Buttock Wasting in HIV:

 

A report on treating an under-addressed medical problem

 

by Albert Benson

 

Background

 

Physicians traditionally have not given much credence to patient complaints about the loss of gluteal tissues. Such concerns have been chalked up to vanity, while the undeniable loss of tissue was attributed to natural processes of aging. It also canŪt be denied that discussions of the anatomical region itself are often avoided.

 

With the arrival of HIV, we have seen two separate and distinct waves of patient concern with the loss of normal tissues in the buttocks.

 

Prior to the advent of treatment with anti-viral drugs and anabolic hormones, we saw in the United States and Western Europe, HIV positive patients present with generalized muscle wasting. This wasting affects the skeletal muscles including the large skeletal muscles that form the buttocks and attach to the back of the legs; the gluteus maximus, gluteus medius and the gluteus minimus.

 

fig 1a gluteus maximus fig 1b gluteus medius fig 1c gluteus minimus

 

With anti-viral treatment came a second syndrome caused by metabolic disruptions from certain classes of HIV medications, centrally the thymidine analogues stavudine and zidovudine (d4T and AZT). This new wasting of normal fat under the skin was termed lipoatrophy. The use of stavudine and zidovudine was ubiquitous in the early days of the epidemic as there were few medication options available.

 

Key to understanding this issue is that in addition to the psycho-social disruptions of self image and personal confidence inherent in watching oneŪs body decay, buttock wasting is a physiological issue that affects functional capacity and causes debilitating pain.

 

Studies have found that subcutaneous (under the skin) fat can return, but only in small measure, and only very slowly after patients switch their medications from stavudine and zidovudine to abacavir (Ziagen) or tenofovir (Viread, Truvada), although by-in-large, these patients do not regain the normal fat they had prior to starting the thymidine analogs.

 

Many patients with HIV-related buttock wasting describe pain and difficulty in sitting down for extended periods of time during their everyday activities. Some have improvised by wearing padded underwear or carrying a pillow with them to sustain a little relief from the discomfort. This has proved to be a limited answer as patients were still compressing delicate skin and nerves against bone in a physiologically abnormal manner, every time they sit or lay down. In all practical reality, it is virtually impossible to live free of pain with wasting of the buttocks. Many simply sit directly without any padding to protect that area, and suffer.

 

Resourceful patients have tried to reverse their gluteal wasting with resistance exercise focused on the buttocks (squats, lunges, dead-lifts), in conjunction with the available legal anabolic therapies (testosterone, nandrolone, oxandrolone, oxymetholone and stanazonol). While anabolic hormones have prevented the worst ravages of muscle wasting, these compounds work best if they are accompanied by vigorous resistance exercise. Unfortunately, most physicians in HIV medicine have not prescribed nor stressed the importance of vigorous resistance exercise when prescribing anabolic hormones, and so the problem of loss of muscle tissues, especially, the tissues of the buttocks, has remained.

 

 

Anabolic steroids with exercise have been proven (Bashin, Sattler) to definitely increase lean body mass, but cannot restore the fat that provides necessary padding and gives the rounded appearance and physiological functionality of normal buttocks. In fact, they can increase fat loss in extremities and the buttocks.

 

This article will review the basic issues and available solutions with their side effects and complications, as gleaned from the collective experience of those actually dealing with them in their daily lives, and as reported and discussed on the largest Internet discussion group about living healthily with HIV: (pozhealth@yahoogroups.com).

 

Buttocks

 

Buttocks are a uniquely human feature. No other mammal has such large deposits of adipose tissue in the buttocks. The loss of these physiologically critical fat tissues in addition to HIV muscle wasting in the extremities and the buttocks have caused a host of new dilemmas for HIV patients and their physicians.

 

Chief among the new problems documented are, localized debilitating pain on sitting (tendonopathy and myo-fascial pain), pain on lying in bed, impaired walking, neuropathy and loss of sensation or pain from the legs, backache, sciatica, and bursitis; there are also reports of neurological impairment both associated with and without pain.

 

Under recognized and devaluated are the accompanying psycho-social problems associated with the pain and stigma of personal disfigurement caused by the double insult of gluteal muscle wasting combined with gluteal lipoatrophy.

 

fig 2a lipoatrophy without myoatrophy fig 2b and 2c combined and severe lipoatrophy and myoatrophy

 

Patients have reported a desire to halt antiretroviral treatment in order to reverse the effects of these syndromes. Some have actually done so despite medical advice, hiding their actions from their doctors. Unfortunately, such a strategy does not work. Studies show that reversing these symptoms by this route is impractically slow if even possible. Further, non-compliance with antiviral regimens or delays in starting treatment or substituting herbs and vitamins for HIV medications brings with it an entire spectrum of classic, pre-HAART, HIV complications, and a much increased burden on the healthcare system. In the broad picture, and in terms of the quality of life improvements possible for patients, treating these twin syndromes makes good medical and financial sense.

