Fast facts

Sculptra


What it is: Permanent dermal filler (cosmetic injection) to restore facial fullness.


What it addresses:

Sculptra is US FDA approved for restoration or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Sculptra is used "off label" to restore facial fullness and to treat:

- Nasolabial folds
- Sunken cheeks
- Deep wrinkles
- Nose humps
- Facial creases


MORE INFORMATION
Question

Why was Sculptra injected directly into bone?

I had Sculptra injected under my eyes 6 weeks ago to plump up my sinking tear troughs. A bean size lump has developed ON the bone of my eye socket, on the edge close to my eye. It does not sound like the lumps I have read about. When I commented about the lump being IN my bone, my doc said, "Yeah, that's where I injected it." ??? Also, will it keep growing? At what point can I do something about it? What are the best "cures?" And should my doc absorb the cost? I'd appreciate information from anyone who's had a similar experience. Thank you.


Asked by: Burned
Hawaii

Answers (1)

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1
August 23, 2008

Lumps from Sculptra Common

Arnold W. Klein, MD
Arnold W. Klein, MD
Board Certified
Dermatologist

I'm sorry to hear of your experience with Sculptra, a "semi-permanent" injectable dermal filler. First of all, I should point out, and it's important to know that Sculptra was approved by the FDA in 2004 for use in individuals with HIV/AIDS related facial fat loss, which can result from the use of some medications used to treat HIV/AIDS.  Any use other than in this population is off label, which is not illegal, but this does mean that there was not sufficient evidence or proof submitted to the FDA to support general cosmetic use.

It is interesting to note that only a small percentage of Sculptra sold in the US is actually used in patients with HIV/AIDS, rather the majority of Scuptra use in the US is used off-label for general cosmetic purposes in people with healthy immune systems. It is also important to point out that a number of clinical studies of Sculptra in Europe and Canada, doctors found a large percentage of lump formation with this filler and a high incidence of foreign body reactions because it is not a biologic agent (naturally occuring) rather it is synthetic (man-made).

What you describe is unfortunately something not uncommon with Sculptra use, and it can occur long after it was injected. I realize this information is of little use to you now, however. At this point, I'm afraid that your treatment options are limited. Occasionally, we are successful in shrinking these lumps somewhat by injecting steroids directly into the lump or lesion, however, this must be done by a properly trained specialist. If this is not successful, I'm afraid that your only other option is to surgically remove the lump. This does not necessarily mean a big procedure; often I can puncture and drain the lump, but it can come back. Therefore, the only way to remove it is surgically. Again, you must be sure that you have a well-trained specialist to do this.

I wish that I could be more helpful, and I certainly wish you the very best in your treatment. The most important thing that I can offer you is that in the future, please take time to research not only your doctor, ensuring that you have someone who is well-trained and experienced, but also researching the materials that they intend to use, i.e. Sculptra. If you had done this, you would have found that this is a very common problem with Sculptra. I very seriously doubt you will get your doctor to absorb the cost of treatment, but you can always ask. Remember, an ounce of prevention is worth more than a pound of cure.

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