What's the Verdict on Pellet Therapy for Menopause?

When Susan Smith (not her real name) was 54, she was feeling the effects of menopause full force. She was tired from not sleeping well and she'd put on weight. But her most significant distress stemmed from the changes in her sex life. Her physician, Deb Matthew, M.D., at Signature Wellness in Charlotte, North Carolina, tells her story. "Susan had zero libido," Matthew explained. "She'd become intimate with her husband because she knew he felt very differently about it." But Smith told Matthew she was so dry, "it felt like the Sahara desert...and [even] cactuses in there—it was so, so painful.

"Obviously, if something really hurts, you're not going to be all that excited about it," Matthew said. "So, sex was a miserable experience—and it was affecting their marriage."

Matthew decided that for Smith, the best solution was pellet treatment, a type of bioidentical hormone replacement therapy (HRT). The use of bioidentical hormones, which come from plant sources, has been around for about 20 years and includes both FDA-approved products, such as oral progesterone, as well as compounded hormones, like pellet therapy, which are not regulated by the FDA.

How pellet therapy works

Pellets can contain bioidentical estrogen, progesterone and/or testosterone in tailored dosages. On your first visit, your hormone levels will be checked to determine which hormones you need and the correct amount. "We don't want to use a hormone that's not necessary," said Matthew.

Next, it's determining what therapy is right for you. If you and your doctor agree on a pellet, an individualized formula of the hormone levels that your body needs is sent to a lab that compounds it into a pellet.

The administration of the pellet is a simple procedure that can be done in your doctor's office. Because the pellet is so small (about the size of a grain of rice), you only experience a tiny incision, which is sealed with small Steri-Strips.

"The pellet slowly dissolves over the next three or four months," said Matthew. Because of this, patients have no need for the more traditional HRT delivery methods, such as creams, patches or pills.

Pellet therapy is not a one-shot deal, however. Your metabolism determines how often you'll need the drug reinserted while you're having peri- and postmenopausal issues. Matthew noted that older and more sedentary women often metabolize the pellet more slowly, so the hormones can last four months or longer, while physically active and younger women may burn it off and need reinjection in less than three months.

The side effects of pellet therapy

Matthew said she usually prescribes pellets that contain bioidentical testosterone. "Women have testosterone, just like men. It's just that we have one-tenth the amount," she said. "Testosterone helps keep our muscles and our bones strong, so it helps prevent frailty as we get older. [It's also] important for how we feel...inside. Estrogen acts kind of like a natural antidepressant, and progesterone is sort of like a natural antianxiety….Testosterone is like our inner strength. It's our confidence, motivation, self-esteem and assertiveness."

Then there are testosterone's effects on sexuality. "It's very important for...even thinking or caring about sex. It's important for arousal. And it's extremely important for vaginal lubrication," Matthew added.

Testosterone treatments can cause hair growth in places such as the face. That's "usually not a deal-breaker for women because, honestly, we're all sort of used to dealing with unwanted hair," Matthew said. She noted that many women who are already used to shaving, plucking and tweezing are more than happy to do extra if it means gaining greater feelings of sexuality and a naturally lubricated vagina.

There are many other side effects to the pellets, especially those that contain testosterone. These side effects include hair loss, acne and weight gain, as well as more severe conditions, such as vaginitis, uterine bleeding, blood clots and cancer.

Not FDA-approved or recommended by leading organizations

Even after 20-plus years of availability, many physicians and leading organizations refrain from using or recommending pellet therapy, which is not regulated by the FDA.

On its website, the Cleveland Clinic says that while bioidentical hormones are advertised as safe and effective, positive reports generally "remain unsupported by any large-scale, well-designed studies," especially since they can contain non-FDA-approved ingredients like DHEA, known as the "anti-aging hormone." And with their specialized compounding, there's no way to ensure each pellet is delivering the same formula after each application.

The American College of Obstetrics and Gynecology (ACOG) states that bioidentical hormones are "compounded drugs...not regulated by the FDA. Customized compounded hormones pose more risk because they vary in strength and purity."

Michael Tahery, M.D., OB-GYN, is based in Los Angeles and has been in practice since 1995. Though a long-time provider of bioidentical hormone therapy, he does not use pellet delivery.

"I don't like pellets because the release of the hormone into the system is not really regulated very closely. Once the pellet is in the body, the level rises very high, very quickly. Then, over time, it drops, and...goes way below what their body needs. So it doesn't give a steady level," he explained.

Matthew acknowledges that once the pellet is administered it can't be removed—it has to dissolve over time. That's why she said if you do choose pellet therapy, the levels should be checked in 30 days, with other checkups depending on any side effects that you report, and your hormone-metabolizing speed.

Additionally, pellet administration and the lab tests required to calculate the correct dosage are not covered by insurance, so women undergoing this treatment must pay out of pocket.

Do your research

Before starting any new treatment, be sure to do your research on what your doctor is recommending and check their credentials. Because pellet therapy is not regulated, extra precautions are needed.

"These days, not just OB-GYNs, but internal medicine physicians, urologists...I've even had anesthesiologists...administer the pellets," warned Tahery, noting that even though these practitioners may prescribe pellets, they typically won't be monitoring for side effects with pre- and post-op checkups. "It's not part of their expertise," he explained. He recommends researching how long a practitioner has been using pellet therapy, what their background is and what training they received regarding this treatment.

A practitioner's website can be a good starting point. Matthew's includes information on bioidentical therapy, while Tahery's shows other options available for vaginal rejuvenation. Asking other women about their experiences with hormone treatments, whether they received pellet therapy or something else, is also helpful.

For Smith, pellet therapy has worked. "Susan noted improvements in desire and in lubrication within two weeks after pellet insertion," Matthew reported, adding, "She is able to enjoy intimacy without pain, and she and her partner have rekindled their romance. She is planning to continue on therapy because of the positive impact it has had on her life."

How long she'll continue, only Smith and her doctor will determine. Matthew added, "Once the ovaries stop making hormones, they don't restart," and it's not usual for a woman who starts HRT to "continue for 15 to 20 years." She also said that at some point, a woman might seek a different delivery method—like a topical hormone cream.