 

Treatments and Complications

 

Initial efforts to treat tissue loss in the buttocks consisted of techniques taken from cosmetic applications, specifically techniques used by physicians and others in addressing the needs of transgendered persons.

 

It is for this reason that insurance companies have denied coverage for these treatments with the claim that buttock restoration is purely cosmetic. We intend this report to lay the groundwork for a legitimate medical discussion of buttock wasting. We seek to provide the information for challenging insurance companiesŪ denials of coverage and establishing buttock wasting as a legitimate medical problem and its correction as a legitimate medical treatment.

 

Solid Silicone Surgical Implants

 

Solid silicone surgical implants have long been used in the United States and other countries to add contour and volume to patients seeking feminine characteristics in the buttocks and elsewhere. Most of these patients had no underlying pathology attenuating the adjacent tissues and most had a degree of initial cosmetic success. However over time the tendency of these implant to migrate was visually evident, and the resultant unintended pressures on nerves and vascular structures often caused complications necessitating removal of the implant.

 

As described by bodybuildingimplants.com the web site of a surgical center specializing in gluteal and other solid silicone implant surgeries:

 

žGluteal or buttock implants are inserted usually under general anesthesia but may be done using an epidural block or even under local anesthesia with sedation The implants, one in each buttock cheek area, are usually inserted through a vertical incision at the upper end of the buttock cleft. Currently buttock implants are placed sub-facially (i.e., under the covering of the gluteus maximus muscle) or intramuscularly (within the substance of the gluteus maximus muscle) depending on the size of the implant needed and the position of the implant needed to produce the desired curve of the butt The surgery will take about 3 hours on average. surgeons use a suction drain to prevent blood and tissue fluid buildup in the implant pocket. Drains may stay for several days.

 

žAfter the incision is closed with several layers of suture, long acting local anesthetic is instilled into the pocket with the implant to control pain. The postoperative buttock implant patient will be restricted to bed for about 2 weeks (most of that time will be spent lying on the stomach) and severely limited in activity for another 2-4 weeks beyond that. The patient will usually be given prescriptions for antibiotics, muscle relaxants, steroids to reduce the swelling, and narcotics for reduction of pain Buttock or gluteal augmentation with implants can be significantly painfulComplications are possible with any surgical procedure.the complication rate with buttock implants is possibly significant, you cannot just will them away by refusing to face the possibilitiesCost for gluteal or buttock implants vary from region to region. In the Eastern US, the average cost is $5800.00 for the surgeon's fee plus cost of the implant material, facility and anesthesia.

 

This sort of surgical procedure along with the long recovery period, possible complications and cost make it the most invasive, painful, problematic and least desirable solution in the view of this author.

 

fig 3a outcome of a solid silicone implant fig 3b solid silicone implant procedure

 

 

Implanted dermal fillers and their complications

 

The following sections rely heavily on papers by Drs. Lemperlie, Gauthier-Hazan, Wolters, Eisemann-Klein, Zimmerman and Duffy, (see reference section) on Foreign Body Granulomas (FBG) and are presented in italics.

 

It is important to understand how tissue fillers can cause the reactions discussed below and also what the clinical experience has shown; to be able to differentiate between theoretical and real world complications in determining treatment choices. All options have risks and all treatments have benefits, some more so than others. For patients in need of treatment and providers offering options, it is critical to understand the basics.

 

žAll injected substances cause an initial influx of [immune] cells. In the case of fillers containing particles, macrophages are initially attached to the particles or microspheres, converting occasionally into giant cells. If these particles are not constantly irritating, most giant cells [will] have disappeared by 6 months and the histological picture will remain stable. (Lemperle et al.)1

 

In resorbable implants such as Sculptra, Dermalive, or Radiesse, the hyaluronic acid or methylcellulose carrier dissipates soon after injection and leaves the particles or microspheres packed with little space for tissue ingrowth. The resorbable particles or microspheres are broken down enzymatically and are subsequently phagocytized by macrophages and giant cells within 6 to 12 months after injection. (Lemperle et al.) 1

 

true of foreign body granuloma is and remains a clinical diagnosis! It can develop slowly or rapidly in certain patients after the injection of any dermal filler such as collagen, hyaluronic acid, silicone, polyacrylamides, and particulate polymers. It occurs significantly less often after implantation of microspheres with smooth surfaces (Artecoll, New-Fill/Sculptra) than after implantation of particles with irregular or edged surfaces (Bioplastique, Dermalive). Its appearance is less dramatic after resorbable implants (collagen, hyaluronic acid) than after long-lasting fluidal implants (polyacrylamide gel, silicone fluid). (Lemperle et al.) 1

