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Sculptra® For Lipodystrophy
Facial Lipodystrophy
Facial Lipoatrophy, or facial fat loss, is characterized by lost volume,
resulting in a marked hollowing of the face, causing sunken cheeks,
bitemporal wasting, oral commissures, and deep nasolabial folds.
Sculptra® is approved by the FDA for restoration and/or correction of the
signs of facial fat loss (Lipoatrophy) in people with human immunodeficiency
virus.
Sculptra is a synthetic injectable material known as “poly-L-lactic
acid.” Poly-L-lactic acid is a biocompatible, biodegradable material that
has been widely used for many years in dissolvable stitches, soft tissue
implants, and other types of implants.
The FDA has approved Sculptra (New Fill) for the treatment of facial
Lipodystrophy. At the present time, Dermik Laboratories, the company which
purchased New Fill from the French inventor is charging $960 for each kit.
Patients with severe facial Lipodystrophy may need 5-7 kits to correct the
defect.
As you have probably read, Sculptra lasts for about 2 years. By the
time you add the physician's fee and the operating room fee, the cost of the
procedure is $1,360 per treatment which is beyond the budget of most of our
patients.
At the present time, there is no indication that Medicare, MediCal or
private insurance companies will cover either the product ($960) or the
physician's fee ($400), but Dermik Laboratories (maker of Sculptra) have
approved a patient assistance program. You can get additional information
about this program by calling 1-888-SCULPTRA (888-728-5787) Ext. 4, or we can provide you with the
form if you call the Foundation office at 415-255-0806 or you can fax a
request to 415-255-0799.
The most commonly observed adverse event was the delayed occurrence of
subcutaneous papules, which were confined to the injection site and were
typically palpable, asymptomatic, and non-visible. Visible nodules, with or
without inflammation or dyspigmentation, have also been reported. Other
adverse events include immediate and transient injection-related events such
as bleeding from the injection site, discomfort, erythema or inflammation,
ecchymosis, and edema.
Sculptra®
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