A cluster of at least 10 botulism cases linked to Botox procedures at a spa outside Boston is raising concerns about the safety of the popular cosmetic procedure.
“It’s kind of unusual for one center to be experiencing a glut of cases” in a one-month timeframe, says Dr. Hooman Noorchashm, a research professor at Northeastern University School of Law.
The as yet unknown causes of the cluster of paralysis-causing iatrogenic botulism could stem from a variety of factors, including untrained practitioners, improper packaging or equipment failure, Noorchashm says.
State investigators will likely look into whether the spa met proper licensing requirements, and the care and skill of the person administering the injections, says David Simon, an associate professor of law at Northeastern.
Botox injections have exploded in popularity in recent years as a remedy, albeit temporary, for forehead lines and crow’s feet by blocking nerve signals in the muscle.
“If the rate of Botox use increases, then the number of people who could be affected will also likely increase,” Simon says. But “the rate of side effects should not be different if all spas are performing Botox injections with equal care and skill,” he says.
There have always been risks involved as Botox’s wrinkle-removing action comes from a neurotoxin derived from Clostridium botulinum, the same toxin that causes life-threatening food poisoning from botulism.
It’s when Botox escapes the muscles it is intended to relax and enters the bloodstream that it can cause iatrogenic botulism, which in worst-case scenarios can lead to death, Noorchashm says.
The causes of this type of botulism tend to be too much or too frequent Botox.
It might be “that the concentration that they’re injecting is too much,” Noorchashm says.
The practitioner might not understand the proper dosing regimen or use Botox from improperly labeled packaging, he says.
It could be that the practitioner is injecting into a vascular space instead of a muscle and that the needle is too large for the muscle site, Noorchashm says.
“Let’s say you want to take furrows out of your forehead. And you inject Botox locally there. That shouldn’t get systemic. When you develop botulism, it means this stuff got systemic, got all over your body,” he says.
“That’s either because they’ve injected too much in the local area or it’s because the way they injected it, it’s gotten into the bloodstream and is circulating around,” Noorchashm says.
The symptoms of botulism include blurred or double vision, drooping eyelids, slurred speech, difficulty swallowing and difficulty breathing, according to the Massachusetts Department of Public Health, which recommends emergency treatment for anyone experiencing these symptoms following Botox injections.
Investigators will be sure to determine whether the spa linked to botulism cases met medical licensing requirements, Simon says.
“All medical clinics, including spas, must apply for a license from the state,” he says. “There is an exception for services like medical spas, but only when they are wholly owned or controlled by one or more of the practitioners associated with the spa. But the medical practitioner is still subject to licensing requirements.”
Physicians, physician assistants, nurse practitioners, specially trained registered nurses and dentists are among those allowed to administer Botox.
The Centers for Disease Control and Prevention one year ago said 17 people from nine states, 13 of whom were hospitalized, became ill after receiving Botox injections from counterfeit or unverified sources or from practitioners who did not follow local and state requirements.
Noorchashm says botulinum toxin has been used very safely for at least half a century for a variety of purposes including treating neurological disorders.
But the growth of medical spas is contributing to a ‘Wild West’ environment, he says. “There are a million Medi spas everywhere that are run by nurse practitioners or internists who have no appreciation for the deep structural anatomy – and, therefore, pose a risk of harm.”
Beyond checking whether a facility is licensed and talking with practitioners about their qualifications, there’s not much Botox clients can do to prevent side effects, Noorchashm and Simon say.
“I think patients are pretty exposed,” Noorchashm says.
“Spas can reduce the risk of administering ‘too much’ Botox by requiring customers to certify when and how much Botox they have received,” Simon says.
He also says a spa may be legally liable if it doesn’t provide consumers with informed consent to understand the risk and benefits of treatment.
“No drug or biologic is completely safe, and there are always risks to using them, even when used appropriately,” he says.
The only way to completely prevent the possibility of side effects is to forgo the treatment, Noorchashm says. Unlike Botox for migraines and other medical conditions, “cosmetic procedures in general are avoidable,” he says.