Why Was Sculptra Injected Directly into Bone?

Question

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.

Ron Shelton, MD · Answer

Your doctor did not inject the Sculptra into the bone! They might have injected it right above the periosteum which is a thin connective tissue layer that is tight and covers the bone. When Sculptra is injected it is not uncommon, despite its dilution, that bumps can form. Sculptra is a great volumizer but we have learned over the many years since inception, that a larger volume of dilution means less chance, but not zero, of lumps to form. A bump might be improved with the injection of saline or local anesthetic into the lump and then vigorous massage.

David Shafer, MD, FACS · Answer

Lumps from Sculptra are mainly due to injection technique and depth of injection. The injections are not into the bone, but right above the bone. Sculptra is a semi-perminent filler, meaning that it takes a long time to go away. Other fillers such as Juvederm last around a year but then need more frequent injections. Sculptra is a great product to replace lost volume in the cheeks, temporal region, nasalabial crease and along the jawline. Good luck.

William Ting, MD · Answer

Lumps were more common among early days of Sculptra when the dilution was not standardized. After few years of trials and few errors, new dilution protocol has been standardized by advanced physician injectors and Sanofi-Aventis to minimize lumps. Injection of Sculptra with the new diliution can be performed either subcutaneously or along periosteum (just above the bony structure of the face/skull). The rule of the thumb is never inject Sculptra above orbital rim, though it can be injected near orbital rim and be massaged upwards with precision by a qualified and trained board-certified dermatologist or plastic surgeon.

Lauren Greenberg, MD · Answer

Sculptra is a good filler.  When first on the market years ago, the dilution instructions and injections were done differently.  We now do many techniques which effectively help minimize lumps.
  -dilution
  -mix it in advance
  -massage 
  -spacing 6+ weeks between injections
It is important how it is injected and to what depth.  Sculptra is not injected into the bone, but in some areas it is injected just above the bone.  

Due to its technical nature, the company only sells to dermatology, facial plastics, and plastic surgeons. It is not like other fillers. Make sure your doctor is trained.

Susan Van Dyke, MD · Answer

I have never heard of Sculptra being purposefully injected into the bone. There may be a miscommunication in that Sculptra may have been injected just above the bony ridge near the eye. Once a bump forms it can take several years to resolve. Various techniques have been tried to dissolve the bumps but time is the best healer. Surgical removal is not the first choice because the problem although frustrating will eventually resolve on its own.

Chris Thiagarajah, MD · Answer

It may take a long time for the sculptra to go away. Also steroid injection may help. Finally if it is large, it may need to be excised if after a long time it is still there. When a plastic surgery procedure is done, there are certain inherent risks to the procedure. If a patient needs a further procedure it is part of the process that they must understand before the original surgery. The surgeon usually doesn't "absorb the cost" for the procedure. The original cost of the procedure is not a "global cost" that covers other further procedures in general. Medicine is not an exact science and there are no guarantees. Even in the most benign of procedures there are risks. When I was a resident we had a patient referred to us, where a surgeon performed an upper eyelid blepharoplasty and cut through the skin, the eyelid muscle and into the eyeball. The patient needed multiple eyeball surgeries to try to save the eye. The original plastic surgeon was not responsible for the costs of the eyeball procedures and further work.

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

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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