Reconstructive Procedures for HIV-Related Lipoatrophy
(Updated March 2008)

By Nelson Vergel, BsChE, MBA

Founder, Program for Wellness Restoration, PoWeR, a 501( c ) 3 non profit educational organization


Facial wasting has become an important issue in the lives of those living with HIV. HIV status sometimes becomes apparent just by looking at someone’s face. Self-image and self-esteem issues among People living with AIDS are further exacerbated because of this daunting problem.

A poster presentation at the second International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV in Toronto September 12-15, 2000 that dealt with the issue of “erosion of self-image and self-esteem, problems in social and threats to locus control, anxiety around HIV disclosure forced by noticeable body change, and a propensity to demoralization and depression” (Collins, Abstract P36).

Some living with HIV related lipodystrophy have minimized visceral fat (“protease pouch”) accumulation with the use of nutritional, exercise, anabolic therapies and insulin sensitizers and by switching HIV medications. However, facial wasting and the loss of subcutaneous fat under the skin of the buttocks and extremities (arms and legs) are problems for which we have found no systematic solutions to treat the problem at the causative level.

Some studies that have followed up patients after they switch from protease inhibitors to non-nucleoside analogs have not found statistically significant changes in body composition. A study presented by Saint Marc, et al, and the Retrovirus Conference in Feb 2000 found that the loss of subcutaneous fat could be reversed partially by switching from Zerit (Stavudine or D4T) to Abacavir (Ziagen) or Combivir combinations. Dr. Andrew Clark from South Africa also presented a poster (Abstract P85) that showed some improvement of facial wasting after switching from Zerit to an alternative NRTI in 10 of 11 patients after 6 months. However, after discussion, all concur, that though these studies show some reversal of this problem, the fat gains in the face are very slow in coming and not sufficient to restore the original appearance of someone’s face. For more on Zerit and fat loss visit: and

Out of despair and necessity, many people living with HIV have in the last decade have been seeking reconstructive options to address wasting in their faces, buttocks and extremities. For results of a survey of over 800 people to learn about the main products and options used in the community, please visit:

Survey Results

Cosmetic products including Collagen, Fascian, Alloderm and silicone injections, along with more traditional medically reconstructive agents such as L-polylactic acid (now branded as Sculptra), polymethylmethacrylate (PMMA), and assorted poly-acrylamide type gels (BioAlcamid), Silikon 1000 and Radiesse are currently being sought out by many. The cost of these treatments are often borne by patients who have had to cash-out life insurance policies and sell property to pay for these costly procedures. Such treatments are rarely covered by insurance companies who often dismiss them as ‘cosmetic’ and not medically necessary. While California now mandates that reconstructive procedures be covered at least in part by insurance, the process of reimbursement is difficult time consuming and not patient friendly.

What products and techniques are available? Who are the providers?

In the last several years there has been a shakeout in the available products and techniques of treatments for what we now call HIV associated soft tissue wasting or lipoatrophy. Several techniques previously popular such as antilogous fat grafting and micronized injectible fascia tissue (Fascian), Teflon paste, surgical implantation of Gore-Tex and ‘hard silicone’ solid implants have fallen off the radar of HIV facial wasting reconstruction options, while new products such as Sculptra, Arterfill (PMMA), Radiesse have been approved for use by the FDA. Other “off-label” product such as Silikon 1000 microdroplet injections are also being used extensively.

The products and how they are used

Where are implants placed?

Skin is divided into layers, epidermis, dermis and hypodermis. Underneath the skin is fat and muscle which is covered by fascia. The epidermis mainly is composed of dead cells, while the dermis contains extracellular matrix, nerves, vasculature, and other structures.

Soft tissue fillers are injected into different layers of the skin and underneath it depending on their composition and properties. Fillers such as Collagen, Restyline, Radiesse, Sculptra, some PMMA compounds and microdroplets of liquid silicone oil are injected into the dermal layer, which allows for incorporation of the material by the skin.

Bio-Alcamid is injected deep under the skin in the area previously occupied by fat. Some PMMA products are injected deep under the fascia and muscle while solid silicone implants are attached directly to bone.

