Highly Purified 1000 centistoke Silicone Oil for Treatment of HIV-associated F

[Guest guest]

Highly Purified 1000 centistoke Silicone Oil for

Treatment of HIV-associated Facial Lipoatrophy: An Open Pilot Trial

H. , MD1

Alastair Carruthers, MD2

Orentreich, MD3

Harold J. Brody, MD4

Mei-Ying Lai, MS5

Stanley Azen, PhD5

S.Van Dyke, MD, PhD1

1Division of Dermatology, Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; 2Division of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada; 3Department of Dermatology, Mt. Sinai School of Medicine, New York, New York; 4Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia;

5Department of Preventive Medicine, University of Southern California, Los Angeles, California.

Address correspondence and reprint requests to: H. , MD, 9201 Sunset Blvd., Suite 602, Los Angeles, California 90069.

THIS PAPER IS ACCEPTED FOR PUBLICATION AND IS CURRENTLY

IN PRESS

DERMATOLOGIC SURGERY

All Rights Reserved

Abstract

Background. Among HIV infected individuals, facial lipoatrophy has become epidemic. Those affected are stigmatized, leading to psychological distress, social and career impediments, and impaired compliance to HIV medications. Temporary treatment options are limited by excessive cost, necessity of frequent treatments, and lack of a natural look or feel beneath the skin. Affected patients require more persistent, affordable, safe and effective treatment options.

Objective. To evaluate the safety and efficacy of highly purified 1000 centistoke silicone oil injected by microdroplet serial puncture technique for the treatment of HIV-associated lipoatrophy.

Methods. Data on 77 patients with a complete correction were analyzed to determine the number of treatments, amount of silicone, and time required to reach complete correction, relative to initial severity.

Results. The volume of silicone, number of treatments, and time required to reach a complete correction were directly related to initial severity of lipoatrophy (p < 0.0001). Supple, even facial contours were routinely restored, with all patients tolerating treatments well. No adverse events were noted.

Conclusion. In this pilot trial, we have demonstrated that highly purified 1000 centistoke silicone oil is a safe and effective treatment option for HIV facial lipoatrophy. Longer-term safety and efficacy in HIV patients remain to be proven.

HIV-ASSOCIATED LIPOATROPHY manifests as wasting of subcutaneous fat in the face and extremities, and may affect up to 50% or more of HIV-infected individuals[1]. Affected individuals usually have well-controlled HIV infection and are otherwise healthy and feel well, but often look quite the opposite. The end result of this apparently permanent and irreversible loss of facial fat stigmatizes those affected as victims of a modern plague, causing psychological distress, social and career impediments, and non-adherence to HIV medications. Potential causes of HIV-lipoatrophy and treatment options are reviewed in this issue [2]. Temporary treatment options (Zyplast, Cymetra, NewFill, Fascian, autologous fat) are limited by excessive cost, necessity of frequent treatments, and/or lack of a natural look or feel beneath the skin. Those affected require more persistent, cost-effective, and safe treatment options that are cosmetically superior to temporary fillers, and associated with minimal downtime.

Patients with facial lipoatrophy not related to HIV have been treated with liquid injectable silicone, with good results. In 1972, Rees, et. al. reported on 10 years of experience with liquid injectable silicone in 73 patients with atrophic facial deformities related to Romberg’s disease (hemifacial atrophy), scleroderma, trauma, branchial arch syndrome or non-HIV related lipodystrophy[5]. Patients were treated with Dow Corning MDX 4-4011 (350 centistoke) liquid injectable silicone, in “small volumes†with treatment intervals of one week or more. Treatment technique was not mentioned. Total treatment volumes ranged from 3.5 ml to 55.5 ml, with 42 patients achieving contour restoration with “not more than 20 ml of liquid siliconeâ€. Sixty-eight patients had improvement in facial contour defined as good (13 patients), very good (26 patients) or excellent (29 patients). Four patients had a “fair†result, defined as adequate contour improvement but development of “tissue firmnessâ€, or insufficient contour improvement. One case was deemed “poorâ€, with the patient developing a hard nodule on the cheek 8 months after completion of injections. She was treated with intralesional steroids, with good results.

