SCULPTRA, a long-lasting filler that has been used since 2004 to plump the cheeks of H.I.V.-positive patients with facial wasting, is finally having its cosmetic debut. In July, the Food and Drug Administration approved Sculptra Aesthetic — as the cosmetic version is named — for use to improve the appearance of nose-to-lip wrinkles (think Jack Nicholson’s Joker), horizontal chin wrinkles and so-called marionette lines that frame lips.

But that is not to say Sculptra is a new-to-the-ball debutante. Since 2004, Sculptra has been used off-label not only to tame stubborn skin folds but also to add volume to cheeks and temples withered by time. Now that Sculptra has been approved for some cosmetic uses, plastic surgeons and dermatologists are expecting a surge of interest.

Previously, little prevented a dermatologist or plastic surgeon from recommending Sculptra to a patient gaunt from exercise or distressed by hollow cheeks. In fact, last year, plastic surgeons and other doctors treated nearly 80,000 patients with Sculptra, up from 46,732 in 2005, according to the American Society of Plastic Surgeons.
Sculptra has already won over some doctors and patients. One advantage is its longevity; it can last up to two years once an optimal result is achieved, while alternative fillers including Restylane, Juvéderm and Evolence generally last a year or less. Another advantage is Sculptra’s ability to address broader depressions like sunken cheeks.

That said, the drawbacks of Sculptra include the need for several treatments in some cases to achieve a desired result, the need to massage the treated area for up to a week, and the risk of developing lumps beneath the skin.

Dr. Z. Paul Lorenc, a plastic surgeon in Manhattan who offers eight kinds of fillers, thinks of Sculptra primarily as a “volumizing agent.” Fillers tackle wrinkles or depressions by discretely plumping up tissue, Dr. Lorenc said. Sculptra, he said, “diffusely increases the volume of the area I’m injecting.”

Made of a synthetic material called Poly-L-lactic acid, Sculptra is injected deep into the tissue below the skin to spur a patient’s collagen growth gradually. Results — sometimes months in the making — look natural, a benefit touted by Sanofi-Aventis U.S., the company that makes Sculptra.

“What we bring to the market is natural and gradual replacement of lost collagen,” said Brent Ragans, the vice president of general therapeutics at Sanofi-Aventis U.S. “If you look at it from a consumer standpoint, the ability to look better over time, without people looking like something has been done” is desired.

Collagen renewal takes patience. “This is not a lunch-time filler,” said Dr. Karol A. Gutowski, chief of plastic surgery at NorthShore University HealthSystem in Illinois. “You don’t come in and boom, you’re ready to go to your cocktail party the next day.”

Often, multiple treatments, spaced four to six weeks apart, are necessary. Some lucky people respond to a single treatment, but two or three is more typical, most doctors interviewed for this article said.

At a time when many anti-aging fillers offer immediate results, that wait-and-see period tested the patience of Dr. Kevin S. Pinski, a dermatologist in Chicago, and that of his patients. “It’s a little bit of a tough sell,” said Dr. Pinski, who injected Sculptra in patients for roughly two years and no longer does.

Cost, too, can be an issue. Dr. Pinski, who is on the advisory boards for filler marketers Allergan and Medicis, then charged $1,000 for each vial of Sculptra. That results would last up to two years “was pretty darn good,” he said, and worth the final bill for some patients.

Other doctors nationwide charge $800 to $1,200 per Sculptra vial. At Dr. Lorenc’s office, a vial of Sculptra is $1,200, while Restylane and Juvéderm are $750 a syringe.

Side effects of Sculptra include tenderness and redness near the injection site. But what has caused the most concern is the occasional occurrence of small bumps that can be felt under the skin. Some bumps are visible. Doctors speculate that they are undispersed Sculptra or a result of not injecting deep enough.

Massaging after injection helps evenly distribute the product, some say, as does massaging injection sites for five minutes five times daily for five days after treatment. Dr. Gerald N. Bock, a dermatologist in Stockton, Calif., was so concerned about nodules that he discontinued his use of Sculptra. In a recent interview, he said, it’s a “nice filler” for broad areas like hollow cheeks and temples, but “you can certainly do that with other fillers like Restylane, Radiesse or Juvéderm.” They just won’t last as long, he said.

