See legal disclaimer at bottom of post.
Paradoxical adipose hyperplasia (PAH) is a known potential adverse side effect of cryolipolysis treatment using CoolSculpting. Cryolipolysis is a non-surgical cosmetic treatment to reduce fat in targeted areas. Unfortunately instead of losing fat, patients who developed PAH experience an increase in the size and density of fat cells in the treated areas. Currently, the percentages of risk of developing PAH after CoolSculpting (provided by the manufacturer) are stated to be 0.033 percent of treatments (1 in 3000).
Per the manufacturer, “Under rare adverse events, paradoxical adipose hyperplasia (ph/pah) is characterized by a visibly enlarged tissue volume within the treatment area, which may develop two to five months after treatment. Surgical intervention may be required. PAH is not related to any CoolSculpting device failure mode but it is included in the risk management files of the device because it is a risk that is inherent to the use cryolipolysis for localized fat reduction”.
The majority of PAH symptoms appear on the lower abdomen (33%), but PAH can develop at anywhere that was treated by CoolSculpting. Other sites where PAH has been reported are (but not limited to) the upper abdomen, flank, inner thighs, submental, outer thighs, back or bra fat, upper arms and knees.
What does PAH mean?
PAH stands for Paradoxical Adipose Hyperplasia. Paradoxical means unexpected. Adipose is fatty tissue. Hyperplasia is an overgrowth of cells. PAH has been described as “a delayed increase in adipose tissue at the treatment site” and “a gradual enlargement of the treatment area; a well-demarcated subcutaneous mass, slightly tender to palpation.” https://academic.oup.com/asj/article/41/8/932/5995602
Think of normal fat cells as squishy grapes; soft, smooth, and fairly uniform, like blobby jello. The fat cells from PAH are more like those original grapes but now they are smaller, somewhat shriveled and tightly glued together; they are uneven and grow together in a tight, dense mass.
The following link provides a picture comparison of normal adipose cells with that of PAH (see figures 3 and 4). https://academic.oup.com/asj/article/36/1/NP6/2613982
What are the statistics for PAH?
There is limited data regarding PAH other than the manufacturer-provided risk ratio of 0.033 percent with a few studies that suggest a higher incident rate. With over 17 million treatments sold, a 0.033 percent incident rate would translate to roughly a total of 5,600 patients who may developed PAH following CoolSculpting. https://www.nytimes.com/2023/04/16/style/coolsculpting-side-effect-risks.html
Notably, for the year 2023 there were approximately 100 reports of hyperplasia due to CoolSculpting reported per month to the FDA’s MAUDE database.(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm)
If there have been 17 million treatments sold and we hypothetically spread those out over 10 years, that would equal 1.7 million treatments per year. At a 1 in 3000 incident ratio that should result in up to 566 incidents of PAH per year. So, do we have a slight discrepancy because the FDA’s MAUDE database suggests possibly 1200 reported incidents per year?
How Is PAH Treated?
Most people originally chose to pursue CoolSculpting because it is a non-surgical/non-invasive option for addressing problem fat areas. Ironically, their only option to address the PAH is to undergo the exact surgery they were hoping to avoid. That surgery does not come without its own risks; the risk of complications from liposuction is estimated to be .004 percent (slightly higher than the PAH reported risk percentage) https://pubmed.ncbi.nlm.nih.gov/38348141/
As the only currently known treatment for PAH, power-assisted liposuction (such as VASER) appears to be primary method to correct PAH because traditional liposuction may not be as successful in fully addressing PAH. Even with liposuction, there is a possibility that PAH can return especially if it was not completely resolved. In some cases, abdominoplasty might be necessary. Because of the bulge and resulting skin laxity caused by PAH, many patients also require skin tightening treatments such as Renuvion or BodyTite.
The need for a subsequent revision surgery following initial treatment is not uncommon, especially in cases where the PAH returns or a deformity still exists after treatment.
What To Do If You Have Or Suspect You Have PAH?