In 1978, Dow Corning initiated a study investigating its MDX4-4011 liquid injectable silicone in treating similar atrophic deformities (IDE Number L002702). Dow summarized its findings in a 1990 report to the FDA[6]. 128 patients were treated, at 2-week intervals, with a variety of treatment volumes and techniques (“fanningâ€, “microdroplet serial punctureâ€, “tattooingâ€). Thirty-six mild to moderate complications were reported in 26 patients, including transient edema (9), pigmentation (9), transient pain (4), erythema (3), limited migration (2), induration (2), infection (2), granulomas (2), nodule formation (1), mild dimpling (1), and mild lumpiness (1). It is very noteworthy that of these 26 patients, 21 reported satisfaction with their treatment results, 4 did not report their satisfaction, and 1 patient reported treatment dissatisfaction, citing a desire for a larger volume of silicone. This patient satisfaction level supports that the majority of reported complications were mild and/or of short duration. Two serious complications were reported, with 2 patients experiencing edema that did not respond to surgical treatment.

There has been controversy regarding the use of injectable silicone. Some physicians believe that injectable silicone is inherently unpredictable, with chronic cellulitis, nodule formation, ulceration, or migration of silicone appearing sometimes years after injection and despite use of appropriate technique and substance[7]. Advocates of injectable silicone argue that such complications may be related to impurities (heavy metals, low molecular weight contaminants) in non-injectable grade silicone, or injections performed with inappropriate technique or injection of large volumes all at once [4]. They note that large volumes injected all at once tend to track along tissue planes, whereas microdroplets injected at intervals of 1 or more months are anchored in place by a limited foreign-body fibroplasia, which also contributes to further tissue augmentation in the weeks following injection [4]. Physicians with substantial experience with liquid injectable silicone rely on a wealth of anecdotal data to argue that complications can be avoided by following these rules: (1) use pure medical grade silicone intended for injection into the human body, (2) adhere to strict micro-droplet serial puncture technique (0.01 ml microdroplets injected at 2-4 mm intervals into the subdermal plane) and, (3) inject limited volumes at monthly or longer treatment intervals[4]. Duffy, a leading expert in liquid injectable silicone, concludes that “liquid silicone used properly is extraordinarily useful, permanent, and capable of providing excellent results for the overwhelming majority of those who are treated. However, despite these protestations, I believe that serious complications can and will occur, despite slavish adherence to optimal protocols[8].†Duffy believes that concurrent infections, particularly dental or sinus infections, may incite immune responses that lead to complications such as granuloma formation. However, he posits that the “instance of serious and untreatable complications following the use of liquid silicone in approved protocols is some fraction of 1%, just as it was in the one FDA-approved study[8].â€

This low complication rate may justify treatment with liquid injectable silicone for those with HIV-associated facial lipoatrophy, which is a particularly devastating consequence of HIV, and no doubt frequently causes tremendous psychological suffering[13]. In 1994, the FDA approved injectable Adatosil 5000 silicone oil for use as an intraocular tamponade to treat retinal detachment. In 1997, a less viscous silicone oil, Silikon 1000, was approved for similar use. Under the U.S. FDA Modernization Act of 1997,which afforded physicians the right to use medical devices under the same off-label provisions previously applicable only to drugs, U.S. dermatologists could, for the first time, employ standardized silicone oils of exceptionally high purity for soft-tissue augmentation[4]. Adatosil 5000 is a highly viscous oil that is difficult to inject through small gauge needles, therefore limiting its utility for soft tissue augmentation. Silikon-1000 is less viscous and may be injected through specially manufactured 30 gauge needles. Recent reports suggest that off-label use of Silikon 1000, when employed in a well-defined protocol, is a safe, permanent and exceptionally effective treatment for HIV-associated facial lipoatrophy[3,4,9]. In the authors’practices, 415 patients with HIV facial lipoatrophy have been treated using this protocol over a 4 year period, with no reported adverse reactions, other than the typical, self-limiting events common to any injections, such as pain, erythema, ecchymosis and edema. Data from a subsample of 77 patients who had not received prior permanent fillers and with a complete correction and appropriate pre- and post-treatment photographs at the time of publication were gathered to determine safety and efficacy, as well as the number of treatments, amount of silicone and time required to reach the endpoint, relative to disease severity. Further data on patients who initiated treatment more recently and are still receiving injections will be reported at a later date, once complete corrections have been achieved.

