December 9, 2010
I attended the second International Congress on Bioplasty in Guadalajara last week. Here is the program in Spanish: www.bioplastia.org.mx/es/programa.php.
Cosmetic and dermatology physicians from Mexico, Spain, Argentina, Brazil, and Colombia came to share experiences on the use of PMMA (polymethylacrylate) to treat HIV related facial and buttock lipoatrophy and other non HIV related physical abnormalities.
Bioplasty is a technique of inyectable implantation done under local anesthesia for facial and buttock lipoatrophy and for reshaping other body parts. The product usually used is PMMA (polymethylmethacrylate microspheres) and it is usually (but not always) injected using a micro-canula (gun like device that enables faster and smooth dispersion of the product under the skin). Two brands used overseas are Metacryl and Newplastic. In the States, Artefill is the only PMMA based product approved (for cosmetic use, not lipoatrophy).
It was confusing for me to find out that Bioplasty really is a brand name for the specific use of NewPlastic which was created by Dr Nagul in Brazil (he wrote a book on the procedure and trains doctors in Porto Alegre, Brazil). But Bioplastic is only one of the several PMMA options available worldwide but it seems to be spreading fast around the world. More on Bioplasty here: www.bioplastia.med.br/bioplasty.htm.
I presented the current status of facial lipoatrophy solutions in the United States and the challenges we still face with access and the lack of an economical permanent solution to facial and buttock lipoatrophy. I presented the results of the 1500 people survey that people subscribed to my pozhealth yahoo group (http://health.groups.yahoo.com/group/PozHealth/) helped me gather about the impact on lipodystrophy on quality of life. They were surprised that almost half of the respondents with lipoatrophy have not done anything to treat it and that 25 percent of respondents had suicidal thoughts in the past due to body changes (http://bit.ly/fg4ODN).
Dr Luis Casavantes reviewed the different options available for facial and buttock lipoatrophy. Dr Gottfried Lemperle from the US reviewed management techniques for potential complications like granulomas. Dr Marcio Serra from Brazil reviewed his experiences during the past 12 years of work. He and colleges from Brazil also described their national free assistance program for people with facial lipotrophy. Physicians in Mexico want to use Brazil's model to provide economical access to patients in Mexico with facial wasting.
The most interesting part of the conference for me was the 3 hours in which all of us got to watch 5 doctors apply PMMA (Metacryl or NewPlastic) to patients in the operating room from a giant screen. Some use a gun-like canula to inject the product and others using insulin syringes. It was great for me to see the different techniques in person. It was a true eye opener for me!
I was impressed with the work on Dr Suzana Barreto from Sao Paulo, Brazil. She does a MRI on patients before she injects them with PMMA and a few months later to see how the implant behaves in people. She showed great slides on MRI results of the face and buttocks. She also compared MRIs done in patients that have had silicone injected to show how silicone migrates and shifts in tissue. I would love for her to present in the United States since I had never seen anyone who has MRI data on patients with any injectable implants.
It amazes me that in the US we are so far behind of all of these countries when it comes to dealing with facial and buttock lipoatrophy in a permanent way. As I said before, the PMMA product in the US is Artefill, which is not approved for HIV lipoatrophy (only for cosmetic purposes- wrinkles, etc) and was priced horribly high for it to be cost effective for us in HIV. Luckily, its patent expires next year, which will open the door for Brazilians to bring their cheaper option to the US. I had a meeting with a few doctors to discuss how feasible it would be to do a study in the United States in 2011 so that we HIV+ patients can have access to a more cost effective permanent correction.
The two options approved by the FDA (Sculptra and Radiesse) are non permanent and not cost effective for those with more advanced facial lipoatrophy. They both require yearly touch ups in most patients. Currently, Medicare pays for both but the reimbursement amounts are too low to entice doctors to use it for HIV patients. Both products have patient assistance programs that are decreasing in scope with time.
The other two products that can be used in the US for facial lipoatrophy but that are not approved for that use are Silicone 1000 micro droplets and Artefill, and both are permanent. Neither gets reimbursed and there are no patient assistance programs for them. It would be interesting to see an economic analysis of the total cost for each for a facial wasting grade 2-4 in a 5 year period. I would not be surprised that permanent solutions will be cheaper in the long run for some patients.
We have a lot of activist work to do to try to get something permanent approved for lipoatrophy that is not outrageously expensive and that has a good patient assistance program for those with no insurance (ADAP patients). Most people with facial lipoatrophy still have no access to treatments for that condition. Let's see what happens in the long run with Medicare and insurance rates for the two FDA approved options we have now. Unless something changes with a petition from the community, Medicare approval may actually hurt us more now since both companies are already reducing their patient assistance programs considerably after they assumed that Medicare would pick up a lot of the patients in their programs. If Medicare does not reimburse doctors properly, we will actually lose ground in this field. Tim Murphy from POZ is writing an article on this problem after he interviewed a few doctors who are having problems with Medicare right now.