In 2008, he called Sculptra a “time bomb” on his Web site because a few patients developed nodules, one 18 months after treatment. That blog post hasn’t stopped Sculptra representatives from wooing him. One once told him that several company representatives who received Sculptra treatments “have nodules they can feel but can’t see.”

Clinical trials found that 8.6 percent of patients who had been treated with Sculptra Aesthetic developed lumps. “That’s a bit high,” said Dr. Mark L. Jewell, a plastic surgeon in Eugene, Ore., and the organizer of the Physicians Coalition for Injectable Safety. “That to me is certainly higher than what I’ve seen with hyaluronic acid-type fillers.”

In a recent interview, Dr. Adriana Guana, the medical director for Sanofi-Aventis dermatology products, including Sculptra, emphasized that the patients who had complications were “still happy.” The lumps “were not bothersome, they were not serious, and they resolved spontaneously.”

But patients who are horrified by their Sculptra lumps are not hard to find; their stories of woe are hotly discussed on cosmetic enhancement sites like RealSelf.com and MakeMeHeal.com.

Several doctors said the solution for a lump is either to wait months or years till it goes away on its own, or, Dr. Lorenc said, “you can excise it, that’s the real answer.” In contrast, after injections with hyaluronic acid fillers, “if you get a lump or bump or whatever, it can be injected with hyaluronidase” to dissolve it, said Dr. Alan Gold, the past president of American Society of Aesthetic Plastic Surgery. A doctor’s skill matters when it comes to all anti-aging injectables, and that is especially true for Sculptra. Dr. Lisa M. Donofrio, a dermatologist with four offices, including one in Manhattan, said she is upfront with candidates for Sculptra. “I can put it safely in you,” Dr. Donofrio said she tells them. “After that, it’s up to how your body forms collagen around this product.” (Dr. Donofrio has been paid to consult for the marketers of rival fillers Medicis, and Allergan; in 2004, Sanofi-Aventis.)

What’s more, off-label usage can be problematic because doctors can’t be educated for such indications by the maker of the injectable. “The company can’t even mention off-label uses,” said Dr. Brian M. Kinney, a clinical assistant professor of plastic surgery at University of Southern California. “If something became too enthusiastically implemented without a critical enough eye, the chances of problems greatly increase and we are not serving our patients.”

Several years ago, before Sculptra was approved for cosmetic use in the United States, Dr. Kinney was trained by Sanofi-Aventis in Europe to use Sculptra for facial wasting in H.I.V. patients. But as Dr. Guana of Sanofi-Aventis said, “what happens after the training is the physician practice and their own judgment.” Dr. Kinney began injecting Sculptra at his practice in Los Angeles after his return, and taught other stateside doctors how to best inject for aesthetic enhancement.

But the trouble, as Dr. Kinney sees it, is that when off-label uses of an injectable are not openly discussed there is a “risk of not wide enough a dissemination of pros and cons.” As of late July, Sanofi-Aventis can offer robust training for cosmetic indications for doctors, but some don’t feel that will necessarily change the landscape.

In the coming months, Dr. Robert Singer, a plastic surgeon in San Diego, foresees “a lot more people using it who aren’t appropriate providers” and he fears an uptick in injectors using Sculptra Aesthetic in inappropriate areas like in the lips and under-eye depressions. “I don’t want to say it doesn’t have its place,” said Dr. Singer, who has not injected much Sculptra in his practice. “I have friends who use it and like it. I think it needs to be judiciously used and I’d be concerned in superficial areas.”

Reposted from the New York Times

“I decided to hold off and see how things go. Who knows what’s going to happen tomorrow. So I decided to go with fillers, because I know that will freshen me up for at least a year, and then I can decide, get the surgery, like a year or so, as long as things are going well,” said Coco.

Dr. Lorenc said during the economic downturn, his office has definitely been seeing more patients practice a similar amount of caution.

“What we have seen is patients, for instance in the past would come in for a surgical procedure, have transitioned, some of them, not all of them, but some of them to non-surgical approaches, fillers, lower toxins. And some of the patients that have come in for fillers, lower toxins, have transitioned into even simpler procedures,” said Lorenc.

