Everyone is offering fillers. If you're practicing cosmetic medicine for any period of time, you're going to have an occasional unhappy patient or unwanted outcome. Since dermal fillers are so popular, we wanted to take a look at how often fillers are causing problems that result in lawsuits.

Restylane, Juvederm, HylaForm, Belotero... the fillers are all here and deeply ingrained in every practice. The safety and efficacy of fillers is pretty well known and you've probably got a lot of experience already since you're performing lip augmentation and facial wrinkle treatments every day. But it's exactly the fact that fillers are so common and performed so often that can put you at risk. The odds that any individual treatment will have an unwanted outcome is really low, but since the number of patients you're treating are quite high, it's still a possibility you need to take seriously.

Here are some interesting results from studies that have been conducted in the last few years. (Links to all of the studies are at the bottom.) 

A couple of things to note here is that sometimes we're not comparing straight apples to apples. While OB-GYNs are the most common specialty to be sued, surgeons are next. If you're a cosmetic or plastic surgeon there may be a bias that elevates your risk somewhat. (If anyone has a study showing this please link to in in the comments.)

• Medscape study, surgeons are second to OB-GYNs for being sued by the public.
• Vila-Nova da Silva et al., 2015, breast surgery was the most common procedure filed for a lawsuit.

You're undoubtedly disclosing the possible side effects and expectations when you're doing your consultations, but there's an interesting study that correlates an expectation of the clinician with an elevated risk of being sued. The study found that disclosing all possible risks and outcomes didn't scare the patients, but that those physicians who thought so were at increased risk of a suit which is interesting. (Boyll et al., 2017) 

One of the last articles JAMA Facial Plastic Surgery published in 2017 were litigation cases filed due to dermal fillers and there is some risk of unwanted outcomes or mid-term issues; Hyaluronic acid fillers typically cause swelling and infection, while CaHA causes infection and pain, and PLLA and PMMA both cause nodules. In the study, most of the swelling were found in the tear troughs, while only infection were found in the nasolabial folds. Additionally, intra-arterial injections especially without sequelae were found in the lip and nasolabial folds (Rayess et al., 2017).

Other than this study, Ezra et al. (2015) also examined litigation earlier, and may have encountered the similar cases as with Rayess et al. (2017) back then, only granulomas were found as an adverse effect that resulted in a filed suit. 

In the Ezra 2015 study,  the real cause of most of the problems becomes clear - non-physicians who are performing the injection and there can be additional disciplinary actions in addition to a patient filing suit.

From the study: (This is about disciplinary actions, not lawsuits)

A total of 24 legal documents were identified: 19 cases and 5 disciplinary actions. Of the 19 cases, physicians were named as defendants in 13. Six of the 7 cases that named a nonphysician as a defendant involved a substance being injected different than the reported filler. Overall, 50% of legal actions from soft-tissue fillers were related to a nonphysician performing the procedure. Of physician subspecialists, dermatologists and plastic surgeons had the highest proportion of litigation (17% each); this is likely due to these specialties performing a higher volume of the relevant procedures. The majority of disciplinary actions were reprimanding physicians for not being present while a nonphysician employee injected patients with soft-tissue fillers. In 3 of the 5 reprimands, physicians were functioning as medical directors of medical spas.

The chances that you'll be sued by a patient for a filler injection treatment is extremely small unless you're doing something stupid like allowing someone who is unqualified, unskilled, or unlicensed. Be sure that you're using clinic best practices and procedures and that your staff is trained. Almost all of these problems can be avoided if you avoid the trap of thinking that any procedure is routine.

References:

• https://jamanetwork.com/journals/jamafacialplasticsurgery/article-abstract/2665429?redirect=true
• http://www.jaad.org/article/S0190-9622(15)01857-5/fulltext
• https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjx182/4461847?redirectedFrom=fulltext