FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
Full FAERS analysis of 1,968 deoxycholic-acid (Kybella) reports: nerve-injury terms lead, off-label and 'drug ineffective' rank high, and a paradoxical fat-growth signal…
526 FDA MAUDE reports on liposuction devices show injuries and malfunctions split nearly even, VASER ultrasound systems dominate, and thermal burns are the signature…
Regenerative aesthetics mapped from 77 trials and the FDA record: PRP leads the research, exosomes and polynucleotides have no U.S. approval, and unapproved stem-cell…
Only about 10 registered trials back thread lifts, and most are non-randomized. Large case series show a real lift lasting roughly 6 to 12 months — not the years…
22,242 FDA MAUDE reports for dermal fillers (product code LMH): the Juvéderm family leads at 55%, HA fillers drive 72% of all reports, and a 2025 surge pushed annual…
Kybella causes expected swelling and numbness, but two side effects are FDA-flagged: temporary jaw-nerve injury and trouble swallowing. What the label, trials, and…
ISAPS 2024 Global Survey: 38M procedures worldwide, eyelid surgery overtook liposuction as the top surgical procedure, botulinum toxin leads at 7.9M, and facial…
Relfydess is the first ready-to-use liquid neuromodulator. A second FDA complete response letter (July 2026) delays US approval. Phase 3 data show day-1 onset and up to…
TrenibotE is the first serotype E neurotoxin submitted for FDA approval. Onset in 8 hours, duration of 2–3 weeks, over 2,100 patients studied. April 2026 CRL addresses…
20 original PMA approvals since 1981, 1,036 total PMA records, and a recent wave of new entrants: what the FDA premarket-approval database reveals about who makes the…