Coolsculpting Made Me Bigger: What is Paradoxical Adipose Hyperplasia?

coolsculpting paradoxica adipose hyperplasia pla

Since the FDA’s clearance of CoolSculpting, a non-invasive form of cryolipolysis, to get rid of unwanted fat, some patients have experienced a condition known as paradoxical adipose hyperplasia, or PAH. Find out what PAH is, why it occurs, how you can prevent it, and what you can do if you have been affected by it.

What is Paradoxical Adipose Hyperplasia (PAH)?

Paradoxical adipose hyperplasia is a rare, previously unreported adverse effect of cryolipolysis. Cryolipolysis uses cooling to damage and destroy subcutaneous fat cells, without damaging the skin to reduce the amount of fat in the treated area. This phenomenon of PAH has a rate of incidence of 0.0051% of the 1.5 million CoolSculpting procedures performed worldwide, which indicates it is rare. This number only reflects reported cases as PAH is not a well known side effect.

PAH causes a gradual enlargement of the treated area. It occurs when the stimulus (the freezing of the fat cell) activates a reactionary process in the fatty tissue that thickens and expands the fat cells rather than breaking them down and allowing the body to process and remove them. PAH is only known to occur following a cryolipolysis, or CoolSculpting, treatment. PAH can typically not be confirmed until you are at least 6 months out from your treatment.

coolsculp sculpsureFigure 1: Left: Photo of Man’s Treatment Area Affected by PAH (courtesy of the JAMA Network)

Benefits of SculpSure

SculpSure is the first FDA approved non-invasive, warm laser treatment for fat reduction, utilizing a 1060 nm wavelength diode laser. It is safe for all skin types and perfect for areas of stubborn fat on the abdomen, flanks, bra line, and thighs. The hyperthermic nature of SculpSure uses heat to destroy fat cells, leaving you with up to 25% less fat after treatment. The contact cooling system keeps the surface of the skin cool while the heat treats the fat and surrounding tissue.

Like most non-invasive treatments, most people will need two treatments of SculpSure to achieve the best results. Each treatment takes 25 minutes, and patients experience absolutely zero downtime afterward. Non-invasive treatments like SculpSure or CoolSculpting do not provide immediate results because it relies on your body to process and filter out the damaged fat cells which take several weeks.  Typically it takes about 12 weeks for you to see full results.

…vs. Cryolipolysis

Unlike cryolipolysis, SculpSure leaves patients with only slight tenderness rather than the intense pain patients can experience as a result of cryolipolysis. Patients have not experienced PAH as a result of SculpSure. If you are looking into a non-invasive fat reduction treatment, and there are many to choose from, consider all of the pros and cons of each procedure and read reviews to see what others are saying about it.

What Can I Do if I Have Been Affected by PAH?

If you already have PAH, know that it can be corrected. Smartlipo is a great option to correct the effects of PAH. Smartlipo is a laser-assisted liposuction procedure, known as laser lipolysis. It is performed under local anesthesia using a laser to melt the fat while simultaneously tightening the skin. Once the fat is melted, suction is applied to manually remove the fat from the area. While we understand the thought of having to have another procedure to fix what a previous procedure left you with isn’t what you had planned for, you can be confident to know that once you have Smartlipo, the problem will be resolved.

It is recommend that if you suspect you have PAH that you return to your treating facility for evaluation. If it is confirmed, they may be able to make contact with the manufacturer on your behalf for resolution.

60 Comments

trevor gill

i was to have coolsculpt , then i heard of this problem , if i went ahead and this happened i would be stuck as i cant have surgery because of a heart bypass i had 17 years ago.

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Lindsay Spires

Hey Trevor. you are in a tough spot. PAH is certainly a risk you take if you choose to have CoolSculpting. Have you looked at any other non invasive fat reduction methods that don’t have the risk of PAH but still deliver great results? SculpSure is one of the newer technologies on the market. Treatments take only 25 minutes and it can get rid of up to 24% of the fat in the treated area with each treatment. Unlike CoolSculpting there is no pain or downtime after treatment. Literally you can leave the office and go right back to work, travel, anything. We really like this procedure and our patients love the results. Please let me know if you have questions.