Key Options for facial reconstruction

Hard Silicone Solid Implants

Some plastic surgeons recommend solid cheek implants for treatment of sunken cheeks. These hard solid silicone implants are very popular and have been used extensively in the entertainment industry. The good thing is that they are permanent, safe, and give you lots of volume. Some people feel that the end result is somewhat "feminine," and in people with HIV, a real problem is that the loss of fat is so severe that the thinned skin leaves the edges of the implant visible. In Los Angeles, Dr. William Binder ( utilizes custom-designed implants using 3-dimensional computer modeling that fit perfectly in the actual deformity. Another doctor that has had good results with implants for facial lipoatrophy is Dr. Stacey Silvers in New York City. You can find more information about her work at

Sculptra (polylactic acid, old name: NewFill)

The following clip from Project inform is by far one of the best histories and descriptions available and can be found in its original at

In August 2004, the FDA approved Sculptra (a poly-L lactic acid formerly known as NewFill) for the restoration and/or correction of the signs of facial fat loss due to HIV related lipoatrophy (i.e. facial wasting). The company, Dermik Aesthetics, filed for approval based on European studies in 278 people with severe facial wasting. The majority of those studied were white men aged 41–45 years, nearly all of who were on anti-HIV therapy. People received three to six rounds of Sculptra treatment, consisting of multiple small injections, at two-week intervals. Volunteers were then monitored for two years. Roughly 40% of people studied had a significant lasting increase in the volume of tissue in their cheeks for up to two years following the series of injections. Quality of life measures (i.e. anxiety and depression surveys) also improved significantly. This is key given facial wasting is linked with depression and a reduced ability to adhere to anti-HIV regimens.

Sculptra causes scar tissue (i.e. collagen) to collect in the areas where it is injected. The amount of Sculptra injected and the method and placement of each injection can strongly impact the results. Proper training is essential to achieve the best results. It can cause very small lumps called micro nodules to form in up to 44% of people receiving it. The micro nodules are not usually visible or the source of ongoing inflammation and infection—as with other types of injectible fillers—but they can often be felt under the skin. Although most doctors use a numbing agent like lidocane when injecting Sculptra, there is usually mild to moderate pain during the injections. Sculptra can also cause tenderness, swelling and bruising at the site of injection. This typically goes away within days.The level of fullness resulting from each round of injections varies from person to person. People with more extreme facial wasting will sometimes require more than six rounds of injections to achieve lasting results. There are little data on the long-term use of Sculptra, or on its use in women and people with darker skin.

The FDA placed two conditions on Sculptra’s approval. First, the company may not encourage its use for cosmetic purposes in people not infected with HIV (e.g. to fill in wrinkles). The company also agreed to conduct an open-label study of 100 volunteers for five years to evaluate Sculptra’s long-term safety. The study will include at least 30 females and 30 people with dark skin types.

When Sculptra was owned, manufactured and distributed by its inventor, Dr. Elisabeth Laglenne, it was typically available for sale in Europe or Mexico for as little as $200 per kit (two vials). Just prior to Sculptra’s FDA approval, the buyer’s club DAAIR in New York sold it for $400 per kit. Post approval, Sculptra is now selling for about $960 per kit. Thus, Sculptra now costs more than twice as much as it did before approval. Activists have been told that its price will be increased in Europe and elsewhere accordingly. In these countries it will continue to be sold as New-Fill.

While the cost Sculptra has risen and there are also professional fees charged by the doctor for injecting it. Thanks to the efforts of HIV advocates and willingness from the manufacturer, Dermik- Aventis, a good patient assistance program has been implemented that helps patients with incomes under 80,000 dollars a year.

Note on Dermik's patient assistance program:

The direct line to the Dermik Patient Assistance Program: 866-310-7551.

Along with the application form that they will fax or send you, which your doctor has to send in to them once you've filled it out, you'll need to send them your last year's tax returns - 1040. In order to receive Sculptra free, your income cannot be above $40K - there is no low end requirement. If it's below $40K you get up to six kits (each kit contains two vials) for free - two kits at a time – that Dermik sends it directly to your Doctor.

