SAN DIEGO — The potential adverse effects of botulinum toxin and fillers aren’t just clinical, a dermatologist warned colleagues.
Physicians are at risk of legal consequences if they aren’t careful with practice-related issues such as providing proper informed consent or overseeing office staff, Swati Kannan, MD, assistant clinical professor at the University of California San Diego (UCSD), said at the 2025 CalDerm-Pacific Dermatologic Association (PDA) Joint Meeting.
Kannan offered the following guidance about protecting patients and preventing lawsuits.
Consent Forms
According to Kannan, failures in documentation and communication can lead to legal problems in aesthetic dermatology when negative outcomes occur, with different risks depending on the service being provided.
Most lawsuits related to botulinum toxin result from “unexpected harm or injury, like a poor cosmetic outcome or complication,” she said. “But the dollar value is really limited because toxin results are temporary,” for negative as they are with positive aesthetic effects.
With fillers, however, “the dollar value can be a lot higher,” because of the risk for more long-term, serious adverse effects that can include occlusion, necrosis, or blindness, she said.
These lawsuits tend to allege lack of informed consent or inadequate documentation of risk. For example, she said, a patient may say, “‘well, I came in, got filler done, and you didn’t tell me that my artery could get occluded.’ If you haven’t documented that, then you’re liable.”
Informed consent forms should “include all of the risks and complications” and note that “there are many others that we may not be able to predict,” Kannan said. “Treatment results differ per patient, and results are unpredictable,” which should be properly documented.
“Consent forms should clearly list the specific, most common risks and complications for that procedure then include language such as ‘These are the most common risks and complications of [the procedure name], but other unpredictable effects may occur,’” Kannan said in a follow-up interview after the meeting. “List risks in plain language and in order of frequency or significance,” and do not bury them in “dense text,” she advised.
‘Watching the Store’
Failure to provide appropriate treatment following a procedure is another risk, she said. For example, she said at the meeting, “I go on vacation, and there was no one to cover me. Or somebody who did not know what to do covered for me. Then I’m still held liable.”
Recording Procedures, Photo Releases
“Nowadays, a lot of physicians and injectors are recording the actual procedure being done and then posting it,” Kannan said. “I usually recommend not doing this, because if there’s a complication,” the video could end up in a courtroom. She also recommended that patients sign forms allowing photos to be used on social media.
In the interview, she elaborated that clinicians should “only record or post after obtaining a signed photo/video consent that clearly authorizes social media use. Ensure the footage is tightly framed or edited so the patient’s identity is completely unrecognizable and avoid any audio or background details that could identify them.”
She added, “Even with consent, store the raw file securely, and document that consent in the medical record.”
Constituting Botulinum Toxin
“For constitution of botulinum toxin, a preservative-free saline is recommended,” Kannan said at the meeting. While some physicians may use bacteriostatic saline, this is off-label, she said, “and both bacteriostatic saline and sterile water can lead to more painful injections.”
In the interview, she noted that state and clinic policies vary on whether nonphysicians are allowed to constitute and draw up toxins. In regard to her institution, “California scope-of-practice law and UCSD policy require that physicians reconstitute and draw up botulinum toxin,” she told Medscape Medical News.
“While some states allow medical assistants and LVNs [licensed vocational nurses] to perform this task under delegation,” she added, “the supervising physician remains legally responsible for any errors or complications.”
Eyelid Ptosis
Eyelid ptosis is a “dreaded complication” of botulinum toxin injection, Kannan said at the meeting. There’s a 1%-3% chance that toxin will migrate to the levator palpebrae superioris (LPS), she said. This muscle elevates and retracts the upper eyelid. Another cause is preexisting LPS insufficiency, in a patient who already has preexisting ptosis, she added.
Treatment options for eyelid ptosis include alpha-2 adrenergic agonist eyedrops, which temporarily “help elevate the eyelid by about 1 mm,” she said.
Another option is to use toxin itself to address eyelid ptosis. “You can do toxin injections into what we call the pretarsal portion, right about 2 mm above the eyelid margin. You need to inject very superficially,” Kannan said.
She showed pictures of a patient who underwent this treatment and initially looked worse but improved over time. “Two weeks later, her eye is more open.”
She added, “Could that same result be achieved with just eyedrops alone? Possibly. Or, of course, with time. But this is just something to keep in your arsenal.”
Kannan has no disclosures.
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