 

Genuine granuloma formation following implantation of injectable dermal fillers is a rare complication, with incidences ranging from 1 in 100 patients (1%) to 1 in 5,000 (0.02%). Foreign body granuloma occurs several months to years after injection. Without treatment, they may grow, [or can] remain virtually unchanged for some years, and then resolve spontaneously. (Lemperle et al.) 1

 

Three clinical and histological types of foreign body granuloma can be distinguished:


žCystic granuloma (synonyms: inflammatory, palisading, necrobiotic) are mainly caused by injected biological gels such as collagens and hyaluronic acids. Their clinical signs are fluctuation (sterile abscess), extreme redness, and induration. Cystic granuloma are small and superficial, occur within the first year and disappear spontaneously within another year. They are surrounded by giant cells. (Lemperle et al.) 1

 

žEdematous granuloma (synonym: lipogranuloma) are caused by artificial fluids such as silicone and polyacrylamides. They appear suddenly years after injection with extensive swelling and are surrounded and infiltrated by mononuclear and inflammatory cells. (Lemperle et al.) 1

 

žSclerosing granuloma (synonyms: sarcoidal and xanthelasmic) are caused by particulate injectables composed of polymethylmethacrylate (PMMA), polylactic acid (PLA), hydroxyethylmethacrylate (HEMA), calcium-hydroxylapatite (Ca-HA) or dextran microspheres. Sclerosing granulomas occur generally 6 months to 3 years after implantation and are visible, often bluish confined nodules. Histologically, the implant is infiltrated by many macrophages and giant cells, fibroblasts and collagen fibers but few inflammatory cells. (Lemperle et al.) 1

 

Permanent implants are not characterized by a higher rate of foreign body granulomas per se than temporary implants; however, their clinical appearance is more pronounced and their persistence longer if not treated adequately. (Lemperle et al.) 1

 

It is also important to differentiate between the appearance of nodules from genuine granulomas.

 

žNodules are isolated single [smallish] lumps in the implanted area, which do not grow, and their fibrous capsule confines them well from the surrounding tissue. The histology of implant nodules reveals the appearance of a dense foreign material, macrophages and giant cells, a normal, deliberate foreign body reaction. In some cases, 2 or 3 months after implantation, a hyper reaction of the skin may take place, which clinically and histologically resembles a scar or a keloid with the typical coloring of the skin. The predominant components present in such cases are fibroblasts and broad collagen strands that are pushing the particles to clusters, not macrophages and giant cells as in foreign body granuloma. These react well to corticosteroid injections (Lemperle et al.) 1

 

Liquid Injectable Silicone Oil

 

Second to solid silicone, there is a 70 year history to the use of silicone oil injections to add volume to the buttocks. žLiquid silicone injected to human tissue for cosmetic reasons started as early as the 1940s and is a separate issue from the silicone gel implants. (Tilleman 3). žDow Corning introduced medical grade silicone oil, polydimethylsiloxane, also called Liquid Injectable Silicone in the late 1950s for soft tissue augmentation. It was approved by the FDA in 1964 but was banned in the U.S. and some other countries in 1967. (Lemperle et al.) 1

 

žThey share a common beginning until doctors Frank Gerow and Thomas Cronin invented the silicone breast implant in the early 1960Ūs. The idea was to insert the silicone oils into an envelope in order to stop it from migrating, a known complication (even at that point) of silicone oils injection wrote the silicone researcher, Dr. Tamara Tilleman of Harvard, in a paper arguing for banning all injected silicone oil preparations for cosmetic augmentation. Her paper contains a very complete history and discussion of the use and complications of injecting silicone oils and should be read by anyone trying to understand the issue. A direct link is here: http://leda.law.harvard.edu/leda/data/727/Tilleman05.rtf

 

Unsurprisingly, inexpensive silicone oil has been the most available option for transgendered persons seeking inexpensive large scale augmentation.

 

Silicone oil (polydimethylsiloxane, PDMS) for injection into human tissue has not won approval from any medical authorities since its banning in the last century except for one specific retinopathy indication we discuss below. Silicone oil injections are specifically illegal in Western Europe, the UK, the US and most of Latin America. Silicone oil is also not widely used in the rest of the world where there are no specific prohibitions, due to its high level of both short and long term problems.

