FDA Highlights Importance of Physician Training in Dermal Filler Injections
On March 23, the Food and Drug Administration (FDA) convened its General and Plastic Surgery Devices Advisory Panel to discuss and make recommendations regarding the benefits and risks of dermal fillers. The sentiments expressed in this meeting and the implications for the practice are notable in the way they underscore the importance of physician training in avoiding catastrophic adverse events from fillers.
The FDA stated that the Panel was convened to specifically discuss the risks associated with intravascular injection of dermal fillers and patient preference and informed decision-making.
As dermal filler injections have become one of the most commonly performed aesthetic procedures, the agency expressed concern that increased use of the procedure has been accompanied by an increase in medical device reports (MDR) of adverse events, for both approved and unapproved fillers, techniques and indications. Specifically, reports of serious visual impairment resulting from unintentional intravascular injection have notably increased.
The FDA previously responded to this concern with premarket and postmarket actions, including the requirement that all clinician and patient labeling include warning and precaution statements informing the user of the risks associated with intravascular injection. In May 2015, the FDA released a Safety Communication and worked with manufacturers to retroactively revise approved labeling to incorporate appropriate warning statements.
However, the agency asserts that despite these efforts to increase awareness of the risk of intravascular injection, it continues to receive anecdotal reports that prospective patients are not informed of the risk. This critical information gap confirms a position ASPS has long maintained, that too many injectors lack the clinical knowledge and training necessary to accurately and adequately convey the accepted risks associated with the injection. They too often do not even know enough to know that they have to look for updates to product risk profiles.
The Panel was charged with determining potential actions and steps that the agency might take pertaining to both patients and providers to ensure that the risks associated with intravascular injection are adequately communicated.
The importance of adequate clinical training in preventing adverse events
It was highlighted in the meeting that making it more difficult for undertrained providers to fly "under a patient's radar" is one concrete step the agency can take toward addressing the issue. Specific actions proposed toward this end included standardized patient labeling with consistent presentation of benefits and risks, a boxed warning regarding the risk of intravascular injection, and a Patient Decision Checklist that includes specific mention of the risks of soft tissue necrosis, blindness and stroke, and allows for patients and providers to affirmatively acknowledge that each item was read and discussed.
The agency's panel of experts clearly stated that a provider's direct, quality training in facial anatomy is critical to preventing adverse events that carry devastating patient effects. Physicians and scientists on the panel discussed the FDA's ability to require that treatment with an investigational device in a clinical study be performed only by qualified individuals by "reason of their scientific training and/or experience."
The FDA's panel of experts also emphasized that the knowledge, training and skillset of plastic surgeons in particular make them uniquely qualified to administer dermal filler injections. In his presentation, the FDA's Dr. Henry Lee stated that "premarket clinical studies typically utilize highly qualified physicians, such as plastic surgeons or dermatologists, with extensive experience with dermal filler injection...In postmarket clinical use, the injector may not have adequate training to safely inject the device for a particular indication." Dr. Lee further emphasized that "well-trained and experienced providers may mitigate risk of complications."
Dermal filler procedures are widely used and accepted as a safe and effective treatment throughout the specialty. But as with any procedure, if not properly administered, these injections have the potential to result in adverse outcomes for patients that can be devastating. Categorizing a procedure as "safe" assumes it is performed by the appropriate medical professionals with substantial training and experience with facial anatomy. It does not mean that it is safe in all hands.
ASPS will continue to monitor the FDA's activity on this issue and work to ensure that the ability to administer dermal filler procedures is limited to those with the proper clinical background and training.