Halloween trick? FDA approves antiwrinkle shots made with plexiglas Posted by Liz at 10/31/06 02:58 PM

The Wall St Journal reports that there has been some controversy with this product, as unlike other antiwrinkle shots--it stays in the body permanently. Some doctors worry that problems with ArteFill would also be permanent. The Wall St Journal:

Many doctors said they will wait and see how ArteFill performs before offering it to patients. It "has a somewhat spotty history in other countries and can lead to long term lumps under the skin that don't heal unless they are injected multiple times with steroids or are excised," said Joel Schlessinger, an Omaha, Neb., dermatologist who said he is an Artes consultant. Kenneth Beer, a dermatologic surgeon in Palm Beach, Fla, said: "I'm a little bit scared of it. After it's out for a while, I might revisit it."

Injections of plexiglas and cow hide? Long term lumps on your skin?...may be a good plot for a horror movie, Boo!

comments (34)

1 Posted by Joe at 11/01/06 03:43 PM

I, like other commentators, find injecting plexiglas disturbing. But if people are dumb enough to do it, so be it. In the fifties, some women injected their breasts with silicone. Then millions upon millions have undergone surgery to implant sacks of silicone or saline to "enhance" their breasts. They inject their bodies with botox. I don't know what else is going on but I don't think you can legislate against stupidity. I'd leave consenting adults to suffer whatever consequences there may be from such elective procedures.

2 Posted by GreenbeltGirl at 11/01/06 03:51 PM

As long as our society says men with wrinkles are rugged and handsome and women with them are just plain old...as long as no one frowns upon middle-aged men trading in their "old" model for a "newer" 25-year old...as long as Kate Moss can do drugs and Naomi Campbell beat up assistants and still be selected by magazine editors to grace their covers...as long as these things continue, there will be wrinkle-fillers, etc. When the idea of beauty can be redefined to include older folks, there will be rich plastic surgeons...all that said, I have noticed that Olay is using "real" people in their ads now and trying to redefine the beauty ideal. This is probably not necessarily an altruistic move on their part, considering the baby boomers are a HUGE group and all aging now, but at least it is a move in the right direction.

3 Posted by Dan 62 at 11/01/06 04:01 PM

Not our place to judge. We still have choice and we still have Capitalism folks! If there is a market, the product will sell. I would assume getting injections of "Plexi-hide" would be elective. So, removal of the bumps should be elective as well. Means, "NOT COVERED BY INSURANCE." Be wrinkle free and take your lumps! It's the American way.....

4 Posted by Lou at 11/01/06 04:23 PM

As Popeye once said, "I am what I am and that's all that I am." Since, as I age, wrinkles are a part of me, I'll live with them. What a shame that we're so youth-obsessed (spelling?) and vain as a society.

5 Posted by bj at 11/01/06 04:44 PM

The procedure has been performed since 1992. In the U.S., Douglas Hamilton, MD, performed the procedure on what is believed to be the first patient treated with Artefill or Artecoll in the U.S. in early 1998. He was one of the 10 investigators chosen around the U.S. (and the only one in the Los Angeles area) to do studies for the manufacturer to apply for FDA approval. By June 2004, Dr. Hamilton had performed more Artefill or Artecoll treatments in his Beverly Hills & Woodland Hills offices in the Los Angeles area than any other American physician. He presented the first two major addresses at an American meeting of physicians when he was invited to speak at the annual convention of the American Academy of Dermatology in 1999 and in 2000. This AAD meeting is the largest annual meeting of dermatologists in the world.

6 Posted by bj at 11/01/06 04:49 PM

efinition
ArteFill is a new permanent soft tissue filler produced by Artes Medical, Inc. (San Diego, Calif.) that is expected to be approved by the FDA for cosmetic use in 2006. It is made of injectable polymethylmethacrylate (PMMA) microspheres with a diameter of 30-42 microns in a bovine collagen base with 0.3% lidocaine. The company says that the PMMA microspheres provide a scaffold for human collagen deposition. After approximately three months, the collagen vehicle is largely replaced by (endogenous) collagen leaving only the original 20% PMMA microspheres.

History
ArteFill differs from Artecoll, its predecessor. There are less than 1% PMMA microspheres less than 20 microns that can be phagocytosed by macrophages (predisposing to granuloma formation). Furthermore, the bovine collagen is from a closed U.S. herd of cows and is processed in a “dedicated” plant in San Diego, Calif. The allergy rate of the collagen was 0% in the trials compared to 3.4% for the previous collagen that had been produced in France. The immunologic ends of the collagen are removed to decrease allergenicity and there is viral and bovine spongiform encephalitis (BSE) inactivation of the product. The syringes for Artecoll and ArteFill are also different, with the latter having a density more similar to glass to prevent drying out of the product, as well as being more ergonomic. In the U.S. clinical trial of 251 patients completed in 2001, Artecoll was found to be superior to Zyplast at three, six and 12 months and had less frequent adverse events. Five year follow-up of the study subjects confirms the permanence of the product.

