The Plastic Surgery Institute, Inc., and its Medical Director, Dr. Harold Bafitis, a Board Certified plastic surgeon, are dedicated to the utmost in patient care and safety. It has become obvious over the last five years that a revolution is occurring in terms of wrinkle and skin crease "fillers". The revolution began almost 20 years ago with the introduction of Zyderm collagen, and it has continued with the deeper dermal Zyplast collagen. Since that time, a host of filler materials have come and gone, and new ones are extremely promising. In the hopes of patient safety and informed consent, The Plastic Surgery Institute of the Palm Beaches, Inc., is providing some important information on all the available filler materials.Yes, there are some astounding breakthroughs, and yes, with a minimal amount of pain and down time, your troublesome "fixed" (static) wrinkles and furrows can be improved sometimes as much as 70-80%! Please review the following pages to see which material or materials are right for you. Ask our surgical staff of nurses, physician assistants, and medical aestheticians for more information or arrange for a consultation with Dr. Bafitis. Remember, we are familiar with and have used all these materials in a hope of giving you a balanced review for your consideration.
NO ONE FILLER MATERIAL IS RIGHT FOR EVERY PATIENT.
BOTOX
First a word on Botox. Believe in Botox!! Male and female patients have shown that this is a revolutionary product. Its ability to temporarily relax muscles which cause tension lines or moderate to deep creases has revolutionized and complemented aesthetic plastic surgery.
First used to treat crow's feet and eyebrow creases, Botox is making significant inroads all over the face of America, Europe and the rest of the world. One new popular use: injecting Botox to soften lines around the mouth, the ones that catch makeup or make you look angry even when you are relaxed, but it takes an experienced surgeon to make it work.
WE ARE ALSO FINDING THAT BOTOX CAN BE USED IN A "COMBO PACKAGE" WITH FILLERS. THAT IS, BOTOX CAN SMOOTH THE WRINKLE LINES TOSOME DEGREE AND THEN KEEP THE MUSCLES FROM ABSORBING THE FILLER MATERIAL TO GIVE A MORE LONG-LASTING AND SOMETIMES PERMANENT IMPROVEMENT!
Fillers absolutely complement Botox, and as we all know, laser resurfacing and some deeper dermabrasion can also complement Botox. Below is a list of the newer wrinkle fillers. Remember, no filler is perfect for everyone, but every person will find a filler that can help improve his or her troubled areas; either temporarily and sometimes permanently. Please note Botox has some degree of pain, which is patient-related.
We recommend that patients who are more pain sensitive place a prescription topical anesthetic (which we can provide) at least two hours before, which will dramatically reduce the pain.
COLLAGEN
Bovine collagen has been used extensively as an injectable biomaterial for facial soft tissue augmentation since its introduction in clinical practice some 20 years ago. Early clinical studies with injectable bovine collagen called Zyderm demonstrated its effectiveness in correcting age related facial wrinkles, furrows and other dermal defects. Zyplast, which is a glutaraldehyde cross-linked Bovine collagen allows deeper placement of the implant and provides a more durable aesthetic effect than Zyderm, with maintenance injections being required every three to four months. Zyplast is usually used for deeper furrows and Zyderm for more superficial furrows. Collagen does have hypersensitivity reactions and needs a skin test to be done at least 30 days before. In our experience, there are between 5% and 7% of patients who are fast absorbers! which therefore means that the patient and the surgeon are both frustrated at the fact that the filler material goes away too quickly. Nevertheless, collagen has come to be known as the gold standard among injectable fillers. This is soon to change with the advent of some other fillers which we will mention shortly. Please remember, it is our experience that for good results with collagen, you have to inject at least 1.5 to 2 cc per each nasolabial crease (the line between the tip of your nose and the corner of the mouth) and at least 1.5 to 2 cc for the upper and 1.5 to 2 cc for the lower lip, sometimes more, depending on patient desire for correction of lines and volume enhancement. Collagen is temporary, and there is some pain, which can be reduced with the application of topical anesthetics. We can provide them for you.
