Recent safety concerns have caused many to question soft tissue filler injections. Researchers examine the evidence leading to their approval.
Soft tissue filler injections are the second most common nonsurgical cosmetic procedure in the USA. Absorbable soft tissue fillers (STFs) are approved for the correction of facial wrinkles and skin folds, such as the nasolabial folds. A permanent STF is approved only for nasolabial folds and acne scars. Approval for other uses is limited to the correction of the localized loss of fat tissue in individuals with HIV1.
The Food and Drug Administration (FDA) has classified soft tissue filler injections as class III medical devices, designated as such because they have the highest risks such as vision impairment, blindness, stroke, and death of skin and facial structures2. These devices require a premarket approval from the FDA, detailing its efficacy and safety3. Recently, the FDA issued a safety warning regarding the risks of blindness and facial necrosis when using STFs. The purpose of the study was to examine the quality of evidence leading to the FDA approval of the soft tissue filler injections.
As published in JAMA Facial Plastic Surgery in October 2017, a total of 14 STF approvals were identified4. Of those, 71% were randomized controlled trials and 60% were masked. Masked randomized controlled trials are considered the gold standard for high-quality research of this type. Ten of 14 trials involved injections solely of the nasolabial folds or cheeks and only 4 trials involved treatment of other facial regions.
These studies effectively demonstrated the overall safety of soft tissue fillers for their intended, approved purposes. There is an urgent need for more research on the safety and efficacy of soft-tissue fillers for other non-approved purposes, particularly following warnings of the possibility of blindness and/or facial necrosis. This study also identified a need for research in a wider range of races and ethnicities, since the majority of the research to date included mostly white participants. This review demonstrated that the safety warnings relate more to the off-label uses of soft tissue fillers, which have not been sufficiently studied. Although soft tissue filler injections remain safe with approval based mostly on randomized clinical trial outcomes, the implementation of unique device identifiers and a greater use of physician-led registries would ensure physician, consumer, and regulatory confidence in soft tissue filler safety.
Written by Dr. Swapna Aleti, Scientific Writer and Associate Professor
- U.S. Food and Drug Administration General and Plastic Surgery Devices Panel. Executive Summary: Dermal Filler Devices. 2008.
- US Food and Drug Administration. Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication. 2015.
- Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012;366(9):848-855.
- Lohman et al. Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers: A Systemtic Review. JAMA Facial Plastic Surgery. 2017;19(5):421-429. doi:10.1001/jamafacial.2017.0082