Inadequate Informed Consent Often Tied to Lawsuits Over Injectable Cosmetic Fillers

By Lorraine L. Janeczko

January 05, 2018

NEW YORK (Reuters Health) - Lawsuits related to complications from injectable cosmetic fillers are rare and most stem from inadequate informed consent, according to a cross-sectional analysis of adverse events and litigation.

"Fillers are very safe with minimal permanent complications, and the most common complications are swelling and infection, which are relatively benign and have no permanent side effects. There is a complications risk and a very small risk of serious complications. Patients need to be made aware of this as part of the informed consent process," lead author Dr. Hani M. Rayess of Wayne State University School of Medicine in Detroit, Michigan, told Reuters Health by email.

Dr. Rayess and his colleagues examined the risks and factors involved in litigation related to injectable fillers and published their results in JAMA Facial Plastic Surgery, online December 21.

The researchers reviewed the U.S. Food and Drug Administration’s (FDA) manufacturer and user facility device experience (MAUDE) database for complications arising from the use of: Juvederm, Restylane, Belotero, Sculptra, Radiesse, Artefill, Bellafill, and Juvederm Voluma from 2014 through 2016.

In all, 1,748 adverse events involving patient injury were reported to the FDA. Complications associated with injections into the cheek (43%) and lip (30%) were the most common. Swelling was involved in 43.2% of adverse events and infection with 41.5%. Dorsal nasal injections were significantly associated with blindness, and Radiesse injections were significantly associated with vascular compromise (with or without dermal necrosis and blindness).

Of the complications, 48% involved Juvederm Voluma, 36% Juvederm, 7% Restylane, 6% Radiesse, 2.7% Sculptra, and 0.3% Belotero.

The researchers used the Westlaw Next Database (Thomson Reuters) of publicly available court records to search for malpractice litigation arising from soft-tissue fillers used in the face. They specifically searched for jury verdicts and settlements related to "medical malpractice" and a variety of other terms that pertain to specific fillers and their components.

Of nine identified legal cases, five were resolved in the defendant’s favor. Of the cases resulting in a monetary award, the mean amount was $242,000.

Six cases were allegedly due to inadequate informed consent, and five allegedly resulted in permanent injury. In five cases, plaintiffs alleged that the chosen filler or the decision to proceed with the injection was not appropriate. Two cases resulted from arterial injection, and one patient went blind after injection to the temporalis region.

Inadequate informed consent was the factor most often cited in litigation.

To put these figures in perspective, the American Society of Plastic Surgeons reports that during this time period, providers gave about 750,000 Radiesse injections, 5.75 million injections involving hyaluronic acid, about 390,000 Sculptra injections, and roughly 53,000 Artefill and Bellafill injections.

Dr. Rayess cautioned that the database did not provide details about who gave the injections.

"The use of fillers is increasing. With more injections being performed at beauty salons and by non-plastic surgery or dermatology board certified physicians, there is a possibility that the complication rate may increase,” he noted. “Further research is needed to answer this question."

Dr. Steven Bernard, a plastic surgeon at Cleveland Clinic in Ohio who was not involved in the study, said in an email that the findings are raising awareness about potential complications from fillers.

He also noted, however, that "the complications listed in the article are well known and extensively discussed at national professional meetings. . . . Yes, these complications occur with the use of fillers, but they are very rare. The article itself points to the limitations of their findings. The article is a review of incomplete databases that have many limitations for both rates and complications."

"The reality is that these data underestimate the number overall complications. Outcomes such as swelling, uneven results, and redness are much more common but go unreported and do not generally cause permanent harm to patients," he added.

"These data would have more meaning if collected prospectively so that we know the actual number of both the injections given and complications that occur. We are left with an estimate of the total numbers for both categories," Dr. Bernard concluded.

SOURCE: http://bit.ly/2CosqfY

JAMA Facial Plast Surg 2017.

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