Methods

Seventy-seven patients with HIV facial lipoatrophy were treated with Silikon 1000 (Alcon Laboratories, Fort Worth, Texas) or VitreSil 1000 (-, Inc., Peabody Massachusetts). Only patients with stable, well-controlled HIV infection, no active opportunistic infections, and no history of treatment with previous permanent fillers (silicone oil, expanded polytetrafluoroethylene, other permanent implants) or no history of facial surgery to correct their lipoatrophy were included in the analysis. Silikon 1000 is a 1000 centistoke silicone oil FDA approved for intraocular injection for the tamponade of retinal detachment, while VitreSil 1000 is a product of very similar consistency and purity, indicated for the same in other countries.

Demographic and clinical characteristics of patients are listed in Table 1. We used the 5-point Carruthers Lipoatrophy Severity Scale (CLSS, 0 = no lipoatrophy, 1 = mild, 2 = moderate, 3 = severe and 4= very severe lipoatrophy) [10] for staging the lipoatrophy at the baseline examination. Of the 77 patients, 37 (48%), 30 (39%), 10 (13%) and 0 (0%) were classified as Stage 1, 2, 3 and 4, respectively. Prior history of treatment for lipoatrophy is summarized in Table 2. Thirty-eight patients had undergone previous treatment with temporary fillers such as Zyderm, Zyplast, New Fill, Fascian, or hyaluronic acid. Seven patients had taken drugs to combat their facial fat loss. In patients who had received prior injections with temporary fillers, silicone injections were not begun until 3 months after their last temporary filler treatment, to allow the material to dissipate.

Each patient underwent silicone microinjections, employing Silikon 1000 or VitreSil 1000. Appropriate written informed consent was obtained prior to treatment. At each session, each patient was photographed and the facial skin was cleansed with povidone iodine, or antibacterial cleanser. Each patient was then anesthetized topically with a topical anesthetic such as EMLA or topical benzocaine under plastic wrap occlusion for 30-45 minutes prior to injection. Nerve blocks were avoided as injectable anesthetic could potentially alter pre-treatment facial contours. If patients complained of excessive pain at the first treatment, they were pretreated before subsequent treatments with an analgesic such as Tylenol #3 and/or alprazolam ½ hour prior to treatment, along with EMLA. The topical anesthetic was removed with gauze. Areas of depression in the malar, preauricular, pre-masseteric and temporal regions were outlined with a Sharpie pen. One investigator (DO) marks prior to applying anesthetic cream, which may cause mild tissue swelling after 30-60 minutes of application (the cream is gently blotted off to avoid smearing the ink). Facial depressions were analyzed in both resting and smiling states, to account for the effect of dynamic motion on facial contours. Care was taken to not overcorrect areas of depression at rest that may turn into elevated ridges with the patient smiling. In some cases, overhead down lighting was used to accentuate depressions. Patients were injected in a sitting or recumbent position, depending on physician and patient preference. Microdroplets of silicone oil (0.01 cc) were injected at 2-4 mm intervals through a 30-gauge metal hub needle (MaxFlo needle, -, Inc.; or 30g 3/8†special order needle number P62230, Dent Supply Technology, lin Park, IL). Silicone microdroplets were deposited strictly into the subdermal plane or deeper (on average, 5mm depth beneath the skin surface, or deeper) using the microdroplet serial-puncture injection technique described by Orentreich[4]. Finger pressure was applied when necessary to areas of pinpoint bleeding, to reduce bruising. In the malar area, injections were not performed above the inferior bony orbital rim. To avoid coalescence of microdroplets into macrodroplets, overlapping (second pass) injections were avoided. One investigator (DJ) occasionally undertook a second pass in areas of deeper depressions, with microdroplets injected 5 mm deeper to the plane of the first pass. Injection volumes were generally limited to 2 mls or less per treatment. Post-treatment, patients were instructed to avoid any contact sports or activities that would predispose the treated areas to trauma. Treatments were performed at intervals of at least 1 month or more, to allow time for limited fibrosis to develop around each silicone microdroplet, theoretically limiting the possibility of migration and contributing to further augmentation. As treatments progressed and subjects neared a complete correction, injection intervals were often extended to 2 or 3 months, or longer, to allow a collagenous capsule to completely form around each microdroplet, thus avoiding possible over-correction. Patients were deemed “complete†when, 1 month or more after their final injection, their facial contour had returned to a level that, in the subjective view of the physician and patient, was similar to their pre-lipoatrophy state. Patients were then re-photographed. Side by side pre-treatment and post-treatment frontal photographs were rated using the CLSS by an independent rater not involved in treatments (GSV).