 

The medical literature and existing documentation is vast on the possible complications from the use of this substance. These complications are not easily treated and in some cases require surgical debridement, often meeting with limited success and producing significant morbidity. Chief among these complications are physical deformations from migration, infection, lymphoedema, tissue necrosis, giant cell (granuloma) reaction, fibrotic and chronic inflammation, and most seriously, a triggering of adjuvant disease, an autoimmune illness where the body becomes hypersensitive to all foreign substances and even to itself. žClinically, the žedematous granulomas appeared suddenly like an allergic reaction with redness, extreme swelling with multiple areas of firm, fixed, but rather soft nodules. No pain was involved but submandibular adenopathy was often disturbing and palpable. However, what impressed more was the rather late onset of foreign boidy granuloma at 10 to 15 years following injection. the FDA limited LIS use in 1965 to a certain number of patients of selected investigators. (Lemperle et al.) 1

 


fig 4 giant cell reaction to the presence in silicone oil in human tiissue (see arrow)

 

fig 5a and 5b immediately after injection of silicone oil and subsequent migration

 

 

fig 6a and 6b migration of injected silicone oil with tissue necrosis

 

žsilicone fluid stimulates [the body to build] only a very thin-walled fibrous capsule so that dislocation by gravity along fascia and muscle can occur. žMigration is a misnomer since nonliving silicone droplets cannot migrate. (Lemperle et al.)1 Silicone does flow downwards with gravity.

   
fig. 7a dense fibrosis, chronic inflammation and fig. 7b giant cells phagocytosing
granulomas subsequent to the injection of silicone oil in human tissue

 

žLate sclerotic reactions can develop around free silicone oil, as it is well known after žbleeding from earlier breast implants. A silicone foreign body granuloma shows the typical vacuolated spaces measuring 1 to 30 microns in diameter, surrounded by numerous histiocytes (macrophages), lymphocytes, plasma cells, some eosinophils, and scattered giant cells. Macrophages and giant cells contained multiple cytoplasmic vacuoles with žSwiss cheese pattern. (Lemperle et al.)1

 

The primary practitioners of large volume silicone oil injections have been by-in-large non-medical individuals working in private homes and in one notorious case, out of a mobile home in the Southern California desert, all the while injecting industrial grade silicone oil more suited for use as an industrial lubricant. The reported cost of one of these black-market procedures is in the range of $500. The reported morbidities are high.

 

With the advent of medical grade silicone oils (Silikon1000 and Silskin) we have seen some medical practitioners use Silikon1000 off-label for large volume augmentation; an indication the manufacturers have adamantly opposed in their publications and in front of the FDA, though apparently not enough to stop selling their products to these quite well known clinicians. Silikon1000 is indicated only as a temporary tamponade for holding detached retinas in place while Silskin continues in trials, Silikon1000 is used for facial reconstruction legally under the Žoff-label useŪ law via micro-droplet injections that may require over 8 sessions in most cases to correct HIV-lipoatrophy related tissue loss on the face.

 

Although, the availability of medical grade silicone oils has significantly reduced the incidences of infection when injected under sterile conditions, migration, fibrosis and chronic inflammation, žlarge cell immune reactions and lymphoedema remain as chief complications (Lemperle et al.)1. Some practitioners of this procedure have reportedly halted its use. Other physicians who are proponents of silicone oil for facial augmentation have also tended to shy away from large volume injections of these oils. A review of Google

 

archived web sites shows physicians who have perform buttock augmentation with large volume injections of off-label, medical grade, silicone oil, have charged from $3,000 to $16,000.

 

Polyacrylamide Hydrogels

The other well known non-absorbable (and hence permanent) implants, the polyacrylamide hydrogels (known variously as Aquamid, Bio-Alcamid, Bio-Formacril) have been available for 3 decades. Initially used mainly in Eastern Europe and Russia, these gels have several well documented complications including infection, migration, and release of toxic acrylimide monomers. All of these complications become aggravated over time.

žThe use of polyacrylamide as an injectable filler material was initiated in 1983 clinically in Russia 1990 as Formacryl (Interfall Ltd, Kiev, Ukraine, now relocated to Bulgaria) and in China as Interfall or Amazing Gel (FuHua Aesthetics Ltd, Shenzhen, China). Since Interfall's European patent expired, at least five European companies are marketing polyacrylamides as dermal filler substances: Formacryl, Interfall, Argiform (contains antibacterial silver ions), OutLine (absorbable), Aquamid, Evolution (contains non-resorbable microspheres in fast absorbing polyacrylamide, and Bio-Alcamid. They may differ in the number of free ends; Aquamid has more [free ends] because it is less cross-linked. (Lemperle, Gauthier-Hazan) 2

 

Some years ago, an Italian company, Polymekon, bought the rights to an existing acrylimide gel and reformulated it with the claims that the new product -- named Bio-Alcamid -- did not release toxic acrylimide monomers, did not degrade and did not migrate. They also ŽchangedŪ the chemical name from acrylimide to alkylimide. The chemistry however remains the same, only with tighter molecular bonds, a process the manufacturer calls ŽreticulationŪ.

 

This product gained a fast acceptance in the HIV community in 2001 when no other permanent options were available. Many traveled to Mexico to get their faces reconstructed in only one or two sessions. The apparent safety and permanence of this product was extolled by patients who had been treated with it for facial lipoatrophy, in the past six years.

