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Emerging Reconstruction Procedures for HIV Facial Wastings
By Nelson Vergel, powertx@aol.com
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Director, Program for Wellness Restoration, PoWeR (www.medibolics.com )
Founder of the Body Positive Wellness Clinic- Houston and www.facialwasting.org
Co-Author, "Built to Survive"
CAUTIONARY NOTE-Editorial note from Jules Levin, Executive Director/founder, NATAP: Many people with HIV have developed lipoatrophy (fat wasting) and facial wasting, and many people are turning to facial reconstruction procedures. Personally, I have concerns about the safety of these procedures. I do not feel there is adequate data on the long term safety of these procedures. There have not been adequate studies to characterize the effectiveness and safety of the procedures. A few studies have been conducted for New Fill but these studies are small and short term, they were not conducted by an independent body such as the ACTG or a major US university hospital. Due to these concerns I do not endorse or recommend these procedures. As you read through this article you will see that bad reactions can result from each and every one of these procedures. The likelihood of bad reactions has not been quantified so we are uncertain how much risk is involved in any of these procedures. Even with New Fill, there have been reports of bad reactions and problems reported by some individuals receiving the procedures. These bad experiences may be associated with the procedures being performed by poorly trained doctors. This raises another concern, besides the absence of adequate safety and efficacy data there is the concern of whether or not the practitioner or doctor performing the procedure is adequately trained. So, I urge caution in your decision to explore using any of these procedures. Please educate yourself about the potential benefits and negative consequences by speaking to your doctor and knowledgeable people, and conduct research if you are considering these procedures.
Facial wasting is rapidly becoming an important issue in the lives of those living with HIV. A person's HIV status sometimes becomes apparent just looking at their face. Self-image and self-esteem issues are now arising because if this problem. A poster was presented in the second International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV (to be called "the LIPO 2000 Conference" in this report) 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 HIV(+) people have minimized visceral fat ("protease pouch") accumulation with the use of nutritional, exercise, anabolic therapies, insulin sensitizers and switching HIV medications. However, facial wasting and the loss of subcutaneous fat (under the skin) are problems that have seen no consistent solution. Some studies have found that the loss of subcutaneous fat could be reversed modestly by switching from Zerit (Stavudine or D4T) to Abacavir (Ziagen) or Combivir combinations, but it seems that after 48 weeks the patients could not perceive a change in their appearance. After talking to investigators, all concur that although these studies show the potential reversal of this problem, the fat gains in the facial area are very slow and still not sufficient to bring the original look back in someone's face. (For more on Zerit and fat loss, visit
http://www.medibolics.com/LipoatrophyandAntiretroviralDrugChanges.htm
http://www.natap.org/2002/ICAAC/day23.htm
Out of despair and necessity, many HIV positive people are searching for reconstructive techniques that could improve their facial wasting. Cosmetic techniques like silicone injections (Silikon 1000 and SilSkin), New-Fill, Artecoll, Bio-Alcamid and others are currently being used by many people who have to spend their savings and cash life insurance policies to pay for these procedures that are usually not covered by insurance. A strong activist effort is starting to emerge.
Where are Implants Injected?
Traditionally, skin is divided into three layers, epidermis, dermis and hipodermis. The epidermis mainly is composed of cells, while the dermis contains extracellular matrix, nerves, vasculature, and adnexal structures.
Injectable soft tissue fillers generally are injected into the dermal layer. The dermal layer allows for host incorporation of the material due to the presence of fibroblasts in the extracellular matrix and vasculature. Some materials preferably are placed in the subcutaneous layer due to implant nodularity and palpability.
For simplicity's sake, I will only review the most popular options currently used in HIV facial wasting reconstruction. For all others, please visit www.facialwasting.org
Synthetic, non-biodegradable implants
Long-term effects are uncertain. Examples: liquid silicone, a base material banned in France, leads to local and systemic complications that are well known, and PMMA, HEMA or EMA microspheres (acrylic base material: Plexiglas). Silicone is banned in most countries. While infection is always a possibility with use of any of these materials, some materials have unique complications. Silicone can cause foreign body reactions and rejection of the implant for up to 20 years following implantation. Synthetic implants of any kind can produce nodularity if placed in an improper plane. The risk for developing granulomas and migration can be present even after 10 years since the application of the product. We have no long-term safety data of any synthetic implant product used in HIV positive people.
Silicone gel or oil:
Silicone injection into facial tissues was popularized in the 1960s and 1970s with the introduction of medical grade silicone (MDX 4-4011) by Dow Corning. Microdroplets of silicone are dispersed within the dermal tissues. Fibrosis around these droplets localizes the material, and it is seemingly well tolerated in small amounts in the face.