Indications
ArteFill is a permanent soft tissue filler that can be used to restore facial volume. It will be FDA-indicated for nasolabial folds. Other uses may include soft tissue defects such as marionette lines, defects after rhinoplasty, acne scars, etc.

Contraindications
Although ArteFill is often used in the lips, lumps are more common in this area of heavy movement, and the FDA panel suggested it may be contraindicated in this area. As the product contains bovine collagen, patients who have a known hypersensitivity to that product should not receive augmentation with ArteFill.

Ingredients
ArteFill is made of injectable polymethylmethacrylate microspheres in a bovine collagen base with .3% lidocaine. ArteFill must be refrigerated. It is an opaque substance that is available in 1.0 cc preloaded syringes, in packages of five pre-loaded syringes, three of which contain 0.8 cc and two of which contain 0.4 cc.

Technique
A 26 gauge, half inch needle is supplied with ArteFill and this should be securely attached to the syringe to avoid inadvertent product loss. A small amount of ArteFill is extruded through the needle tip to ensure the smooth flow of the ArteFill. It is important that this smooth flow continues during the injection in order to avoid depositing the material irregularly. Excess pressure on the plunger should never be necessary. If the smooth flow stops, do not increase the pressure, but rather remove the needle from the skin and check that the ArteFill will still flow smoothly, then continue.

ArteFill should never be injected superficially and injection at the lowest level of the dermis is ideal. The material is usually injected using a threading technique as the needle is withdrawn to get the most even microstrands, not microdroplets, of deposited material. However, some physicians inject as the needle is advanced and withdrawn. Injection of ArteFill is a different technique to that used with other available fillers, and it is necessary to acquire this new skill in areas which are low-risk such as the nasolabial or melomental folds. The company recommends deep dermal placement and injection on withdrawal only, but experienced users may prefer injecting just under the dermis and injecting on both advancement and withdrawal of the needle. A few treatments (at four week intervals) may be necessary to gradually and safely get to correction.

As ArteFill is permanent it requires proper training.

Complications
ArteFill side effects can be seen and are usually due to technical mistakes, such as injecting too superficially, unevenly or overfilling. This can result in lumps or nodules, especially in the lips, which may need to be excised. If blanching occurs during injection, the substance has been injected too superficially. Granulomas are reported in .01% (1:10,000) patients. The latter can be treated by an intralesional injection of corticosteroid and disappear with time, but are disturbing for patient and physician.

Conclusions
Artes expects ArteFill to be approved by the FDA in 2006. An FDA Advisory Panel recommended approval with some conditions and the FDA also imposed certain manufacturing issues, which have now been addressed. As with any permanent filler, ArteFill requires proper training before it is used on patients.

References
Cohen SR, Holmes RE. Artecoll: A long-lasting injectable wrinkle ?ller material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects. Plast Reconstr Surg. 2004; 114:964-976.

Lemperle G, Morhenn VB, Charrier U. Human histology and persistence of various injectable ?ller substances for soft tissue augmentation. Aesth Plast Surg. 2003; 27:354-66.

Smith DC. The genesis and evolution of acrylic bone cement. Orthop Clin North Am. 2005; 36:1-10.

Lemperle G, Romano JJ, Busso M. Soft tissue augmentation with Artecoll: 10 year history, indications, techniques, and complications. Dermatol Surg. 2003; 29:573-587.

Lemperle G, Gauthier-Hazan N, Wolters M, Eisemann-Klein M, Zimmerman U. Foreign body granulomas after all injectable dermal ?llers: Possible causes and treatments. Plast Reconstr Surg. In press.

7 Posted by Liz at 11/01/06 04:57 PM

Talk about wrinkle inducing, check this out: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3934t1-am%20session.htm

It's the transcript of the FDA advisory meeting where they discussed this product.

8 Posted by Roberta J. Meyer at 11/01/06 05:06 PM

I'll ask my dermatologist's opinion; if he recommends it, I'm changing doctors.
If people are worried about society's attitude, move to an Active Adult Retirement community for the 55+. If you dress nicely, wear a tad of makeup and cut out the perms, your wrinkles will disappear.

9 Posted by Walter at 11/01/06 05:12 PM

Oh, Good! At last a chance to use something so ridiculous that approval by any phase of government should be dubious.

What is wrong with Botox? Why should anyone in their right mind shrink from cosmetic surgery, various electronic "snake oil," the advice of "eminent" plastic surgeons, Estrogen therapy, and social acceptance at least one level above our real income?

After all, it goes with the overpriced home, vehicle, entertainment, false social status, and shunning of the terrible cast tag, "Blue collar" of any form of physical labor (oh, the stigma of it all!) not mandated by a "personal trainer."

This is not the "Atomic age," or the "religious war" age, this is the "personal facade" age. Too fat? don't do anything rash such as to adjust your diet, or walk to the gym, or ride a bicycle to work, oh, no. Get liposuction and surgery performed instead.

