Sculptra (New-Fill) Polylactic Acid Injectable Approved By FDA

Sculptra, New-Fill. or New-Filla: (technically: polylactic acid (PLA) hydrogel belonging to the family of aliphatic polyesters) Known as Sculptra in the United States. Brought to you by Biotech Industry/Aventis, this product has become very popular in the US the last 2 years. . There are no animal compounds and it has been used for over 20 years in orthopedics, plastic and reconstructive surgery in Europe.

"BIOTECH INDUSTRY NEW-FILL® is a polylactic acid (PLA) hydrogel. PLA is a synthetic polymer that is biocompatible, biodegradable, immunologically inert ; it has been widely researched and used for a range of applications in medicine and surgery. Its complete safety has been a proven fact for over twenty years.

The manufacturing process for NEW-FILL® and the quality assurance system deployed, which comply with Good Manufacturing Practice and ISO 9000 industrial standards, offer every possible guarantee of safety.

Laboratory and clinical studies have demonstrated excellent tolerance for NEW-FILL®.

..."New-Fill™ gives way to the formation of new collagen induced by the properties inherent in the polylactic acid. The process of new collagen formation ( the natural restructuring of the skin )is manifested by the formation of a fibrous dermal layer which is responsible for the filling action. Once this tissue restructuring is induced, the process persists despite the resorption of the microparticles of polylactic acid.

New-Fill™ is intended for the treatment of fine lines, wrinkles and more marked furrows or creases, as well as for the augmentation of the tissue volume in certain areas of the face (cheek-bones, cheek depressions, lips chin, etc )." http://www.sculptra.com

The injections can be pretty painful and sting quite a bit during application. You can use a topical anesthetic like Marcaine or the newer, Anodyne Anesthetic Prescription Strength (5% Lidocaine, 5% Tetracaine). Alternatively, PLA can also be mixed with Lidocaine. The appropriate ratio would be 150 mg of powder:2 ml of sterile water:1 ml of Lidocaine.

Company's Description:

"The L-PLA is in the form of microspheres whose diameter is distributed over the range 40 µ to 60 µ, held in suspension in a CMC gel. Microsphere diameter is greater than 10 µ in order to avoid immediate phagocytosis by macrophages, greater than 30 µ to avoid intracapillary dispersal, but nevertheless under 100 µ to guarantee ease of use in syringes for injection via fine intradermal needles, as well as to avoid a granulated appearance. The product is lyophilized, thus enabling hydrolysis of the polymer to be avoided, and allowing very good temporal storage stability to be obtained. Following reconstitution, the product takes the form of a polylactic acid hydrogel whose viscosity is inversely proportional to temperature." http://www.sculptra.com

Allergy Test: n/a
Longevity: New-Fill is not permanent, it eventually absorbs into the body. It is essentially a bio-catalyst and your own collagen will eventually diminish.
Retail: £250 for lip, nose-mouth lines, forehead
Cost: per Two 3 ml bottles; DEM 750,00, that is roughly 375 US dollars (Thank you Pieter!). In the US, most of our visitors were getting it for approximately $1,000. US per treatment at first. This price has since decreased by as much as half!
Available in the United States? New-Fill™ is not approved by the FDA for typical cosmetic use in the US as of yet Although I know several patients who have gotten this in various areas of the face -- including the lips "off label." I also know that there are clinics all over the US which offer the injections if you have access to the products -- or order the products for you if you have HIV/Protease induced facial wasting disorders.
Website: http://www.sculptra.com
Update! 07/23/01: Several of our visitors have had New-Fill and you may speak with them on the message board. Two of them found that it did not last as long as expected although they did not have the number of treatments suggested.
Update! 12/18/02: Dr. Gail Humble advised the New-Fill trials are going very well and they have found exceptional longevity -- especially in the cheek area. You may contact her for more information or a consultation for New-Fill.
Update! 01/21/04: The product is reportedly going to be approved soon, but under the name Sculptra.
Update! 08/03/04: Sculptra was officially approved this morning for facial wasting for those with HIV and is being marketed under the name, Sculptra in the United States. Distribution should be underway by September 2004. Since gaining approval, Sculptra will be available for off-label use for patients seeking cosmetic soft tissue augmentation under the CHAPTER IX - MISCELLANEOUS; SEC. 906 PRACTICE OF MEDICINE Act. --

Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

source: http://www.fda.gov/opacom/laws/fdcact/fdcact9.htm

"The Food and Drug Administration today, August 3, 2004, approved Sculptra, an injectable filler to correct facial fat loss in people with human immunodeficiency virus (HIV).

Sculptra is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheek, eye and temple areas of the face caused by the loss of fat tissue under the skin which can affect HIV patients. FDA expedited review of the product because of its importance in treating people living with AIDS.

Sculptra is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches, bone screws and facial implants.

FDA approval of Sculptra was based on data from four studies, totaling 277 HIV-positive patients with severe facial lipoatrophy. The patients, who were all being treated with antiretroviral drugs, were primarily white males, mostly ages 41 to 45. Patients were given three to six injections of Sculptra at two-week intervals and were followed for two years.

Skin thickness measurements and serial photographs from clinical studies were assessed, as well as other data submitted by the manufacturer, Dermik Laboratories, of Berwyn, Pa. Analysis indicated that the product significantly improved facial appearance, and was safe for restoration and/or correction of shape and contour deficiencies resulting from facial fat loss in patients with HIV/AIDS. Sculptra was shown to produce significant increases in dermal thickness (up to 2 to 3 times baseline values), adding volume to facial tissue and restoring shape to areas of the face with fat loss.

After an initial treatment series, repeat treatments may be needed to maintain the correction.

Most adverse events were related to the injection itself and included nodules, redness, swelling and bruising in the injection area.

The studies also demonstrated significant improvement in quality of life, and measures of anxiety and depression, conditions which can be associated with lipoatrophy.

Sculptra should only be used in patients with HIV by health care providers who are fully familiar with the product training materials provided by Dermik and the entire product package insert. The use of the product for other indications, such as to treat wrinkles, has not been approved by FDA.
Sculptra should not be used in anyone who is allergic to any of the product's components.

As a condition of approval, Dermik has agreed to conduct an open-label registry study of 100 patients for five years to evaluate Sculptra's long-term safety. The study will include at least 30 females and 30 people with dark skin types.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration"

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