 

Bio-Alcamid was widely used in Italy, the UK, Mexico and Canada. Best known for the use of the product was a Mexican clinic during the time it was led by Dr. Luis Casavantes who was its medical director. Dr. Casavantes developed many of the injection techniques which became standard in the use of Bio-Alcamid, lecturing and demonstrating his new techniques at international dermatological gatherings.

 

After a few years of use, it became apparent from reports coming from medical practices around the world including from Italy where the product was developed, that many physicians and patients were suffering higher than expected complication rates, infections, indurations (hardening) and also dislocation of the implant. Many patients are still happy with the results after 5 years, however.

In an interview, Dr. Luis Casavantes, who has performed many Bio-Alcamid implants, he expressed his view that the high complication rate for these implants, in his opinion, perhaps 10% or more, stem from two main causes: a not-fully sterile field on the skin surface with 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 bad placement of the implant by poorly trained practitioners. Late onset complications can sometimes be traced to disruption of the encapsulation pocket, while some late complications have not been able to be traced to any identifiable cause at all.

 

Very large volume buttock implants, he elaborated, žare more prone to deformation and migration from sitting pressure. This remains true with all polyacrylamide hydrogels including Bio-Alcamid, and became apparent after Bio-Alcamid became extensively used in HIV facial and buttock wasting restorationŪ

 

žIts [polyacrylamide gel] clinical and histological behavior is very similar to that of silicone fluid. In patients with very loose connective tissue, larger quantities can žmigrate or more accurately dislocate from the face to the neck, from the breast to the groin, and from the buttock to the hollow of the knee. The reason for its ease in dislocation is due to its good biocompatibility, which does not stimulate much capsule formation and even less cellular ingrowth. It would be the ideal filler (like silicone fluid) if it were not followed by a rather high rate of late complications. (Lemperle et al.) 1

 

 

fig 8a bilinear acrylimide migration from sitting pressure fig 8b side view of acrylimide migration

 

Many dermatologists throughout the world were sold on its use by patient demand for a permanent solution to facial and buttock wasting. Unfortunately, training was not provided with the product and so unacceptable levels of complications developed. Notable were patient reports from Italy, the UK and Canada reporting complications arising from poor placement.

 

Abstracts on Polyacrylamide Hydrogel complications can be found on the Blackwell Synergy website:

 

Derek H. Jones MD, Alastair Carruthers MD, Rebecca Fitzgerald MD, G. Peter Sarantopoulos MD, Scott Binder MD (2007) Late-Appearing Abscesses after Injections of Nonabsorbable Hydrogel Polymer for HIV-Associated Facial Lipoatrophy Dermatologic Surgery 33 (s2) , S193ŮS198 doi:10.1111/j.1524-4725.2007.33360.x

 

Another abstract from the Science Direct website discusses a study of 18 cases of Bio-Alcamid complications: Complications of polyalkylimide 4% injections (Bio-AlcamidŰ): a report of 18 cases . Journal of Plastic, Reconstructive & Aesthetic Surgery , Volume 59 , Issue 12 , Pages 1409 - 1414 R . Karim , J . Hage , L . van Rozelaar , C . Lange , J . Raaijmakers.

 

4 years ago when the above paper was written, the incidence of Bio-Alcamid complications were documented at 4%. Since then Dr. Luis Casavantes has reported in communications with us a 7% complication for faces and a 20% rate for large volume Bio-Alcamid implants of the buttocks.

 

This has not been confirmed by any other sources, and when questioned, Dr. Casavantes commented that when complications arise among the client base of the Mexican clinic which pioneered the use of Bio-Alcamid, he is often sought out for consultations as the former medical director of that clinic.

 

Bio-Alcamid has since been removed from the Mexican market by the owners of its distribution rights, but this was done for financial reasons rather than medical concerns. Bio-Alcamid remains available in Canada. A recent news release from Polymekon announced a partnership with an American firm, Ascente Medical Corporation to market Bio-Alcamid.

 

Pricing is not available for this product from Canada where itŪs still used because it is heavily subsidized, but a Mexican clinic which was the first in North America would charge upwards of $10,000.00, for buttock reconstruction. The owners of the Mexican clinic confirmed to me 3 years ago that their inability to get better pricing for Bio-Alcamid from the manufacturer led them to eventually abandon its use on buttocks.

 

Polymethylmethacrylate (PMMA)

 

Perhaps the least well known yet one of the oldest materials used in medical application is the permanent tissue filler polymethylmethacrylate, or PMMA. 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.

 

Medical PMMA from pharmaceutical sources, when injected in human tissue does not exhibit the complications seen with other non absorbable materials. Additionally, there is no migration observed, documented or reported anecdotally. Black market versions of PMMA popular at esthetic spas unfortunately cause a wide range of complications and have created much confusion as to the usefulness of this material to people with HIV soft tissue defects.

