Jul 14, 2008 9:17 pm US/Central
Medical Spa Leaves Woman With Severe Tissue Damage
(CBS)
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These photos show tissue damage a woman suffered after undergoing a lipodissolve treatment, a controversial weight reduction procedure, at Pure Med Spa.
CBS
Medical spas are popping up everywhere. The CBS 2 investigators have been uncovering problems and tonight, Pam Zekman reports on a chain with a controversial treatment performed at six locations.
It's called Pure Med Spa and it was recently hit with a lawsuit alleging fraud and negligence. The suit was filed by a patient who suffered horrifying complications from a fat dissolving treatment.
The woman believes she was the victim of a cosmetic con.
Her first introduction to the Pure Med Spa chain was their website. It described its "non-surgical technique" for "spot weight reduction" as "generally considered a safe procedure."
The website says "side effects are extremely minimal
usually limited to minor bruising."
But after the woman had the treatment, she said "I had rotting flesh on my legs for almost five months."
Mesotherapy, also known as lipodissolve, involves injections of a solution that includes phosphatidycholine, a main component of bile. Bile is what breaks down fat in our intestines.
Plastic surgeon Dr. Julius Few says "the problem with phosphatidycholine is if it's not in that controlled system and it's in a high enough concentration, it's like battery acid. It'll eat through anything."
Few has treated patients who had the treatments elsewhere and had complaints ranging from "no effect at all, meaning the patient spent thousands of dollars and saw no benefit" to tissue damage to "flesh eating infections that could have been life threatening."
Medical spas fall into a gray area because the state does not regulate them. Many do not necessarily have doctors performing or even supervising lipodissolve or mesotherapy treatments, even though state regulators say they should because lipodissolve is not FDA approved.
Pure Med Spa's website implies its treatments are performed by 'highly skilled physicians," but it was a nurse, not a doctor who screened the woman who filed the lawsuit in this case.
"She said it was FDA approved," the woman said. The same nurse injected her stomach, hips and thighs for several hours.
Afterward, the woman said "I went to sit up and was shocked by the fact that my hips and my thighs were almost black.
I became incredibly nauseous and began vomiting."
She was rushed by ambulance to a hospital, stabilized and sent home. Over the next week, she says she repeatedly called Pure Med Spa to complain of increased pain, redness and swelling at the injection sites.
Finally, a Pure Med Spa doctor bandaged her sores, gave her an antibiotic and sent her home.
"It just became progressively worse," the woman said. "It was not scabs. It was rotting flesh
and the whole outside was just completely infected. And it was just eaten from the inside out. Oh my God."
Hospital doctors diagnosed dry gangrene and warned that two things could happen if surgery was required.
"One is removing large parts of your legs. And the worst case scenario would be the removal of one or both of my legs," the woman said.
In her lawsuit, filed last month, she accuses Pure Med Spa and its doctors of negligence and consumer fraud.
Her attorney, Marc Shuman, said "it's misleading (to say) that it's FDA approved. It's misleading as to the side effects. And it's misleading as to who actually gives the procedure; a nurse versus a doctor."
Many doctors believe the treatments should not be done at all. Few said, "It has not been evaluated scientifically and therefore we do not know what the long term or even the short term risks are."
The woman's wounds finally healed but she's badly scarred. "I'm angry at the fact that these medical spas are allowed to perform such a procedure," she said.
In a statement the company said "We have performed thousands of these procedures to date and the vast, overwhelming majority of these clients are completely satisfied with their results. We've had very few reported complications from these procedures."
As for the issue of a nurse giving the fat dissolving injections, the company said Illinois law allows doctors to delegate their tasks or duties to nurses or other staff.
The company issued this statement to CBS 2 in response to our questions:
"Pure Med Spa is a leading international provider of med spa services with over 50 locations across North America. We have thousands of satisfied clients who are thrilled with the results of their treatments. Our services are provided by trained professionals including medically trained and accredited physicians, nurses and aestheticians. Our practices, procedures and protocols, together with our training and certification programs, ensure that our clients receive the highest quality standards of treatment. All procedures involving injections are handled either by physicians themselves or by nurses trained by a Pure Med Spa supervising physician. All physicians and nurses are required to take continuing education in their fields. With respect to mesotherapy/lipodissolve procedures, we have performed thousands of these procedures to date and the vast, overwhelming majority of these clients are completely satisfied with their results. We have had very few reported complications from these procedures. We truly regret any situation where a client is not 100% satisfied with the results of any procedure. We strive to make every client a satisfied and loyal Pure Med Spa client.
"With respect to certain procedures which are being performed by nurses, please see Section 54.5 (d) of the Medical Practice Act which states "Nothing in this Act shall be construed to limit the delegation of tasks or duties by a physician licensed to practice medicine in all its branches to a licensed practical nurse, a registered professional nurse, or other persons." We are not aware of any ruling from the Department of Financial and Professional Regulation or any other regulatory body or agency that supersedes the provisions of the Medical Practice Act."
The company did not respond to our specific questions about the two cases of tissue damage highlighted in this report.
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