Safety Concerns
Another of the concerns with lipolysis treatment is whether there might be long-term effects from phosphatidylcholine or sodium deoxycholate, or acute problems from exposure to those ingredients or from the release of so much fat at once.
The substances are both naturally present in the human body already, and used the way they are to reduce fat, have only "relatively benign, localized effects," said Dr. Adam Rotunda, a physician who now works as a medical director of research and development at Allergan Inc., but who conducted research on injection lipolysis as a dermatology resident at the University of California, Los Angeles.
Dr. Rotunda has a patent for a formulation of sodium deoxycholate (licensed to Kythera Biopharmaceuticals Inc.) alone for injection lipolysis, which he claims might be as effective as the phosphatidylcholine/sodium deoxycholate combination. That formulation is at present in clinical trials. Dr. Rotunda has no financial interest in the product, though he has received consulting fees from Kythera. The licensing fees are paid to the University of California, Los Angeles, he disclosed.
A Flawed Business Plan?
Dr. Wright said he is very familiar with one of the now-defunct companies, Fig, which was based in the St. Louis area. He is not only well acquainted with the former principals in the company, but he has treated about 30 former Fig patients. And he suggests that many of the complaints and complications being reported about injection lipolysis come from Fig clients, who were guaranteed results or a refund.
The company often had no physician onsite at its locations and many sometimes used doses too high and treated inappropriate patients. Dr. Wright recalled one patient who went to a Fig location every month for a year to be treated and never once saw a physician.
"The company was selling to inappropriate candidates and overselling," he said.
Many Fig patients that Dr. Wright said he treated were extremely overweight, and the proper candidate for lipolysis is one who is not overweight but simply has a localized area with a small amount of fat they would like to be rid of. Figwhich had 18 locations in various statesceased its operations in December and filed for chapter 11 bankruptcy in January. The other prominent company that recently closed was MedSculpt, a firm with locations in Rockville, Md., and Fairfax, Va., which went into receivership in January.
Officials from both companies were unavailable for comment, and physicians connected with the companies either declined to comment or did not return calls and e-mails. However, in statements, Fig representatives said their investors pulled funding, and blamed the situation in part on a downturn in customers and bad press. MedSculpt needed a cash infusion and had investors lined up, but when Fig closed those investors balked, the representatives claim.
Recent Studies
Two studies have looked at whether the treatment has any identifiable systemic effects, and neither found any, said Dr. Rotunda. "We don't have the quality of data we need, but what we do have is pretty reassuring."
Brazilian investigators treated 30 patients with a series of four sessions of abdominal injections of sodium deoxycholate and looked at the local and systemic effects. At different time periodsranging from 2 hours after an injection to 12 weeksthey measured lipids and kidney and liver function and found no significant changes (Dermatol. Surg. 2007;33:17889).
In his own work, Dr. Rotunda has found that injecting phosphatidylcholine and sodium deoxycholate can produce changes in muscle architecture but the substances have to be injected directly into the muscles (Dermatol. Surg. 2004;30:10018).
Patients can experience nausea from the procedure, but that appears to be a cholinergic effect that occurs when too high a dose is used, he said.
Currently the evidence of the efficacy of injection lipolysis is anecdotal. But in November, a clinical trial of the combination solution got underway, sponsored by the Aesthetic Surgery Education and Research Foundation, run by Dr. V. Leroy Young, a former professor of plastic and reconstructive surgery at Washington University, St. Louis, who is now in private practice. The trial will enroll 20 subjects, who will be followed for 46 weeks.
In the meantime, both Dr. Crutchfield and Dr. Wright said they would have no problem if the FDA or some other agency came to regulate lipolysis procedures or the compounded ingredients used.
But Dr. Crutchfield also noted that injection lipolysis is not the first cosmetic product to be used off-label, and he cited Botox as an example. Botox was used cosmetically before its approval and currently is used in locations where it is not approved.