Saturday, June 11, 2011

‘Vampire Face-Lifts’: Selphyl Injections of Your Blood Platelets

In fact, it’s not surgery, but an in-office procedure that entails having blood drawn from your arm, then spun in a centrifuge to separate out the platelets. They are then injected into your face, with the hope of stimulating new collagen production. Selphyl, as the system is called, arrived on the booming facial-rejuvenation market in 2009, and is now used by roughly 300 doctors nationwide in the name of beauty, said Sanjay Batra, the chief executive of Aesthetic Factors, which manufactures the Selphyl system.

This year, the “vampire face-lift” has been promoted on “The Rachael Ray Show” and “The Doctors.” It’s also gotten air time on more than a dozen local news programs, some of which presented unproved claims that results will last two years.

Dr. Drew Ordon, one of the hosts of “The Doctors” and a board-certified plastic surgeon, gushed on air, “Vampires have moved into plastic surgery, too, and I’m one of them.” The patient in his segment had also recently had her own fat injected into her face to plump it, so it wasn’t clear that platelets had anything to do with her fresher appearance. (Not that that stopped audience applause.)

Ghoulish as the procedure sounds, some patients prefer the idea of using their own blood rather than a neurotoxin or synthetic filler to rejuvenate their faces. “We all want to look better,” said Joan Sarlo, 56, who underwent a Selphyl “vamp-lift” performed by Dr. Lisa A. Zdinak, a Manhattan-based doctor whose specialty is ophthalmic plastic surgery. But the “less unnatural the better,” Ms. Sarlo said. “What could be better than your own blood?”

Some doctors say that fillers taken from one’s body are less likely to cause irregularities and bumps in thin-skinned areas than synthetic ones like Sculptra Aesthetic. But at this point, it’s hard to tell whether “platelet-rich fibrin matrix,” or P.R.F.M. (the medical term for the golden-hued platelets that Selphyl extracts), is an effective filler for hollowed-out cheeks and wrinkles.

Dr. Anthony P. Sclafani, the director of facial plastic surgery at the New York Eye and Ear Infirmary, said he’s seen the revivifying effects of P.R.F.M. on cosmetic patients last for more than a year — sometimes 18 to 24 months. (Dr. Sclafani is a paid consultant for Aesthetic Factors, and most of his research on Selphyl has been financed by the company.)

But no national clinical trial has been done to prove such claims. “There simply isn’t any objective data out there supporting the claim of two years,” Dr. Jeffrey M. Kenkel, a board-certified plastic surgeon and a spokesman for Physicians Coalition for Injectable Safety, wrote in an e-mail.

Dr. Phil Haeck, the president of the American Society of Plastic Surgeons, is troubled by the lack of research proving the efficacy of Selphyl, which costs $900 to $1,500 for a procedure that takes less than a half-hour. “There are no scientific studies, only personal attestations,” he said, adding that he thinks the “creepy” concept is as antiquated as bloodletting to cure disease. “This is another gimmick that people are using to make themselves stand out on the Internet in a real dog-eat-dog part of medicine.”

What’s more, doctors and consumers aren’t clear on where Selphyl stands with the F.D.A. In a YouTube video featuring Dr. John Argerson, a board-certified family medicine doctor who works out of Refine MediSpa in Johnson City, Tenn., tells consumers that Selphyl is a “newly F.D.A.-approved filler” for nose-to-lip folds. And in a December 2009 article in Dermatology Times, a trade publication, Dr. Ranella Hirsch, a board-certified dermatologist, said Selphyl is “a new F.D.A. approved dermal filler.” This week, Dr. Hirsch, who doesn’t use Selphyl in her practice, said that she couldn’t explain why she misspoke, adding in an e-mail that “the lack of clarity between F.D.A. approval versus F.D.A. clearance to market is a key point.”

Indeed. The F.D.A. has not approved or cleared P.R.F.M. derived in a Selphyl centrifuge to be marketed for facial rejuvenation. In 2002, the agency cleared a blood-collection system called Fibrinet, whose platelet-rich byproducts orthopedic doctors then used to speed tissue repair. In 2009, this same machine was born again as Selphyl, and since then, the company promoted it as a way to “reverse the natural aging process.” This week, Shelly Burgess, an F.D.A. spokeswoman, said that Selphyl’s maker would have to file an amendment to get clearance to market its blood collection system in a new way, and no such amendment could be found at this writing.

View the original article here

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