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# Soft Tissue Filler Approvals Can be Strengthened: Researchers
- URL: https://www.fdaweb.com/soft-tissue-filler-approvals-can-be-strengthened-researchers/
- Published: 2017-07-20T12:00:00.000Z
- Updated: 2026-09-14T22:35:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139175

Researchers from Northwestern University and the University of Chicago say that soft tissue fillers (STFs) are safe and are often approved as Class 3 medical devices based on data from randomized clinical trials. However, they [write](http://jamanetwork.com/journals/jamafacialplasticsurgery/article-abstract/2642913?ref=fdaweb.com) in *JAMA Facial Plastic Surgery*, “an opportunity remains to strengthen the approval process, particularly through multispecialty engagement to strengthen the approval process.”

The report notes that STF injections are the second most common nonsurgical cosmetic procedure in the U.S., preceded only by botulinum toxin injections. It references a 5/2015 FDA safety communication highlighting reported complications of STFs, including vision impairment, blindness, stoke, and death of skin and facial structures.

The researchers evaluated 14 STF approvals that had 10 pivotal studies as randomized clinical trials and nine that were masked. The median number of patients per trial was 144.

They conclude that safety warnings relate more to the off-label use of STFs, which they say has not been sufficiently studied prospectively. Approvals could be strengthened, they write, through implementation of unique device identifiers and greater use of physician-led registries. They say those changes would lead to physician, consumer, and regulatory confidence in STF safety.