If your income falls in the $40 - $80K range, Dermik will sell you the kits on a sliding scale; the patient is responsible for the doctor's fee for each treatment which ranges from $350 up to $500, or more depending on who you go to see.

Once you're approved for the program by Dermik, the approval is good for 18 months, after which you'd have to apply again.

Elsewhere on this site there is a sample letter for submitting to 3rd party payers. For the latest details of the Sculptra Patient Assistance Program and to find doctors in your area, go to  You can also view the form here:

Dr Doug Mest ( in Hermosa Beach, CA and Dr Gervias Frechette ( in NYC and San Francisco, are among the most experienced doctors working with Sculptra and have trained many US doctors for Dermik.  You can find a doctor in your area by typing your zip code or city in the box at the top right hand side of this page:

Comments about Sculptra:

Sculptra has shown good results in those with mild to moderate facial wasting. In those patients with more servere cases, this options turns out to be too expensive even for those helped by the patient assistance program. Mild to moderate cases require from 3-5 sessions. More severe cases require over 8 sessions. Most doctors are charging 300-600 dollars per session for injecting it. Many people get disappointed when results start wearing off and they need yearly touch-ups. But some people love it and are happy that it is not a permanent product that may have long term consequences. To read and share experiences with others subscribe to our discussion list by sending a blank email to or look at the chat room in this site:

Radiesse (formerly Radiance)

Primarily used in cosmetic and facial “rejuvenation”, Radiesse is being used more often in HIV facial reconstruction because of its FDA approval for HIV facial lipoatrophy (it is the only approved agent for this indication besides Sculptra). Their web site is Radiesse is chemically, calcium hydroxylapitate, (CaHA). Microspheres are suspended in an aqueous polysaccharide gel for the injectable version for use as a skin filler. It is manufactured by Bioform of Franksville, Wisconsin. It is not a permanent solution for facial wasting and like Sculptra, touch ups are required after a year to 18 months in most cases.

Calcium hydroxylapitate has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic implants such as cheek, jaw, cranial and chin implants (hard bony areas). Calcium hydroxylapitate creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow. The calcium hydroxylapitate microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is reabsorbed and the collagen takes place. When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, creating volume in the treatment area.

Cost to the practitioner is about $200 - $275 per 1.3 cc syringe. So with labor and markup doctors are charging $500 to $1000.00 per syringe. For HIV facial lipoatrophy, depending on the severity, it may take 10 to 20 syringes, so the might vary between $5000 and $20,000 to achieve a full correction.
However, Radiesse now has a patient assistance program( ) for people with HIV. For those with a yearly income under $40,000, the program will provide 6 syringes (per year) at a cost of $75 per syringe. This does not include the injection fee and in most cases 6 syringes does not provide enough product to achieve a full correction. It is possible to request extra syringes, but the provider must submit additional documentation. You can search a doctor here:

Silicone Microdroplets (Silikon 1000 or SilkSkin)

Silicone microdroplets, along with Arterfill (PMMA), is a permanent solution to facial wasting. It is not FDA approved for facial lipoatrophy but doctors use it legally in an “off-label” use since it was originally approved for cytomegalovirus (CMV)-related retinal detachment.

The following information is from Richard James Company, the manufacturers of SilSkin brand of liquid silicone oil.

Microdropplet liquid silicone injections build soft-tissue by encouraging the production of new collagen, the skin's natural structural protein. Silicone injections are used primarily to fill depressions such as may be seen in HIV lipoatrophy.

Microdropplets of LIS are injected into the skin at multiple points (the microdropplet serial-puncture technique) with a slender, sterile needle. Because LIS is chemically inert, it remains a liquid after injection and is not altered or changed by the body. Over a period of months, microdropplets of LIS stimulate skin cells (known as fibroblasts) to produce new collagen around each microdropplet. Once a microdropplet is surrounded, collagen production stops. Through repeated injections over several months the combination of LIS microdropplets and new collagen gradually fills depressions. Slight swelling may be seen immediately after injection, giving the appearance of instant improvement; however, this swelling subsides in several days.

