Doctors in Europe Refuse to Use Sculptra, Why Do You Continue To Use It?

Honestly, I ask myself the same question every day.  Sculptra is made of poly-L lactic acid, the same substance that Vicryl sutures are made of.  Vicryl sutures are great, they handle extremely well , hold a knot phenomenally and absorb over an appropriate period of time.  The problem is that the human body does not like them.  If they are remotely close to the skin surface they will form what is called a 'suture abscess' or 'sterile abscess.'  Most abdominoplasties will have at least one or two sutures spit and recently I had some very annoying vicryl sutures spit in a facelift.  This is with a tiny amount of poly-l-lactic acid.  In these applications it is annoying but generally acceptable when it happens.  To inject a mass of this substance deep into the face is in my opinion absolutely undoctorly!

So why did Sculptra ever get approved...its all about the money.  Companies look at substances that are already approved for implantation ie suture material and in the case of Radiesse, bone cement, another evil.  It short circuits part of the FDA process and money rolls in while patients faces are destroyed. 

When I first heard of the product being used in this manner, I was disgusted and said" here comes another flood of complications."  I am prpoud to say that I have NEVER injected the substance and NEVER will.  The ONLY kind of doctor that can inject Sculptra is one that doesnt think, doesnt see their follow up patients or is just to unethical to care.  Good for you for bringing up this subject that is near and dear to my heart as I see my fair share of patients with atrophied facial fat, deep granulomas, and infections from this product that should NEVER be injected into the face.  To add insult to injury, the manufacturer calls the violent inflammatory response and scaring a "stimulation of your bodies own natural collagen."  You serve other potential patients well for getting the word out.  Good for you!

 

All the best,

 

Rian A. Maercks M.D.

For those in the lay public reading this question and answer thread, Sculptra is a very safe product.  As I was told in my training, "There is no such thing as a minor procedure, but there are minor Surgeons".  As has been threshed out in this Q&A, Sculptra is made from L-polylactic acid and is designed to act as a bio-stimulant of collagen production.  It is very technique specific and requires 5-7 days of reconstitution in sterile water prior to use. If it is not injected or reconstituted properly, injected too superficially, or if the patient does not follow the guidelines for post-treatment massage, it can lead to nodule formation.  For these reasons, it is critical to see a Physician who is very well versed in Sculptra.  Having been a trainer for this product, I will freely tell you that it does not belong in every injector's hands, but can produce marvelous results.  Statements such as, "It's over in Europe" are incorrect and misleading. I would reference Dr. Tholen's very thoughtful remarks on this issue.

Sculptra is used commonly in over 30 countries throughout the world since 1999, including European ones. Just as there are advocates and detractors of many products, techniques, and procedures, so are there for this product. It's NOT "over with" in Europe, and the material Sculptra and Vicryl sutures are made from has been exhaustively studied in the human body for many years.

Vicryl sutures used to close skin incisions can indeed develop stitch abscesses. But that is not because the human body "does not like them," it is because the braided suture material is placed within and adjacent to sweat glands, sebaceous glands, and hair follicles, all of which contain bacteria. These "normal skin flora" can multiply and thrive in the warm, wet, microscopic spaces (interstices) within suture braids, and this is true for Vicryl or any other type of braided suture used for skin closure. It's the braided suture construction and the proximity to bacteria, NOT the synthetic material!

And that's why thoughtful ethical plastic surgeons who follow scientific methods have commonly switched to monofilament skin sutures rather than continue using Vicryl or Dexon (another company's synthetic braided suture) for skin closure. Some of us even have switched our drain fixation sutures from silk (another braided suture) to Nylon or Prolene (monofilament sutures), even though it takes more careful knot tying and two additional throws. But there is less reaction, inflammation, and less bacterial contamination traveling from the drain stitch to the drain and then inside the body!

It's NOT a "Vicryl reaction," it's a stitch abscess, and it's due to bacteria, even if the lab culture comes back "negative." (Laboratories typically do not report "normal skin flora" bacteria as pathogens, nor do they provide antibiotic sensitivities, but that does not make these abscesses "sterile," just unrelated to nastier bacteria that typically are reported in cultures.)

Sculptra is the same material as Vicryl sutures, but in a powder form. It is mixed with sterile water, and is injected into the deep dermis where it stimulates collagen production gradually over a period of several weeks. Small amounts are tunneled in a grid pattern; it is NOT injected as a "mass" nor is it injected "deep in the face." Properly injected and with proper patient compliance (massage of the treated areas), lumps or irregularities are rare, and the gradual improvement in volume occurs over several weeks. This is an effect that is subtle and appreciated by patients with contour depressions or decreased facial volume that are the intended recipients of this kind of biostimulant. Since each vial of reconstituted Sculptra has a volume of 7-8cc, and one or two vials are used per session with 1-4 sessions at 3-4 week intervals, this is a much more effective way to achieve visible changes as opposed to injecting multiple1cc HA fillers.

Hyaluronic acid fillers (Juvederm, Restylane, etc.) are fine products, but it would be prohibitively expensive to use these kinds of volumes for treating facial contour deformities or lipodystrophy.

Many European doctors continue to use Sculptra; those that use it properly, for appropriate indications, see beneficial results and happy patients, especially since the improvements last 1-2 years, significantly longer than HA fillers. Those that never learned to use it properly may indeed have poor outcomes, lumps, and unhappy patients; such is true for any product, procedure, or technique. RealSelf statistics from the public list a 63% approval for Sculptra, so there are both good (and some not so good) users.

I'm quite happy to call a spade a spade, and I owe no company allegiance due to "consulting fees" or "spokesperson honararia." But when a good product is unjustly maligned, I feel I must speak out.

And BTW, Radiesse is not "bone cement." It is hydroxyapatite, the mineral content in bone and dental enamel, so it is a naturally-occurring substance in the human body entirely distinct from methyl methylacrylate, which is the bone cement used in orthopedic surgery.

Sorry, but facts trump unsubstantiated bluster. Best wishes to all! Dr. Tholen