The use of injectable fillers for lip augmentation dates back for nearly three decades. While it remains one of the most common cosmetic uses of injectable fillers, ironically it has never been approved by the FDA for that specific use. It has been used ‘off-label’ ever since any of the injectable fillers have become commercially available.
That is about to change. On April 27, 2011 the FDA finally made a decision to approve the use of at least one injectable filler, Restylane, for lip augmentation. An FDA panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation. The panel also voted 6-0 with 1 abstention that the filler is safe and effective for the expanded indication.
Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated by Streptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether. The filler was first approved in 2005 for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as the nasolabial folds. Medicis recently conducted a clinical study to evaluate the safety and effectiveness of the filler in the augmentation of soft tissue fullness of the lips. The study included 135 patients, who received lip augmentation with Restylane, and 45 patients with no treatment. The mean volume of filler was 2.9 cc per patient, with a range of 0.6-5.6 cc per patient. At 8 weeks, 92% of patients who received Restylane were considered responders.
Does this have any great clinicial relevance to patients? Does it mean that injectable fillers are safer than before when put into the lips? The answer is no, although the manufacturer of Restylane will make great hay of it from a marketing perspective. They will now advertise that they are the only injectable filler approved for use in the lips which puts other injectable fillers at a perceived disadvantage. Patients are likely to assume that Restylane is safer when it is actually not. This will force the other injectable filler brands, such as Juvederm, to eventually apply for similar FDA approval.
An interesting question is why has lip augmentation for fillers never been approved by the FDA before? The answer is what happened way back in 1981. This is when the first injectable filler, bovine collagen (Zyderm, Zyplast), was approved by the FDA. At that time, the original application for indications did not include use in the lips. When new forms of injectable fillers, the hyaluronic-acids, applied to the FDA decades later they went for the identical indications as that of bovine collagen which made approval much easier. It was well known that fillers were widely used off-label in the lips anyway.
Dr. Barry Eppley
Indianapolis, Indiana