At the onset of treatment, visits are usually spaced at one month intervals. Ordinarily, desired improvement is not achieved until after several visits. The number of treatments depends on the depth of the depression(s) or the degree to which a facial contour is to be enhanced. As the desired degree of soft tissue augmentation is approached, visits are scheduled at three to six month intervals, or longer. Because LIS and the collagen it stimulates are long lasting, it is important to allow sufficient time to elapse between treatments to observe the amount of soft tissue formed and thus avoid over correction. Furthermore, although LIS corrects previous loss of soft tissue, it cannot prevent future loss caused by aging, repetitive facial muscle action or progression of lipoatrophy. Maintenance injections at six to twelve month intervals may be desired to treat additional soft tissue loss as time passes.

SilSkin remains only for testing in clinical trials, but a similar formulation to SilSkin is Silikon1000 which is approved for use in the eye for treating detached retinas attacked by a virus called CMV. It is this product that is being used off label in microdroplets as a skin filler.

These are the only medically approved formulations of silicone oil and the manufacturers go to great lengths to differentiate them form older, impure and industrial grades of silicone oil. Additionally the manufacturers of SilSkin emphasis that silicone oil should only be implanted with the microdroplet procedure, where many hundreds if not thousands of micro drops are injected to create volume rather than the wholesale injection of large amounts at one time which would predispose the implant to migrate with gravity.

The cost of microdroplets varies widely and can run up to $800 per visit ( the more compassionate doctors are charging $250- $300) as the technique of applying hundreds or thousands of microdroplets is highly labor intensive. Mild to moderate facial wasting cases may require 4-6 sessions while more severe cases may require up to 20 sessions. There is no patient assistance program for this product. Several doctors around the county are using it but we do cannot find a web site that lists them. Dr Derek Jones in Los Angeles, Dr Brad Bowden in Houston, Dr Orentreich in New York City, Dr Hal Brody in Atlanta, and Dr Carruthers in Vancouver have used the product successfully for years.

Dr. Derek Jones's web site is and Dr Orentriech (New York City) web site is . Dr Carruthers’ web site is and he is available for questions and consultations via email: or phone:  Toll Free: 1-877-714-8222.  There is also a doctor in Florida using the microdroplet technique:  Barry I. Resnik, MD. Resnik - Dermatology Aventura, FL (telephone 305-692-8998)

Bio-Alcamid (poly-akylimide gel)

Manufactured in Italy, and widely available in Europe and Mexico, Bio-Alcamid was approved in Canada in 2004 for treating facial wasting. It is a permanent product with the fastest results in the market. It is not approved by the FDA (as of March 2008) but a U.S. company just acquired its rights and will proceed with the required FDA paper work to get it approved in the US.

Other polyacrylamide hydrogels (known as Aquamid) have been available in various preparations for 3 decades in different countries. Used mainly in Eastern Europe and Russia, there gels had several well documented complications including infection, migration, and release of toxic acrylamide monomers. All of these complications become aggravated over time.  For more information , read this article Bio-Alcamid Blues and this paper Late-Appearing Abscesses.

Some 7 years ago, Polymekon, the Italian company that manufacturers Bio-Alcamid, bought the rights to an existing acrylamide gel and reformulated it with the claims that the new product, Bio-Alcamid, did not release toxic acrylamide monomers, did not degrade and did not migrate. They claim that their product was not a polyacrylamide but a poly-akylamide. We are yet to find someone who can explain what the difference is between those two molecules.

The seeming safety and permanence of this product made many patients rush to Tijuana, Mexico to get a permanent solution. Bio-Alcamid has been widely used in Italy, the UK, Mexico and Canada since 2002. Best known for the use of the product was the Mexican Clinic’Estetica during the time it was led Anna Love and by Dr. Luis Casavantes as medical director.

BioAlcamid was approved in Canada in April 2006. You can visit this site for more details:

This is a report from a patient who got BioAlcamid in Canada. Look also at the links he provides at the bottom of the article:

It became apparent after a few years from reports coming from medical practices around the world including from Italy where the product was developed, that many physicians and patients were reporting higher than expected complication rates, mainly infections.