 

 


fig 9 Microspheres of PMMA, synthetic polymethylmethacrylate thermoplastic.

 

Professor Gottfried Lemperle, a medical doctor, 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.


fig 10 PMMA microspheres must be between 40 and 60 microns to avoid immunological reactions including the body attempting removal via macrophage action (phagocytosis).

 

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. .žBecause 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. (Lemperle et al.)1

 

In a communication, Dr. Lemperle said žnative collagen was detected at 3 weeks, and the density of collagen increases after that.

 

The clinical experience of Dr. Casavantes shows that collagen deposition finishes for the most part in 6 weeks but continues in small measure for up to 6 months. Dr. Casavantes has observed žif gluco-corticoid (not the same as anabolic) steroids are taken during the first weeks after the implant, collagen growth will slow down significantly, but picks-up again later on. This author can attest to the accuracy of these observations from personal experience.

 

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.

 

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 žPMMA 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 compound of 20% PMMA in 80% bovine collagen and a small amount of lidocaine.

 

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.

 

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.

 

The documentation shows that as ArteFill∆ was developed and purified over several generations from the original Arteplast, the appearance of granuloma have decreased dramatically.

 

In a personal communication, Dr. Luis Casavantes said that based on his experience in the past 4 years and on information presented in the bioplasty technique textbook published by Dr. Almir Nacul (Almir Moojen Nacul, M.D.: Bioplastia, a Plastica Interativa. pub 2007) 4, a PMMA product produced in Brazil and widely used in Mexico and worldwide, NewPlastic∆, does not appear to produce either palpable nodules or true foreign body granuloma, when grafted underneath the fascia in technique discussed in detail below.

 

Metacrill∆

 

Another approved and registered PMMA product is Metacrill which is a 30% solution of PMMA microspheres, most of which are between 40 and 80 microns, in carboximethylcelulose. Pricing of Metacrill is listed on their web site as follows: A box with 2 vials of 5 cc is available. It costs US $400 per box.
A box with 10 syringes with 1 cc is available for US $500 per box. Providers normally charge an office fee top of the price for their professional services.

 

As the product is not used legally in the United States, we have no actual pricing information on what would be charged here. Dr Serra in Brazil as we discuss below, uses Metacrill and we have reprinted sections of a letter from him detailing his prices.

  


fig. 11a and 11b Metacrill∆

 

Metacrill comes in microspheres mainly sized between 40 and 80 microns, however it contains a high percentage of particles sized 10 to 20 microns or less, which the body will attempt to remove via phagocytosis. We noted the significant amount of impurities that may cause inflammatory reactions.

 

 NewPlastic∆

 

NewPlastic∆ was developed in Porto Alegre Brazil by Dr. Almir Moojen Nacul, a plastic surgeon in clinical practice, regarded as the inventor of žBioplasty, described as soft tissue augmentation with fillers. He has authored a medical textbook and many articles on soft tissue augmentation with PMMA. Dr. Nacul uses intramuscular and sub-facial PMMA grafting, but does not use subcutaneous injections. He has written in his textbook that he does not use subcutaneous injections to avoid palpable granulomas and nodules. (Nacul, Bioplastia, a Plastica Interativa. 2007)4

 

fig 12 cover of Dr. NaculŪs textbook on Bioplasty with NewPlastic PMMA. It is currently being translated from the Portuguese into Spanish and English by Dr. Luis Casavantes.

 

NewPlastic is the commercial name for a series of PMMA, products containing 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. There is no lidocaine in NewPlastic∆. In a personal communication, Dr. Nacul said that he is 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.

 

fig 13a and 13b NewPlastic∆ PMMA contains microspheres between 40 and 60 microns with few smaller sized particles.

 

Compounded PMMA products have been widely available in Brazil, considered the world center of cosmetic medicine. Recently, as reported on the official Brazilian Government site ANVISA (National Sanitary Surveillance Agency of the Minister of Health), regulators have cracked down and closed the small compounders for not providing clean and safe products and causing serious medical complications.

 

As of this publication of this piece, there are no other legally registered and approved PMMA products in the Americas or in Western Europe than the products discussed in this article. Readers are urged to be suspicious of black-market products claiming to be PMMA and read the warnings and decisions about compounded PMMA on the ANVISA web site.

 

Clinical Practices

 

For purposes of this review, the we will focus on three legal practices using PMMA as a treatment for the reconstruction of HIV associated soft tissue defects; the clinic of Dr. Marcio Serra in Rio de Janeiro, Brazil, Dr. Everardo Garza in Monterrey, Mexico and Dr. Luis Casavantes, across the San Diego border in Tijuana, Mexico.

