Please introduce yourself and tell us how you got involved in treating lipoatrophy.
My name is Minas Constantinides, and I am the director of facial plastic and reconstructive surgery for the Department of Otolaryngology, which is the ear, nose and throat department at New York University School of Medicine. I have been here in that capacity for the last 12 years.
About eight years ago or so, I became interested in lipoatrophy patients, only because there didn't seem to be much that could be offered to them. I tried to make myself an expert as to what the various options for them were. At that time, the options were really minimal.
We tried all kinds of things, and all kinds of things failed. One thing that we tried early on was sort of standard fat transfer techniques, where we'd take fat from one part of the body and transfer it to the other.
Of course, the problem with lipoatrophy is that there is a loss of fat throughout the body -- really a loss of subcutaneous fat throughout the body, as well. So even patients with a little round belly, because there's some fat redistribution, don't have much fat there to use. The only real fat that we could use reliably in severe cases was buffalo hump fat -- the fat from the back that developed as a hump in patients.
So we tried fat transfer from all kinds of sources, including other parts of the patients and from buffalo humps, and rapidly learned that that fat suffered the same fate as facial fat, in the sense that it would atrophy just like facial fat would. There was no good long-term improvement whatsoever. Initially, patients looked great, but about six to eight months later, they were back to where they started. So that was unsatisfactory.
Was this before the cause of lipoatrophy was connected to HIV drugs?
I don't know. I don't have any real knowledge of that, of what the dynamic is, actually. So, we tried other things. We tried implanting Gore-Tex sheets. Those are sort of microporous medical rubber -- really, sheets made out of Gore-Tex -- the same stuff that's in your ski jacket that makes it waterproof. Well, medical grade Gore-Tex can be stacked and implanted, and we tried that. The stuff would shift around a little bit and it was just not satisfactory, either.
We tried directly excising [cutting out] parts of the nasolabial folds, those folds between the nose and the side of the mouth, that would get redundant and fall forward [as a complication of lipoatrophy]. And that made the fold go away [closing it so the scar would lie in the natural line of the face]; but it didn't really fix the lipoatrophy problem. We even tried different face lifting techniques to try to lift what was there to try to give a tighter look to the face. That was unsatisfactory, because what really was needed was volume.
Were you struck by how severe the cases were, and by the psychological impact that was having on people?
Yes. The severity of the cases ranged from the relatively mild, where a patient might just look a little bit gaunt or a little bit more defined, in terms of cheekbone area. Most people who would see that patient on the street wouldn't think twice about their appearance. Yet, that same mildly-affected patient would bring in a picture of themselves before lipoatrophy and they would have full, round faces. It would still be a dramatic change for them. This was extremely debilitating to them, in terms of their being able to deal in their day-to-day world with society, both with their friends and also in their professional lives.
They felt -- and the echo that resounded throughout every patient's tale was -- I feel like I have a mask on my face that has labeled me as a patient with AIDS. That's very stigmatizing and depressing, especially when treatment has so advanced and viral counts are undetectable, and CD4 levels are nearly back to normal. To still have that label is a very psychologically difficult thing for most patients to handle.
Along with the saga goes the efforts to try to get insurance companies to pay for some treatment for lipoatrophy. That has, pretty much across the board, failed, except for some very sort of rare policies that might allow for some treatment, based on the psychological impact of the disease. But it's striking that insurance coverage is relatively rare for this pretty prevalent problem related to a medical problem, not to anything other than that.
Why is it so difficult to get coverage?
Well, I think insurance companies view this as a cosmetic problem. Just like they won't pay for your face lift, they won't pay for lipoatrophy treatment. Of course, the two things are completely different.
Especially in the sense that a treatment for lipoatrophy is really reconstructing the face to what it was, whereas a face lift could be said to be enhancing.
Well, you can play semantics all you want, and I could probably make an argument that face lifting was rebuilding the face to a younger age. But the truth is that I don't believe that face lifting should be paid for by insurance, but I do believe that lipoatrophy should because it is a disease that is a result of a disease process and/or a series of medications.
So that's sort of the history behind lipoatrophy and my own personal struggles with treating these patients. When Sculptra [poly-L-lactic acid, New-Fill] came along as a possible treatment choice, I was a little skeptical, because I had tried other fillers for lipoatrophy patients. The volume required was always extraordinarily large and it didn't seem that other fillers really were satisfactory, in terms of long-term goals for these patients.
Having said that, I have personally not tried silicone, liquid silicone, for lipoatrophy. I know that there are some doctors that are using it. I have not tried it.
Silicone is permanent, and can be given in large volumes, right?
Well, silicone is permanent, and has to be given in small volumes over multiple sessions. But the total, aggregate effect, if properly placed, is to give sort of a larger net volume. The problem with large volumes of silicone is that silicone can move around a little bit, and can -- if too large a volume is placed at once -- lead to massive inflammatory, tumor-like reactions, which are essentially irreversible. So not being a silicone fan for cosmetic use, I have not become a silicone fan for reconstructive use with lipoatrophy.