In the interview of Dr. Casavantes, who has performed more Bio-Alcamid implants than any other doctor, expressed his view that the high complication rate for these implants, perhaps 7% to 10%, stem from 2 main causes: a not-fully sterile field on the skin surface and the concomitant capture and injection, at the time of the procedure, of pathogenic skin bacteria (staphylococcus aureus, micrococcus luteus, staphylococcus epidermis and methicilin resistant staph aureus) and poor placement of the implant by not well trained practitioners.

Dr. Garza ( used to charge $80.00 per ml. But recently the manufacturers have pulled the product from the Mexican market. Dr. Garza is now employing other fillers including PMMA.

We caution patients about potential long term complications with this product. It forms a “pocket” of material that can become a perfect medium for bacteria growth if punctured.

Polymethylmethacrylate (PMMA)

PMMA has been used for many years in reconstructive medicine as a bone bonding agent because of its unique ability to form a lattice structure which encourages infiltration by osteoblasts (cells that arise from fibroblasts and which, as they mature, are associated with the production of bone) if placed in bone. In skin, PMMA also promotes fibroblast and vascular infiltration of the soft tissues it is implanted in leading to a high safety profile vis-a-vis non-vascular implants such as acrylamide gels and silicone oil. Most of the volume gained from PMMA filler is the body’s own tissues and blood vessels growing into the PMMA. And as the PMMA matrix does not dissolve like Radiesse (calcium hydroxylapitate or Sculptra L-polylactic acid, the implant is considered permanent.

PMMA is available in the United States under the trade name of Artefill ( This formulation was developed and approved after many years of clinical trials by Dr. Gottfried Lamperle, but for one indication only; filling the deep folds next to the nose called the nasio-labial fold. Unlike Sculptra and Radiesse, this product is not FDA approved for HIV-related facial lipoatrophy. The single reported complication appearing in clinical trial results of ArteFill® and its predecessor products have been a small number of tiny palpable granulomas. The clinical experience suggests that granulomas with PMMA tend to develop in thin skin areas or when the product is dermally injected in a too shallow fashion. These granulomas often respond to treatment with Kenalog 40, a powerful glucocorticod. As ArteFill® was developed and purified over several generations from the original Atreplast, the appearance of granulomas have decreased dramatically. We also have noted from the clinical experience that NewPlastic® does not seem to produce granuloma formation when grafted sub-facially in the Nacul/Casavantes technique discussed in detail below.

ArteFill® costs medical providers $2,100.00 per 1.2 ml prepackaged in a box of 2 syringes containing 0.8 and 0.4 ml of product. This kit and the professional services of the provider are often sold to the patient for $3,500 to $4,000, thus making it impractical, as a corrective for large volume tissue loss. At a cost to the patient of $3,500 for the treatment, the per ml price comes to $2,917. Common in the faces of people with HIV tissue loss, are deficits which can require from 30 ml to 40 ml of filler. A face requiring 30 to 40 ml of Arte-Fill® would cost from $87,510 to $116,680. This calculation leaves aside the issue of the labor involved in administering the contents of 35 kits with 70 small syringes necessary for such a procedure.

The only reported problem with PMMA in the trials was the development of granulomas in thin skin areas; a concern of some significance to HIV positive men and especially women suffering with the depletion of fat in the skin. Many patients are attracted to PMMA because of its permanence and lack of ‘touch-ups’ necessary with the temporary or long lasting implants. Some patients also report small bumps that may be smoothed out by follow-up work.
Brazilian esthetic medicine doctors and dermatologists have been using PMMA as a treatment for HIV associated soft tissue wasting for the better part of a decade, virtually from the start of the identification of lipodystrophy syndrome.

Dr. Márcio Serra ( has been in practice for almost two decades and has become well known as a major provider of PMMA soft tissue augmentation and reconstruction threrapies in Brazil. Dr. Serra has treated a great many HIV positive patients and had worked with HIV skin pathologies virtually from the start of the epidemic. Dr. Serra is a consultant to the Brazilian government on HIV lipoatrophy and has trained dermatologists and plastic surgeons treating HIV lipoatrophy throughout Brazil.

