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New ways to plump up those wrinkles
February 04, 2007
Some beauty junkies are excited about ArteFill, billed as the first permanent filler.
Our Review Summary
This story described a product called ArteFill, and said it was “billed as the first permanent filler.” But the story never challenged that claim, and didn’t quantify potential benefits or harms.
It said "known side effects are minimal." But on the FDA website, it’s easy to see that side effects include:
* Lumpiness at injection area more than one month after injection
* Persistent swelling or redness
* Increased sensitivity
* Rash, itching more than 48 hours after injection
And several contraindications for use are listed. Perhaps consumers should judge if those sound "minimal" or not. The story also never mentioned that one of the conditions of FDA approval last fall was that a five-year study for safety be done after approval, a clear sign that reviewers were not convinced that all the evidence on safety was yet in.
The story also profiled only one woman who had the injections, saying that “she thought she looked fresh” and “was sold” “in less than 30 minutes.” That is hardly a balanced testimonial, especially when the FDA website makes clear that “In a clinical study most patients needed more than one injection to achieve optimal wrinkle smoothing. The average number of treatment sessions was 2.28.
There was some caution provided by a second source, from the American Society of Plastic Surgeons, and some useful background given by the reporter at the very end of the piece.
But Dr. Gupta’s joking summary about whether he or the reporter had a “need” for the product only tends to promote its use and promote the disease-mongering idea that wrinkles, indeed, are a disease that must always be treated. Such a parting comment can undo any balance that may have existed in the piece prior to that point.
Click on Criteria for definitions.
The story stated that "We've even heard now that dentists and gynecologists are getting into the act of giving people these shots." And it advised, "What you want to look for is a certified plastic surgeon or a cosmetic dermatologist. You want someone who gives these shots all the time, not just as a side business. You also want to ask if the facility where you're going to be getting the shots can handle emergencies, because sometimes things do happen, and you want to make sure that you're at a place that can handle something happening." But it gave no idea of how difficult it may be to find such ideal professionals or settings.
The story said "One visit can cost hundreds, even thousands, of dollars." And it explained that insurance won't cover it. But it didn't explain what is clearly available on the FDA website, that "In a clinical study most patients needed more than one injection to achieve optimal wrinkle smoothing. The average number of treatment sessions was 2.28."
Any such story about a cosmetic procedure can tend to medicalize a normal variant of health - wrinkles that come with age. This story crosses a line in the summary when Dr. Gupta jokingly refers to whether his colleague or he himself "need" the procedure. Such a parting comment can undo any balance that may have existed in the piece prior to that point.
The story didn't make it clear what the product is approved for. Is it for all wrinkles? The FDA says it is intended to be injected into the nasolabial folds around the mouth to smooth these wrinkles. No sense is given of the labeled approved use of the product. Indeed, the lead-in and the first line of the story refer to face-lifts, which have much broader application than this product. No sense is given of the quality of the evidence in the clinical trials.
The story says that known side effects are minimal. But the FDA offers this list:
Side effects of ArteFill® include:
* Lumpiness at injection area more than one month after injection
* Persistent swelling or redness
* Increased sensitivity
* Rash, itching more than 48 hours after injection
When should it not be used? ArteFill® should not be used in patients who have:
* A positive response to the ArteFill Skin Test
* Severe allergies with a history of anaphylaxis or presence of multiple severe allergies
* Allergies to bovine collagen or lidocaine
* Susceptibility to form keloid or hypertrophic scars
Perhaps these side effects and contraindications are not "minimal" issues for some people. And there is no quantification of these potential harms. The story also never mentioned that one of the conditions of FDA approval last fall was that a five-year study for safety be done after approval, a clear sign that reviewers were not convinced that all the evidence on safety was yet in.
The novelty of this product and its place among competing approaches is clear in the story.
There is no quantification of benefits in the story. One could assume from the story that it has a 100% success rate after one use, as with the patient profiled, who, the story said, "thought she looked fresh" and "was sold" "in less than 30 minutes." The story said ArteFill was billed as a permanent wrinkle filler but never challenged that claim of permanence.
We can't be sure if the story relied solely or largely on a news release.
The story included the perspective of one physician who uses the product, and added a brief perspective of a spokesman for the American Society of Plastic Surgeons. The reporter's summary seemed to include the perspectives of other sources, although they were not named.
The story did mention many other products used as wrinkle fillers.
Total Score: 4 of 9 Satisfactory
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