Medical spas face new scrutiny

As less invasive cosmetic treatments such as Botox and laser hair removal have come within financial reach for an increasing number of patients, so too have concerns grown about who is performing such procedures and whether they are being done safely.

At the root of much of many of the safety worries is the fact that more of these services are now being delivered at what are known as medical spas, or medispas. The term “medical spa” usually refers to a facility that performs traditional spa treatments, such as facials and massage, but which also provides more medically oriented cosmetic procedures, including injectable fillers and skin resurfacing. In many regions of the country, those spas can be found anywhere from the local mall to a dentist's office.

According to Eric Light, executive director of the International Medical Spa Association, a trade group based in Minnetonka, Minn., there are roughly 2,500 medical spas operating across the country. And that number is growing, Light says, adding that his association currently represents about 10% of the market.

The issue, according to many physicians who routinely perform these services, is that there is little to no oversight of these spas. In the absence of overarching federal rules for cosmetic medical procedures, decisions regarding training requirements, disclosure and physician supervision are left up to individual states, says Lawrence Green, a Rockville, Md.-based dermatologist.

“Each state makes their own rules,” says Green, who also is chairman of the scope of practice committee for the American Society for Dermatologic Surgery, and an assistant professor of dermatology at George Washington University School of Medicine and Health Sciences, Washington. “In many cases, you have people who are not properly trained who are performing these procedures.”

That was the case in Maryland, too, until recently, he says. Green lobbied alongside the state's medical society, making the case to the Maryland Board of Physicians that changes needed to be made. And in August, the state enacted some of the toughest regulations of outpatient cosmetic medical procedures in the country.

The new rules define which cosmetic procedures are medical and which ones are not. Microderm abrasion, for instance, is not considered a medical procedure, while Botox—injections for treatment of facial wrinkles—and laser treatments are. The regulations also stipulate to whom a physician can delegate a procedure, and they require that personnel receive training from an accredited continuing medical education body, and not from a device manufacturer, Green says.

Finally, Maryland's new rules include stringent rules for record-keeping, licensure and medical directors. They also require that those delegated by a physician to perform procedures, such as physician assistants or nurse practitioners, adhere to supervision and training requirements.

“We were so fortunate that the board of physicians took on this issue and decided to do something,” Green says. “I wish it could happen in other states. The bottom line is that we need to perform these procedures safely and give patients the best possible results.”

The motivation for the new rules was purely and simply to improve patient safety, says Karen Wulff, policy analyst for the Maryland Board of Physicians. “At this point, we are still trying to get the word out,” Wulff says. “When it comes to getting things done, though, regulations are the gold standard.”

And although states vary considerably in their regulations, several also have begun to focus more intently on the issue of medical-spa safety.

Several years ago, during a trip to her dermatologist, Massachusetts State Sen. Joan Menard (D-Fall River) listened as her doctor told of patients he was treating for burns and scars inflicted by inexperienced people using laser equipment. That conversation piqued her interest, Menard says, and before long, she had formed a Medical Spa Task Force made up of physicians, nurses, electrologists, estheticians, cosmetologists, attorneys and other stakeholders.

The group met repeatedly over the course of the next few years and ironed out disagreements about who was qualified to perform which procedures and what level of oversight was appropriate to ensure patient safety. They crafted a bill calling for clarified definitions, tighter physician supervision restrictions and more accountability. But in 2009, bogged down by last-minute objections, the bill failed to pass, Menard says.

“That was difficult, but we plan to re-file the bill,” Menard says. “We're going to try to bring everyone together and talk about how we can make changes that address their objections.”

The bill's failure to pass was especially disappointing, Menard says, because Massachusetts' current law requires only that a spa have an appointed medical director. The rules don't include any specific provisions requiring medical directors to work on-site or even in the same state, she says, and that creates real risk for patients.

And as more people recognize cosmetic medical procedures as a big source of potential revenue, there's an even more urgent need to create a framework of guidelines.

“This is becoming a cash cow,” Menard says. “There's no insurance involved, and you can pretty much set your own rates, so a lot of people are looking at this as a pretty good deal.”

In California, a medical-spa bill sponsored by Assemblymember Wilmer Amina Carter (D-Rialto) has been vetoed twice, first in 2009 and again this year. The bill would have targeted the large chains that own many of the state's medical spas by beefing up fines for safety violations and lapses in supervision for those corporate entities.

In September, after the bill passed successfully through the state's House and Senate, Gov. Arnold Schwarzenegger vetoed the measure, calling it unnecessary given the requirements of existing law.

“I believe the members of the board want to protect patients,” the governor said in a letter following the veto. “I just don't agree that the board's time is better spent on medispa enforcement when other physicians should be more quickly investigated and prohibited from practicing medicine when they have caused serious patient harm.”

Light of the International Medical Spa Association says these and other state efforts have less to do with real safety concerns and more to do with physicians looking to protect their turf. He called the arguments against medical spas “specious at best,” and he says, as a rule, these kinds of spas are very safe. He also objected strongly to the notion that a medical director needs to be a dermatologist or trained in dermatology to effectively oversee a facility.

“There is no data to support the idea that one kind of physician is a better medical director than another,” Light says. “The facts are that medical spa procedures, when compared to the rest of the medical world, are extremely safe. Obviously, every time someone gets injured, it's worrisome, but that's why there are protocols in place.”

Light also disagreed with Green and other dermatologists, who have lobbied to make accredited continuing medical education mandatory. He says instead that training provided by manufacturers and medical device companies is sufficient. “As long as people are operating within the scope of their practice, we don't see an issue,” he says.

Peter Kamhout, the owner and medical director of Be Medical Spa & Salon, Grand Haven, Mich., has set his own guidelines in the absence of strict rules from the state. “There's a lot of grey area,” he says.

A physician with a background in emergency medicine, Kamhout is the only person in his spa who performs dermal filler procedures, but he allows his nurse and two physician assistants to perform other treatments such as Botox. Kamhout scoffed at the idea that physicians need to perform every procedure, but he acknowledged that some medical spas were talking advantage of the lack of oversight.

And while Kamhout says patient safety is the ultimate goal, he also says he is skeptical of increased government scrutiny and regulations.

“I do have a concern any time the government tries to get involved in businesses because I believe improvements are best achieved by people within the community,” he says.