Dr. Serra began using a compounded PMMA in the trials he ran for the Brazilian government, treating HIV positive patients needing facial wasting corrections almost 10 years ago.

Perhaps the most remarkable work Dr. Serra has done was the study culminating in a law providing free facial wasting treatments for patients in public hospitals. Your author can’t help but cringe at the thought of how difficult and expensive it is to get any treatment for HIV lipoatrophy in the United States, while in Brazil, thanks to Dr. Serra, medical care of this sort is given freely to those who need it.

Since September/October of 2007, ANVISA, the Brazilian health authority has outlawed the compounding of PMMA products. Since that time, there have been only two legally available PMMA products in Brazil, Metacrill® and NewPlastic® and since then Dr. Serra has switched over to Metacrill® which he has informed us is double the price of the older compounded product he had used. He accounts his price increases to this issue as well as the weakness of the US dollar.

From the photographs on his web site and from reports from patients, Dr Serra apparently uses a cross thatching technique with subcutaneous injections only utilizing conventional needles.

We were unable to trace any reported complications or adverse reactions from Dr. Serra’s approach or PMMA products. However the clinical and preclinical research of Dr. Gottfried Lemperle, an expert on PMMA formulations and professor at the Universityof California in San Diego, suggests that there are greater incidents of palpable nodules and granulomas when PMMA is injected too superficially. One correspondent, a physician from Miami has reported minor and non-troublesome granulomas as a result of treatment with the subcutaneous approach. In general, people on who have traveled to Rio de Janeiro to use his services are generally pleased with the results.

NewPlastic®, was developed in Porto Alegra, Brazil by Dr. Almir M. Nacul. Dr. Nacul is in clinical practice and is recognized as the inventor of Bioplasty (soft tissue augmentation with fillers) and has authored a medical textbook and many articles on soft tissue augmentation with PMMA. NewPlastic is the commercial name for a series of PMMA, products with microspheres of 40 to 60 microns, in different concentrations. These products are currently available as 2%, 10% and 30% concentrations of PMMA in a vehicle of 98% 90% and 70% methylcellulose, respectively. Dr. Nacul is also developing a 40-45% concentration for specific reconstructive applications where a denser implant is desired. NewPlastic® is approved and registered throughout South America and in Mexico in North America.

Dr. Nacul’s practice is more expensive then Dr. Serra’s and does not focus on HIV. He has made his reputation for developing the “Brazilian Butt Lift Bioplasty” technique for butt enhancement with PMMA delivered via micro-canula and a specially engineered hand piece which meters out PMMA very precisely. Dr Nacul is closely collaborating with Dr. Luis Casavantes of Tijuana, Mexico ( in bringing his micro-canula technique to North America.

Dr. Casavantes practice is primarily an HIV facial wasting treatment clinic and dermatologic pathology practice. Dr. Casavantes uses a number of technologies adapted and expanded from the work of Dr. Almir Nacul’s Bioplasty. Employing rounded microcanulas to replace conventional sharp needles with a metered implantation device. The “PMMA Grafting Technique” (PGT) is touted as “a breakthrough in patient comfort and reduced trauma”.
PGT avoids sharp needles and the damage they can cause when used in areas dense with nerves and blood vessels as the face. The round tipped microcanula easily travels under the skin and fascia with little resistance and cannot damage vascular and nerve bundle structures as needles do.

PGT uses only 2 to 3 entry points per side as opposed to the 50 or more injections used with conventional needle techniques with accompanying reductions in trauma and bleeding and virtually zero bruising. Plavix and other blood thinners are not contraindicated by PTG.

Dr. Casavantes as of this writing charges $140.00 per ml for facial reconstruction. Patients need to add the cost of air fare to San Diego, meals and taxis to the clinic. We estimate these ancillary costs come to $ 80.00 in addition to treatment fees. Treatment with the Casavantes PGT usually takes 2 to 3 sessions. For patients on a limited income, Dr Casavantes offers a patient assistance program with significantly reduced costs. Click on the assistance tab on Dr. Casavantes’ medical information site: .

Dr. Casavantes has posted a video of the microcanula procedure on line.

