The Aesthetic Guide is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

CST Web Exclusive: Injection lipolysis debate heats up, clinics shut down as safety issues loom

Article-CST Web Exclusive: Injection lipolysis debate heats up, clinics shut down as safety issues loom

Injection lipolysis debate heats up, clinics shut down as safety issues loom

Nancy A. Melville
Staff Correspondent

Las Vegas – Injection lipolysis, which consists of a series of subcutaneous injections to break down fat stored in fat cells, goes by various names, including mesotherapy, lipodissolve and lipotherapy, and the array of practitioners offering the procedure is even more varied, often including nonphysicians.

Well-publicized before-and-after photos show striking improvement in best-case treatment scenarios. But receiving less publicity are the potential complications and concerns, says Joel Schlessinger, M.D., at a recent meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS).

“People have made strong statements against this product, reporting that they’ve seen problems such as abscesses, nodules, poorly performed procedures or odd symptoms that never were resolved,” says Dr. Schlessinger, Director of the Advanced Skin Research Center in Omaha, Nebraska.

Treatment fallout

One big reason why some cases of complications may never have been aired in public is because two leading chains that offer or offered injection lipolysis, MedSculpt and the now-defunct Fig., made sure they were kept quiet.

“The interesting way companies like Fig. and MedSculpt get around this is they have patients sign a waiver saying that if they have a problem with their treatments and have their money refunded, they can’t talk about the company or sue them,” Dr. Schlessinger tells Cosmetic Surgery Times

When Fig. (formerly known as Advanced LipoDissolve) abruptly closed its doors and filed for bankruptcy in December, the company already had hundreds of Better Business Bureau complaints in its headquarters city of St. Louis alone, and the chain’s closure included 17 of 18 clinics nationwide.

The closure came just a week after Kansas became the first state in the nation to take action against injection lipolysis when its Board of Healing Arts passed rules requiring that physicians examine patients before administering injection lipolysis and disclose information about known side effects such as infection and nodules at the injection site.

Regulatory action has also been taken against injection lipolysis in the European Union and several other countries, including Brazil, the U.K. and Canada, and the American Society of Plastic Surgeons does not recommend the procedure until appropriate research documents its safety.

The two active ingredients in injection lipolysis treatments are phosphatidylcholine and deoxycholate (PC/DC). The fact that neither ingredient has FDA approval for any indication sets the practice of injection lipolysis apart from the otherwise common practice of using FDA-approved drugs off label.

The treatments are typically made in compounding pharmacies, and likewise, since the drugs have no FDA approval, that also makes the compounding process unlike conventional compounding, Dr. Schlessinger says.

“PC/DC production is well outside the balance of typical compounding, and to prepare it without an individual prescription is clearly not compounding as the compounding laws describe,” he says. “The compounding pharmacies are essentially acting as drug manufacturers in doing this.”
Add to that the fact that injection lipolysis has become highly popular at medspas, where nonphysicians are injecting a unapproved drug, and the result is a perfect recipe for potential problems.

“If there is a poster child for the dangers of a nonphysician practice of medicine, it would be [injection] lipolysis,” Dr. Schlessinger says.

In fact, some doctors see the primary safety risk as mainly involving that very issue –practice by nonphysicians. In the hands of well-trained, board-certified dermatologists, they argue, injection lipolysis can be a beneficial addition to a cosmetic surgeon’s armament.

Control issue?
Helen M. Torok, M.D., who treated more than 200 patients in working out an injection lipolysis treatment procedure that she felt was safe and effective, pointed out that most of the bans and restrictions have targeted use by nonphysicians.

“If you look at Brazil, the main reason [injection lipolysis] was banned was because they couldn’t control the use by nonpractitioners. And the warnings in the U.K. and Canada, again, are also against nonphysicians,” says Dr. Torok, clinical professor of dermatology at Northeastern Ohio University College of Medicine and medical director of Trillium Creek Dermatology in Medina, Ohio.

A key to successful injection lipolysis treatment is using only the core ingredients of PC/DC and making sure the treatments are only administered by physicians, according to Dr. Torok.
“Many of these treatments involve a cocktail of ingredients, so when we got the compound, we systematically removed each active ingredient and found the compound that worked the best and gave the least side effects was primarily the PC/DC combination,” she says.

And then there is the technique. “I can’t emphasize enough that it’s all about technique, technique, technique,” Dr. Torok says. “Whether it’s filler or Botox that you’re using, technique is critical, but I think it is even more critical with this than with any of the rest.”

Everything from the depth and speed of injection to the concentration of the solution, the use of pre-gridded spaces, ultrasound and infrared heating to give a more uniform dispersion, and homeopathic remedies to help with healing, adds up to provide a successful outcome, Dr. Torok asserts.
They also add up to fewer treatment sessions. “There are some people doing this in four to seven sessions, but we have reduced this to two to three sessions because we’ve been able to increase the amount of volume we use per session,” she explains.

Potential with proof
While he’s not ready to hop on the injection lipolysis bandwagon yet, Dr. Schlessinger says he is as excited about its potential as anyone and is, in fact, involved in early FDA trials to try to develop a product that is evidence based and safe. 

Dr. Schlessinger is working with Kythera Biopharmaceuticals on research focusing on the deoxycholate side of the injection lipolysis equation. He says there is some evidence that deoxycholate works better on its own, without the phosphatidylcholine.

“We feel the deoxycholate is probably the most important part of this, and with that alone, you can likely get better results and have less problems in the long run,” he explains.

With the tremendous benefit that a safe and effective form of injection lipolysis could offer patients and doctors, the stakes are high to prevent the procedure from becoming the next big headline-grabbing medical concern, Dr. Schlessinger stresses.

“[Injection lipolysis’] potential for improvement will probably make a big difference in our practices, but I don’t want this to become a disaster before it’s even FDA approved due to its use in black market clinics by people who didn’t know what they were doing,” he says. “We have to approach this carefully.”
“The bottom line is that the standard of care in this country is to put science before profit, and it makes the most amount of sense,” he adds. “When we don't do this, we have problems that can bring … distrust from the public – and with good reason.”

Dr. Schlessinger’s injection lipolysis talk at the ASCDAS was supported by an unrestricted educational grant provided by Kythera Biopharmaceuticals.

Dr. Torok has no relevant disclosures.

For more information
Helen M. Torok, M.D.
[email protected]

Joel Schlessinger, M.D.
[email protected]

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.