Everyone’s situation is different. The important thing to do is not rush to any decisions. Depending on where you live, you may have 2 years or more after you have been officially diagnosed with PAH before your statute of limitations for personal injury expires. If you do decide to pursue a claim directly with the manufacturer, their agent may try to pressure you into making decisions in a very short period of time. So the best thing to do is to do your research and have an idea of how you want to proceed before taking any action.
With that, here’s a list of suggestions if you’ve decided to pursue corrective surgery and file a claim:
- Find out what the statute of limitations is in your state. On average, it is 2 years from date of diagnosis or injury but this varies by state.
- Consult with a plastic surgeon familiar with PAH to get a diagnosis and a quote for the corrective procedure.
- Take photos of the affected area(s) regularly.
- Avoid gaining too much weight if possible. They may claim weight gain, not PAH, is the problem.
- Contact your CoolSculpting provider, who will confirm the diagnosis made by your surgeon and will begin submitting all the documents needed for your claim to AbbVie for participation in their Cool Confidence Program. Also, ask your CoolSculpting provider for copies of your medical records and any CoolSculpting releases that you signed.
- If your original provider is not able to assist you, you can ask your surgeon to submit your claim or reach out to AbbVie representatives directly at PLSProductSurveillanceteam@abbvie.com
- Report your PAH to the FDA’s Manufacturer and User Device Experience (MAUDE) for non-invasive body contouring devices
- https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Select “Medical Device”.
- You can request that your information not be shared with the device manufacturer, or you also have the option list your first and last name as “Anonymous”.
- If you are in Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/medical-device.html
- https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
There is also a PAH CoolSculpting Support Group if you want to reach out to others.
What Happens After You Submit Your Claim?
Once your claim as been submitted, you will be contacted via email by a representative of a third-party insurance provider and claims processor for AbbVie. They handles claims that are processed through the Cool Confidence Program (see below). Their role is to essentially resolve your claim at a dollar amount they are authorized to offer you without the need to have AbbVie lawyers intervene. They will be your sole contact for this process, as long as things go smoothly and as long as you don’t have legal representation (also, more on that below).
You will be asked to provide a copy of your surgery quote (they’re only interested in the cost of liposuction, and will ignore anything else in the quote), and the need for your address, social security number and signed release before any funds will be issued to you.
A few weeks after you provide your surgery quote, you will receive a financial offer for settlement along with a deadline to accept the offer.
The claims processor seems to routinely offer up to $7,500 (per Cool Confidence) but there have been rare reports of offer adjustments up to $10,000, $11,000, and $15,000. Keep in mind these reports of offer increases don’t reflect whether there was more than one affected PAH location (i.e. stomach and thigh).
The Cool Confidence Program
The manufacturer of CoolSculpting offers up to $7,500 for a corrective procedure if you have a confirmed PAH case. Presumably, the Cool Confidence program is meant to reduce litigation due to PAH, as well as assure CoolSculpting providers that AbbVie will take care of claims on their behalf.
Keep in mind that the Cool Confidence program is only meant to reimburse you for the cost of standard liposuction, which varies widely but on average is $5000 for uncomplicated procedures (PAH is complicated). It does not cover costlier VASER liposuction, skin laxity treatments or procedures, lost income due to appointments or recovery, or any emotional distress resulting from the PAH disfigurement or surgical experience.
It also does not address any subsequent procedures should your initial corrective procedure not be effective in completely eliminating your PAH, or if you have any complications that arise from the corrective procedures.
Your claim will be processed within the Cool Confidence Program as long as there are no “hiccups” that might require the need for AbbVie lawyers to intervene and as long as you don’t retain the services of an attorney. If things do get complicated or if you disclose that you’ve retained an attorney, your claim will get referred to AbbVie’s counsel (currently Butler Snow LLP) who will handle your claim moving forward.
What’s In The Release Form?
In exchange for compensation, you’ll be asked to sign a release that indemnifies AbbVie, its representatives, and your original CoolSculpting provider from any future liability. A very general overview of a sample release is as follows:
- You are prohibited from sharing any details with anyone regarding the terms of the settlement other than to say it was “amicably” settled.
