Is Sculptra Likely to Cause Lumps if Injected in the Temples?

Question

A PS suggested this could be done to create volume in this area. But Im very thin there. Its just like under my eyes and is skin on bone. I find it hard to believe it wouldnt end up visibly lumpy. Then I watched the Sculptra dvd and it shows before and after pics featuring only the area around the mouth. The dvd even states Sculptra has only been evaluated for nasolabial wrinkles and folds. Is Sculptra effective at creating natural looking volume in the temples?

Jeffrey J. Roth, MD, FACS · Answer

Sculptra can be used effectively in this area. What you describe is a good indication for the use of Sculptra. I agree with the other doctors that it should be administered by a well trained and experienced injector. You may need a few treatments to get the desired result.

Babak Azizzadeh, MD, FACS · Answer

Sculptra is a beautiful filler to use in the temples. However, no matter where you have Sculptra injected it must be done by an expert injector - this will help avoid complications like lumps - which are completely avoidable if performed correctly.

Gerald Minniti, MD, FACS · Answer

Hello MissSpot,

	This is a similar situation you see with Botox Cosmetic.  The FDA has only evaluated Boytox Cosmetic's use for wrinkle reduction between the eyebrows where 'the elevens' exist.  However, it is commonly used it to reduce wrinkles around the eyes (crow's feet) and forehead too.  This is called 'off label use' and does not mean it is ineffective or unsafe, only that it was not evaluated by the FDA.  Sculptra Cosmetic's usage is much broader, and encompasses the entire face and temples, like it's identical sibling, Sculptra Reconstructive.

	Lumps and bumps have become a very negative and real side effect of Sculptra that is injected improperly.  That is why the company that distribute it requires that the physician has successfully completed an injection training course.

	The temple is an area where Sculptra can be injected both deep (not on the bone but under a layer called fascia) as well as under the skin successfully without lumps.

	Be sure the person you go to has had a lot of experience with the product.

	Best of luck!

Kimberly Finder, MD · Answer

Sculptra is a volume stimulator. It doesn't occupy space instantly the way a filler does. Sculptra stimulates you to make your own collagen in a gradual process over weeks and months. By doing a series of sessions we can gradually, and very naturally, turn back the clock. I love using it for temple rejuvenation. Dermatologists and other aesthetic physicians have been using Sculptra for softening hollow, sunken faces for nearly a decade and I find it to be an essential part improving the aging face. I love what Sculptra does for my patients, and for myself--I'm a Sculptra patient, too!

	The Sculptra DVD doesn't discuss using it for temple areas because of the very specific wording of FDA approval for Sculptra. But, it's important to remember that almost everything we use in medicine is used in an off-label way. Botox is only FDA-approved for frown lines between the eyebrows, yet it's used just as frequently to treat the crow's feet and forehead lines in an off-label use.

Steven F. Weiner, MD · Answer

As we age, a fat pad in the temples shrinks and makes them depressed. To fill this area, Sculptra is injected deeply in the temples, along the bone in a series of about 3 sessions. By injecting at this level, the risk of nodules is very low, and the product spreads out evenly. It creates the collagen at the periosteal layer (lining of the bone). It's a very quick and easy procedure. It cause some skin tightening around the eyes and eyelids too.

Kimberly Lee, MD · Answer

Sculptra is a great way to improve the temple region to look natural appearing. The sculptra would be injected deep under the muscle. There are ways to avoid getting a lumpy result, mainly with careful preparation, injection technique, and post-procedure massaging.

Donna Bilu Martin, MD · Answer

Sculptra is a wonderful filler for the temple area. It's very important that the injections are placed deep and that a board certified dermatologist or plastic surgeon with an extensive knowledge of facial anatomy performs the treatment. Sculptra is made of poly-L-lactic acid and is performed with a series of 2-3 treatments 6-8 weeks apart. Sculptra stimulates collagen growth and results in a natural, revolumized look. Injections in the temple are considered off label. Lumps can occur when the Sculptra is injected too superficially and if the solution is too concentrated (physicians mix the solution differently). Overall, sculptra can achieve really great results, as long as the injector is experienced with the product.

Grant Stevens, MD · Answer

Yes!  Sculptra is ideal for treating the hollowing of the temples.  Your provider should be very experienced with Sculptra if she/he is going to inject this area.  These injections are done deep and if done correctly, results are beautiful.  You will typically need 3 to 4 treatments depending on how severe your temples are.  Massaging the area as much as you can, as often as you can, after the injections will help prevent any lumps or bumps from forming.

	Good luck.

	 Dr. Grant Stevens

Emily Altman, MD · Answer

Sculptra used to cause many more lumps than it does now.  Over the last couple of years the dilution instructions for Sculptra have changed to diluting it several days before injection and increasing the volume of dilution.  That decreased the risk of lumps.

	In addition, another frequent cause of lumps include injecting Sculptra into circular muscles, such as those around the eyes or lips.

	Massage after Sculptra is essential to diminish risk of lumps.  Firm massage needs to be done immediately after injections in the doctor's office.  The patient needs to follow up with massaging for 5 minutes, 5 times a day for 5 days after Sculptra injections.

	As far as the temples are concerned, the injection in that area is fairly deep.  Adding volume to temples improves the appearance by giving the face a more heart-shaped or inverted egg shape, bringing the facial proportions closer to a youthful look.

Arnold W. Klein, MD (in memoriam) · Answer

The filler Sculptra&reg; was at one time considered an important agent in managing facial fat loss in HIV+ patients. Prior to FDA approval, it was used in a clandestine manner. In clinical trials evaluating this agent for correction of fat loss in HIV+ patients although the study patients were for the most part satisfied, up to 50% of the injected individuals developed some degree of lumpiness in the treated areas. Furthermore, these lumps were often far from invisible. Nevertheless, Sculptra&reg; received rapid track compassionate release approval from the FDA for use in patients with HIV. The panelists on the General and Plastic Surgery Device panel were strongly unanimous in limiting approval only for patients with HIV. At the FDA hearing, not one histologic slide showing the fate of Sculptra upon implantation was shown. Again, how can an agent gain approval without scientific data supporting its application. According to the European literature the consequences of Sculptra&reg; in the normal host has been very problematic (foreign body granulomas, infections, etc.) Nevertheless, the lay press, medical conferences and internet began to promote this substance for soft tissue augmentation in HIV negative patients. Although Prospective studies for the use of this agent in individuals with normal immune functioning were  completed in the United States and it was approved for such,yet we did have reports of the European experience.
	In 2000, at the World Congress of Dermatology in Paris, Pierre Andre reported cystic, nodular, and granulomatous lesions when this agent was used in individuals with normal immune functioning (non-HIV+ patients). Additionally, long-term allergic reactions have since been described, which are very difficult to manage. In another report concerning its aesthetic use in 100 patients with normal immune functioning, 20% of the treated individuals experienced significant adverse reactions. Obviously, this product is not immunologically inert as the manufacturer stated. Foreign body granulomas are being seen with this agent in HIV-positive as well as immunocompetent patients.
	While the manufacturer as well as investigators claim this product produces neocollagenesis or new collagen this is not what is seen under the microscope. On biopsy one sees a severe immune reaction to the product.Sculptra stay away

Is Sculptra Likely to Cause Lumps if Injected in the Temples?

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