I am encouraging companies from other countries that have cheaper PMMA to start studies on facial and buttock lipoatrophy in the US soon to get ready for the time when the patent of the expensive Artefill expires next year.
I will try to post some videos I took of several presentations from the conference. I am still traveling a lot and have not had much time to download and process them.
From www.FacialWasting.org (collaboration with Al Benson)
The use of PMMA for medical uses dates to 1936 in as a bone cement. PMMA has presented a good degree of bio-compatibility and as a result it has been extensively used as a soft tissue filler, bone cement, component of denture materials and tooth bond, housing for pacemakers and intra-ocular and contact lenses. The material itself was chemically synthesized in 1904.
Dr. Gottfried Lemperle developed the concept of using PMMA micro-spheres for tissue augmentation in Germany in 1989. PMMA has been available in Germany since as sub-dermal injections used to reduce wrinkles, scars and for certain larger soft tissue deficits.
PMMA as a tissue filler was first introduced to Europe in 1991 as Arteplast and marketed as a non absorbable injected material. It was composed of microspheres suspended in a gelatin solution. It was observed that the gelatin material was reabsorbed and replaced by native collagen. Not fully recognized at the time was that PMMA itself was stimulating the deposition of new healthy collagen around the individual microspheres without causing fibrotic reactions seen in the implant of foreign materials such as siloxane. Arteplast has since been superseded by newer generations of PMMA of greater consistency in granule size and surface smoothness. Dr Lemperle said: "because of the extensive fibrous network associated with PMMA related granulomas, intralesional corticosteroid injections are considered the best treatment. We saw an Arteplast® granuloma develop as late as 10 years after injection, which responded well to high doses of local steroids and a pulse light therapy. After sieving and washing, the second generation Artecoll in Europe caused a significant lower number of foreign body granuloma."
There are several PMMA injectable products available. Among the approved and registered PMMA based products are Artecoll and Artesense®, manufactured in Holland and approved in Mexico and Canada since 1998. Both are formulated with 20% PMMA in a vehicle composed of 79.7% bovine collagen and 0.3% lidocaine. Metracryl and BioPlastic are two other PMMA products widely used in Mexico, Brazil, Argentina and Europe.
Published safety and efficacy studies of PMMA in the United States done for FDA review dealt with PMMA use for the cosmetic correction of nasolabial deficits and concluded that "PMMA is the first soft tissue filler that demonstrates continued improvement and persistence of correction over a 5-year period post-treatment." PMMA is now manufactured in the United States and was approved by the FDA in October 2006; marketed as ArteFill® (a new formulation of Artecoll), a compound of 20% PMMA in 80% bovine collagen and a small amount of lidocaine.
However, Artefill is extremely expensive for facial or buttock lipoatrophy correction. ArteFill® costs medical providers $720.00 per ml prepackaged in a box containing 4 syringes of 0.8 ml of product. The professional services of the provider are often sold to the patient for double the cost of the product, thus making it impractical as a corrective for large volume tissue loss. Calculations for the cost-of-treatment climbs astronomically since quite common in the faces or buttocks of people with HIV tissue loss are deficits which can require from 30 ml to 400 ml of filler to correct. A severely atrophied buttock requiring 300 to 400 ml of ArteFill® would cost in the range of $200,000 to $300,000.
Dr Lemperle has shown that the reported complication appearing in clinical trial results of Arte-Fill has been a small number of tiny palpable nodules. The clinical experience suggests that nodules tend to develop in thin skin areas or when the product is dermally injected in a too superficial manner. These nodules often respond to treatment with Kenalog 40, a cortico-steroid and in many cases also spontaneously remiss. ArteFill® was developed and purified over several generations from the original Arteplast, the appearance of granuloma have decreased dramatically after the micro sphere surface was cleaned up of any imperfections that may have caused macrophages to attack them as foreign objects.
Dr. Luis Casavantes said that based on his experience in the past 5 years of experience with NewPlastic, a PMMA product produced in Brazil and widely used in Mexico and worldwide, does not appear to produce either palpable nodules or true foreign body granuloma, when grafted underneath the muscle fascia. NewPlastic seems to be a lot cheaper than Artefill. A moderate to severe facial lipoatrophy correction would cost from 2500 to 3500 depending on the volume needed. Buttocks require a lot more volume, with costs running from $4000 to $8000 depending on the severity of wasting. Of course, no one knows how much this product would cost in the US if it gets studied and approved here.