- You agree to not be party to any future class action lawsuit.
- You agree not to sue for any future health issues associated with PAH.
- You agree to be solely responsible for any and all medical bills.
- You agree that neither you nor your heirs can pursue lawsuits in the future (what if your corrective surgery goes badly?).
- You agree not to disparage AbbVie or any of its representatives (to news orgs, social media, etc).
There are plenty of things to consider in this release. The ones that stood out:
The Class Action Lawsuit Prohibition
Should you decline their offer with hopes to participate in a possible future class action lawsuit? That seems tempting but keep in mind that class action lawsuits can take 2 to 5 years if it is not settled in advance. You should research the average per-person payout from class action lawsuits to get a better idea of what you might expect if the litigation is successful. You’ll probably find that the majority of the settlement or proceeds are distributed to the attorneys and the primary plaintiffs. The class members divide up the rest. If there were 17 million class action members, what would that per-person payout look like? Just food for thought. One of the benefits of class action suits is holding big companies accountable.
The Known Injuries And Future Lawsuits Clauses
As a layperson, these clauses seem to suggest that you are aware that there could be future known or unknown risks or complications as a result of the PAH and you (and your heirs) waive any right to pursue litigation for these known or unknown risks. As mentioned earlier in this post, there are risks associated with the corrective surgery needed for PAH. If you accept the settlement and develop serious complications (or worse) after corrective surgery, you and your heirs waive the right to hold them accountable. Another hypothetical situation to consider could be that at some point in the future it is found that PAH could be far more serious than just a “cosmetic” adverse side effect.
If you are going to consult with an attorney about your best course of action or to help review the release documents, do not disclose this to their representatives until you have officially retained counsel. They may abruptly end all communications and settlement discussions with you even if you don’t retain an attorney.
Try to keep all communications with AbbVie representatives in email or other written format.
Summary
Again, how you proceed is a very personal decision. You might decide to sign their release, take the settlement amount, get your corrective procedure, and put the whole mess behind you.
Based on the risks related to surgery, would it be better to wait until after the corrective procedure to sign the release? (For many, paying for the surgery up front is not financially possible.)
PAH Survey
A survey has been created to gather aggregated information from people dealing with PAH after CoolSculpting. It will hopefully provide a general idea of what to expect along the way.
Your responses are anonymous, none of the answers are required, and only contribute what you are comfortable answering. Google does require that you log in to participate in the survey (the survey is limited to once response per person), but no email addresses or account data is shared.
Link to survery: https://docs.google.com/forms/d/e/1FAIpQLScmhsV6xbziZCS-Tj9DxSE3CHN43FK2qMVbJ8F3iTCvo8Tzzg/viewform
One Final Consideration
While PAH is a known risk related to CoolSculpting sessions, what if the development of PAH coincided with a machine-reported error or malfunction? Was there an applicator error, treatment quality error, or thermal event detected? Was the equipment part of a previous voluntary recall due to higher incidences of PAH? Had it been serviced for malfunction before or after your treatment?
Were there any device or procedure-related adverse events that occurred during your sessions? The technician would have manually documented this and/or the Coolsculpting machine’s system messages will have logged this (see page 49 of their user manual https://media.allergan.com/products/BRZ-101-TUM-EN3-J.pdf). This could be relevant given that there were four device and/or procedure-related adverse events (out of 60 subjects) in one of AbbVie’s own clinical trials. https://www.accessdata.fda.gov/cdrh_docs/pdf15/k151179.pdf
It’s doubtful that you would be able to get this information from AbbVie without going through actual litigation, but it’s something to keep in mind should you pursue legal action.
Sources
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
https://classic.clinicaltrials.gov/ct2/show/results/NCT03909100?term=NCT03909100&rank=1
Link to possible surgeons from Facebook support group
Disclaimer: The information contained in this post is not intended to be used as medical or legal advice.