 

 

 

 

We will not review the filler product used by Mexican ClinicŪEstetica in Tijuana, Mexico, a popular clinic used in 2002-2006 by many in the HIV community, since we have yet to find any records anywhere of their PMMA product žPrecise, in any clinical trials data, pre-clinical data (information on animal studies done before a drug or device is used on people), Internet references or any legal governmental registration information in Mexico, Brazil, Europe and the rest of the Americas.

 

The American Society for Aesthetic Plastic Surgery keeps track of injected fillers approved by the FDA (and a few not approved) and itŪs available on the internet: ASAPS Glossary of Injectables and Dermal Fillers.

 

We actively advise patients to avoid unsubstantiated medical claims by non-medical personnel running these operations and injecting questionable and possibly toxic materials into the flesh of unsuspecting HIV positive patients searching for wasting treatments.

 

 

Dermatologia Medico Cosmetico Quirurgicia

 

Another doctor treating facial and buttock lipoatrophy is Dr. Everardo Garza in Monterey and Mexico City, Mexico. Dr. Darza is a dermatologist and surgeon with 15 years of experience with different skin fillers. Dr. Garza started using PMMA when Bio-Alcamid became unavailable in Mexico. Dr. GarzaŽs practice seems mainly cosmetic but he has treated a number of HIV positive patients and is familiar with the issues surrounding HIV lipoatrophy. Dr. Garza has worked with HIV positive patients since 2000. Unlike many providers, he has informed us that he uses the Žmicrocanula infiltration deviceŪ as opposed to traditional needles, in deference to patient needs, as microcanula are not as painful as needles. Patients who have seen Dr. Garza report no dissatisfaction with his services. Dr. Garza is known as a relatively low cost provider of body and face reconstructive and cosmetic enhancement services.

 

ClŐnica M∑rcio Serra

 

Dr. M∑rcio 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 therapies 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 canŪt help but compare 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. Dr Serra Žs treatment for gluteal lipoatrophy usually involves two to four sessions of 50 to 100 injections to achieve a satisfactory correction.

 

We were unable to find any reported complications or adverse reactions from Dr. SerraŪs approach or PMMA products. However the clinical and preclinical research of Dr. Lemperle 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 pozhealth@yahoogroups.com who have traveled to Rio de Janeiro to use his services are pleased with the results.

 

Importantly, Dr. Serra does not use intramuscular or sub-facial injections. Dr. Serra recent letter to us stated, since žthere are no long term safety studies of this approach. (letter from Dr. Serra).

 

 

fig 14a Dr SerraŪs work plan fig 14b Dr Serra exclusively uses dermal injections

 

fig 15 Before, immediately after and at end of 2 treatments from the weblog of a patient of Dr. Serra

fig 16a and 16b Dr. SerraŪs web site pictured a brand of PMMA unknown to the author. From the label, itŪs apparent that the PMMA itŪs a compounded and registered brand. However the Brazilian government has since closed down all the compounders of generic PMMA.

 

Dr. Serra confirms to us that he žuses only Metacrill now.

  

Reports of Dr. SerraŪs pricing patients on Pozhealth@yahoogroups have varied, but in a recent communication he has given us his pricing. Dr. Sera charges in Brazilian Real. He notes that he price fluctuates for Americans depending on the relative strength of the two currencies. As of May 6th 2008 1 US Dollar was worth 1.66 Brazilian Real. His explanation of the pricing is quoted here from his letter:

 

ž3- Prices: US$500, 3 years ago was not for a full buttocks treatment, was for one session with 40cc of PMMA, and at that time I was using the compound, that was cheaper and at the same time the dollar was stronger compared with brazilian reais. At that time US$1 was about BR$4, nowadays  one dollar is about BR$1.7. I started to treat body lipoatrophy more then 4 years ago, and today I use larger volumes of PMMA per session (sometimes 120cc). Prices are in brazilian reais as the dollar is really weak, and I use just Metacrill that is more expensive then the compound that I used to use in the past. (letter from Dr. Serra)

It is unclear from Dr. SerraŪs letter just what is being charged for gluteal reconstruction. Reports over the years in Pozhealth@Yahoogroups, and letters from patients of Dr. Serra to the author range from $500 in 2004 to $1,500 in 2005 to $3,600 in 2007.

 

In calculating the price of treatment, patients must take into account the added cost of airfare, hotels and food for several days in Rio de Janeiro each time a treatment is needed. For buttock reconstruction, our information and Dr SerraŪs comments suggests two to four treatments. We recommend that patients considering buttock reconstruction with Dr. Serra send photographs to the doctor to attempt to get an estimate on how much volume is required to calculate approximate costs.