You are a fan of Sculptra?
I am a fan of Sculptra. The story behind Sculptra is interesting because here, the FDA [U.S. Food and Drug Administration] approved it only for use in lipoatrophy patients. Yet in Europe it was approved initially as a cosmetic filler, as New-Fill. I would have patients who would come to me and ask me if I would do New-Fill before Sculptra was available here. My policy is not to do anything that is not FDA approved, in terms of injecting non-FDA-approved materials into the face. So I never did.
I'm kind of glad I didn't, because New-Fill went through a period where the dilution was wrong, and there would be lumps and growths, and that type of response was seen in patients in Europe. So I think that by the time it came to the U.S., all those kinds of problems had already been worked through in Europe, and we got a product that was essentially ready to use, with a time tested experience behind it that we could rely on.
So Sculptra now -- which is New-Fill, but just labeled Sculptra as a different name in the U.S. -- is doing remarkably what it says it will do, and that's rare. Many times, the hype of a new material exceeds its ultimate utility. Yet, with Sculptra, it seems to be doing exactly what the company says it will do, which is to provide reliable, large volume filling in lipoatrophy patients that can last two to three years and then needs a little touch-up. Of course, it's only been approved here for about a year and half, I guess, now. So we don't have that long-term personal experience yet. But so far -- in terms of its response and its ability to fill large volumes -- it's doing exactly what it's supposed to do.
Personally, I have treated probably about 50 patients so far, and I have not had patients with lumpiness or any downsides at all, other than perhaps needing more than initially we had expected they would need, for really adequate filling.
What's the actual procedure like?
What we do is, patients avoid aspirin and nonsteroidal anti-inflammatories, like ibuprofen, for a week or so before the procedure, because it is a series of injections into the deep parts of the face. So anything like that can cause more bruising than they need to have. So they avoid those types of things. Other than that, they basically just come in as an office procedure.
Typically, when I'm treating a full face, as I would with lipoatrophy, we would do some nerve blocks to anesthetize most of the face. The Sculptra is mixed the night before. Sculptra has to be mixed the night before use because it has to hydrate for a number of hours. So it comes as a freeze-dried powder, and we hydrate it the night before.
Hydrating means just adding a lot of water?
Adding water, not a lot of water. We basically add 3 cc of water, which is less than a teaspoon of water, the night before. Then we come up to a teaspoon, which is a total volume of 5 cc, with some lidocaine, which is like a local injection that will add to the numbing effect of the injections so that the patient is more comfortable during the injections themselves.
What is the active ingredient?
It's L-lactic acid, which may not be the full name. It is essentially an irritant that is injected that the body forms a collagen reaction to. So each little particle of Sculptra is like sand in an oyster. The body forms a pearl around it. Now, if you have too much sand altogether, then you get a lump. So the trick with Sculptra is to dilute it to the proper dilution, so the individual particles are spread apart enough so that you don't get lumping, but you get a total volume improvement once all that collagen is formed around each little particle that is in excess of the initial volume of material that's placed. Is that clear?
Yes, very clear.
OK. So the patient comes in, we give them some nerve blocks to anesthetize the face -- which is essentially what you get at a dentist before you get dental work done. Not a pleasant experience, but nonetheless, not a difficult one to take. No anesthesia is needed; no intravenous or sedation or anything like that is needed. Then we proceed with the injections. The injections are a series of needle sticks throughout the face, in the areas that we want to fill with Sculptra.
The needle gauge is a fairly small needle gauge. It's relatively painless, although not completely painless -- the process. But most patients grade the whole experience, on a zero to 10 scale, if 10 were the most severe pain that they had, they would grade it at around a three or a four, in terms of how painful or how uncomfortable the experience is.
How long does it take?
The whole process of injecting takes about 15 to 20 minutes.
How do you go about determining where the injections go exactly?
Well, I get the patient involved to tell me where they want to have filling. That's the best way. Then, just based on experience with how the material should be placed in different parts of the face -- because there is a little bit of a difference, depending where we're trying to fill -- how deep or how superficial the material should be placed to give the best possible result.
It's very helpful to see pictures of what the patient looked like before they had the lipoatrophy, because that way we can also try to figure out with the patient if they [are] going to actually be able to be like that [again]. Or will they have to settle for some filling, but less volume in their face than they had before they had the disease.
How long before you see an effect? Do you see one immediately?
Well, immediately, you have some swelling. So patients love the way they look immediately. They look great, all swollen up, and just like they ought to have looked before. Then, within the first few days, all the swelling goes away, and so all the effect goes away completely.
