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UPDATE #6
RESTYLANE
Sometime in the next few months the FDA is expected to approve a new filler substance, Restylane, that may revolutionize the field of facial augmentation. Currently that role is filled by Collagen. Collagen, which comes in three forms (basically fine, medium, an thick) is used to puff up lines and folds, particularly those around the nose, mouth and eyes, across the forehead and, increasingly, on other areas of the face. Derived either from cows (Zyderm and Zyplast) or, more recently, from human fibroblasts in tissue culture (Cosmoderm and Cosmoplast), these products have been the only non-permanent injectable filler substances available legally in the United States. That may be about to change. Restylane, which has been shown to last up to twice as long as collagen, may become the new filler of choice as soon as it becomes available.

The use of fillers has skyrocketed as people seek to put some volume back in their faces. Two types of things happen with aging in the face: 1) Skin stretches and sags, in which case the patient becomes a candidate for a range of procedures known, among others, as facelifts and eyelid tucks, and 2) there is a loss of volume - both fat and bone - in which case fillers may be beneficial. This loss of volume causes an increased number, and depth, of lines, folds, and creases, as well as a loss of cheekbones and sagging of some of the cheek fat. The increasing awareness of these age-related changes has driven doctors and patients alike to look for new ways to combat them.

Sounds great, right? Well, for whatever degree of comfort this provides, there are more choices than ever for the person who wants to do something about it. In fact, there are so many choices that it would take much more than this newsletter to discuss them all. There are, though, several different categories of corrective procedures.

1) Implants versus Injectables - Implants are inserted by making small incisions in or near the areas to be augmented, and then inserting any of a number of implants. All of these are permanent, which can be a problem if they shift, shrivel, migrate or otherwise change their appearance. For example, cheek and chin implants are typically made of solid silicone blocks that can be inserted as is but can also tailored as needed for each individual patient. Injectables are materials that are injected through fine needles directly into the position desired. Injectables fall into two general categories:

2) Permanent versus Non-Permanent - Permanent injectables, such as liquid silicone, have the advantage of permanency but many of the same disadvantages as implants. Non-permanent fillers need to be reinjected periodically but have the enormous advantage of everything dissipating eventually - including any irregularities that may have appeared. For many reasons, non-permanent fillers are the mainstay of filler treatments in the United States. There are some fillers that are a mix of, or act like a mix of, permanent and non-permanent substances. These include Artecoll - to be called Artefill in the US once it gets its expected FDA approval - which is 25% permanent and 75% non-permanent (although some of that is replaced by permanent collagen) and autologous fat injections, or transplants, which have a variable degree of permanency. Some doctors claim and seem to be able to show that the majority of the transplanted fat remains, or is replaced by a permanent form of collagen; others find those results difficult to duplicate or somewhat unpredictable. The jury is out on whether or not fat transplants should be considered permanent in the strictest sense.

Where does Restylane fit in? Restylane is a non-animal, stabilized hyaluronic acid, a type of sugar material. It comes from a laboratory - not an animal - and for that reason alone is a huge theoretical advantage in this era of heightened concern for disease transmission. While there have been few if any documented cases of disease transmission from injections of fillers, it has been shown that DNA persists in a number of the human-derived cadaveric products. It is much too much of a concern, however theoretical, to justify their use if there were a case of disease transmission. Hence the enormous plus that Restylane is a laboratory-produced filler. It also lasts longer - up to a year or more, versus the four to six months for collagen. While the price has not yet been established, it will undoubtedly be competitive. It will be available in three formulations: Restylane Fine Lines, Restylane, and Perlane, which are injected, respectively, from the most superficial to the deepest locations. (The three forms are referred to generically as "Restylane.") For example, Restylane, which is expected to mainstay of the formulations, will be used to puff up nasolabial lines (the lines that go from the nose down to the mouth) and "marionette" lines (those that go from the corners of the mouth down to the chin. Perlane will be used to build up cheek bones and the chin, as well as filling deeper scars, and as the lowest layer of any combination filler treatment. Fine Lines will be used for the most superficial lines, such as those around the eyes and the cobblestone appearance of skin on the cheeks.

What's bad about it? For one, it hurts more than collagen does. Collagen contains lidocaine, an anesthetic that helps numb the areas being treated. Restylane doesn't, so you may need to either endure some discomfort, or have the areas numbed through the application of a topical anesthetic (which will add half and hour or so to the length of the treatment), or with nerve blocks (which necessitate a few additional injections of local anesthesia). For another - if you get a lump or a bump in an areas where you didn't want one, it will last a lot longer than if you'd used collagen.So, be on the lookout for Restylane. It is likely to be on - and in - lips all over town. Time will tell whether or not it lives up to its promise but, for now, that promise is impressive. While it will not replace any of the permanent forms of filler treatments (for those who want them), it has many advantages over those, and it will probably move quickly and comfortably into the lead in the Maintenance category of Fillers. And if you want more information, there will be a book, titled Restylane, released at about the same time Restylane gets its FDA approval. Published by Berkley, a division of Penguin Putnam, it will be authored by me, and by Sonia Weiss. Once it's out, we will add a hyperlink connection to this space.

Alan M. Engler, MD, FACS - Board Certified Plastic Surgeon
122 East 64th Street New York, NY 10065 USA
(212) 308-7000 alan.engler@gmail.com

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