Silicone oil has many advocates among those who used it prior to Food and Drug Administration (FDA) withdrawal of approval. However, silicone, although chemically well tolerated, becomes encapsulated as a foreign body by a chronic inflammatory reaction. Giant cells surround the material and cannot process any ingested material, establishing a low-grade inflammatory nidus. Fibrous tissue surrounds and encapsulates the silicone; this capsule is avascular and is a potential site of infection. A number of late infections, granulomas, and palpable masses have been reported following silicone use. It has been observed, following injections that silicone droplets migrate into the tissues under the injection site, drawn there simply by gravity. Silicone is a frequent cause of granuloma and even of delayed allergic response. Silicone is not biodegradable and is often detected in the human liver.
Silicone injections have been used for many years in the gay community in big cities. Female impersonators and transsexuals have used it to alter their faces, buttocks, and breasts (http://www.tsroadmap.com/early/silicone.html ). Non-medical personnel in people's homes have performed the procedure. Several reports of severe reactions have been reported from this illegal and underground procedure. Many people living with HIV have obtained silicone injections in the past through non-medical persons in Miami, Los Angeles, and New York.
Silicone injections are banned in Europe. The FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles, or enlarging the breasts. It is currently being used "off-label" (see below) in the US but the FDA seems not to mind. The adverse effects of liquid silicone injections have included movement of the silicone to other parts of the body, inflammation and discoloration of surrounding tissues and the formation of granulomas (nodules of granulated, inflamed tissue). However, there is a HIV protocol soon to be launched in Canada and the US (after FDA go ahead) for the use of silicone micro- droplets (SilSkin ) . SilSkin seems to be a purer form of liquid silicone injected in very small amounts. For more information about this protocol in Canada and the US contact drichard@richard-james.com.
For more information about SilSkin and future research sites, emaildrichard@richard-james.com, or visit Dr Orentriech's (New York City) web site at http://www.orentreich.com . Dr Orentreich is one of the pioneers in the use of silicone injections and has treated over 200 patients with HIV facial wasting. The FDA is reviewing his data prior to starting SilSkin protocols in the US.
OFF LABEL SILICONE USE: Some US physicians are using a silicone product called Silikon 1000 off label for facial wasting. This product is FDA approved for use as a long-term tamponade for complex retinal detachments, but can be used legally "off-label" for facial lipoatrophy. Some of these physicians use the micro-droplet procedure already while others inject larger quantities. The number of sessions needed for micro-droplet silicone gel injections are between 4 and 8. The cost of each session averages $600 per session (some doctors charge more). Many of the physicians have not been trained by the manufacturer of the company, Richard-James. One word of caution: if the physician tells you that you will need fewer than 3 sessions, he/she is using too much silicone at once and may put you at risk of long term complications.
Microspheres of polymers.
Microspheres of polymethylmethacrylate (PMMA), hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA), with diameters in the ranges 20 µ to 40 µ or 40 to 60 µ, placed in a gelatin suspension or solution, a collagen solution or a hyaluronate gel. HEMA and EMA are not used as much anymore. PMMA has 10 years of research in humans. In addition, in some cases the vector used is once again a collagen of bovine origin (in Brazil, the vehicle used is a cellulose solution- hydroxyethylcellulose.) The desired material is an implant allowing controlled resorption. The aim would be first to find a type of implant offering a resorption period of one year in order to allow possible cosmetic adjustments. PMMA has been used successfully by Dr. Marcio Serra in Rio de Janeiro- Brazil (mserra@dermatologista.net or mserra@netfly.com.br with over 223 HIV positive patients for over 3 years. The cost for the entire procedure in Brazil is $500 (total cost for two sessions.) Dr Serra told me that he injects the implants in the subcutaneous (sub-dermal) area to avoid granuloma formation. No long-term safety data are available.
Artecoll (Artefill)
Another PMMA product that has been approved in Canada and is soon to be approved in the US for general cosmetic use is Artecoll (to be called Artefill in the US). Artecoll is the improved version of a product that had some problems in Europe. It is a permanent option that will require 3-5 sessions, depending on the severity of facial wasting. Doctors need to be very well trained since it is very difficult to remove excess product. The developer of the product is Dr Gottfried Lemperle (email glemperle@aol.com ). For more information about Artecoll and research sites in the US can be found at www.artecollusa.com . No cost information available yet.
