Why Medical spas are booming

Would you be tempted to head into a high-end salon for a chemical peel or Botox shot for wrinkles? How about trying one of those new body-contouring devices advertised to shrink fat without pain or incisions?

The number of medical spas - hybrids of medical clinics and day spas - have grown by 80 percent in the past two years and is now up to an estimated 4,250 nationally, according to the International Medical Spa Association. That’s partly due to an increasing array of cosmetic procedures that look easy enough to perform without medical training - but often are not.

“A lot of people assume that the person treating them in a white coat is a physician, and they don’t ask,’’ said Dr. Matthew Avram, who directs the dermatology laser and cosmetic center at Massachusetts General Hospital. Procedures done by inadequately trained clinicians may result in an increased risk of complications ranging from unsatisfactory results to injuries such as burns, scarring, and even death, in rare cases.
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Massachusetts has more than 250 medical spas, ranging from upscale salons to university-affiliated medical practices staffed by dermatologists and plastic surgeons. They are not required to be licensed and are not regulated by the state if they are owned by, or affiliated with, a physician. A doctor is not required to be physically present at the spa.

Legislation to more tightly regulate medical spas - defined by the state Department of Public Health as any facility that performs cosmetic procedures using medical devices such as lasers and ultrasound machines or involving injections such as Botox or Restylane - stalled in the State House last summer. There were disagreements among doctors, nurses, electrologists, and cosmetologists who helped write it.

“We weren’t particularly pleased with the consensus,’’ said Boston dermatologist Dr. Jeffrey Dover, who served on the task force that created the medical spa bill. “Some of the stakeholders had an interest in protecting the status quo.’’

Dover would like to see laser or cosmetic treatments performed only by physicians or by those employed by a medical practice. He said he’s had patients referred to him by their own doctors for laser removal of facial brown spots that, to his specialist’s eye, appeared to be melanomas - and they were. “If those patients had gone to an aesthetician at a med spa, their spots most likely would have been lasered and their cancers missed,’’ he said.

But Representative Jeffrey Sánchez, chair of the committee that decided not to move the bill on for a House vote, said the task force lacked testimony in support of the legislation. “There hasn’t been evidence brought to us to show a pattern of bad outcomes that have resulted from these med spa treatments,’’ Sánchez said.

Adverse event reports submitted to the FDA reveal that safety often rests in the hands of the practitioner. For example, the agency received 930 reports of dermal filler injuries (such as facial palsy, infections, and scarring) over a five-year period. It found indications in a number of cases that injections were being performed by “untrained personnel or in settings other than health clinics or doctors offices,’’ according to an FDA report.

Dover points out that some med spas have no physician on site to supervise procedures. “A business person buys the equipment, and a nurse or technician provides the treatments,’’ he said.

That’s the case at Sound Shapes, a medical spa in the North End that offers noninvasive, fat-reducing treatments using an ultrasound device that’s rubbed in circular motions over the skin. Opened nearly a year ago and owned by a former nurse, Sound Shapes employs a technician - a former marketing manager with 15 hours of manufacturer-provided training - who performs treatments for $795 each. Clients usually opt for three treatments on trouble spots such as underarms, the belly, thighs, or buttocks.

The spa’s VASER Shape ultrasound device was approved by the FDA two years ago for the “temporary removal of cellulite.’’ Sound Shape clients are told the treatments will “increase your body’s metabolism to firm and tighten your skin’’ or spot-reduce trouble areas such as love handles or a beer belly.

“From what I’ve learned about it, once the fat is removed, it disappears and does not come back,’’ said Frankie Boyer, 60, a Sound Shapes client who had a buttocks treatment in December to remove cellulite and underwent four treatments over the past two months to reduce flab and tighten skin on her upper arms. “The results have been fabulous, and it feels like a hot stone massage.’’

During a treatment at Sound Shapes last summer, observed by a Globe reporter, a client who wanted his belly fat reduced saw his 41-inch waistline shrink to 40 1/8 inches after the heated probe was rubbed over his stomach for 45 minutes.

How long the effects last, however, remains uncertain. Sound Shapes owner Theresa Sapienza-Cote said clients are told results may be temporary but that clinical trials have found fat loss can last for three years in those who exercise and watch what they eat. They are not examined by a physician to determine whether they are appropriate candidates for the procedure.

Dr. Jeffrey Kenkel, president of the American Society for Aesthetic Plastic Surgery, disagrees with that approach. “A doctor should absolutely examine them beforehand,’’ he said, “since they may have hidden hernias that could lead to bowel injuries from the ultrasound device.’’

A physician, he added, should also assess whether a patient has enough excess fat in the treatment area to avoid damage to bone or other tissues from the ultrasound waves and whether the skin is elastic enough to bounce back, and not droop, after fat is removed.

While Sound Shapes employs a physician as medical director to review client files once a month, Sapienza-Cote said, “He’s not required to see patients beforehand since this isn’t a medical procedure, it’s a treatment.’’ The spa does require clients to fill out a seven-page health form, she said, and turns away those who have certain conditions, including hernias.

Kristy Matteson, vice president of Sound Surgical Technologies, which manufacturers the $99,000 VASER Shape device, said she was surprised to hear that medical exams were not being performed since the company sells machines to spas under the condition that a physician will be evaluating patients prior to treatment. Sapienza-Cote responded that the company “never explained to us that a physician needs to be there.’’

Massachusetts law states that spa treatments using ultrasound devices, lasers, or injections need to be performed under the direction or supervision of a physician, but it’s not clear that the doctor actually has to see the patient to order any of these procedures. “It’s a gray area,’’ said public health department spokeswoman Jennifer Manley.

http://bostonglobe.com/lifestyle/health-wellness/2012/01/30/medical-spas-are-booming/EN79O1cjxxgN07LOJeQCzI/story.html

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