Dr. Alan Gold, president of the American Society for Aesthetic Surgery said it’s a trend that’s happening across the board.

“We have seen in a poll taken for the American Society for Aesthetic Surgery, in our members, we have seen approximately 50 percent, a little over 50 percent in our members have reported a downturn in their practices as a result of the downturn in the economy,” said Gold.

In the midst of a recession, Dr. Lorenc’s practice has implemented a fancy term for discount, they call it “compassionate pricing”.

We care about our finances, and we care about our patients finances. And if we can help someone make the decision, maybe they will not be able to have surgery today, but let’s give them something to make them feel better. By giving them a compassionate pricing program it helps them to say, maybe I can afford it,” said Lorraine Russo, Executive Director, Lorenc Aesthetic Plastic Surgery.

According to Dr. Gold, the demand in the field of plastic surgery will always be there.

“When we see the economy turn around, whenever that may be, I think that you are going to see an abrupt uptick higher than what we usually see, because that is pent up demand. People will say, okay, I can’t have a surgery this year, or in this last six months. But six months to a year from now, they are still going to be interested and are still going to pursue that concept of having surgery,” said Gold.

Reposted from NY1

I recently decided to get quadruple blepharoplasty, which means I’ll get the fat sucked out from under both eyes and have some skin and fat removed from the crease of both eyelids. Those fat pockets have been giving me angst for years—I feel like they make me look tired and older—and I want them gone! My upper eyelids weren’t really a problem, but I have noticed some sagging there and I figure this will keep them looking good for another 10 years or so. I chose to have the procedure done by aesthetic plastic surgeon Paul Lorenc, M.D., who’s been practicing in New York City for more than 20 years and who’s very well known and respected. During my initial consultation, I felt so comfortable with him and his staff. I didn’t have one iota of doubt about his—or their—ability to take care of me.

The main “hump” in deciding to get the procedure was having surgery, which I’ve never done, and undergoing anesthesia. Also, I admit I did have some concern about becoming one of “those” women, who’ve had work done and altered their appearance. I hate seeing all those scary facelifts in Hollywood—and on the Upper East Side in New York City—but my fat bags really bothered me. I finally realized, why put up with it when I can do something about it? I kept a diary of my experience—from a few days before to a few weeks after—and snapped some photos of my progress. Take a peek:

Four days before the surgery:
I have to go see a medical photographer who will take shots of my eyes and face (for those photos you often see on doctors’ websites). I have to take off all my makeup and when I see the images several days later, it’s not pretty. You can see the before shot here.

Three days pre-surgery:
I see my primary care physician for a physical and blood workup so they can spot any potential health issues that could pose problems during the procedure. I get a clean bill of health (except for a high cholesterol reading!) and am cleared for surgery. I create a living will online—just in case…. (I’ve been meaning to do that anyway and now seems like a good time.)

The day before surgery:
I’m very nervous. I meet with Dr. Lorenc, who explains how the surgery will go. I tell him again that I don’t want to come out of this looking different…just better. He assures me that he’s not going to give me that surprised look that so many women have after eye surgery. Dr. Lorenc is very direct yet reassuring, which I find comforting. He doesn’t sugarcoat anything or over-promise. He seems to take a conservative approach, which I like. I feel better after talking with him and Lorraine Russo, who’s the executive director of the practice. Tonight I get a call from anesthesiologist Tim Vanderslice, M.D., who works with Dr. Lorenc. He wants to see if I have any questions and to make sure I take the anti-nausea medication I was given (to counteract potential side effects of the anesthesia). It’s the anesthesia that worries me the most. My procedure only requires a very light sedative, often referred to as “Twilight” or conscious sedation. It’s not as deep as general anesthesia and has fewer risks as a result (no anesthesia is 100 percent risk free, though). You wake up from it immediately after the procedure and it clears your system quickly. I’ve had it for an endoscopy, which only lasted a few minutes. This procedure will take an hour.

