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Questions raised about evidence for FDA approval of soft-tissue fillers

Despite FDA approval based largely on randomized clinical trial results, questions about the safety of soft-tissue fillers prompted a recent retrospective investigation.

The researchers conducted the systematic review to evaluate the level of evidence required for FDA approval of soft-tissue fillers. Specifically, they investigated risks for blindness and facial necrosis associated with off-label use of the devices.

They identified 14 approvals of soft-tissue fillers. Among those approvals, 10 of the pivotal studies (71%) were randomized clinical trials, according to the results. Masked trials were reported for nine (60%) of the studies.

The studies included a median number of patients of 144 (range, 30-439).

The primary outcome measure was met in 11 of 12 studies analyzed.

In 10 of the 14 trials (71%), injections were administered only in the nasolabial folds or cheeks. Treatment of other facial regions occurred in four trials.

An uncertain selection bias risk was found in all 10 of the randomized controlled trials. Exclusion and attrition were reported in just two of the randomized controlled trials.

The researchers suggested that safety warnings pertain more to off-label use of soft-tissue fillers than to on-label use. However, they added that there is an insufficient number of prospective studies investigating off-label use.

“Although [soft-tissue fillers] remain a safe device, with approval based mostly on [randomized controlled trial] outcomes, implementation of unique device identifiers and greater use of physician-led registries would ensure physician, consumer, and regulatory confidence in [soft-tissue filler] safety,” they concluded. “This finding underscores the need for robust post-marketing surveillance mechanisms that involve multiple specialties.” – by Rob Volansky

Disclosure: The researchers report no relevant financial disclosures.