In 2022, a woman went to the Skin Beauté Med Spa in Randolph to get injections of a filler meant to plump up her lips — an increasingly popular procedure fueled by social media and beauty influencers. Under Massachusetts law, the only people allowed to perform these kinds of injections are licensed nurses, doctors and physician’s assistants; the woman holding the syringe at Skin Beauté told the woman she was a nurse, according to documents filed in federal court.
After injecting the customer’s lips, the provider — a Stoughton woman identified in those documents as Rebecca Fadanelli — proceeded to use the same syringe between the woman’s eyebrows. But some time after, the woman experienced “bumps” in her lips and “tingling” in her forehead.
She filed a complaint with the Food and Drug Administration that led to an investigation and ultimately federal charges of smuggling and dispensing counterfeit Botox and fillers. Fadanelli is accused of performing thousands of injections using counterfeit products over three years. And while she allegedly told clients she was a nurse, she was actually an aesthetician and not permitted to administer injections under state law.
Fadanelli’s case is still playing out in U.S. District Court and her attorneys did not return requests for comment. But the case points to growing risks to customers navigating a booming and largely unsupervised industry of “med spas” and similar businesses in Massachusetts at a time when experts say counterfeit — and potentially contaminated — products are flooding into the United States.
“In Massachusetts, perhaps surprisingly, we have among the most lax oversight of who can inject patients,” Dr. Matthew M. Avram, director of the Massachusetts General Hospital Dermatology Laser and Cosmetic Center said. “It’s kind of like the wild west out there.”
Cosmetic injections are usually considered safe when they are done with approved products and correctly administered, but med spas are rarely inspected and there are no state standards for training aesthetic injectors. And when things go wrong, Massachusetts has no central repository for reporting adverse outcomes from those types of injections in order to track the problems.
Avram told GBH News that many patients end up seeking help from his department after bad results from cosmetic procedures elsewhere, leaving doctors to treat everything from drooping eyes to blocked blood vessels. In the most extreme cases, complications can be life-threatening — like a recent cluster of 18 suspected botulism cases tied to cosmetic injections at Rodrigo Beauty in Milton. The CDC says infection from botulism through cosmetic injection could be caused by a counterfeit product or mishandling by untrained practitioners.
Avram says too many people wrongly assume the industry is well supervised.
“Sometimes I think people spend more time figuring out where they’re going to get their hair cut or they’re gonna make a reservation for dinner than they do vetting who’s gonna be injecting a substance into their face,” he said.
A spokesperson from the Massachusetts Department of Public Health told GBH News that the agency is examining the med spa industry to see if more needs to be done.
“Public safety is DPH’s primary concern. DPH is actively evaluating this new and evolving landscape with the goal of ensuring safe and accessible health services,” spokesperson Omar Cabrera said in an email.
Who’s holding the syringe?
Nationwide, estimates on the size of the medical spa industry vary — but they all point to enormous growth. According to MarketResearch.com, the nearly 9,000 medical spas across the United States reached an annual revenue of $17.5 billion in 2022 with sales expected to grow nearly 10% per year over the next two years as more businesses open.
It appeared to be a lucrative business for Fadanelli: Despite not being legally allowed to perform cosmetic injections in Massachusetts, she earned more than $900,000 from clients for injecting these products over a period of three years, according to court records.
Fadanelli’s business website shows a photo of her and says that she is a “dedicated mother” and “aesthetician” who “graduated in Anatomy from Harvard and specialized in Advanced Cosmetic Procedures licensed by the Massachusetts Estate Board.” Harvard University officials did not respond to requests to verify Fadanelli’s credentials and GBH News could find no state entity called the Estate Board.
But in Massachusetts, medical experts say the existing requirements leave a lot of room for bad actors.
“There are more and more people performing treatments who have less and less training doing them,” Avram said.
While the state spells out who can perform injections, it doesn’t require or recognize any specialized training or certification. There are no supervision standards. If med spas are owned or controlled by a licensed doctor or nurse practitioner, the businesses don’t need to be licensed by the Department of Public Health. And if a business isn’t licensed by DPH, the agency doesn’t have the authority to conduct spot checks or regular inspections.
The Department of Public Health could not provide data on the number of botulism cases specifically linked to cosmetic injections. Officials also would not comment on its ongoing investigation into the Milton spa, but urged people to seek “cosmetic procedures only from licensed professionals in accredited medical settings.”
But health advocates said few people realize cosmetic injections are actually medical procedures, and said it’s a challenge for consumers to even know what constitutes “an accredited medical setting” — because of the lack of licensing requirements.
Dr. Anthony Rossi, a dermatologist at New York’s Memorial Sloan Kettering Cancer Center, has researched the practice of cosmetic dermatology in places like med spas and said poor outcomes are higher with “non-physicians.” Knowing where to safely inject, he said, is something that takes extensive training about the function of facial muscles and vasculature.
“There is a certain level of training that you need in order to perform these procedures not only well and aesthetically well — meaning that they actually look good — but also in a safe way,” Rossi said.
The risks from dermal fillers, which are meant to plump up areas of the skin, are even greater.
Fadanelli allegedly injected filler between her client’s eyebrows, something the Food and Drug Administration has warned against because the area contains many blood vessels. Still, it remains a popular treatment buoyed by social media.
“You can get things like nodules or infections, but even more severe complications like blindness or stroke,” Rossi said.