One "Appearance center" owner I know, (It used to be a "beauty parlor") went whole hog for all of the above, and more. She, of course, received a commission for recommending the treatments for her customers. Last week at a funeral, I happened to encounter her, however, I didn't recognize her. Her face had all headed for her chin, leaving her contact lensed, falsy-colored eyes, blinking from a field of large, swollen or overlapping folds of skin, complete with nasal noises from a now largely dysfunctional nose, and wrinkled lips. She looked, for all the world, like a clothed, speaking, blood-hound standing on its varicose veined hind legs!

Ladies and gentlemen, if this is what you want, go to it! After a few years, when your immune system, your muscular structure, and your skin all reject the "wonderful new you," you can get a part in "Little shop of horrors, or the "Elephant Man." The rest of us, wrinkled, bald, living in hovels, driving our "out of date vehicles", and avoiding various "chic" restaurants, and fast food, using our own eyes, and wearing glasses, etc. will then inherit the advantage over you, the deformed, ill, and "freak show" objects.

You, in turn, will inherit the permanent status of "Adams Family look alikes."

10 Posted by Zelda at 11/01/06 06:34 PM

It's no worse than injecting Botulism into your face, which is basically what Botox is. Anyone who feels they have to inject their faces with poisons, just to hide some wrinkles, is nuts in my opinion. I agree with Evelyn Montonen, what happened to growing old gracefully??

11 Posted by Don at 11/01/06 08:54 PM

Sorry but I trust no drug that is advertised on TV. Most are what I call VANITY DRUGS

12 Posted by John at 11/01/06 10:25 PM

I don't even know what to say. plexiglas injections for wrinkles. Grow old naturally and WAKE UP people.

13 Posted by Lisa at 11/01/06 11:04 PM

I get really sick of seeing the same pretty faces on the covers of all the magazines. Where are the "real" people. I applaude Mervyn's department store for using larger models in their ads. I think we need to see more of this. We need to change our opinion as a society of what beautiful is. It is not just how you appear.

14 Posted by Betsy Wolf-Graves at 11/01/06 11:44 PM

I was hypnotized by bj's profesional and dispassionate description of ArteFil. Seems there could be a lot of missteps in the procedure. Also, once in, it seems to be impossible to remove this witch's brew.
And should the plexiglas travel throughout the system, what might be the consequences? It would be interesting to learn how the FDA voted in this monster.
Betsy 11-1-06

15 Posted by david bergman at 11/02/06 04:38 AM

Nothing surprises me considering Pres. Bush replaced the head of women's health issues at the NIH (the one who refused to release RU486, even though approved) with a VETERINARIAN! Moo.
Kept waiting for women to be burning things in the street, even the NIH on the evening news. No such luck.
Anticipated same or similar response to pharmacists at chain stores refusing to fill scripts that disagreed with their religion! That died out in a flash, but still goes on.
Alternative medicine anyone? Let's hear more about that. Suzanne Sommers, local here, has a lot to say.

16 Posted by DANIEL CELLARS at 11/02/06 08:27 AM

IT'S INSANITY.FDA THAT SAYS IT ALL.MONEY NOT HEALTH

17 Posted by Craig at 11/02/06 11:15 AM

Most of the people who get these treatments should be put in a mental institution anyway, because they have serious inferiority complexes. In general, they are a walking mass of self-doubt and fear about what others think about them. They're the same people who react in horror at some poor child with disfiguring birth defects who desperately needs love and acceptance. Yet they blow the money on their own appearance, thinking it will make people love and accept them better. In reality, it only makes people use them for their looks, then throw them away when surgery no longer works. The answer is not to live in a fantasy world, but to force yourself to deal with reality. IMHO, cosmetic surgery should be reserved for those who medically need it; otherwise, it severely damages the maturity of people everywhere. And remember, civilization is about serving others and helping the weak. Barbarianism is about serving yourself. A civilized society cannot exist when nothing but barbarians are around to form it.

18 Posted by M.E. at 11/02/06 06:13 PM

I've been waiting two years for this product to be approved in the USA. My plastic surgeon hopes to use this for my scar revisions from an accident and I can't wait.

19 Posted by Linda A. at 11/03/06 03:32 PM

Injectable plexiglas? Well, why not? After all, we've been able to get injectable botulism toxin (Botox Cosmetic) for a while now. It's a free country; no one's holding a gun to our heads, so we should be able to get ourselves injected with anything we want at our own risk, right? Oh, only if it's FDA approved, of course, (like THAT'S a real guarantee of safety). Remember that Bextra, Celebrex, and Vioxx were also FDA approved, and look what happened with them.

20 Posted by Hilary at 04/12/07 02:44 PM

PMMA (what you call plexiglas) is not actually plexiglas. There are a lot of factors- such as size of spheres that makes up something. PMMA has actually been used in the body for a long time as bone cement- for hip replacements. Haven't seen people with problems with this substance in the body (and its used in a lot larger quantity!) Education- Education. It is fine.