Sculptra FDA Approval

What has the US FDA Approved for Sculptra Use

Doctor Answers (5)

Sculptura approved for cosmetic

+2

Thanks for your question,

Yes it is true the FDA just gave approval for Sculptura. The previous indication was for facial wasting for patients with HIV. It has been a safe and effective treatment for sometime. Many physicians have been using it "off label" for sometime.

At our San Francisco area office we're using it for people who have experience with other fillers and like the results and want a longer lasting result.

I hope this helps.


San Francisco Plastic Surgeon
4.5 out of 5 stars 23 reviews

Sculptra approval has been extended to cosmetic uses in addition to HIV facial atrophy

+1

As most physicians who picked up Sculptra early, we have been using it off label in cosmetic patients since it originally was approved.

It is a great product for properly selected patients who are not in a hurry to see their results. It is a "stimulatory" filler so that the built up develops slowly and usually takes several sessions. However it has the longest durability of any "non-permanent" filler.

Nathan Mayl, MD
Fort Lauderdale Plastic Surgeon
4.5 out of 5 stars 7 reviews

Sculptra approval by FDA

+1

Sculptra Aesthetic was approved by the FDA on July 29th, 2009 for use in correcting shallow or deep nasolabial fold contour deficiencies as well as other facial wrinkles. Sculptra is one of the most advanced treatments for restoring depleted volume to areas such as the cheeks, jowls, and nasolabial fold regions.

Sculptra Aesthetic differs significantly from traditional fillers, such as Juvederm, Radiesse, and Restylane. The duration of effect is at least 2 years, and possibly much longer. The “fill” effect of Sculptra comes from the body’s production of its own natural collagen, and does not come from the actual product itself. As such – the volume enhancement which Sculptra produces does take some time to develop in a gradual fashion, usually two to six months for full effect. Sculptra Aesthetic is made up of an injectable natural material, which is broken down by the body after inducing the growth and formation of new collagen. Adequate treatment typically requires 1-3 separate sessions to achieve full correction, but provides a more gradual and potentially more natural effect than some other fillers. The mechanism of action has been compared to planting seeds (Scupltra) and allowing grass to grow in over time (body’s collagen production).

Brian S. Glatt, MD
Morristown Plastic Surgeon
5.0 out of 5 stars 12 reviews

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Is Sculpta FDA approved?

+1

Sculptra has been FDA approved in the US since 2004 as treatment for facial fat loss in HIV patients (facial lipo-dystrophy). However, Sculptra has been used by physicians for non-FDA indications such as cosmetic treatment of facial wrinkles or volume loss in non- HIV patients. This is known as an off-label use of the drug. There are many other instances of off-label use of drugs, such as injection of Cosmetic Botox into crow's feet area. (Cosmetic Botox is only FDA approved for use in the mid-forhead lines near the nose) The company has requested approval for additional indications for use from the FDA. Although there is rumors of pending approval of Sculptra for use as a facial filler in general population, the approval has not been issued yet.

Maurice M. Khosh, MD
New York Facial Plastic Surgeon
5.0 out of 5 stars 4 reviews

Sculptra just approved for Facial Cosmetic use

+1

Yes, it is correct. Two days ago FDA approved Sculptra for cosmetic use on the face.

It has been approved since 1999 for use in HIV individuals who lose fat in the face as a result of the anti retroviral therapy leading to sunken cheeks and temples.

We i.e., the physicians have been using it off label for cosmetic reasons as well. It works very well but you have to be trained before using Sculptra.

Regards

Tanveer Janjua, MD
Bedminster Facial Plastic Surgeon
5.0 out of 5 stars 25 reviews

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