Advocates like Alex Thiersch, CEO of the Chicago-based American Med Spa Association, told GBH News that problems are rare and most med spas follow a “strict medical framework” that makes them safe. The overwhelming majority of “bad outcomes,” he said, happen at places without proper medical supervision, although he didn’t provide data.
Thiersch said his organization has around 90 members in Massachusetts, although he estimates there are nearly 500 med spas in the Greater Boston area alone. He believes there should be better supervision of medical spas, but stopped short of saying he’d like to see more regulations.
“The problems are caused by unlicensed, noncompliant, untrained providers doing treatments they shouldn’t be doing,” Thiersch said by email. “The problem is NOT with medical spas as a whole — it’s with the rogue med spas that have been allowed to operate unchecked.”
Illegal injectables ‘in every single state’
The risks of cosmetic injections also increase with the use of counterfeit products. Prosecutors say Fadanelli imported products from China and Brazil, which are not approved by the U.S. Food and Drug Administration.
An FDA spokesperson told GBH News that counterfeiting is a “problem” but the agency couldn’t quantify the scale of the fake Botox problem and other counterfeit drugs “due [to] its illicit nature.” In an email, spokesperson Emily Hilliard wrote the problem stems from “the rise of injections in non-medical settings, high profit margins making counterfeiting attractive for bad actors, [and] the proliferation of illegal online pharmacies.”
George Karavetsos, a former director of the FDA’s Office of Criminal Investigations, told GBH News that stopping the flow of illegal and unapproved cosmetic injectables, like counterfeit Botox, into the United States has become more challenging as the popularity of treatments have grown.
“It’s like trying to find a needle in a haystack,’’ he said. “They don’t openly come in labeled or declared as Botox products.”
Karavetsos estimated unapproved products are “in every single state” in both licensed and unlicensed spas. He said the problem has likely worsened in recent years given the rising demand for cosmetic injections. Adding to challenges, the federal government announced major staff cuts at the agency this year.
‘It’s not at all clear’ how to report problems
But even when people encounter untrained providers, questionable products or life-threatening outcomes, the next steps are unclear. One of the biggest issues in the state, several doctors told GBH News, is the lack of a central place to report problems that occur at med spas.
“If for some reason, they’re advertising and selling it for a price that seems too good to be true, well, then that’s exactly what’s happening.”Emily Brems, owner of Medical Aesthetics
It’s a problem that Dr. Yakir Levin says he knows well.
On a night in August of 2023, Levin said he was called to the emergency room of Massachusetts General Hospital to treat a patient experiencing a complication from a filler injection he received at a Newbury Street med spa.
The man had a patch of blue-purple skin that Levin said was the result of a blocked blood vessel. The med spa had attempted to correct the problem, he said, but in his view they didn’t know how to do it properly. Instead, Levin said the patient had been given a note scribbled on a page torn from a notebook and was told to go to an emergency room.
Levin was distressed at how the patient was treated.
“If I have a patient of mine that has a complication, I’m with that patient the entire time and making sure that either I am fixing their problem or that someone else is fixing their problems,’’ he said. “I am not just turfing the patient with a note that says, ‘Here’s what we did, now you deal with it.’”
GBH News was unable to reach the patient. The owner of the Newbury med spa, Carmen Rivera, acknowledged in an email that the injections had been done at her business, Luxury Aesthetics Center. But she said the injections were done properly by a medical practitioner who sent the customer to the emergency room for an ultrasound to be safe.
Levin said he knew how to resolve the patient’s medical problem but didn’t know where to report it. He said he called the state Board of Registration in Medicine and was told they’d only take the complaint if it involved a doctor. But Levin didn’t know who had done the injecting.
“I know if someone has a reportable disease, I can at least look up the Department of Public Health and find out how to report a reportable disease,” he said, “For this, it’s not at all clear.”
Eventually, Levin says he gave up trying to find the right place to file a report. He and other doctors said a lot of cases likely go undetected because reporting to the state Department of Public Health is largely voluntary, unless a case involves a disease.
“And so nothing happened,’’ Levin said. “That’s it.”
Other doctors also told GBH News that the state also needs to create training requirements for the medical spa industry and tighten requirements for supervision.
“There’s a lot of laxity in the laws that are governing this space,” said Dr. Hooman Noorchashm, co-director of the Amy J. Reed Collaborative for Medical Device Safety, a watchdog group formed by Northeastern University School of Law and Tufts Medical Center. “What’s driving this whole process, really, is how lucrative the business is. There’s a lot of money to be made in the unrestrained sale of this service.”
While some in the business say more attention to the industry may help, they’re skeptical about more regulations.
Janaina Batista, who owns Jana Esthetic in Braintree, told GBH News that several years ago she’d hired a nurse to be a partner so she could legally do cosmetic injections in her business. But she said she soon ended the partnership when she began to worry about the risks of injections.
Referring to the botulism outbreak linked to the Milton med spa, Batista says customers have to do their own research.
“There’s only so much the state can do, right? People can hide things all the time, so I don’t think it’s this state’s fault,” Batista said.
Emily Brems said she received a lot of frantic calls after the news of the botulism outbreak, but reassured customers that her business, Medical Aesthetics, is owned by two nurse practitioners who follow state regulations. And she warns people to beware of cheap injections.
“If for some reason, they’re advertising and selling it for a price that seems too good to be true, well, then that’s exactly what’s happening,” she said.
Have a story about your experience at a Massachusetts med spa? Reach out to us at investigations@wgbh.org.