Results

Seventy-seven patients were treated with 376 treatments, performed at monthly intervals or longer. Treatment summary results are outlined in Table 3 and Table 4. Of the 376 patient-injections, 97% were with Silskin. The average time between treatments ranged from 34 to 123 days, and the average time between the first and last treatment ranged from 100 to 872 days. The majority (57%) of the injections were 2 ml; only 9% of the injections were >2ml. The average total volume injected was 8.4 ml.

Table 5 describes the number of treatments and total volumes required to achieve a complete correction based on the CLSS. On average, stage 1 patients required 3.2 treatments with 5.4 ml total volume, stage 2 patients required 5.6 treatments with 9.3 ml total volume, and stage 3 patients required 8.6 treatments with 16.9 ccs total volume. The average number of treatments and volume of silicone injected significantly increased with worse CLSS stages (p<0.0001).

Table 6 describes the average number of weeks needed to achieve complete correction based on CLSS, as well as average follow-up times from first treatment and last treatment. On average, stage 1 patients required 17.1 weeks to achieve complete correction, stage 2 patients required 35.7 weeks, and stage 3 patients required 59.7 weeks. Patients have been followed an average of 58.9 weeks since their first treatment, and 27.1 weeks since their last treatment. The average number of weeks from first to last injection significantly increased with worse CLSS stages (p<0.0001).

Adverse Events. No adverse events were noted after any treatment. Adverse events are defined as post treatment pain, erythema, or edema persisting for longer than 3 days or ecchymosis lasting longer than 2 weeks. The majority of patients experienced mild to moderate discomfort related to multiple needle punctures required for the serial puncture microdroplet technique, with only 5% or less requiring pre-treatment analgesia beyond topical EMLA (alprazolam, and/or Tylenol #3). Many patients described the pain as less than that experienced with administration of decorative tattoos. As with any injectable treatment, rarely patients experienced vaso-vagal symptoms (diaphoresis, faintness, brief syncope) that in all cases resolved promptly with no sequelae. In no cases did a treatment have to be abandoned because of patient discomfort. Patients generally complained of more sensitivity with injections near the nose and higher in the medial malar area. Most patients experienced mild post-treatment erythema and edema, and occasionally mild tenderness, which in all cases resolved within 3 days. Most patients enjoyed the modest post-treatment edema, stating that it temporarily contributed to beneficial augmentation. Occasional ecchymosis was noted, particularly in the temporal areas, and in all cases resolved within 14 days. Post-treatment, the majority of patients were able to return immediately to work and to normal daily activities, with no restrictions. Patients continue to be followed for dyschromia, over-correction, embolism, granuloma, nodules, drift, infection, ulceration or signs of connective tissue disease. To date, none of these events has occurred in the 415 patients treated in our 4 practices. In all patients, the silicone correction continues to feel soft and supple, much like natural facial soft tissue. The great majority of patients are exceptionally satisfied with their treatment. In those who have had augmentation with temporary fillers, the silicone correction is much preferred by both patient and physician. Many patients stated that they preferred the gradual correction, as their resultant and often dramatic transformation occurred slowly and progressively over time, and thus was not immediately obvious to others with whom they interact more frequently.

