Lipodissolve (also referred to as injection lipolysis, mesotherapy, lipolysis, lipostabil and other terms) is not FDA approved. Informed consent is particularly important when using any type of cosmetic technology that is not FDA-approved or has not been generally accepted by the plastic surgery and dermatology communities and professional associations.
Note: The use of drugs disapproved or not yet approved by the FDA is often excluded from professional liability insurance coverage. NORCAL policyholders should contact Customer Service at 844.4NORCAL to determine whether cosmetic services being offered are covered.
Allegation
The physician failed to inform the patient that lipodissolve was not an FDA-approved treatment and that the treatment could result in skin necrosis.
Case File
In May 2014, the patient, a 37-year-old woman, presented to a medical spa owned by her child’s pediatrician for a lipodissolve consultation. The patient, having learned about lipodissolve on a television talk show, asked the pediatrician if the procedure could remove the lipomas on her hip and buttocks. By way of training, the pediatrician had taken a one-day seminar on the use of lipodissolve four years earlier and had successfully performed this procedure approximately 200 times. At the consultation, the patient signed a consent form that listed various risks (but not skin necrosis) and stated that lipodissolve was an “off-label” treatment for her condition. At the first treatment session, the pediatrician injected 55 ccs of the lipodissolve solution into the patient’s hip and 40 ccs into her buttocks.
One week later, the patient returned to the medical spa complaining that the treatment areas were painful and swollen, and appeared severely bruised (blackish and purple). The pediatrician additionally noted that the areas of treatment were blistering, warm and tender to the touch. The pediatrician instructed the patient to apply warm, moist packs and bacitracin and to keep the area bandaged. She also prescribed Keflex 500 mg, four times per day.
For two months, the patient returned every week for wound care. By July 2014, the pediatrician felt it was necessary to refer the patient to a wound care specialist for debridement. The specialist noted the patient’s hip and buttocks wounds were 10 x 7 cm and 5 x 5.5 cm, respectively, and that there was full tissue necrosis that had probably gone into the fatty tissue. He debrided the wounds and applied a VAC 1 dressing system.
When the patient’s wounds had finally healed a year later, she had various firm subcutaneous areas of fat necrosis and significant scarring. She sued the pediatrician. She claimed if she had known lipodissolve was not FDA-approved and carried the risk of skin necrosis, she never would have consented to its use on her.
Discussion
Lipodissolve is generally marketed as a non-surgical alternative to liposuction. During lipodissolve, a “chemical cocktail” is injected into the fat layers and connective tissue of the area to be reduced. The ingredients used in lipodissolve vary but typically include compounded phosphatidylcholine and deoxycholate. Neither phosphatidylcholine nor deoxycholate are FDA-approved for eliminating fat. According to the FDA, “Any claim that a mixture of phosphatidylcholine and deoxycholate is being used ‘off-label’ for a lipodissolve procedure is false.”1 The FDA does not view their use in lipodissolve as “off-label” because, by being compounded, they constitute a new drug — a drug that is not approved for subcutaneous injection. Consequently, both the provider and pharmacist providing the compound need to meet criteria outlined in the FDA Compounding Compliance Policy Guide, as well as adhere to any state regulations governing compounding.2
Expert Opinions
While the plaintiff’s expert claimed that using lipodissolve was per se below the standard of care, defense experts did not feel there was a problem with the pediatrician’s technique of injecting the lipodissolve. However, they could not support the treatment because of informed consent problems. First, the informed consent form stated that lipodissolve was being used “off-label,” which was inaccurate. Second, skin necrosis was missing from the list of risks. They were also critical of the pediatrician for waiting two months before referring the patient to a wound care specialist.
Due to problems with the informed consent and referral processes, the physician agreed to settle the case.
Medical Liability Risk Management Recommendations
- Know the FDA status of the cosmetic treatments you are offering. Carefully consider the risks and potential malpractice insurance coverage issues associated with prescribing drugs that are not FDA-approved.
- Comply with the requirements of the FDA Compounding Compliance Policy Guide and state regulations governing compounding, when applicable.
- Document discussions with the patient, particularly on risks and alternatives that were covered during the consent discussion. Make sure patients are correctly informed about non-FDA-approved, compounded and off-label use of medications.
- Review your consent documents to ensure they adequately cover risks and alternatives.
- When a patient has an adverse reaction to a cosmetic treatment, refer the patient to a specialist in a timely manner. This is particularly important when a complication threatens to compromise the expected cosmetic result.
Before expanding a practice to include cosmetic services, contact your medical professional liability insurance carrier to determine if there are specific underwriting guidelines and requirements that must be met before the performance of cosmetic services will be approved for coverage under your policy. NORCAL Group policyholders should contact Customer Service at 844.4NORCAL to discuss coverage and to make proper arrangements.
References
1. FDA. Information on Lipodissolve. (accessed 3/27/2017)
2. American Society of Plastic Surgeons (ASPS). Guiding Principles for Mesotherapy/Injection Lipolysis. (accessed 3/27/2017)
