|Figure 1 (left) and Figure 2 (right). Before and after New-Fill application in a patient with severe facial atrophy.|
As a physician engrossed in HIV treatment and often exploring new treatments, work has taken me to places outside the United States over the years. Sometimes these travels have been to very unlikely places. In 1994 for example, I made several trips to Kiev to collaborate with the State University of Ukraine. We attempted immune system regeneration by an investigational project to infuse fetal stem cells into many of our patients (in Kiev). Some of our patients gladly participated in this venture at that time. This was before protease inhibitors were available and fetal stem cell research for HIV infection was not available in the U.S. at that time. Recently, my interest in new treatments led me to Tijuana, Mexico. I traveled past the southern U.S. border to investigate, and be trained in, the use of a new treatment for facial wasting.
New-Fill is the product name for the polylactic acid treatment. I first became interested in New-Fill after attending the 2nd International Workshop on Adverse Reactions and Lipodystrophy in HIV conference held in Toronto in September of 2000. I spoke with Patrick Amard, M.D., a plastic surgeon from France, who presented his results of using polylactic acid injections for facial wasting.
|Figure 3. Side profile of a patient with facial drawings outlining areas of needed filling, prior to procedure.|
New-Fill was approved for use in Europe in November 1999 and in Mexico during June of 2000. Polylactic acid is a synthetic polymer polyester chemical; it is immunologically inactive, biocompatible and absorbable. This product has undergone many toxicology studies and is currently being sold as New-Fill in France and Mexico. Demand for New-Fill is increasing rapidly, because of its versatility. The mechanism of action of New-Fill is to stimulate collagen production as the filling agent. A U.S. based pharmaceutical company is rumored to be in negotiations to acquire the distributorship in the United States and a study is being undertaken at a Texas university for cosmetic application for healthy (non-HIV-positive) individuals.
Tijuana is the home of plastic surgeon Jorge Tagle. I landed in San Diego, then took a cab to the border, crossed over by foot into Mexico, and taxied to Hospitale del Prado, the location of Dr. Jorge Tagle's clinic. Dr. Tagle seemed down to earth and an easy-going friendly person who enjoys many of the good things in life, such as golf and a good beef steak. But on further acquaintance, Dr. Tagle, or Jorge as I call him, is quite a unique person. He studied medicine at the Universidad Autonoma de Guadalajara (Autonomous University of Guadalajara), a school that many Americans have also graduated from. He started residency in plastic surgery in Mexico City, in a program that emphasized reconstructive surgery for burns and other injuries. Jorge, more interested in cosmetics, moved to Madrid, Spain to study and train in his chosen field. After completing four years in Madrid, Dr. Tagle enrolled in a special program to attain an International Masters Degree in plastic surgery. This unique degree allows him to practice plastic surgery in almost any country of Europe. Moreover, Jorge teaches in many European countries and maintains a plastic surgery practice in Madrid, for which he travels to from Tijuana three times, yearly.
Jorge's office is pleasing. There I met another physician, Dr. Pedro Cervantes, who serves as an anesthesiologist and surgical assistant for Dr. Tagle. The afternoon was spent with both physicians discussing polylactic acid and other plastic surgery methodology for HIV-positive patients who have facial wasting and lipodystrophy. We talked some in Spanish and some in English. Being fluent in Spanish came in handy (I had spent a few years in Mexico during my student days). It was obviously easier for Dr. Tagle to explain in his native Spanish his technique and passion for the work. He passionately described the technique that he employs with this particular product as being different than other plastic surgery products. Jorge has extensive experience in facial cosmetic surgery and now with HIV-associated facial atrophy. Also, the method of instillation of New-Fill has been modified for HIV-associated facial wasting and then perfected by Jorge, based on results he observed using different techniques.
|Figure 4. Local anesthesia with nerve block applied by Dr. Pedro Cervantes.|
On Saturday morning, Dr. Cervantes, who lives a hop from my hotel in San Diego, picked me up for an early breakfast. We then proceeded to the clinic in Tijuana, where we met with several HIV-positive American patients from New York, Baltimore, San Diego and Hawaii. All of these individuals had severe facial lipodystrophy, or facial wasting. In addition, two plastic surgeons from California were also on hand for training.
From about 10 in the morning till 3 p.m., six patients were brought in, one at a time. Lunch never happened. Each patient was examined for facial wasting and then had their faces drawn on with magic markers by a surgeon (see figures 1 and 3). The face is divided up into several quadrants and each area is given special attention. The purpose of drawing on the surface of the face is to mark places where New-Fill is applied. Emphasis in areas of deeper deficiency is also made. Areas that need filling are marked carefully with the anticipation of what that individual's normal facial contour should be. If the pre-surgical drawings are not accurately performed, the final outcome of the treatment can be jeopardized. Therefore, the surgeon must give proper attention to detail while envisioning the outcome.
|Figure 5. New-Fill being applied into facial wasted areas.|
Patients then had ice applied to their face for five minutes. This procedure helps the anesthesia, while causing vasoconstriction (blood vessel shrinking) so that bleeding is minimized. Following this step, Dr. Cervantes proceeded to skillfully apply nerve-block anesthesia and other smaller injections of xyloacaine to the facial areas (see figure 4) of each patient. Care to the individual anatomy of the face is important so that blood vessels are avoided with each injection. None of the patients experienced bleeding problems, nor complained of being uncomfortable during the procedure.
