A recent FDA advisory on the potential adverse effects of widely-available injectable cosmetic fillers raises concerns about how their safety profile was established. A review of the clinical trials shows that the safety warnings are more warranted for intended off-label use.
The injection of soft tissue fillers (STFs) or cosmetic fillers into the dermis of the skin is one of the most popular office procedures in the world. Plastic surgeons, dermatologists and other medical care providers are using STFs to cosmetically augment age-related changes in patients.Cosmetic fillers can be used to create a softer, fuller look by filling out the furrows of the face, cheeks, lips, even the backs of hands. Other indications also include the treatment of acne scars, or to correct the facial atrophy that is common among individuals living with HIV. Among the STFs approved by the US Food and Drug Administration (FDA) are hyaluronic acid (RestylaneTM), Calcium hydroxyapatite (RadiesseTM), and lactic acid (SculptraTM).
While these cosmetic fillers have been approved for use for quite some time, a recently published FDA advisory warns of reported complications from their use. Skin and soft tissue loss have been seen from STF injections; more alarmingly there have been reports of severe incidents, particularly of inadvertent injections into the bloodstream which can lead to blindness or stroke.
The advisory has prompted researchers at an Illinois university to look back into the clinical trials that demonstrated the safety and efficacy of these popular cosmetic fillers. The Department of Dermatology at Northwestern University in Chicago conducted a systematic review of these STF trials to determine the quality of evidence that led to their approval. The results of their study have been subsequently published in the July edition of the JAMA Journal of Facial Plastic Surgery.
As in all pharmaceutical products intended for patient use, these cosmetic fillers underwent rigorous, multi-phase trials to determine their safety and efficacy. The original approvals were reviewed to find out if the clinical results were indeed valid, and more importantly, that the safety profile of these STFs was completely evaluated.
The review of 14 identified studies indeed showed the rigor in which the clinical trials were conducted. The majority of the trials involved injections in specifically identified regions of the face (primarily the jowls and the nasolabial folds) in strictly controlled amounts. In these controlled conditions, both the safety and efficacy of the STFs were well documented, with minimal complications reported.
So why the concerns on safety, prompting the FDA advisory? The researchers theorize that these complications occur when providers go off-label when providers use the STFs for other indications. These may include injecting STFs in other areas of the face or body not previously specified (areas around the eyes, or even the buttocks), or injecting them in greater quantities than prescribed.
With the conclusion that the cosmetic fillers are inherently safe, the researchers recommend further studies on STF use, particularly on monitoring their off-label usage. Physicians must be willing to share actual clinical results to get a better picture of how cosmetic fillers are used, and therefore how complications can be prevented. And as the popularity of the use of cosmetic fillers continues to grow, providers must ensure that they are truly safe and effective, well beyond the confines of the laboratory. That is the best reassurance that we can give to both the FDA and to the patient.
Written by Jay Martin, M.D.
Lohman, M et al. “Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers: A Systematic Review”. JAMA Facial Plastic Surgery, July 2017. Doi: 10.1001/jamafacial.2017.0082
FDA information on dermal fillers: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/cosmeticdevices/wrinklefillers/