The big day!
It’s Friday morning. I sleep surprisingly well and feel more excited than nervous by the time I get to the doctor’s office. Dr. Lorenc has a state-of-the-art, fully accredited operating room in his offices where he can perform most procedures. I have to admit, I like the fact that I don’t have to go to a hospital. It’s much more relaxing to be here and I feel safe. (If I were having a more invasive procedure, I might opt for a hospital.) Lorraine talks to me for a while when I first arrive, and then I speak with Dr. Vanderslice in person, who asks more questions about my health and does so much to relieve my anxiety about the anesthesia. Tall and very fit with fun, sleek eyeglasses, he just looks capable, which helps calm me down as well.

Pretty soon I’m on the table. Dr. Vanderslice inserts a needle for the sedation (hate that part!) and Dr. Lorenc asks me to close and open my eyes a few times. He marks the skin on my eyelids where he’ll trim. The anesthesia begins and we start chatting about restaurants in my neighborhood. The next thing I know I’m waking up and being moved to a chair. I sit for a while and then my friend Trisha comes to take me home. I can open my eyes a little but things are blurry since I’m not wearing my glasses.

Once I get home, I take a pain pill—the only one I’ll take during my recovery—and go to bed for a few hours. When I wake up I lie there and answer phone calls from family and friends. There’s no pain and soon I get up and move to the living room. I start icing my eyes with cold compresses every 20 to 30 minutes or so to reduce swelling (this continues all weekend). By the time Trisha comes back to check on me and bring me dinner Friday evening, I’m watching television and feeling surprisingly good. (Although I don’t look so good. Check out this photo.)

The day after:
Dr. Lorenc told me to take it easy all weekend, although he did encourage me to go out for a walk. It just happens to be the first really nice weekend this spring and everyone’s outdoors. I put on my sunglasses to cover my eyes so I don’t scare people, but I don’t have my contacts in so I can’t see much—it’s a very blurry walk (note to self: Get prescription sunglasses). I’m still a little tired, probably from the anesthesia, and if I do too much, I get a little woozy. It’s a good opportunity to just lie around on the couch and relax. I’m amazed that there’s no pain, and I’m still icing regularly. I snap another shot to show my family how much my swelling and bruising went down in just one day.

Two days after:
More of the same: A little less icing, a little more walking. Still no pain.

Three days after:
It’s Monday and I can’t take being in my apartment a minute longer. I head to work wearing my glasses, which kind of cover the bruising along my lower lids, but I still have white bandages across the stitches on my upper lids. Nobody at work really says much—maybe they’re afraid I got into a bar fight. I feel great.

Four days after:
I get my stitches out today! There aren’t any stitches inside my lower lid, where Dr. Lorenc removed the fat through tiny incisions. The upper stitches are somehow done inside the incision, so all he has to do is pull the string on one end and out they come—and that’s when I feel like I’m going to pass out.

I’m not allowed to do heavy exercise for a few more days and nothing where my head is down for the first couple of weeks (no yoga). I do daily walks to stay active, but I’m missing my studio-cycling classes!

Five days after:
I can’t believe how much the bruising and swelling has decreased!

Ten days after:
I have to attend a strategy meeting for a group I’m involved with and I was initially a little worried about how I’d look, but there’s only a sliver of bruising and nobody notices a thing (at least, nobody says anything).

Two weeks after: There’s no bruising and my eyes look great. There’s no puffiness underneath and the scars in the crease of my eyelids get lighter every day (plus, they’re well hidden). My upper lids are still a little numb; Dr. Lorenc says the sensation will return over time as they heal. My lower lids hurt if I pull on them, which I sometimes do in the morning if I forget and start rubbing my eyes.

A month later:
I see girlfriends over Memorial Day and nobody notices that I look different, although they all say I look great. The same thing happens at a meeting: I get several compliments and I start to wonder if people are seeing a difference without knowing exactly what it is. It doesn’t matter to me that nobody can tell what I’ve done (in a way, that’s good). What matters is that I notice and I love not having those fat bags under my eyes anymore! I feel more confident and I actually don’t mind getting my picture taken (I used to dread it because I hated how I looked).

Dr. Lorenc tells me it will take a few months before I’m completely healed and the swelling is 100 percent gone. That’s when I’ll see the “final” results. Even if it doesn’t get any better than it is now, though, I’ll still be ecstatic!

Reposted from Shape Magazine, July 2009.

The office is located at 500 Doyle Park Drive, Suite 300.

Republished from PressDemocrat.com

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