This article comes to us courtesy of California Watch.
UPDATE: After this story was published, the Medical Board of California concluded it's review of the complaint against Dr. Gail Altschuler and "found no violation of the law." The case was closed on Nov. 30, 2012.
Previously:
In a complaint filed with the Medical Board of California, a consumer advocacy group is claiming that a physician's use of a massage machine for weight loss is endangering patients.
Public Citizen has alleged that Dr. Gail Altschuler, a California physician who runs a Novato weight loss center, and other doctors who use and promote a medical device called the LipoTron for fat reduction are demonstrating a "reckless disregard for the health and welfare of patients."
The device manufacturer, Fullerton-based RevecoMED, is registered with the U.S. Food and Drug Administration to make the low-risk therapeutic massager known as the LipoTron. But it has not been approved or cleared by the FDA for weight loss-related uses, according to a search for RevecoMED and the device on FDA databases. The FDA declined to respond to questions about the LipoTron, including whether the device is undergoing a pre-market review or whether RevecoMED is seeking clearance from the agency.
Public Citizen's complaint letter [PDF] to the state medical board, filed Aug. 3, is part of an effort by consumer advocates to prevent the use of the LipoTron for weight loss until it undergoes additional regulatory scrutiny.
"It is concerning to us when a device not approved or cleared by the FDA is being used for a multitude of uses for which the safety and efficacy is not established," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group.
But Altschuler said it is common for physicians to go "off-label," or use medical devices or pharmaceuticals for purposes not explicitly sanctioned by the FDA.
"There are so many procedures that are off-label," said Altschuler, who said she had not known about the medical board complaint against her until California Watch notified her. "As long as the patient is informed that the process is not FDA-approved and they consent to it, there is no limit to using it."
One example, she said, is the use of Botox for wrinkle reduction on body parts other than between the eyebrows.
"The complaint is untrue in that we are not using the LipoTron in a reckless or irresponsible way," she added in an email. "By my own experience I have seen the results of our procedures and they are effective as we use it. Furthermore, in comparison to the costs and risks of alternative procedures such as liposuction, we are inexpensive and considerably safer."
The medical board does not comment on complaints against physicians, said Jennifer Simoes, the board's chief of legislation. In an Aug. 8 letter [PDF], the medical board told Public Citizen that it would assign an analyst to review the complaint. A second letter [PDF] from the board's executive director, dated Aug. 13, noted that Public Citizen had referenced other doctors in its complaint and asked for additional names. The medical board said it would also research the LipoTron itself.
Legal concerns about the LipoTron were first reported by the nonprofit health and safety journalism organization FairWarning, which noted that the device "has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss."
RevecoMED is registered with the FDA to make a low-risk "class I" device for therapeutic massage, a device that falls in the same category as tongue depressors and arm slings. Class I devices must meet certain labeling and manufacturing requirements, but they mostly are exempt from pre-market review, according to the FDA.
The company Web address www.revecomed.com no longer works, and an online search didn't find it advertising the product as a weight-loss system aimed at American consumers. The website for RevecoMED Asia, a subsidiary of RevecoMED, bills the LipoTron as "the future of fat reduction."
RevecoMED President James Rosen declined to comment.
U.S. law overseeing food and drugs [PDF] makes it illegal for medical device manufacturers or distributors to misbrand a product by marketing it for uses not approved or cleared by the FDA. However, physicians are generally free to use the device in an off-label manner as long as its use is based on the doctor's professional judgment, according to David L. Rosen, an attorney with the law firm Foley & Lardner who worked for the FDA for 14 years, and who is not related to James Rosen.
In its regulatory guidance document, the FDA states that if "physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."
Altschuler said she is following ethical medical practices in her use of the LipoTron, and she tells patients that she is using the device in an off-label way.
Altschuler said she has been using the LipoTron as part of her practice for about a year and a half. She charges $2,000 for a package of 10 one-hour sessions, and she said the procedure has been effective 80 percent of the time.
She added that the product's efficacy has been demonstrated to her through personal experience, testimonials from patients, conversations with other physicians and European studies.
"Like all providers, we follow specific protocols and monitor our results, and we train technicians to use the equipment correctly," she said. "It's not random."
Like a number of "body contouring" devices such as the VelaSmooth, which has received FDA clearance as a device that can improve the appearance of cellulite, the LipoTron uses radiofrequency waves to dissolve fat cells, according to the description of the procedure on Altschuler's website. The device also reduces wrinkles and improves the appearance of cellulite, Altschuler said.
Dr. Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, said there have been clinical studies on the effects of using radiofrequency to reduce fat, but there is not yet conclusive evidence about whether it has health benefits.
Stafford said in an email that while destruction of fat cells just under the skin "may have aesthetic benefits," it is "usually not associated with the reversal of obesity related health problems."
Dr. Christopher B. Zachary, a professor and chairman of the dermatology department at UC Irvine, said that while he is not familiar with the LipoTron, he has successfully used body-contouring devices for cosmetic procedures. Those devices primarily are cleared by the FDA for use in temporarily reducing the appearance of cellulite.
"Not all radiofrequency devices are made equal," Zachary said.
He said he has found that the procedure is best for someone who is active and of normal weight but who "can't get rid of localized fat and they don't want to have a liposuction procedure; they want their clothes to fit a little better and they don't want to take time off of work," he said. "This is not for people who are particularly skinny, and it's not for the overweight or obese."
Altschuler is not the only California physician or medical center using the LipoTron for purposes not approved or cleared by the FDA.
The Porter Ranch Medical Center, northwest of Los Angeles, posted a series of ads on Craigslist last month claiming that the LipoTron can "reduce cellulite and tighten, firm and contour the skin" around jawlines, chins, eyes, breasts, underarms, buttocks and thighs.
Cesar Ascencio, a supervisor at Porter Ranch, referred questions about the device to Kathy Dunklin, a consultant to the center and medical aesthetician who owns the machine and who lists LipoTron procedures as one of her specialties on the medical center website. She did not return repeated requests for comment.
In addition to the California complaint, Public Citizen has submitted two letters to the FDA about its concerns over the LipoTron and filed grievances with public health departments or medical boards in eight states.
The Fort Worth, Texas-based distributor of the LipoTron, Advanced Aesthetic Concepts, also has been the subject of a 2011 investigation by the Texas Department of State Health Services. The investigation noted that the distributor's advertising and website suggest that the LipoTron is "being promoted for uses not approved by the U.S. Food and Drug Administration."
Recent complaints against the Texas company, which is now operating under the name Profit Solutions MD, have triggered another investigation, which is ongoing, said Christine Mann, spokeswoman for the Department of State Health Services.
Representatives of Profit Solutions MD did not respond to requests for comment.
Bernice Yeung is an investigative reporter for California Watch, a project of the nonprofit Center for Investigative Reporting. Find more California Watch stories here.