Table 1: Demographic and Clinical Characteristics (n = 77 patients)

Variable

N (%)

Center

DJ

67 (87%)

DO

3 (4%)

HB

4 (5%)

AC

3 (4%)

Age (years)

30-39

12 (16%)

40-49

46 (60%)

50-59

17 (22%)

60+

2 (3%)

Gender

Male

76 (99%)

Female

1 (1%)

Ethnicity

Caucasian

70 (91%)

Hispanic

6 (8%)

Other

1 (1%)

Duration of HIV (years)

<10

21 (27%)

10-19

46 (60%)

>20

6 (8%)

Not recorded

4 (5%)

Duration of lipoatrophy (years)

< 1

14 (18%)

2-5

43 (56%)

> 6

8 (10%)

Not recorded

12 (16%)

Duration of protease inhibitor therapy (years)

< 5

33 (43%)

6 – 9

34 (44%)

>10

1 (1%)

Not recorded

9 (12%)

Carruthers Severity Scale (CLSS)

1 (Mild)

37 (48%)

2 (Moderate)

30 (39%)

3 (Severe)

10 (13%)

4 (Very Severe)

0 (0 %)

DJ = , DO = Orentreich, HB = Harold Brody

AC = Alastair Carruthers

Table 2: Prior History of Treatments for Lipoatrophy (n = 77 patients)

Variable

N (%)

History of facial treatments

Zyderm

1 (1%)

Zyplast

30 (39%)

New Fill

2 (3%)

Fascian

4 (5%)

Hyaluronic Acid

1 (1%)

None

41 (53%)

Drugs taken to treat facial lipoatroaphy

None

70 (91%)

Human growth hormone

2 (2%)

Testosterone IM

4 (5%)

Testosterone topical

1 (1%)

Note: patients may have received more than 1 treatment

Table 3: Silicone Treatment Summary (n = 376 injections)

Variable

N (%)

Silicone Product

Silikon

366 (97%)

Vitresil

10 (3%)

Volume (ml)

< 1

23 (6%)

>1, <2

105 (28%)

2

214 (57%)

>2

34 (9%)

Table 4: Silicone Treatment Summary (n = 77 patients; 376 injections)

Visit

N

Volume injected at each visit (ml)

Time since previous treatment visit (days)

1

77

1.9 + 0.4

---

2

76

1.9 + 0.4

42.6 + 21.5

3

68

1.7 + 0.5

49.3 + 52.3

4

52

1.7 + 0.6

56.3 + 39.6

5

37

1.5 + 0.6

58.5 + 40.5

6

23

1.5 + 0.5

60.1 + 39.6

7

14

1.6 + 0.6

50.1 + 26.6

8

12

1.4 + 0.5

54.4 + 26.8

9

7

1.3 + 0.4

122.6 + 163.4

10

5

1.1 + 0.6

104.0 + 38.8

11

3

0.9 + 0.3

78.7 + 44.5

12

1

1.1

36.0

13

1

1.0

34.0

Total volume injected (ml)

N (%)

Time from first to last treatment (days)

<5

15 (19%)

100.2 + 75.8

5 to <10

39 (51%)

184.5 + 109.3

10 to <15

14 (18%)

260.5 + 86.0

15 to <20

7 (9%)

293.9 + 99.8

> 20

2 (3%)

872.5 + 529.6

Average

8.4 + 4.3

---

Table 5: Silicone Treatment Profile Stratified by

Baseline Carruthers Lipoatrophy Severity Scale (CLSS) (n = 77 patients)

Silicone Oil Treatment

Baseline CLSS

p-value*

1 (n = 37)

2 (n = 30)

3 (n = 10)

Number of treatments

3.2 + 1.2¶

5.6 + 1.9

8.6 + 2.3

<0.0001

Total volume injected (ml)

5.4 + 1.6

9.3 + 2.4

16.9 + 3.0

<0.0001

*P-value obtained using analysis of variance across CLSS groups1 = mild; 2 = moderate; 3 = severe.