 

 

Luis Casavantes

 

Dr. Luis Casavantes states that his practice differs from others in that it is purely a reconstructive clinic specializing in HIV buttock and facial reconstruction. He is an expert on tropical diseases of the skin and certain skin cancers and has worked in soft tissue reconstruction for 15 years.

 

In a recent news release he has announced that he has žcurrently chosen to focus on the needs of people with HIV lipoatrophy requiring reconstructive services. Dr CasavantesŪ is the only clinical practice with a financial assistance program providing partially subsidized PMMA treatment for people with HIV (and Parry-Rombergs Syndrome, a very rare facial deformity that attacks young people) who have been unable to afford facial wasting treatment. Dr. Casavantes uses NewPlastic PMMA exclusively.

 

Dr. Casavantes uses a number of technologies adapted from the work of Dr. Almir NaculŪs Bioplasty. Employing rounded microcanula instead of conventional sharp needles along with a metered implantation device, the žPMMA Grafting Technique (PGT) is reported by his patients to be ža breakthrough in comfort and reduced trauma, producing žno bleeding or bruising.

 

 

fig 17a. round tipped microcanula fig 17b. metered implantation technology

 

fig 17c. metered implantation technology with a microcanula attached

 

PGT reportedly avoids the problems of sharp needles and the damage they cause when traveling in tissues dense with nerves and blood vessels such as the buttock and face. The round tipped microcanula travels under the skin and fascia with little resistance and cannot damage vascular structures and nerve bundles as needles do. On encountering critical structures, the round tipped microcanula glides around or under them unlike sharp needles which slice through them.

 

PGT uses only two to three entry points per side as opposed to the 50 or 100 injections used with conventional needle techniques; the accompanying reduction in trauma results in little bleeding and virtually no bruising. Plavix, aspirin and other anti-clotting agents are not contraindicated by PTG.

fig 18a. 18b. and 18c. work plans for PMMA grafting using sub-fascia grafting with 3 entry points per side

 

Dr. Casavantes also employs intramuscular PMMA Grafting known as Permanent Muscle Enhancement (PME) for patients who are suffering from muscle wasting in addition to fat wasting of the buttocks.

 

fig 19a. and 19b. work plans for Intramuscular PMMA Grafting, known as Permanent Muscle Enhancement also employing only three entry points per side. Pictured are patients receiving their second treatment.

 

Dr. Casavantes reports žthe sub-fascia and intra-muscular placement of NewPlastic, in contrast to conventional dermal placement has eliminated the problem of palpable granuloma formation which is the sole documented complication reported in the Arte-Fill trials and also common with PMMA formulationŪs containing high numbers of impurities.

 

Following the recent volatility in the value of the dollar, Dr. Casavantes (as of this writing) charges $3,500 for 200 ml of NewPlastic∆ inclusive of professional fees, and $175 per each 10 ml increment thereafter.

 

Patients need to add the cost of air fare to San Diego, an overnight stays at a San Diego or Tijuana hotel, meals and taxis to the clinic. It is estimated that these ancillary costs come to $200.00 a day each for two days in addition to treatment fees.

 

Treatment with the Casavantes PGT usually takes two sessions although patients desiring greater cosmetic enhancement have had up to four sessions and up to 450 ml of PMMA.

fig 20a. 20b. and 20c. before, work plan, and immediately after sub-fascial PMMA Grafting Technique (PGT) involving three entry points on each side

 

 

 

Conclusion

 

Our research, input from patients and the comments from HIV doctors who have had patients who have been treated for buttock wasting leads us to conclude that treatment can produce dramatic improvements in quality of life, functional capacity, psychiatric health and in eliminating pain and discomfort from the lives of thousands of people suffering with HIV related gluteal tissue loss. PoWeR advocates for increased research in gluteal reconstruction therapy for people living with HIV related buttock lipoatrophy so that it may become an FDA approved option and recognized as a legitimate and reimbursable treatment.

 

 

References

 

1.        Gottfried Lemperle, M.D., Ph.D., Nelly Gauthier-Hazan, M.D., Marianne Wolters, M.D., Marita Eisemann-Klein, M.D., Ute Zimmermann, M.D., David M. Duffy, M.D.: Foreign Body Granulomas After All Injectable Dermal Fillers: Possible Causes. Plast Reconstr. Surg 122: October 2008

2.        Gottfried Lemperle, M.D., Ph.D., Nelly Gauthier-Hazan, M.D.: Foreign Body Granulomas After All Injectable Dermal Fillers: Treatment Options. Plast Reconstr. Surg 122: 2008

3.        Tamara Raveh Tilleman, MD, PhD, Professor Peter Barton Hutt: Cosmetic Use of Injection Silicone Oils; Approved Material with Unapproved Procedure. Time to Ban žOff-Label Use? Jan 2005.

4.        Almir Moojen Nacul, M.D.: Bioplastia, a Plastica Interativa. 2007


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