RESTYLANE
Restylane is a non animal stabilized hyaluronic acid gel that is currently used in Europe and Canada and will soon be approved in the United States for facial wrinkles and folds and for lip enhancement. Hyaluronic acid derivatives developed for soft tissue augmentation confer less risk of immunogenicity because unlike collagen, hyaluronic acid is chemically identical across all species. Because Restylane is derived from a non animal source (it is produced from bacteria by a biofermentation process), there is less likelihood of contamination with antigenic proteins during manufacture. There is no need for any type of sensitivity testing before use. We recommend that Restylane be placed in the mid to deep dermis. Significant studies have shown that Restylane provides a more durable aesthetic correction than Zyplast as indicated by a significant treatment difference in favor of Restylane that was evident as early as two months after treatment and was maintained for at least six months after treatment. What is safe to say is that Restylane will last slightly longer than collagen and may require slightly less "cc" material with more results. With the excellent safety profile with this material coupled with the superior longevity, we feel that Restylane will soon supplant and replace collagen as the gold standard. Remember, they may claim it may last up to a year. We are finding more clinical data including our own patients stating between four to seven months. The patient will need touch ups just like collagen. Please note that Restylane and collagen can have side effects, which are predominately mild in intensity and short lasting, less than seven days. More frequently reported symptoms include swelling, redness, tenderness, pain, and bruising, and the incidence of most reactions was lower after the touch up session than after the initial treatment session.
PERLANE
Perlane is identical to Restylane, but offers bigger partical sizes which are well suited for the nasolabial folds and deeper facial lines. We would be hesitant to use these larger particle sizes on the lips which may cause more of an un-natural appearance. The side affect profile is exactly the same as for Restylane.
COSMODERM AND COSMOPLAST
CosmoDerm and CosmoPlast are natural human collagen and will cost slightly more than bovine collagen. They are highly purified human collagen fillers derived from the same tissue-engineered technology that has been used to grow living human tissues for more than a decade. The tightly controlled manufacturing process ensures that the end product is free of any detectable viruses. You do not require a skin test and at this point, they appear to have the same life span as collagen, although some research is showing slightly more. CosmoPlast and CosmoDerm may also replace collagen as a gold standard. There is some pain with injection and again similar short lived postop issues, i.e. pain, bruising, swelling, and skin redness. CosmoPlast and CosmoDerm should not be Considered permanent.
RADIANCE FN
Radiance is a relatively new injectable version of an old familiar molecule, hydroxyapatite. While it, like any filler, can elicit an inflammatory response occasionally, it has no allergenic properties. Therefore, it needs no
initial testing injection. It is important to inject it more deeply than the superficial dermis, as it has the capacity to create permanent white beads just under the epidermis (if placed too superficially). The injection technique is slightly different in that small "threads" of the solution should be injected so that the liquefied droplets of the material may become individualized as smaller isolated particles that act together to plump up the tissue as desired. It is approved by the FDA, and it has been used widely. The present use is indicated for augmentation of the vocal cords in patients with vocal cord paralysis and for the x-ray marking of soft tissue. Its use in soft tissue augmentation is still considered "off label", but it has been used extensively in this regard with excellent results. The main problem is the potential for nodule formation, especially in the lip. Therefore, this may not be the ideal material here. Patients do experience some pain and bruising and some skin redness. Patient satisfaction has been overwhelmingly excellent to good, and peer controlled scientific studies have shown that it has a life span of at least several years. Remember, it is considered off label and can be used at the discretion of the treating physician for soft tissue augmentation. Please note, some surgeons have injected Radiance for two to three sessions to provide a longer lasting improvement.
NOTE: It has been generally felt that a permanent soft tissue filler is not suitable for facial dynamic expression lines, i.e. lips, because of changes in the facial anatomy with time. A filler of semi permanent longevity may be ideal.