¶ Mean + SD

Table 6: Treatment Time Profile Stratified by

Baseline Carruthers Lipoatrophy Severity Scale (CLSS) (n = 77 patients)

Length of Time (weeks)

Total

Baseline CLSS

p-value*

1 (n = 37)

2 (n = 30)

3 (n = 10)

From first to last injection

29.9+24.2¶

17.1 + 9.9

35.7 + 16.0

59.7 + 44.1

<0.0001

Since first injection

58.9+ 25.1

45.5 + 15.2

60.3 +14.1

89.0 + 45.0

<0.0001

Since last injection

27.1+14.2

28.3 + 12.6

24.7 + 10.3

29.5 + 26.1

0.49

Note: Time from first or last injection: Date of first or last injection to cut off date 7/31/2003. Time from first to last injection: Date of first injection to date of last injection.

*P-value obtained using analysis of variance across CLSS groups: 1 = mild; 2 = moderate; 3 = severe.

¶ Mean + SD

Discussion

Our results suggest that liquid injectable silicone, when appropriately employed, is an excellent and safe treatment option for HIV facial lipoatrophy. Patients should be medically stable, have well-controlled HIV infection with stable CD4 counts and viral loads, and no active opportunistic infections. Silikon 1000 or VitreSil 1000 should be employed with the microdroplet serial puncture technique, as described by Orentreich[4]. Volumes should be generally limited to 2 ml or less at each treatment session, with treatment intervals of one month or longer. However, if the surface area requiring treatment is larger, up to 1.5 ml may be injected per side, provided the microdroplet serial puncture technique is followed. Pre-treatment CLSS ratings may be used to help predict how much silicone and how many treatments may be necessary to achieve a complete correction. The authors suggest a “rule of threes†in predicting treatment number and total volume. That is, for each point of severity on the CLSS, a patient will need, on average, 3 treatments utilizing 2 ccs of injectable silicone per treatment. Therefore, stage 1 patients will, on average, need 3 treatments with 6 ccs of LIS, stage 2 patients will need 6 treatments with 12 ccs of LIS, and Stage 3 patients will need 9 treatments with 18 ccs of LIS (stage 4 patients were not included in our analysis). Our results support the utility of this guideline. However, patients should be counseled that this is a guideline, and individual needs will vary depending on depth of lipoatrophy, surface area to be treated, and the amount of collagen each individual deposits around the microdroplets over time. Furthermore, in many patients facial lipoatrophy is not static and may continue to progress, with larger treatment volumes needed over time than originally predicted. If lipoatrophy progresses once a complete correction is achieved, touch-up treatments with injectable silicone are easy to perform with good results. Good quality pre-treatment photographs, especially frontal photographs (as patients most commonly see their frontal image in the mirror), are important to both physician and patient, as many patients fail to recall how severe their lipoatrophy was pre-treatment. Furthermore, some patients may notice pre-existing nevi, sebaceous hyperplasia or other benign lesions post-treatment, and question whether these are treatment-related. Good pre-treatment photographs, particularly high resolution digital images with zoom capability, will usually resolve these questions and reassure the patient and physician that the lesions were pre-existing, and not treatment-related.