So here they are. They have either spent a fair amount of money on this, or they have certainly gone through an uncomfortable procedure and they don't see anything a week later. Then the body starts to form collagen. It takes about three weeks, when most patients tend to start to see some filling and feel some feeling. If they have never had Sculptra before, they will feel it before they see it, in the sense that the tissues will feel fuller and firmer to them, as they touch their face.
So it's a gradual process of growing collagen.
Right. So the process is sort of 80 percent, 85 percent there at about six to eight weeks. Typically, I'll see a patient back at about six weeks and decide whether they need another cycle of treatment.
Very typically, even with mild lipoatrophy patients, the patients need at least two cycles of treatment, and each cycle involves injecting one vial of Sculptra -- which is 5 cc of fluid with the Sculptra mixed into it -- per side of the face. A minimal sort of a treatment would be two cycles, so four vials altogether. But more typically, with more severe lipoatrophy, we'll inject eight to 10 vials, fairly typically. And that's spread apart. Each injection session is two months apart from the one before. So it's a long process of gradual filling, but it is reliable.
The collagen itself, once it's established, does it remain in place, and is it fairly permanent?
Collagen deposition is a dynamic process. So it's not like the collagen is deposited and it just sits there. It's constantly being deposited and reabsorbed by the body. The role of Sculptra is to maintain itself there, to stimulate ongoing collagen production. The studies that were done that the FDA reviewed before approving Sculptra actually showed that at two years, patients were better off than they were at one year after treatment. So you even have some increase, gradual increase in volume, even down the line.
So there's collagen turnover, but as long as the irritants from Sculptra remain in place, the body produces collagen there.
What happens if the irritants go away?
Well, they all do. They dissolve to water, eventually, and go away. So what happens then is that the collagen that was deposited there starts to go away. That's when patients will come in. And like I said: We haven't seen that yet because we are only about a year and a half into the experience of Sculptra here. But judging from what the European guys tell me, at that point, patients will come in and need another touch-up treatment with another couple of vials of Sculptra to maintain the result.
What are some of the responses? What do patients say to you when they come back for that second visit?
Typically, after one treatment session most patients say, "Well I see a little bit of an improvement. I don't see a whole lot. Is this worth it?" I tell them yes, because it is, and I know that it will be for them.
Then after the second treatment they come in and say, "Wow, this is looking really good. Can we do more?" But the response is always, at each session, "Gee, I wish we had a little bit more funded." So it's important to actually realize that the 5 cc of volume we're putting in to each side doesn't translate to 5 cc of actual volume of collagen response. It's more like 2 cc. So it's about half, or a little bit less than half, of what patients will see at the end of their injection session, is what they'll end up with after that first treatment.
But that builds a nice base. Then with the second treatment, patients really see usually a pretty impressive improvement. Then with ongoing treatments after that, again, satisfactory improvement with each session. So it's clear to them that it's worth doing as they proceed in this process. I have not had an unhappy Sculptra patient yet.
Yes. As long as patients know what to expect and don't expect to have overnight improvement, and [realize] that it's going to take many, many months to get them to where they want to be -- as long as they know what to expect -- the material does what it's supposed to do.
Do you ever use it for other parts of the body?
I'm a facial plastic surgeon, so I don't do anything outside the face. But I do use it off-label, for cosmetic use in patients. But of course, that's off-label, and it's not sanctioned by its FDA uses.
Are there any other particular products that look really promising to you?
The other big product that's being used, I think, fairly commonly -- in New York, anyway -- is Radiesse [calcium hydroxylapatite]. Radiesse is temporary filler that can give volume that is a one-to-one volume ratio. It's relatively inexpensive, compared to Sculptra, and the effects last for about a year. You don't have to wait as many weeks between treatment sessions. You just put in what you want to put in, and you're done.
Does it work in the same way by producing collagen?
No. It works just as a space filler. So it just sits there and takes up space. It's very popular, and I think the results are good, judging from colleagues of mine that use it and like it. I think patients like it because it's less expensive than Sculptra, but the longevity is not there. I'm more of a proponent of doing something that will last as long as possible, so that patients don't have to keep running back and getting more injections.
What's the cost of Sculptra treatment?
Typically, the cost of treatment is about $1,000 per vial, so it's quite costly. It's a very costly material for us to obtain, as doctors. So you can imagine if even a mild case of lipoatrophy requires two vials, that's a $2,000 investment -- which is not inexpensive, for sure; but it's $2,000 over two to three years, so that's, I don't think, too bad. Probably most patients spend more on their hair than they do on that. But having said that: [Dermik Laboratories], the company [that produces Sculptra], has a program where patients who earn less than a certain income per year can qualify for either reduced cost or free Sculptra. It's a fabulous program. It's, I think, a wonderful thing that the company's doing. Every doctor who has had Sculptra training knows about this program and can supply the appropriate forms to their patients. I have a number of patients on that program, as well.
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