ARTECOLL / ARTEFILL
Artefill has received approval by the FDA in February of 2003. It has over a 10 year history and appears to be a significant filler with tremendous potential. Artefill is a suspension of 20% polymethyl-methacrylate microspheres in 80% bovine collagen solution. It also has 0.3% lidocaine placed to prevent any discomfort. It is designed for implantation into the deeper dermis. Because of its component of collagen, it is recommended that the patient have an intradermal test injection four weeks before planned Artefill implantation. Artefill must be considered as a more permanent filler material, as it seems to have a replacement of 80% bovine collagen with the patient's own natural collagen. Artefill provides a scaffold for the 80% volume of connective tissue deposition. A complete replacement of this injected collagen has been documented. Filler material beneath the crease acts like a splint and prevents the possibility of its further folding. It takes about three months to see an optimal result. This is so, as it takes that long for the body to start replacing the collagen with its own natural tissue. Artefill has been used with long-lasting results (longer than one year) on horizontal forehead lines, glabellar frown lines (areas between the eyebrows), lower lids, crow's feet, cheek depressions, irregularities of the nose, nasolabial folds, and lip enhancement. It has been used in the corners of the mouth, on the marionette lines, on acne scars, and even for nipple augmentation. As stated before, Botox has become an excellent adjunct to these fillers, specifically Artefill. Artefill can be implanted either concomitantly or at a later time. The augmentation effect of Artefill may even be enhanced by the relaxing effect of Botox, which eliminates the motion of a particular wrinkle line and therefore increases collagen remodeling. Side effects can include a mild allergic reaction, some mild scarring which has responded to steroid creams, and very rarely granuloma formation, which again responds to steroid creams. There have been some pinpoint blood vessel formation (telangiectasia) which may occur at the implantation site in patients with very thin skin, but they usually disappear within six months. These are rare complications. In conclusion, during its 10 years of clinical use, Artefill has proven to be a reliable and predictable soft tissue filler substance. You may need more than one implantation to give the optimal result. It appears to be a tremendous boom for a longer lasting filler.
FAT GRAFTS
There is no doubt that fat tissue implantation from one area of the body to another can remain as live tissue, filling out depressions and creases. There are definite specific techniques that can improve the "take" of the grafts. Usually fat is taken from one area of the body, i.e. abdomen or hip roll, washed, and then placed carefully in sterile syringes and spun down. The oil is wicked off, and any infranatant is removed. This provides the most reliable fat for a long-lasting result. Fat can be placed in any area of the face and is usually over injected by 30%. We also freeze some of the fat and give the patient touch ups at one to two months and again at three to six months. This gives the best chance of a more longer lasting survival. Overall, fat in highly mobile areas - lips, nasolabial creases - seems to resorb over time. It is the safest filler we know because it is made from your own tissue. No skin test is needed. It also can be used in conjunction with Botox to help relax the muscle and assure a longer lasting result. Please note that we have extensively used DERMAL FAT GRAFTS, i.e. skin inclusive of its dermis, fat and often muscle that is taken from another part of the body to help improve facial lines.
For example, if we are doing a forehead lift or a face lift or breast surgery or body contouring, we can harvest these grafts and place them through hidden incisions to help improve the nasolabial folds, the lines between the eyebrows and even acne scar depressions. The results have been excellent and have been noted to stay for one to three years.
There are some dermal fillers that we have not mentioned. They are Symetra, Dermalogen, and Fascian, which are human cadaveric derived collagen products.The usage of these products has diminished greatly due to safety concerns.
The Plastic Surgery Institute and Dr. Bafitis are dedicated to optimal patient safety and satisfying end results. We have used all the above filler materials and feel that this primer will give you, the patient, a jump start on finding the right filler for you. Do not hesitate to contact us at any time. Do not hesitate to ask any of our medical professionals about these filler materials.
A new revolution is among us. New improved soft tissue fillers do bring about the promise of facial improvement with low down time. As you can see, we are experienced with all the materials and feel that one or more of these procedures may be perfect for you. Remember, knowledge is power. Be happy!