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A few years ago, Denver internist Samuel Fountain, MD, suspected a patient’s stroke was linked to a treatment they had received at a local med spa: compounded hormone therapy in the form of long-acting pellets implanted under the skin. These products — delivered via creams, gels, pellets, and more and not approved by US drug regulators — are often marketed as safer or more natural alternatives to standard hormone therapy and are frequently administered at med spas.

After contacting the clinic and reviewing notes from the med spa, Fountain grew concerned about the establishment’s prescribing and monitoring practices. He’s not alone.

Nora Lansen, MD, a primary care physician (PCP) and chief medical officer at Elektra Health — a telemedicine site specializing in menopause care — regularly encounters patients experiencing side effects from “hormone therapy gone wrong.”

More than 10,000 med spas perform millions of treatments annually, but they operate in a regulatory gray zone, often outside the oversight required in traditional medical settings. And despite the availability of safe, FDA-approved hormone therapies for menopause, an estimated 2.5 million US women use compounded hormone therapy each year — often at med spas.

“Because these places exist in an unregulated state, they can put patients at risk of practices that aren’t necessarily in their best interest,” Fountain said.

A 2021 study in Menopause found postmenopausal women using compounded hormone therapy in the form of pellets were significantly more likely to experience adverse effects — including abnormal uterine bleeding and hysterectomy — than those using FDA-approved therapies. The website Reddit is full of threads with women and men asking questions about them, and people reporting they’re everything from “life-changing” to a horror story.

The growing popularity of med spas combined with persistent gaps in menopause education among clinicians reveals not only risks to patient safety but also a fractured healthcare system where middle-aged women too often struggle to find appropriate care.

Risky Business

“None of these compounding products have been studied in careful, controlled trials. We don’t know how much of the prescribed dose is absorbed or the resulting blood levels,” said Jan Shifren, MD, director of the Midlife Women’s Health Center at Massachusetts General Hospital in Boston.

One analysis found that 34% of compounded hormone products failed potency testing compared with just 2% of FDA-approved therapies.

Pellets often contain androgens, which, in excess, can cause side effects such as acne, hirsutism, and deepening of the voice. Lansen said one of her patients registered testosterone levels triple the normal range.

The only evidence-based indication for testosterone therapy in women is hypoactive sexual desire disorder with no other identifiable cause. “If you spend half an hour taking a history, there’s almost always another cause that should be treated first,” Shifren said.

Pellets typically deliver supraphysiologic hormone levels, too, far beyond what’s needed for symptom relief. “Estrogen stimulates the uterine lining, and anyone with a uterus needs adequate progestogen to protect against endometrial overgrowth or cancer,” Shifren said. Yet no data show compounded therapies reliably provide that protection. Shifren said she has treated patients with abnormal bleeding and knows colleagues who have diagnosed cancer potentially linked to compounded hormone therapy.

Nor are any long-term data available on the potential for compounded hormone therapy to cause cardiovascular disease or breast cancer, Shifren said. And because pellets aren’t easily removed, patients often have to wait months for side effects to resolve.

“I do think there are plenty of prescribers who are using compounded treatments in a safe and mindful way, but it’s just not evidence-based, and we have FDA-approved options,” Lansen said. “Even when side effects aren’t an issue, some patients tell me, ‘I’ve spent thousands on this and I can’t afford to keep going.’”

Why Patients Visit Med Spas

Med spas, while not without risks, often fill gaps in the current medical system and can feel more accessible to patients.

“Certain patients don’t want to go to the doctor to treat a medical problem; they just want to feel better,” Fountain said.

In women’s health, especially, where care can sometimes feel “more additive than necessary,” alternative providers are quick to step in, Lansen said. “You can have vendors who say, ‘Your doctor can’t do it, but I can.’”

Aggressive marketing reinforces the appeal. “As primary care physicians, we’re not out there advertising that we’re better than the clinic down the street, but med spas do that,” Fountain said. Their messages often frame treatments as safer, more natural, and more effective, too, regardless of the evidence. One study found 77% of people who used compounded hormone therapy believed it was safer than conventional hormone therapy despite the lack of FDA approval and standardized safety testing.

The long shadow of the Women’s Health Initiative has also shaped current patient and provider attitudes as the study’s early reports raised alarms about the potential hazards of hormone therapy, leading to decades of confusion and avoidance.

“When I was in medical school and residency, we didn’t even really talk about hormone therapy,” Lansen said. “I would say most practicing clinicians are relatively unaware.”

“Women are turning to these questionable alternatives because they can’t find a thoughtful clinician who will provide safe, evidence-based care,” Shifren said. “So in some ways, we’ve contributed to the problem.”

PCPs’ Role in Med Spa Management

PCPs have a critical role to play in both educating patients and managing complications related to med spa treatments, including hormone therapy, Lansen said.

For women within 10 years of their final menstrual period who are younger than 60 years, FDA-approved hormone therapy is generally considered safe. “Beyond that, we’re still learning,” he said.

For patients confused by hormone therapy, Shifren suggested education. “‘Bioidentical’ is a marketing term, not a medical term,” she said. “If patients request ‘natural hormones’ identical to those made by their ovaries before menopause, we should prescribe FDA-approved formulations of estradiol and progesterone, not compounded hormones.”

FDA-approved hormone therapies are also typically covered by insurance, an important consideration for patients paying out of pocket at med spas.

Shifren also stressed the importance of clinician confidence in managing menopause. “Women deserve care for their symptoms,” she said.

Referrals are essential, especially because menopause training among physicians remains limited, though with growing public interest and awareness, menopause care is gaining traction. The Menopause Society is advancing a menopause training program to reach 25,000 healthcare professionals within the next 3 years, many bills have been put forward to address critical gaps in physicians’ training and knowledge, and medical residents have reached a general consensus about the necessity of a standardized menopause curriculum.

Lansen also urges more holistic care in menopause, noting that symptoms can be difficult to distinguish from other midlife challenges such as lack of sleep, stress, caretaking, and work. “The average midlife woman is cooking on all burners.”

While treatment can come in the form of a prescription, it also involves optimizing sleep and stress levels, conversation, and simply acknowledging life’s stressors.

“We can’t just say, ‘These pellets are terrible, don’t ever use them again,” Shifren said. “We need to say, ‘Compounded hormone therapy and pellets can be dangerous. I strongly advise you not to return to the med spa. Let me refer you to someone with expertise in menopausal hormone therapy, and I’ll make sure you get a timely appointment.’”

To guide patients toward evidence-based care, The Menopause Society’s Menopause Society-Certified Practitioner database is a reliable resource for finding trained clinicians. Shifren also helped develop MenoNotes, a free online resource produced by the organization.

Ultimately, Fountain said patients will seek medical treatments outside the traditional medical system, and clinicians must adjust their expectations and counsel patients on the potential hazards.

“I will sometimes say, ‘This is not a treatment that the traditional medical system would offer, and that’s not because we’re trying to withhold some magical cure, it’s because we took an oath to do no harm,” he said.

So long as standards are upheld, he doesn’t take issue with the med spa model. “I just think they have to be held to the same kind of scrutiny as every other medical provider. That’s where the lines get blurred a little bit,” Fountain said. “Doctors can do bad things, too. What matters is whether providers are acting within their scope, following evidence and guidelines, and doing what’s beneficial for the patient and not harming them.”

The sources in this story reported having no relevant financial conflicts of interest.

Cassie Shortsleeve is a health journalist and regular contributor to the country’s top publications, including Women’s Health, Men’s Health, Medscape Medical News, and others. She is the co-founder of the maternal health newsletter Two Truths and lives in the Boston area with her husband and three children.