The skinny on "lunchtime lipo"

LINCOLN, Neb. — Many women know the story: Work out, diet, follow all the advice in magazines and still, a pocket of fat on the thighs or tummy refuses to disappear.

Cosmetic surgery may be unappealing and expensive. So what if someone promised an easy treatment that promises to literally melt the fat?

Some doctors now offer injections of chemical cocktails they say will do just that, providing a noninvasive way to shape the body. But the procedures are not federally approved, and some doctors say they can lead to serious complications.

Generically referred to as "lipo-dissolve" after a popular treatment brand, or "lunchtime lipo," the procedure is aimed at people with trouble spots, not the obese.

"We're just kind of pecking away at the fat," said Dr. Julie Waddell of Omaha, who has injected the drugs into dozens of patients, including herself. Side effects are minimal, she said — some bruising and swelling are common — and she thinks the results are exciting.

"I've never had this flat of an abdomen, and I've had kids," Waddell said.

Doctors administering the procedure typically use a combination of chemicals. The chemicals themselves have been federally approved for use in some drugs. But the precise combinations and treatment regimes used for lipo-dissolve have not been approved by the Food and Drug Administration and are left up to individual doctors and pharmacists.

"There's a lot of chicanery and I would say hucksterism that's involved," said Dr. Joel Schlessinger, an Omaha cosmetic surgeon, who has campaigned against the procedure. "We don't even know if this product works."

States such as Nebraska, Kansas and Nevada are trying to ban the procedure, with Kansas already banning the most popular combination injection.

On the surface, melting away fat "sounds terrific and may well turn out to be terrific," said Dr. Alan Gold, president-elect of the American Society for Aesthetic Plastic Surgery.

"We have an overweight population that is looking for things other than diet and exercise to help them lose the weight," Gold said.

But so far the drugs offer a "poorly understood, potentially beneficial treatment that has an unknown number of side effects," Gold said. "It's really sort of a Wild West out there with this."

The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery warn people to avoid the treatments, saying they are scientifically unproven and that the ingredients are poorly defined, leading to complications that can include infections, inflamed tissue and tissue death.

The process, technically called injection lipolysis, dates to the late 1960s in Europe, when doctors experimented with a combination of drugs to dissolve lipids in the blood. It gained traction there and South America, and started getting popular in the United States in the past few years, so far primarily in the Midwest.

Most doctors use a combination of two substances — phosphatidylcholine, which is derived from soybeans, and sodium deoxycholate, which is derived from bile and used to remove waste from the body.

The drugs are supposed to break down the walls of fatty cells so the body can flush out the fat, although some doctors say there's no way to know yet how the fat is excreted.

Waddell said the lack of FDA approval doesn't mean the product isn't safe or effective, and she's convinced by studies she's seen and personal experience that it's both.

Donna Erker, who owns the Omaha clinic where Waddell practices, said doctors such as Schlessinger who disapprove of the process are "trying to scare people."

Plastic surgeons stand to lose money from patients who do lipo-dissolve instead of liposuction, she said. Waddell says some clinics may not use good practices, but others do.

Waddell administers six to seven injections per visit and usually sees a patient six times. The cost is around $2,000 per zone — the abdomen, or love handles, for example — for all the visits.

She uses ice to numb the area because the injections can hurt. Most patients can go back to work, but some take the day off to rest.

Waddell says when she first started giving the injections, a few patients went to the emergency room for what she said was pain management or hyperventilation. She now uses lidocaine, a numbing medicine, and limits the amount of the chemicals administered during each visit.

Several studies of the chemicals could offer answers in the future.

Schlessinger is one of several doctors testing one of the ingredients — sodium deoxycholate — to see if it works to dissolve small fatty tumors under an FDA-approved study with pharmaceutical company Kythera.

The California company is also testing whether the chemical can be used for cosmetic purposes to dissolve fat in small areas such as a double chin or arms.

Keith Leonard, CEO of Kythera, said they're still years away from a finished product and FDA approval.

"This is exactly the process that lipo-dissolve is missing," Leonard said. "These things take time."

The American Society for Aesthetic Plastic Surgery is funding a limited FDA-approved study to see if a single formula of the two commonly used lipolysis drugs is safe and effective.

"I think this procedure at some point will be a very positive procedure and we will be able to do it for limited areas or certain people," said Schlessinger, the Omaha doctor. "But without knowing who it's good for and how it is best used, it's a disaster in the making."