapy.

However, if estradiol, or other estrogen therapy is prescribed, progesterone is also needed. The main indication for the use of progesterone, is to prevent the proliferation (stimulation) of the uterine lining or stimulation of breast tissue caused by estrogen. Progesterone therapy is NOT required if estrogen therapy is not prescribed. However, there may be health benefits to progesterone.

How are hormones monitored during therapy?

Hormone levels may be evaluated before therapy is started. This may include an FSH, estradiol, testosterone (free and total) for women. Men need a PSA (prostate specific antigen), sensitive estradiol, testosterone, LH, liver profile and blood count prior to starting therapy. Thyroid hormone levels (TSH) may also be evaluated.

In men, follow up levels, including a PSA, blood count and estradiol, may be obtained prior to subsequent testosterone implantation. Men must notify their primary care physician and obtain a digital rectal exam each year. Women are advised to continue their monthly self-breast exam and obtain a mammogram and/or pap smear as advised by their gynecologist or primary care physician.

How much does this cost?

The cost for the insertion of pellets is between $230 and $500 depending on the dose of the hormone and the number of pellets needed. Men need a much larger dose of testosterone than women and the cost is higher. Pellets need to be inserted 2 to 4 times a year depending on how
rapidly a patient processes hormones.

When compared to the cost of drugs to treat the individual symptoms of hormone decline, pellets are very cost effective.

Will insurance cover the procedure?

Some insurance companies cover the cost of pellets, especially in men. Others do not. Most physicians require payment for their services. Patients may want to contact their insurance companies to see if their costs will be reimbursed.

Can a patient be allergic to the implants?

Very rarely, a patient will develop local zone of redness (3-8 cm) and itching at the site of the testosterone implant. There is minimal or no tenderness and no other sign of infection. Pellets are made of up testosterone, stearic acid and PVP (povidone). Patients may react to the PVP. Implants can be compounded or made without PVP. Many patients who develop a local reaction to the implant have low cortisol levels and upon further questioning, have symptoms of adrenal insufficiency. Cortisol testing may be recommended. If needed, 25-50 mg of benadryl works well for the itching.

In conclusion, testosterone therapy by implantation of pellets is a safe and effective method of hormone replacement therapy for both men and women. Continuous administration of hormones by pellets is convenient and economical for the patient. Pellet implantation has consistently proven to be more effective than oral, intramuscular, and topical hormone therapy with regard to bone density, sexual function, mood and cognitive function, urinary and vaginal complaints, breast health, lipid profiles, hormone ratios and metabolites.