Dangerous Beauty Injections?

Is our quest for youth and beauty taking us down the path to deformity and unnecessary health risks?

I’m usually an early adopter of new technology, processes and products. I’ve had “work” done via injectable collagen before it was even fashionable – long before before it became hip to have lip boosting lunches with the gals. However after reading the Wall Street Journal article on a new injectable permanent wrinkle-smoothing product called ArteFill I found myself questioning whether or not it would be wise for me to “rush in” for this treatment that promises a permanent youthful (no wrinkles) appearance. I’ve excerpted portions of the article and annotated with my thoughts. [Note: all emphasis mine]

[...]ArteFill consists of microscopic plastic particles suspended in calf collagen. The collagen is absorbed by the body and then replaced by the patient’s own collagen, Ms. Goostree [Artes' CEO - manufacturer of ArteFill ]says. The polymer beads are permanent. Ms. Goostree says similar polymers are used in other implanted medical devices, including bone cement and pacemaker covers.

The technology was invented by a German physician, Gottfried Lemperle, who co-founded Artes in 1999 with his sons, Stefan and Martin. Earlier versions of ArteFill, called Arteplast and Artecoll, have been sold by other companies for years in Europe and Canada. In 2001, the Swiss Federal Health Agency advised physicians against the use of any “non-resorbable filling material” for treatment of wrinkles, though it wasn’t an outright ban.

Although, the Swiss did not ban the product their strong wording does make me take pause about the safety of ArteFill. Why? Typically it is so much easier to get drug approval in Europe and Canada then it is here in the USA. The FDA makes drug companies jump through hoops (at times for years) prior to product approval. So if the less stringent European equivalent is raising red flags..then I am certainly going to pay attention.

Another alarming issue raised with Artefill was the possibly rogue (and illegal?) actions of Artes’ co-founder and ArteFill inventor, Dr. Gottfried Lemperle:

In a Securities and Exchange Commission filing for its stock sale last year, Artes disclosed that Dr. Gottfried Lemperle illegally injected nine people in the U.S. before ArteFill was approved for marketing. The FDA, the filing said, confirmed to the company that it had opened a criminal investigation of the matter. A product-liability and fraud suit filed against the company and Gottfried and Stefan Lemperle, among others, was withdrawn after the FDA probe came to light, but an attorney for a patient who claims she was disfigured says he expects to refile it later. Artes says the Lemperles are no longer affiliated with the company, except as stockholders. Gottfried Lemperle’s attorney, Megan Richmond, San Diego, Calif., declined to comment. Neither Stefan Lemperle or his attorney could be reached.

ArteFill, eventually did get FDA approval and Artes has begun the roll out of this permanent wrinkle-smoothing injectable.

Artes says it has so far trained about 600 doctors in the injection technique for ArteFill. Tina Alster, a Washington dermatologist, says her patients haven’t had any problems with ArteFill. She says that patients who have spent “oodles” of money over the years are asking for something longer lasting. She charges about $1,800 per syringe of ArteFill, or more than double the $800 price for the first syringe of a temporary filler like Restylane.

However, FDA approval and a five year long-term study by Artes on patients that have had excellent results from the ArteFill injections has not satisfied renown plastic surgeons, as to Artefill’s safety, such as Dr. Klein (plastic surgeon to the Hollywood and Trust Fund crowd):

Dr. Klein has become the loudest voice in the hottest debate in the small world of cosmetic dermatology: How safe is a new wave of antiwrinkle shots that — unlike their predecessors — are long-lasting or even permanent? At medical conferences in recent months, doctors have bickered over whether these products receive rigorous enough testing to gain FDA approval. Products like ArteFill are considered implanted medical devices, not drugs, and undergo a different approval process because, unlike drugs, they are believed to basically be inert fillers, leaving bodily processes unchanged. Some doctors, however, believe that the effects of these products on tissue need to be studied before they are approved because unlike earlier facial injections — such as Restylane, a device, or Botox, a drug — these treatments don’t just wear off in four to six months.

It’s also important to note that Dr. Klein has worked for Artes’ competitors in the past and perhaps his interests may not be the welfare of the patient receiving the ArteFill injection.

Dr. Klein has past and current ties to ArteFill competitors. From 2000 until last April, Dr. Klein worked for Allergan Inc., which sells Botox and Juvederm, and since 2004 he has been a consultant to Restylane maker Medicis Pharmaceuticals Corp. Dr Klein, who made $250,000 a year from Allergan for several years, says such ties “have nothing to do whatsoever” with his concerns about ArteFill. “I refuse to see the field of soft-tissue augmentation destroyed,” he says of his motivation. Allergan and Medicis say that Dr. Klein is acting on his own.

As plastic surgeons and dermatologist fight it out I think Iwill take a wait and watch stance on ArteFill. Who knows, maybe the product is the long searched for “fountain of youth” that makes good on the promise of smooth skin ( also includes filling those ugly acne scars) but it could also turn out to be a “Pandora’s Box” that leaves deformity and scarring in its wake.

You can read the article and make up your own mind but I must say it does sound quite scary at this time. I’ll leave you with this quote which certainly makes the decision , to use (for now) less permanent injectables such as Restylane or even self-donor fat, a no-brainer. (Please note, I know that there are horrible plastic surgeons out there that botch cosmetic surgeries and these deformity cases may be due to incompetent surgeons. However, there isn’t enough data yet to prove that it was bad medicine or a bad product.)

A New York plastic surgeon who signed the letter, Daniel C. Baker, says he has seen half a dozen patients who had Artecoll injections in other countries “with significant deformities.” Last month, “I did a pretty extensive operation to remove it” from the lips and smile lines of a woman injected in Paris, he says. Dr. Baker says he hasn’t reviewed Artes’s data, and adds that he has “no commercial interests or affiliations and I never have.” Ms. Goostree says it was “quite likely” that the physician who had administered the shot hadn’t been properly trained.

Further reading:

• ArteFill website
• Things Get Ugly Over a Beauty Injection – Wall Street Journal article used in this post.
• Skin Doc Worried Over Safety of New Beauty Injection