Sculptra, the U.S. trade name for New-Fill was approved by the FDA in August 2004. New-Fill is the previous trade name for the substance polylactic acid. It has been used for cosmetic purposes, such as filling out the cheeks, the hollows under the eyes, the marionette line areas around the mouth, the neck and other areas that have lost fat with aging or trauma, in Europe and Mexico since 1998. More than 200,000 thousand patients have been treated. Polylactic acid is a simple synthesized sugar that once injected into an area, stimulates the production of collagen. Polylactic acid is non-antigenic in human use and has been used in joint replacements, reabsorbable sutures and other human applications for more than 60 years.

Dr. Sabean is a very experienced “filler” injector with over 24 years experience using them.  Dr. Sabean was trained by Dr. Englehard of ApexSouthBeach in Miami, Florida in the fine nuances of Sculptra use.  Dr. Englehard has treated more than 3000 patients with Sculptra and was the first U.S. physician to import Sculptra with the FDA’s blessing in 2001 and he performed the studies that were instrumental in getting Sculptra approved for use in the U.S.  Sculptra is a filler that restores volume that other fillers cannot and it is the newest addition to the multiple filler options offered by Dr. Sabean for restoration and rejuvenation of the face and neck.  Sculptra is compatible with most other fillers like Restylane and Perlane.  

What is Polylactic Acid/Sculptra?
Polylactic acid is a synthesized simple sugar that is used in cosmetic applications as a soft tissue filler. Sculptra is different from other tissue fillers.  It lasts up to 24-36 months in European studies. Once adequate correction is achieved, it needs to be touched up only once every twelve to twenty-four months.  Unlike other fillers, Sculptra is used as a volume filler, more like fat grafting but without the downtime, the trauma, or the concerns over “viability.” As one ages, one’s face loses four to five grams of volume a year, the loss showing primarily in cheeks, under the eyes, in the chin and sagging neck.  The loss of volume with aging has often been treated with surgical “pulling-back,” but Sculptra allows Dr. Sabean to slowly restore volume loss with a simple in office 30 minute procedure.  Most cosmetic restorations require two to three treatments.  Severe lipoartophy (fat loss) from HIV infection requires four to six treatments. The Before and After photos demonstrate the impressive results that can be achieved with Sculptra and its skilled use in any patient that has lost volume due to aging.

How does Sculptra work?

Right after a procedure, the correction appears fully treated, but most of the apparent correction is fluid used to deliver the polylactic acid particles into the subcutaneous layer.  The fluid disappears within a few days of the procedure and the correction appears lost.  But polylactic acid stimulates collagen formation in the skin and slowly over the two to three months following injection, the volume slowly increases from the newly-formed collagen.  The restoration of volume loss is slow, but builds noticeably with each treatment.  When fully corrected, the volume restored usually lasts two to three years.  Cosmetic touch-ups are usually needed every two years.  Patients with severe lipoatrophy may need touch-ups yearly. 

How is the procedure done?
Sculptra is injected into the subcutaneous areas that need volume replacement with a 25-26 gauge needle in an overlapping fanning pattern or a droplet pattern with a number of individual injections, depending on the site of injection.  An anesthetic is mixed with the Sculptra just before the injections are started and eliminates the need for nerve blocks.  Each “procedure” takes fifteen to thirty minutes and procedures are usually done four weeks apart for the first two cosmetic procedures and no sooner than eight weeks for the third, in order to assess the degree of correction and determine whether any additional treatment is necessary. The exact number of sessions to achieve maximal correction of the areas being treated depends on the depth of the original deficit and the “volume” loss prior to treatment. Sculptra can be used to augment as well as fill. It can build out one's chin or fill in large areas of depressed acne scars. Sculptra can restore the volume time steals.

What are the cosmetic uses of Sculptra?
Sculptra may be used to restore volume to the sunken parts of the face: filling in the hollow under the eyes, heightening cheekbones, reshaping and re-supporting the mouth, chin, neck and the decollette. Its use is similar to fat transfer injections to the face, without the 2-3 weeks of swelling, the bruising or the pain.  Please look at the Before and After photos for great examples of cosmetic correction using Sculptra.

Is Sculptra/Polylactic acid safe?
Polylactic acid is extremely safe. It is a simple sugar with a long history of use in cosmetic procedures. With time, it is biodegraded to lactic acid, a normal by-product of the body’s metabolism.  In sixty years of use, there have been no reported allergic reactions. When placed too superficially, transient nodules may occur, sometimes even several months after treatment. They are usually not visible, but can be felt when they occur. This is very rare reaction, but again it is technique dependent. They go away with time.  It is extremely important that the cosmetic physician treating you be well trained in the administration and esthetics of Sculptra, which Dr. Sabean has been.