Reimbursement Issues

A few insurers and HMO systems in the US are starting to pay for Sculptra and/pr Radiesse (Kaiser Permanente in No CA and others). If you need to negotiate with your insurance company to get them to pay for product and/or labor , you may want to use this letter:


Insurance Co Name

Insurance Co Address

Patient Name

Subscriber #


To Whom It May Concern:

This letter is written in regards to the medical necessity of restorative treatment for the facial deformities this patient suffers from secondary to HIV-Associated Lipoatrophy. Facial fat loss is the most devastating aspect of this condition as it can not be disguised by clothing or other means. Although the exact underlying mechanism of HIV-Associated Lipoatrophy is unknown (1), the devastating effects of this condition are known (2,3). Patients suffering from this condition are at an increased risk of depression, socially withdrawn and potentially suicidal. Furthermore, patients have even stopped their life saving HAART therapy without consultation with their physician in an attempt to stop this side effect. The implications for viral mutations, increasing viral load and worsening of patients underlying condition requiring more expensive treatments cannot be stressed enough. Treatment of HIV-Associated Lipoatrophy with Sculptra (Poly-L-Lactic Acid) has been shown to improve anxiety and depression scores (4) as well as improve patient’s quality of life as measured by visual analogue scale (5). The use of Sculptra is clearly indicated as a reconstructive procedure; that is, repair of abnormal facial structure caused by HIV or its treatment, in order to create a normal appearance.

The safety and efficacy of Sculptra in restoring the normal facial contours of patients suffering from HIV-Associated Facial Lipoatrophy has been evaluated by the US FDA (6). Based on the available scientific evidence (4,5), the FDA granted approval of Sculptra as a restorative medical device for the specific indication of HIV-Associated Facial Lipoatrophy in August 2004.

For your information. the ICD9 diagnosis code for lipodystrophy is 272.6. HIV-related lipodystrophy syndrome consists of lipo-hypertrophy (fat accumulation in the visceral area and dorsocervical pad) and lipoatrophy (subcutaneous fat loss in the face, extremities and buttocks).

Due to the medical necessity of this treatment and the availability of a safe and effective treatment option, pre-approval is hereby requested for treatment of this patient's HIV-Associated Facial Lipoatrophy with Sculptra.

As this approval is relatively recent, I would be happy to further educate your company on this issue in any way that you might deem helpful. Please feel free to contact me at the above office with any questions you may have.



1) Montessori, V. CMAJ. 2004;170:229-238.

2) James J, Carruthers, A. Dermatol Surg. 2002;28:979-986.

3) Martinez, E. Drug Saf. 2001;24:157-166.

4) Moyle, GJ. HIV Medicine. 2004;5:82-87.

5) Valantin, M. AIDS. 2003;17:2471-2477.

6) FDA Scientific Advisory Panel 3/25/2004 Washington DC


The impact of facial lipoatrophy on self-image and self-esteem has been devastating for the entire community of people living with HIV.

Some treatments for HIV related soft tissue wasting have emerged. Patients now have access to various products and services in the US but many more permanent and cost effective options are available in Canada, Mexico, Europe and Brazil.

Some options may require frequent touch ups, some are long term and others are permanent.

In all instances, including US approved treatments; the patient has to pay amounts that range from two thousand to eight thousand dollars while at the same time little to no reimbursement is currently available for some of these treatments.

There are limited long-term HIV specific data available, so it is difficult to assess long term safety. Current information is limited to small studies with no clinical data other than before and after pictures.

A comprehensive and effective advocacy campaign is needed from the HIV community to stress all important issues at the FDA level for safe protocols and access to those who may want to make an informed decision based on risks and benefits. Additional advocacy in the area of reimbursement is also needed since these are corrective measures that treat a drug induced side effect, and like any other side effect corrective measures available, it should be reimbursed by third party payers. Hopefully, we will see a lot of activity on this issue in the near future.

For up-to-date information, join our free lipodystrophy discussion group by sending an email to pozhealth at

A great article to read besides the information provided below is :

For a list of providers and results of our lipodystrophy survey, visit our next page:

Other resources to read:

Address comments or concerns to Nelson Vergel at

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