2006 · Allergan
Juvederm family
Material. Crosslinked hyaluronic acid gel
First approved June 2, 2006 for moderate to severe wrinkles and folds. The family now covers lips (Volbella), cheeks, chin and temples (Voluma), jawline (Volux) and under-eye hollows (Volbella).[1][2][3]
Suits. Voluma is approved for deep injection. In its cheek trial, 85.6% were responders at month 6, 85% at 12 months and 67% at 24 months.
Trade-offs. In the Voluma trial, treatment-site responses lasted 15 to 30 days in 24.6% of subjects. Side effects rose with injection volume and with age.
2003 · Q-Med
Restylane family
Material. Non-animal stabilized hyaluronic acid gel
Approved December 12, 2003 for moderate to severe wrinkles and folds. Its approvals cover lips (Restylane), cheeks and chin (Lyft) and under-eye hollows (Eyelight).[1][2][3]
Suits. In the 2003 trial of 138 patients, Restylane was rated better than bovine collagen in 56.9% of patients at 6 months and collagen better in 9.5%.
Trade-offs. In the Eyelight trial, tenderness followed 89.7% of injections and swelling 85.0%. Over 63.7% of these reactions lasted 7 days or less.
2017 · Teoxane
RHA
Material. Hyaluronic acid gel for dynamic wrinkles
RHA 2, RHA 3 and RHA 4 were approved October 19, 2017 for moderate to severe dynamic facial wrinkles and folds.[1][2]
Suits. Two split-face randomized trials of 174 and 140 subjects ran 15 months, with repeat treatment. Each RHA formulation was non-inferior to the control filler at 24 weeks.
Trade-offs. Responder rates fell over time for all three formulations, which FDA described as an expected loss of effect.
2011 · Merz
Belotero Balance
Material. Hyaluronic acid gel, mid-to-deep dermis
Approved November 14, 2011 for moderate to severe wrinkles and folds such as nasolabial folds.[1][2]
Suits. In a split-face trial of 118 subjects against collagen, 55.1% of Belotero-treated folds improved by more than 1 point at 24 weeks.
Trade-offs. 5 of 116 subjects formed antibodies, with no allergic symptoms. Post-market reports included the Tyndall effect, granulomas and tissue necrosis after glabella injection.
2006 · Merz (current PMA holder)
Radiesse
Material. Calcium hydroxylapatite
Approved December 22, 2006 for subdermal correction of moderate to severe wrinkles and folds. Added the back of the hands in 2015. Calcium hydroxylapatite is a mineral found in teeth and bone.[1][2][3]
Suits. FDA puts the effect at about 18 months. In a 117-patient study, 40% of folds were still rated improved at least 30 months after the last treatment.
Trade-offs. It shows on x-rays and may hide underlying features. It is not hyaluronic acid, so it can be difficult to remove.
2004 · Q-Med
Sculptra
Material. Poly-L-lactic acid
Approved August 3, 2004 for facial fat loss in people with HIV. Sculptra Aesthetic was approved July 28, 2009 for nasolabial folds in immune-competent people. It is a biodegradable polymer also used in absorbable stitches.[1][2][3]
Suits. Given as up to 4 sessions over 9 weeks. In the 233-subject trial, it beat control at 13 months and improvement continued at 19 and 25 months. FDA puts the effect at up to 2 years.
Trade-offs. Nodules or papules followed 17.2% of Sculptra treatments, against 12.8% on control. The effect builds over weeks, not at once.
2006 · Artes Medical; now Tiger Aesthetics Medical
Bellafill (ArteFill)
Material. PMMA microspheres in bovine collagen
Approved October 27, 2006 as ArteFill for nasolabial folds. As Bellafill it added acne scars on the cheek on December 23, 2014. PMMA beads are not absorbed by the body.[1][2][3]
Suits. Nasolabial fold improvement held 5 years after treatment in 119 subjects. In the acne scar trial, 64% succeeded at 6 months against 33% on saline.
Trade-offs. It contains cow collagen, and FDA advises allergy testing for animal-derived fillers. Permanent filler can be difficult or impossible to remove.