Corrections achieved with liquid injectable silicone are more persistent (barring progression of lipoatrophy), and, as treatments do not need to be repeated indefinitely, potentially more cost-effective than corrections achieved with existing temporary fillers. Used correctly, injectable silicone routinely restores even, natural facial contours that feel and look like normal facial tissue. Such natural corrections are difficult to achieve with permanent, surgically placed rigid implants. Our results support the excellent short-term safety and efficacy of injectable silicone for HIV facial lipoatrophy. Long-term safety and efficacy will have to be proven with longer-term, close follow-up of our treated patients. Currently, SilSkin ( Development, Peabody, MA), a highly purified 1000 cs silicone , is currently undergoing FDA study for HIV-associated facial lipoatrophy.

It may be hypothesized that HIV patients have immune system changes that may predispose them to development of granulomatous disease, particularly during the immune reconstitution period [11,12]. To date, our results with Silikon 1000 and VitreSil 1000 do not support a predisposition to development of silicone granuloma among those with HIV facial lipoatrophy, with some patients 4 years from their initial treatment. Until longer-term data is available from our cohort and from other well-designed studies, patients should be informed that this treatment is considered investigational, and should be made fully aware of possible risks.

References

1. Lictenstein KA, Ward DJ, Moorman AC, Delaney KM, Young B, Palella FJ, PH, Wood KC, Holmberg SD. Clinical Assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS 2001; 15:1389-1398.

2. DH. HIV Facial Lipoatrophy: Causes and Treatment. Dermatol Surg, 2003: Current Issue

3. DH. Injectable Silicone for Facial Lipoatrophy. Cosmetic Dermatology 2002; 15:13-15.

4. Orentreich DS. Liquid injectable silicone: techniques for soft tissue augmentation. Clin Plast Surg 2000; 27: 595-612.

5. Rees TD, FL, and Delgado JP. Silicone fluid injections for facial atrophy: a ten-year study. Plast Reconstr Surg 1973; 52:118-27.

6. Dow Corning IDE Number L002702: Limited Applications for Silicone Injections Using Dow Corning MDX4-4011, final report to the FDA, 1990.

7. Rapaport MJ, Vinnik C, Zarem H. Injectable silicone: cause of facial nodules, cellulitis, ulceration, and migration. Aesthetic Plast Surg 1996; 20: 267-76.

8. Duffy DM. The silicone conundrum: a battle of anecdotes. Dermatol Surg 2002; 28: 590-4.

9. Orentreich D, Leone AS. A Case of HIV-associated Facial Lipoatrophy Treated with 1000cs Liquid Injectable Silicone. Dermatol Surg 2003; in press.

10. J, Carruthers A, Carruthers J. HIV-associated facial lipoatrophy. Dermatol Surg, 2002. 28: p. 979-86.

11. Baselga E, Pujol R. Indurated plaques and persistent ulcers in an HIV-1 seropositive man. Silicone granulomas (reaction to silicone injection). Arch Dermatol 1994;130: 785-6, 788-9.

12. Murray CA, DeKoven J, Spaner DE. Foreign Body Granuloma: A New Manifestation of Immune Restoration Syndrome. J Cutan Med Surg 2003; 38-42.

13. E, Wagner C, Walmsley S. Psychosocial impact of the lipodystrophy

syndrome in HIV infection. AIDS Reader 2000;10:546-551.

VergelDirector, Program for Wellness Restoration (PoWeR)An all volunteer non profit organizationwww.powerusa.org

AIDS is not over. There are 40 million people infected with HIV and 20 million people have died so far while 14,000 people are infected every day. Only 5% of those needing treatment get it. Most PWAs in the world are dying helplessly while rich nations watch. We will be remembered by future generations as the people who allowed greed and profits to be more important than human suffering and lives.

[Guest guest]

Another thing to keep in mind here is that silicone microdroplet

technique is not an option for everyone. It is not an option for

level 4 lipoatrophy and an expensive option (requiring many sessions

and lots of silicone)for level 3.

This may not be specifically stated in the article, but they included

no level 4 patients in the trial and only 10 level 3 patients. Level

3 required an average of nine treatments with a total of 18 cc LIS

injected. That's a lot of silicone.

