Buttock Wasting in HIV:
A report on treating an under-addressed medical problem
by Albert Benson
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
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
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:
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
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
fig 2a lipoatrophy without
myoatrophy fig 2b and 2c combined and severe lipoatrophy
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.
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
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
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
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
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
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
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
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
These react well to corticosteroid injections (Lemperle
et al.) 1
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
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
granulomas subsequent to the
silicone oil in human tissue
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.
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,
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
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,
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
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:
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) ,
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
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.
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
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
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.
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∆ 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
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
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 email@example.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
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.
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
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
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
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.
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
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
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.
Almir Moojen Nacul, M.D.: Bioplastia, a Plastica