FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue.
More information about the FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the dermal fillers when injected into specified areas of facial tissue.
Most dermal fillers have a temporary effect, because they contain materials that are absorbed by the body over time. The FDA has approved only one product made from a material that remains in the body and is not absorbed. Some dermal fillers also contain lidocaine, which is intended to decrease pain or discomfort related to the injection.
The materials used in dermal fillers include:
Absorbable (temporary) materials
- Collagen: Collagen is a type of protein that is a major part of skin and other tissues in the body. Sources of purified collagen used in soft tissue fillers can be from cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting of injectable filler materials.
- Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage. It is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6 – 12 months.
- Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. For wrinkle filling in the face or for the hand, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the back of the hand. The effects of this material last approximately 18 months. While in the body, calcium hydroxylapatite will be visible in x-rays and may obscure underlying features.
- Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years.
Non-absorbable (permanent) materials
- Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. When used as a soft tissue filler, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face.
The FDA is aware that unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, and 4 are being sold and distributed in the U.S., including by online retailers. Juvederm is a prescription device that should only be injected and sold by or on the prescription of a licensed health care provider. The FDA is warning health care providers and patients not to use any Juvederm Ultra 2, 3 or 4, because these products are not approved for use in the U.S. As such, the safety and effectiveness of these products cannot be assured. A list of approved products and indications for use in the U.S. can be found in the table below.
The FDA has NOT approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.
The Summary of Safety and Effectiveness Data for each approved dermal filler contains links to additional information about the clinical data the FDA reviewed. Links to this information can be found under the “Trade Name” column in the table below. This table lists all FDA-approved dermal fillers. It should be noted that not all of the dermal fillers listed below are currently marketed.
|Trade Name (with link to additional information)||Material||Applicant||PMA Number||Decision Date||Approved For|
|Restylane, Refyne, Restylane Defyne||Sodium Hyaluronate||Q-Med AB||P140029||12/9/2016||Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial fold) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe deep facial wrinkles and folds (such as nasolabial fold) in patients over the age of 21.|
|JUVEDERM VOLLURE XC||Hyaluronic Acid||Allergan||P110033/S020||3/17/2017||Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.|
|JUVEDERM VOLBELLA XC||Hyaluronic
Acid with Lidocaine
|Allergan||P110033/S018||5/31/2016||Injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.|
|RESTYLANE LYFT WITH LIDOCAINE||Hylauronic acid with lidocaine||Galderma Laboratories||P040024 S073||7/1/2015||Moderate to severe facial folds and wrinkles or in patients over the age of 21 who have age-related volume loss.|
|RESTYLANE SILK||Hyaluronic Acid with Lidocaine||Valeant Pharmaceuticals North America LLC/Medicis||P040024 S072||6/13/2014||Indicated for lip augmentation and dermal implantation for correction of perioral rhytids (wrinkles around the lips) in patients over the age of 21.|
|JUVEDERM VOLUMA XC||Hyaluronic Acid with Lidocaine||Allergan||P110033||10/22/2013||Deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.|
|Hyaluronic Acid with Lidocaine||Medicis Aesthetics Holdings, Inc.||P040024 S056||8/30/2012||Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles/folds (such as nasolabial folds) and for lip augmentation in those over the age of 21 years.|
|BELOTERO BALANCE||Hyaluronic Acid||Merz Pharmaceuticals||P090016||11/14/2011||Injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds).|
|RESTYLANE INJECTABLE GEL||Hyaluronic Acid||Medicis Aesthetics Holdings, Inc||P040024 S051||10/11/2011||Lip augmentation in those over the age of 21 years.|
|JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC||Hyaluronic Acid with Lidocaine||Allergan||P050047||1/7/2010||The addition of 0.3% Lidocaine into Juvederm Ultra and Juvederm Ultra Plus.|
|SCULPTRA AESTHETIC||Poly-L-Lactic Acid (PLLA)||Sanofi Aventis U.S.||P030050 S002||7/28/2009||Use in shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.|
|EVOLENCE COLLAGEN FILLER||Collagen||Colbar Lifescience l||P070013||6/27/2008||The correction of moderate to deep facial wrinkles and folds (such as nasolabial folds).|
|PREVELLE SILK||Hyaluronic Acid with Lidocaine||Genzyme Biosurgery||P030032 S007||2/26/2008||Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|RADIESSE 1.3CC AND 0.3CC||Hydroxylapatite||Bioform Medical, Inc||P050037||12/22/2006||Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV.|
|RADIESSE 1.3CC AND 0.3CC||Hydroxylapatite||Bioform Medical, Inc||P050052||12/22/2006||Subdermal implantation for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|ELEVESS||Hyaluronic Acid with Lidocaine||Anika Therapeutics||P050033||12/20/2006||Use in mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|ARTEFILL||Polymethylmethacrylate Beads, Collagen and Lidocaine.||Suneva Medical, Inc.||P020012||10/27/2006||Use in facial tissue around the mouth (i.e., nasolabial folds).|
|JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM 30HV||Hyaluronic Acid||Allergan||P050047||6/2/2006||Use in mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|RESTYLANE INJECTABLE GEL||Hyaluronic Acid||Medicis Aesthetics Holdings, Inc||P040024||3/25/2005||Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|CAPTIQUE INJECTABLE GEL||Hyaluronic Acid||Genzyme Biosurgery||P030032 S002||11/12/2004||Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).|
|SCULPTRA||Poly-L-Lactic Acid (PLLA)||Sanofi Aventis U.S.||P030050||8/3/2004||Restoration and/or correction of the signs of facial fat loss (facial lipoatrophy) in people with Human Immunodeficiency Virus (HIV).|
|HYLAFORM (HYLAN B GEL)||Modified hyaluronic acid derived from a bird (avian) source||Genzyme Biosurgery||P030032||4/22/2004|
|RESTYLANE INJECTABLE GEL||Hyaluronic Acid||Q-med Ab||P020023||12/12/2003|
|COSMODERM 1 HUMAN-BASED C||Collagen||Inamed Corporation||P800022 S050||3/11/2003||Injection into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.|
|FIBREL||Collagen||Serono Laboratories||P850053||2/26/1988||The correction of depressed cutaneous scars which are distendable by manual stretching of the scar borders.|
|ZYPLAST(R)||Collagen||Collagen Corp.||P800022 S011||6/24/1985||Use in mid to deep dermal tissues for correction of contour deficiencies.|
|ZYDERM COLLAGEN IMPLANT||Collagen||Allergan||P800022||9/18/1981||Use in the dermis for correction of contour deficiencies of this soft tissue.|
|RADIESSE||Hydroxylapatite||Bioform Medical, Inc.||P050052/S049||6/4/2015||Subdermal implantation for hand augmentation to correct volume loss in the dorsum of the hands.|
- Listing of all Approved Wrinkle Fillers in Devices@FDA
- Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler
- FDA Consumer: Filling in Wrinkles Safely