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Having a double chin isn’t a disease. But Allergan summary of treatment for it disease mongers anyway

Allergan Receives FDA Clearance For the CoolSculpting® Treatment To Improve Appearance Of Lax Tissue In The Double Chin

Our Review Summary

This news release by the Irish pharmaceutical company Allergan covers a recently FDA-cleared fat reduction technology to treat double chins. CoolSculpting is claimed to be the first of its kind to be cleared by the US regulatory agency.

However, we found that not to be entirely true, since other non-surgical, FDA-approved fat reduction technologies like injectable Kybella already exist on the market. Kybella is also made by Allergen. Whereas Kybella uses acid to induce cell breakdown, CoolSculpting crystallizes the cells. While Kybella and other technologies reduce double chin, they do not deal with lax skin in the area. Only the Cool-Sculpting technique claims to treat lax skin.

It needs to be highlighted that when a product is “cleared” by the FDA (as this one was) it is not the same as an “approval” which is what Allergan received for Kybella. As outlined in our toolkit primer, a device that is cleared may not go through the same testing nor be required to show the same level of evidence that an earlier product may have.

The news release also doesn’t disclose many details regarding the procedure, costs and corresponding clinical trials leading to FDA approval. Benefits data are given in relative terms, and study design and limitations are not really discussed. The release cites results from a survey that found 73% of patients are bothered by chin fat. The suggestion here is that all of these people are candidates for chin fat reduction — something we equate with disease-mongering.

On the plus side, readers do get a good sense of how available the treatment is and where to find CoolSculpting centers from this news release.

 

Why This Matters

Conservative therapies to reduce or eliminate double chins through diet and exercise don’t work very well. Lipolysis, also called liposculpture, can include liposuction and may give more dramatic results, but this procedure requires a local anesthetic and a recovery time of one to two weeks. If the problem is sagging, loose skin, the patient might even opt for neck lift surgery, which is usually performed under general anesthesia or intravenous sedation.

If there is a non-invasive, cost-effective fat reduction technology clinically proven to eliminate double chins, that would be a viable alternative and newsworthy for both clinicians and the public.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

According to CoolSculpting.com, the company estimates costs ranging between $2,000-$4,000, depending on the number of areas treated. Purely cosmetic procedures are typically not covered by insurance, unless you can make a case that it’s “medically necessary” (e.g. your droopy eyelids interferes with vision).

Since costs are not discussed in this news release, we rate this one Not Satisfactory.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release presents all evidence in relative terms. For example, the double chin treatment “reduced fat up to 20 percent in the treated area after one treatment.” Furthermore, “77 percent of patients showed improved appearance of lax tissue and 75 percent of patients reported their chin looked more toned following treatment.”

When data are given like this, it’s important to ask “x percent of what?” There’s a big difference between having 4 people in a study versus 10,000. And how big was the treated area and how exactly was improvement measured?  How much improvement is there with a 20 percent reduction in fat collection?  How much was the improvement in lax tissue?

We recommend presenting benefits data in absolute terms when possible. One journal article reported that in 60 study volunteers, 20 percent chin fat reduction correlated to a 2.0 mm reduction on average. Clinical photographs and ultrasound imaging were used to assess treatment efficacy. Pre-treatment and post-treatment photographs were shown to three physicians, who had to determine which image was the pre‐treatment one. Participants were also given a written questionnaire after 12 weeks to evaluate their satisfaction.

Since benefits data are given in relative terms and we are not told how many patients were involved with the studies (it was 60 in the study cited above and just 14 in another), we rate this one Not Satisfactory.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

CoolSculpting.com states the procedure is proven to be a safe and effective. However, there are risks associated with this treatment. The addendum to the release does contain information about potential harms so we rate this as Satisfactory.

According to CoolSculpting’s patient safety document, subjects may have redness, blanching, bruising, tingling and stinging immediately after the procedure. One to two weeks after treatment, patients could also experience cramping, numbness, skin sensitivity and “sensations of fullness.” In addition, cold exposure to certain nerves may cause tongue deviation, lower lip weakness, dry mouth and a decrease in saliva production. Some rare side effects include late-onset pain, first and second degree frostbite, fainting, nausea, dizziness, nodules in the treatment area and hyperpigmentation. Some patients have even experienced “paradoxical adipose hyperplasia,” meaning they experience the reverse reaction and end up with more fat cells in the area.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

We don’t know much about the study design from the news release — only that the clinical trial lasted 18 weeks.

We find out more about the quality of evidence from the original journal article, patient safety document and ClinicalTrials.gov entry. This was a multicenter, prospective, open label, non‐randomized interventional cohort study. All 60 participants underwent the cooling treatment — most receiving two cooling cycles — and were followed up for 12 weeks. According to the original journal article, the study’s primary endpoints included the monitoring of adverse events and the identification of at least 80 percent of the pre‐treatment images by three blinded independent reviewers. The journal article also mentioned that chin “fat layer thickness” on ultrasound actually increased in eight subjects.

One limitation was there was no control or comparison group in the clinical trial, since everyone received the cooling therapy. This was also a small study with only 60 subjects, with an average age of 49.3 years and a mean BMI of 31.8. Investigators acknowledge another limitation — namely that chin fat reduction wasn’t quantified on a standardized scale, “thus providing an assessment of the relative clinical improvement.”

We would have liked more details like these on the study, which is why we give the news release a Not Satisfactory here.

Does the news release commit disease-mongering?

Not Satisfactory

The release suggests that a 2017 consumer survey “…revealed that 73 percent of patients are bothered by excess fat under the chin.”  Really?  Are these survey participants bothered enough that they want the “excess fat” removed?  And if so, what is wrong with the rest of us who are not eager to do so?  This statistic suggests that the vast majority of the population are candidates for treatment with this device — and that’s simply not the case.  We’re rating this Not Satisfactory for disease-mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The 2015 clinical study we found online states that Zeltiq Aesthetics, then manufacturers of the CoolSculpting System, sponsored the research. All three authors of the study were on the medical advisory boards for Zeltiq and received research support and grants from the company. One of the investigators also owned Zeltiq stock.

Just for clarification, Dublin-based Allergan acquired Zeltiq Aesthetics in April this year.

Since none of this is explicitly disclosed, we rate this one Not Satisfactory.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release is silent on alternative approaches which is why we rate this one Not Satisfactory

Double chins are often associated with weight gain. Therefore, most people can get rid of double chins through a healthy lifestyle, like a nutritious diet and regular exercise.

There’s anecdotal evidence that chin exercises could help eliminate double chins, like holding a ball under your chin, puckering your lips while looking at the ceiling and stretching your tongue in various directions.

Other approaches include mesotherapy, which delivers fat-dissolving substances through a series of injections.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release says the technology is available through a network of CoolSculpting centers worldwide. It also refers readers to its website, where you can search for a list of clinicians and specialists offering the procedure.

We rate this one Satisfactory.

Does the news release establish the true novelty of the approach?

Not Satisfactory

We don’t think Allergan can claim novelty with this product since other non-surgical, FDA-cleared fat reduction technologies like Kybella (also made by Allergan) are already on the market.

The news release, as well as the CoolSculpting website, states this is the “first and only non-surgical fat reduction technology to be FDA-cleared for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments.”  We also consider Kybella to be a “non-surgical fat reduction technology” that was on the market before the CoolSculpting treatment. Therefore, we rate this one Not Satisfactory.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not include sensational, unjustifiable language.

Total Score: 3 of 10 Satisfactory

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