What happens after the procedure?
There is some swelling and occasionally bruising afterwards from the volume injected so ice packs may be applied.  Usually the patient can return to work immediately.  The treated areas may be a little sore for a few days and the treated areas need to be massaged for five minutes at night for the week after treatment.

See below for excerpts from the European Sculptra Product brochure and Before and After Pictures courtesy of Sanofli Aventis

       Joel A. Sabean, MD

                                                                       Medical and Cosmetic Dermatology Center

                                                                                        350 Cottage Road

                                                                               South Portland, Maine 04106

                                                                         207-767-2146    www.cyberderm.com

                                                              Information and Consent:      

                                                                 Sculptra^tm Therapy

Sculptra^tm is a cosmetic product used to fill defects of the skin at deep levels. It is important that you understand that Sculptra^tm is simply a collagen stimulator. The Sculptra^tm product itself is NOT providing the filling action.  The Sculptra^tm product causes a reaction in the skin, which forms new collagen. The Sculptra^tm product itself is digested by the skin and is gone about 2 years after a treatment, but the new collagen layer which is left behind may last 2 or more years. Sculptra^tm requires a SERIES of treatments to achieve adequate filling for most. skin defects. You may need anywhere from 2 to 6 treatments at 4 to 8 week intervals to achieve your best result.

Sculptra^tm was approved for U.S. use by the FDA in August of 2004, initially only for the treatment of HIV-related facial fat loss. U.S. general cosmetic use of Sculptra^tm is considered "off label" use. The doctor will discuss with you whether this product is appropriate for you.

What you can expect:

1) The doctor will take an abbreviated medical history from you before your first treatment, as well as take photographs of your treatment area. It is your duty to disclose to the doctor your complete medication list, and any pertinent medical history, particularly of bleeding disorders, previous cosmetic surgical procedures, keloid scar history, history of facial herpes, and use of aspirin, anti-inflammatory, anticoagulant, or immuno- suppressive therapies. Stop all aspirin, ibuprofen/Motrin, Aleve, and Vitamin E (pills) for 1 week prior to treatment.                                        

2) Sculptra ^tm is injected under the skin in the area to be treated (usually the    face) using several injections per area. These injections are mildly painful. The treated areas will be mildly sore for up to 3 days after treatment.

3) Your skin will be deeply massaged/manipulated by the doctor after treatment, and then ice packs applied for several minutes. This helps to minimize bruising. You may resume normal activity immediately.

4) Your skin may appear "lumpy" and mildly red or swollen for 24 to 48 hours after the treatment. This is normal. There may be mild bruising of the skin, especially if treatment is around the eyes, which may last for up to 7 days. If swelling is severe, pain or bruising is increasing, or fever develops, call the doctor.

5) You will have puffiness (not severe) for up to 10 days after the procedure. This is simply the water used to carry the Sculptra^tm product into your skin, and most of this is reabsorbed within the first week.

6) Treatment sessions are generally spaced 4 to 8 weeks apart. Deep defects may require 4 to 6 treatment sessions; persons with lesser skin defects can often be treated with as little as 2 sessions. The volume of Sculptra^tm injected at each session is entirely dependent on the size of the defect being corrected. Single treatments every 1 to 3 years appear to "keep up" with the natural loss of tissue volume due to aging.

7) The effect of Sculptra^tm is slow and gradual as your skin forms collagen around the product crystals. Your best results are seen about 3 months after your last treatment. Please be patient!

Possible adverse events:

  1) Swelling and bruising, as noted above. Temporary numbness or tingling in the treated area    or temporary partial facial muscle paralysis (from the lidocaine anesthetic), lasting less than  2 hours.

  2)  Infection at the injection sites. This would be very rare and treated with

       routine antibiotics.                                                                                                                

  3)  Undesired cosmetic effect, such as an unexpected appearance after 

       treatment. 

       These events can be limited by clear communication with the doctor about  

       your specific treatment goals.

  4) Small "bumps" commonly form deep in the skin in the treated areas, which are usually not     visually apparent. This represents new collagen which has formed deep in the skin.

After each treatment, please avoid the sun for 48 hours and deeply massage the treated area 5 minutes each night for 7 days.

Your signature below indicates that you have read the above and consent to Sculptra^tm treatment. The full cost associated with Sculptra^tm administration falls entirely upon the patient. A copy of this signed consent form will be given to you.

Signature:___________________________                 

Patient Name:_________________________________

Signature:___________________________                                                           

Witness Name:________________________________

Date:

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