Sculptra Aesthetic 2010; Dr. Persky's Thoughts

Tuesday, February 2. 2010 posted in Sculptra

Sculptra Aesthetic (Dermik Lab., Sanofi-Aventis) is an exciting, new facial injectable treatment. Sculptra is injectable Poly-L-lactic acid (PLLA). PLLA is what absorbable suture material is made of. Sculptra has been used cosmetically outside the U.S. since 1999 and is a very popular procedure in Europe and Canada.

Dr. Persky has been following the use and development of Sculptra since its introduction to Europe in 1999. As with all new products and treatments related to facial plastic and reconstructive surgery, Dr. Persky is extremely conservative and believes that it is important that the treatment be proven not only effective, but more importantly safe. The Hippocratic Oath admonishes, "Physician, first do no harm!"

Early Sculptra treatments were very effective at replacing lost facial volume, so much so that in 2004 Sculptra was FDA approved for use in volume restoration from fat loss (facial lipoatrophy) for HIV patients. Some plastic surgeons and dermatologists began using Sculptra off-label to treat non-HIV lipoatrophy patients for cosmetic volume replacement. There were troublesome nodules and granulomas (lumps and bumps) during the early years of treatment with the product before techniques were improved.

In the past few years, physicians have learned how to minimize the occurrence of nodules with Sculptra. It is now injected in a much more dilute fashion. Patients massage the injected areas for 5 minutes, 5 times a day for 5 days. Injection techniques now avoid injecting through muscles that previously caused nodules. Superficial injections are now avoided. With a much greater safety profile, Dr. Persky now feels very comfortable treating his patients with Sculptra.

At The South Beach Symposium in February 2009, Dr. Persky met with the world leaders in Sculptra use, including Danny Vlleggar, MD. Impressive and natural before and after photos of patients treated with Sculptra, along with the much improved safety profile piqued Dr. Persky's interest in the product. What ultimately convinced Dr. Persky that Sculptra was going to be the filler of the future was seeing and speaking with 3 relatively young, beautiful, intelligent, well known female U.S. dermatologists who have had Sculptra injected into themselves as their facial volume filler of choice. If it is good enough for those experts to use on their world famous faces, then that was good enough for Dr. Persky to begin using Sculptra.

In July of 2009, the FDA approved Sculptra for the cosmetic indications of volume deficiency and facial wrinkles. Once it was FDA approved, Dr. Persky began using Sculptra to contour and sculpt faces.

The beauty of Sculptra is that is works by stimulating natural collagen production. John Joseph, MD of Beverly Hills says, "It is like putting a grain of sand into an oyster to form a pearl". I like to think of Sculptra as wonderful "seeds" that are spread where facial structure needs volume to restore youth.

Sculptra Aesthetic is different from all other filler products. Sculptra is injected as a very dilute cloudy solution that is mostly water and local anesthetic. Once injected, the patient can see a "preview" of what they will ultimately look like after their complete correction. Within hours to days, the fluid is reabsorbed by the body, and the treated patient’s appearance returns what it looked like before the injections, with possibly a new bruise or two. Over the next 6 to 8 weeks as collagen production occurs, the patient's face subtly and gradually establishes a foundation for the correction. Re-evaluation and a second injection session are then carried out. Most patients are treated over 3 sessions with varying amounts of Sculptra depending on their individual need and individual response. At full correction, the result is natural and has been shown to last 25 months and longer. As aging continues, touch-up treatments restore lost volume.

Sculptra gives physicians the ability to treat faces after analyzing the skin, muscle, fat, and bone; determining what needs to be replaced, and then using asthetic injection skills to achieve facial rejuvenation. Patients with early signs of aging from volume loss in their 30's and 40's are great candidates for Sculptra to correct early "jowling" and loss of volume in the cheeks. In older patients, Sculptra can be used beautifully to restore volume in hollow temples, jaw lines, chins, and to shorten elongated upper lips, restoring the proportions of youth to the face. Other than in the nasolabial folds, all of these cosmetic uses are "off-label."

Patient satisfaction studies have shown 84.9% satisfaction at 13 months and 80.0% satisfaction at 2 years. Sculptra should not be used in patients with a history of keloid formation or hypertrophic scarring, or in those patients allergic to absorbable stitches.

Dr. Persky is very excited about having Sculptra as a new powerful facial filling and contouring agent to go along with traditional fillers and fat. As with any treatment or product, it behooves the patient to do their homework and choose their injecting physician most carefully. It takes a combination of proper Sculptra technique with an aesthetic sense of beauty and proportion to help patients gradually look natural without feeling different or like someone else.

To view before and after patients who have been treated with Sculptra go to http://www.sculptra.co.uk/content.asp?section=3&subsection=3&picID=44.

Be well.
Dr. Persky is now offering Sculptra to patients who wish to re-volumnize their face with a long lasting filling agent. Studies have shown results lasting up to 30 months. Sculptra works by stimulating the patient's own collagen production. Sculptra is very effective for patients in their 30's and 40's who are showing early signs of aging, as well as in patients over 50 who have lost bone and fat volume in their face. Depending upon how much volume needs to be replaced, the treatment entails using one to two vials of Sculptra, one to four times, separated by about six weeks. Contact me if you have any questions about Sculptra. Be well.

Sculptra FDA Approved for Cosmetic Use

Thursday, July 30. 2009 posted in Sculptra

The long awaited FDA approval of Sculptra for facial cosmetic use was announced yesterday. Company spokespersons from pharmaceutical company Sanofi-Aventis announced yesterday that federal clearance had been given to use their dermal filler Sculptra in cosmetic procedures. Although (off-label) cosmetic use of Sculptra has been happening for years, the original FDA approval of Sculptra was for treating lipoatrophy; i.e. facial fat loss, in AIDS patients. People in the industry are excited to get official clearance for this long-lasting dermal filler.

The Food and Drug Administration gave clearance for the following cosmetic purposes:
-Correction of mild-severe nasolabial folds
-Wrinkles and contour irregularities

Regulators based their evaluation of Sculptra on a study of 233 patients that had received treatment with the filler for their nasolabial folds. According to the official press release, the aesthetic results of Sculptra “were maintained up to 25 months after the last treatment session.”

I look forward to using Sculptra to replace lost volume in the faces of my patients in the near future.



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