Special to Dermatology Times - Spurred by consumer complaints, the state of Kansas has restricted the use of Lipodissolve to scientific studies, while the state of Nebraska might ban the procedure.
National Report - Spurred by consumer complaints, the state of Kansas has restricted the use of Lipodissolve (Fig) to scientific studies, while the state of Nebraska might ban the procedure altogether.
In early December, the Kansas State Board of Healing Arts (KSBHA) approved a temporary regulation that limits the use of Lipodissolve in Kansas to research situations. The rule says physicians must inform the board of their intent to perform Lipodissolve, work with an IRB (institutional review board), and report results to the IRB monthly.
The regulation represents an ongoing attempt to limit Lipodissolve and similar treatments, says Mark Stafford, KSBHA general counsel.
The board concluded that PCDC was an unapproved drug that was being offered in settings that didn't provide adequate public protection, he says.
"Then we started hearing about some of the potential hazards, and some reports of complaints," Mr. Stafford tells Dermatology Times.
Specifically, the KSBHA received numerous calls from patients saying the procedure resulted in extreme pain, while the board also tallied about six documented adverse events - including disfigurement, serious allergic reactions and infections, and aggravation of a pre-existing liver condition - in Kansas patients, he says.
Therefore, in April 2007, the KSBHA adopted a temporary regulation prohibiting Lipodissolve. However, Fig, based in St. Louis, Mo., successfully appealed this regulation, and a Kansas District Court ruled that the matter required more public hearing, Mr. Stafford says.
The District Court also restored an earlier version of the regulation that allowed physicians to order compounded PCDC for individual patients, he says.
However, in December, the KSBHA issued the stronger temporary regulation, which Mr. Stafford says addresses many of Fig's objections while protecting patients. The board scheduled a public hearing on the matter for Feb. 27.
Depending on comments received, Mr. Stafford says, the board will vote on the regulation or potential modifications a few days later.
In Nebraska, State Sen. Rich Pahls of Omaha, who represents the state's 31st District, says he plans to introduce legislation in the 2008 session that would ban Lipodissolve for the purpose of eliminating or reducing fat accumulation, until or unless the Food and Drug Administration (FDA) approves it for these uses.
"Dr. Joel Schlessinger has convinced me that this product is potentially dangerous and is contraindicated without FDA approval," he says.
"Unfortunately," Dr. Schlessinger says, "we've seen an explosion of Lipodissolve and PCDC not only in our state, but also other states. And the only way we can regulate it without the FDA stepping in is to pass legislation that prohibits it."
He says that along with significant discomfort, Nebraska physicians have seen half a dozen complications, including panniculitis, swelling, dimpling, textural irregularities and bloating. He estimates that 12 to 15 medspas, salons and aestheticians' offices offer lipotherapy in the state - almost never with physician oversight.
Sen. Pahls says after he introduces the bill, it probably will be referred to the Legislature's Health and Human Services Committee for a public hearing.
Already, Brazilian regulators have banned use and manufacturing of any cosmetic products containing phosphatidylcholine, and England's Medicines and Healthcare Products Regulatory Agency discourages cosmetic use of Lipostabil (PCDC, Sanofi-aventis).
For more information: http://www.ksbha.org/ http://www.leg.ne.gov/