I had a consultation for the microdroplet technique with one of the

authors of this article and was told this was not an option for me

since he rated me as level 4.

I'm think it is probably a good option for those who have mild facial

wasting. Otherwise, it will be costly for many treatments and

require a lot of silicone. I would have went with this treatment if

the doctor had told me it would work on me. Besides, it is available

closer to home.

To the doctors credit though, he was up front with me about it not

being an option and suggested that I should look at other options.

I have since received Bio-Alcamid treatment and very pleased with the

results. I know Bio-Alcamid is not FDA approved and the long-term

problems may be unknown. But, with severe lipo, I needed help right

away so I could get back to living a normal life. I received

immediate results from just one session, and the one-time firm fixed

price of treatment was very appealing to me since I don't have a lot

of money. I really can't express the difference it has made in my

life to be able to go out in public again without people staring at

me.

> Highly Purified 1000 centistoke Silicone Oil for

> Treatment of HIV-associated Facial Lipoatrophy: An Open Pilot Trial

>

> H. , MD1

> Alastair Carruthers, MD2

> Orentreich, MD3

> Harold J. Brody, MD4

> Mei-Ying Lai, MS5

> Stanley Azen, PhD5

> S.Van Dyke, MD, PhD1

[Guest guest]

I was a level 4 (using the Carruthers scale referenced) when the Silskin study began. I received 6 treatments (2ml each treatment) and have now been rated at level 0. I guess that in my case moving from a level 4 to level 0, using the silicone microdroplet technique, is an example of how silicone can be (and was for me) a successful treatment option.

Re: Highly Purified 1000 centistoke Silicone Oil for Treatment of HIV-associated F

Another thing to keep in mind here is that silicone microdroplet technique is not an option for everyone. It is not an option for level 4 lipoatrophy and an expensive option (requiring many sessions and lots of silicone)for level 3. This may not be specifically stated in the article, but they included no level 4 patients in the trial and only 10 level 3 patients. Level 3 required an average of nine treatments with a total of 18 cc LIS injected. That's a lot of silicone.I had a consultation for the microdroplet technique with one of the authors of this article and was told this was not an option for me since he rated me as level 4. I'm think it is probably a good option for those who have mild facial wasting. Otherwise, it will be costly for many treatments and require a lot of silicone. I would have went with this treatment if the doctor had told me it would work on me. Besides, it is available closer to home.To the doctors credit though, he was up front with me about it not being an option and suggested that I should look at other options.I have since received Bio-Alcamid treatment and very pleased with the results. I know Bio-Alcamid is not FDA approved and the long-term problems may be unknown. But, with severe lipo, I needed help right away so I could get back to living a normal life. I received immediate results from just one session, and the one-time firm fixed price of treatment was very appealing to me since I don't have a lot of money. I really can't express the difference it has made in my life to be able to go out in public again without people staring at me. > Highly Purified 1000 centistoke Silicone Oil for > Treatment of HIV-associated Facial Lipoatrophy: An Open Pilot Trial > > H. , MD1> Alastair Carruthers, MD2> Orentreich, MD3> Harold J. Brody, MD4> Mei-Ying Lai, MS5> Stanley Azen, PhD5> S.Van Dyke, MD, PhD1If you received this email from someone who forwarded it to you and would like to join this group, send a blank email to lipodystrophy-subscribe and you will get an email with intructions to follow. You can chose to receive single emails or a daily digest (collection of emails). You can post pictures, images, attach files and search by keyword old postings in the group.For those of you who are members already and want to switch from single emails to digest or viceversa, visit www.yahoogroups.com, click on lipodystrophy, then on "edit my membership" and go down to your selection. The list administrator does not process any requests, so this is a do-it-yourself easy process ! :)Thanks for joining. You will learn and share a lot in this group!Forward this email to anyone who may benefit from this information! Thanks!In Health, VergelInterim List Administratory benefit from this information! Thanks!In Health, VergelInterim List Administrator