Doctors using Artecoll in Canada for HIV lipoatrophy: Dr. Alastair Carruthers in Vancouver and Dr. Kent Remington in in Calgary, Dr. Frank Beninger, Dr. Sheldon Pollack and Dr. William Middleton in Toronto, and Dr. Jorge Schwartz in Montreal
Polylactic Acid (New Fill) - or PLA -
New-Fill (http://www.new-fill.com/Page/Anglais ) is the most talked about option so far because of the work of Dr Patrick Amard and his presentation in Toronto in 2000. There are more studies presented on this option than any other in the HIV facial wasting arena. It is a biocompatible, bioabsorbable synthetic polymer belonging to the family of aliphatic polyesters. It has been used in a range of medical and surgical applications over a number of years (rheumatology, reconstructive traumatology). It seems that it takes 3-5 sessions for moderate facial wasting, and 6-7 for severe facial wasting. Touch ups are needed after a year since it seems to dissipate faster than silicone, PMMA and polyalkylamide gel. The current average US cost of each session is in the range of $600 per session.
Dermik Laboratories, a dermatology company and a division of Aventis Pharmaceuticals Inc has acquired the rights of New-Fill¨ from Biotech Industry S.A. in Luxembourg. The community is waiting for a multi-center study soon (there are only two small protocols set up by private doctors in the US, visit www.facialwasting.org for details)
Patient report on problem they experienced after receiving New Fill:
I had parts of my face injected 1.5 years ago. About 6 weeks ago the
injection areas (naso-labial lines and frown lines) swell up and have not
gone down. I can feel big lumps underneath. Where the swelling ends, a few
pimple showed up and the area looks more pale than other parts of my face.
When I went to see a dermatologist, he gave me an antibiotic and various
lotions for the pimples. None of the medications have worked so far. He
clearly did not have an idea what it was before I told him about the
New-Fill. He told me to go to the doctor who did it (which I will do
tomorrow). He also mentioned that the doctor can give me shots of cortisone
(which is not that simple either, it can supposedly cause dents and
discoloration of the skin, etc.) or, maybe I have to have some of the
granulomas removed via surgery through the mouth. I cannot believe that
New-Fill, the harmless wonder drug is doing all this! I'm not a happy camper
right now, not anymore.
Polyalkylamide gel (Bio-Alcamid)
This product has been used in Italy for 6 years as gel type prosthesis in plastic surgery without major complications. I started hearing about it at the beginning of 2001 from patients in Los Angeles and San Diego, who were reporting great and durable results with only 1-3 sessions, so I decided to investigate it. Everyone had gone to Clinic'estetica in Tijuana to get the procedure done by Anna Love, who has been in that business for 9 years and had trained cosmetic surgeons from the US. A presentation at the European Lipodystrophy Conference in Marbella, Spain (April 2002) made by Dr. Jose Arevalo of Madrid showed good and lasting results in over 100 patients in the past 3 years. One to two sessions were needed to correct most cases. No "touch ups" are needed unless lipoatrophy continues. It seems that two of the advantages of Bio-Alcamid is that it can be removed easily if too much product is injected (just like a "pimple") and large quantities can be injected (ideal for buttocks also) without an immune response ( no long term data are available to confirm this claim). The manufacturer sent me an email to ensure that I did not confuse this product with polyacrylamide gel since they believe polyalkylimide is a lot more stable than polyacrylamide gel (there have been reports of bacterial contamination of polyacrylamide gels from Russia.) Presently, the only source of this product in North America is Anna Love at http://www.clinicestetica.com/ . Clinic'estetica has treated over 150 patients with HIV facial wasting in the past two years. The average price for a full restoration job is $4500 plus travel expenses (two to three trips). Pictures of different applications (implants in different body parts like buttocks, face, chin, nose, biceps, etc) can be found in the Italian web site http://www.bioalcamid.com/index2.htm . You can also find information at www.polymekonresearch.com and www.polymekon.it
Nuovo Sciences owns the North American rights of Bio-Alcamid. The company will soon start the FDA protocol process.
Conclusion:
The impact of facial lipoatrophy on self-image and self-esteem is devastating for the HIV surviving community. Several non-FDA approved options for lipoatrophy related facial reconstruction are emerging to deal with this problem that may be induced by HIV medications. Patients can access these products in Mexico, France, Brazil or through FDA approved IDE protocols in the US. In all instances, including US protocols, the patient has to pay amounts that exceed $4000 (some companies are trying to set up their research protocols to provide free or discounted access.) No reimbursement is currently available for these options. Furthermore, no long-term HIV specific data are available, so it is difficult to assess safety of any of these options. Current information is limited to small studies with no clinical data besides before and after pictures. Some options may require frequent touch ups and others tend to be more permanent. 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 lipodystrophy-subscribe@yahoogroups.com
Please address any comments or concerns to powertx@aol.com
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