Finally, Dr. Jorge Tagle is ready to perform his magic. Unlike other products or other surgeons' practices, Dr. Tagle applies the polylactic acid in three different planes using needle injections. In fact, he goes deep to the periosteum (above the bones of the face). He starts with a method called tunneling under the skin (see figures 5 and 6) and covers the entire area of facial wasting in each individual. Dr. Tagle is careful to note that in each HIV-positive patient with lipodystrophy, the abnormalities are not always symmetric. Often one side of the face is worse or different than the other (see figure 1). Eventually Jorge proceeds to the second and third deeper planes to instill the product. Only a total of three cc's is administered to each side of the face. With such small amounts, Jorge needs to apportion the product to the various parts of the face, so as to derive at the most benefit for each patient. Patients did not show any discomfort during the procedures, nor were there any complications. All the patients were happy with the results, and I thought their appearance was dramatically improved. However, as in any surgical procedure, bruising, bleeding and infection are always possible side effects.
|Figure 6. Dr. Tagle applying New-Fill with the "tunneling" technique under the skin surface.|
Some of the patients have had similar procedures done by other surgeons; some with failed outcomes. This is often not necessarily due to poor surgical skill, nor faulty product. These procedures require the surgeon to be experienced with the application of various products and to use them based on their track record for specific problems. Different products are useful for specific treatment situations.
I think it's important to note that patients need to feel at ease with their doctor or surgeon. These physicians exercised patience and compassion with each of the patients present during my visit.
Physicians performing the procedure should have extensive experience in facial cosmetic surgery. A medical doctor not fully trained or adept at facial plastic surgery can potentially cause harm or the results may not be the most optimal. I believe it is questionable whether an internal medicine or infectious disease physician can use facial reconstruction techniques, having not been trained in such. An internist doing the procedure, not fully trained, might apply the product under the skin only. This superficial application restricts the potential benefit and durability of effect. It appears useful for plastic surgeons to educate themselves regarding the product itself and the techniques used with New-Fill, developed by Dr. Tagle, Dr. Amard and others.
|Figures 7 (left) and 8 (right). Figures 2, 7 and 8 demontstrate the change in three individuals' appearance immediately following the procedure.|
For the procedure to be successful it is suggested to have New-Fill applied a total of three times (for most patients with HIV-associated lipoatrophy of the face). There should be 3-5 weeks between each treatment. The first treatment establishes a base of treatment. Subsequent applications are done to continue the stimulation of further collagen production. The durability of the treatment is expected to be approximately 12 to 18 months. Dr. Tagle has seen patients one year post-treatment and notes that with his technique the effects are still holding.
Many attempts have been made to help HIV-positive individuals with the disfiguring manifestations of HIV. It is not the purpose of this article to list or discuss alternative surgical therapies. While not all patients on HAART (antiviral therapy) develop facial complications, for the significant numbers of persons with facial atrophy, a new treatment, albeit surgically based, can be applied. Patients should have the right to seek this option, if they so desire. However, Patients should also be wary of medical doctors willing to apply the treatment without the proper surgical training and skill. Additionally, DAAIR (Direct AIDS Alternative Information Resources), a New York-based buyers club, is committed to assist patients through attaining New-Fill product, while responsibly advising on its use (www.daair.org).
I have been impressed with the treatment. We are formulating a program at NorthStar Healthcare in Chicago. In time, the use of this not-yet-licensed product in the United States may become more widespread. HIV-related research has led me into some personal research projects and controversial investigations. I continue to conduct many clinical trials for antiviral drugs, immune system response modifiers, and alternative treatment with less conventional agents. Now we are probing into the mechanical application of a polylactic acid product. If treatment with this product is successful, it will improve the morale, quality of life and sense of well-being for many HIV-positive individuals affected by HIV-related facial lipodystrophy. I welcome further inquiries and comments.
Daniel S. Berger, M.D. is Medical Director of NorthStar Healthcare and Clinical Assistant Professor of Medicine at the University of Illinois at Chicago and editor of AIDSInfosource (www.aidsinfosource.com). He also serves as medical consultant and columnist of Positively Aware. For further inquiries, Dr. Berger can be reached at DSBergerMD@aol.com or 1-773-296-2400.
|Where to Go|
DAAIR has compiled a list of plastic surgeons now using New-Fill. Prices do not include the cost of New-Fill unless indicated. One kit of two vials of New-Fill currently costs $250.00 plus shipping charges. Each administration usually takes one kit (two vials). The estimated number of kits needed to restore normal appearance varies from two to six kits, depending on severity. Call toll-free 1-888-951-5433. -- Enid Vázquez