The “Vampire Facelift” – Is Selphyl FDA Approved?

Selphyl Vampire Facelift 
There are so many clichés that one can draw on when discussing the facial volume replacement treatment known as the “Vampire Facelift”. Coming “out of the dark’ and “biting” into the hope of “eternal youth,” the savvy marketing team behind the medical device officially known as Selphyl is likely not only happy to be discussed alongside the undead; they’re probably counting on it.

Garnering images of flawless, porcelain skin and capitalizing on the ghoulish sex appeal of Edward Cullen, Selphyl was introduced to the facial rejuvenation market in 2009 and purports to use a patient’s own blood platelets to ignite collagen growth and fill in hollow areas of the face.

Far less creepy than it sounds, Selphyl is actually the name of a system that uses a centrifuge to separate out the platelets found in blood. During the 30-minute office procedure, the doctor withdraws blood from the patient’s arm, processes it in the Selphyl device and mixes the separated platelets with a proprietary concoction. The final substance is golden in color and called a Platelet-Rich Fibrin Matrix or P.R.F.M. It is then reinjected into facial areas such as the nasolabial folds (smile lines), under-eye hollows, marionette lines, temples and cheeks to restore lost volume.

Unlike synthetic dermal fillers such as Restylane and Juvederm that provide immediate results, Selphyl’s effects are gradual and often aren’t seen in full for several weeks as the P.R.F.M. works to stimulate new collagen growth. This can be seen as a benefit to those patients who don’t want the dramatic “before and after” tell-tale filler look. Some people also prefer the “what’s-better-than-me?” idea of using their own blood to plump their wrinkles rather than animal derived or synthetic hyaluronic acid fillers.

The procedure has been featured on both Rachel Ray and The Doctors, but is it FDA approved? Well, sort of. The device itself was originally approved by the FDA in 2002 under the name Fibrinet as a blood collection tool that assisted doctors in creating platelet-rich product for tissue regeneration. It was and is still manufactured by Cascade Medical Enterprises and an identical device was reintroduced as Selphyl by Aesthetic Factors, LLC in 2009. The FAQ section of the Selphyl.com web site says that the system has been cleared with permission to market with a 501(k) by the FDA; however, the original Fibrinet system has 501(k) clearance. No new clearance for Selphyl is found in the FDA database as of this publishing date.


 
However, many of today’s cosmetic procedures made their start in other medical fields.  For example, Botox was initially introduced in 1989 to treat eye muscle disorders, such as spasms that caused lazy eyes.  In addition, many “off-label” uses have been found for FDA-approved products.  If we look at Botox again, as an example, it is approved only to treat the appearance of wrinkles between the eyebrows.  But it is widely used in other areas such as crow’s feet and foreheads.  This common practice is called “off-label use” and not generally frowned upon by the larger medical community.

No significant adverse side effects have been reported, and results are expected to last about 12 months. However, the procedure is only offered by about 300 doctors in the United States, and long-term results are unknown due to Selphyl’s newness. Selphyl procedures typically cost between $1,000 and $1,500, and subtle results are usually achieved in one treatment.

By definition, the cosmetic procedure industry is always in search of the next best thing. Only time will tell if Selphyl will be another flash in the pan or will be true to its vampire name and endure – for all eternity.

 

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About Victoria Strander

Writes about the latest beauty procedures. Her articles are available for syndication. Use Contact Page for inquiries.

Comments

  1. Charles Runels says:

    Vampire Facelift procedure explained here http://vampirefacelift.com/
    Watch the video on news reports featuring the Vampire Facelift http://youtu.be/xzW5Ys-MU0w

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