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Ann

I developed PAH after 3 cycles of coolsculpting..spongy, sensitive, 4″ of fat in bra-line, abdomen, flanks and tummy. 5’7″ 139LBS I wasnt expecting a miracle – only what coolscuplting promised. According to my provider it was the policy of the parent company, Allergan to pay 100% of corrective surgery if diagnosed with PAH. I was diagnosed by my provider and board certified plastic surgeon after physical examinations – neither of them contacted by the medical review before they DENIED my claim that this is PAH. The pictures prove it, the areas are 4 times the size of when I was treated and I lost 5lbs from my initial weight. DO NOT DO COOlSCULPTING!

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Patricia

Hi Ann! I had the same problem. I am so depressed because my body is just all deformed . I contacted Allergan but haven’t heard from them . What is your status now? Did they reimbursed you anything ?
Thanks
Patty

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Rob McIntosh.

The same thing has happened to me.The clinic will not give me Allegan’s contact number.do you have a contact number .it would be greatly appreciated.

Thanks

Robbie.

cherri

it happened to me to. I am 5’8′ and weigh 123 pounds. i cannot wear any fitted clothes now and it actually feels like there is something on my abdomen. it is very uncomforatable, as well as depressing.

Alyssa

I would be interested if there is a suit going. They told me my case was so rare but it obviously isn’t if all of you had this problem as well. It’s the worst thing that’s ever happened to me. Trying to make myself look a little better and now I look 10x worse. It’s so embarrassing. Someone please contact me!

Richard Gaetano

Hi Ann. I had Coolscupling done last year and I have was also diagnosed with PAH. I am working with an attorney on a class action suite. Did Allergan ever compensate you for your claim???

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Shannon Groomes

Let me know if you get that suite going. I too am a victim, never was this mentioned to me at my appts. I assume Allergan owns CoolSculpt ? Which means my claim through them will be denied as well

Ms. D.

Hi Richard,
I also was diagnosed with PAH too a year ago It’s not where I had the procedure done they’re working with me its the Coolscupling company that’s giving me the run around on my claim.
May I have the information of the attorney you’re working with if it’s ok.
Thank you

Eliza

would be interested in the class action suit. this is a horrible undisclosed side effect!

LM

I had coolsculpting done on my abdomen. Afterwards I developed two large bulges and an indented line that runs hortzontally across my abdomen above my belly button. I returned to the facility where I had it done and all they offered me were more coolsculpting treatments. After several more treatments my stomach has not improved and the bulges and disfiguration still remain. The facility did not refund me the money I had spent and has not provided a resolution. I plan to contact Zeltiq and possibly seek out legal representation. I can only imagine how many thousands of dollars I will have to spend on attorney fees and a plastic surgeon.

Karen

I was just diagnosed with PAH and on the contrary allergen was quite responsive and covered 100% of my corrective procedure.

Alisha M

Don’t do it. I went back to the facility here in Atlanta on Friday 8/11/2018 and was diagnosed with PAH in the back area. I did notice it 6 months after the procedure and knew something was wrong, but being so busy with life I finally made an appointment to see them. As soon as I took off my clothes the MA knew exactly what it was. She told me that I was the first person to be diagnosed with this at there facility. I think that this is more commen then they tell you. I am so upset that now I have to have lip. I also had the treatment perfomed on my left flank and I feel that has happened it that area as well.
She told me no but there is a difference. I am out 1500 that I paid last year and I really want my money back as well as the procedure that they are offering to perfom.

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Michel

I had it happen to me. I went back yesterday a year after having the coolsculpting done and the photos taken yesterday have been sent to Zeltiq. I do not want to go through smart lip or any kind of lipo surgery, that is why I did cool sculpting. I am hoping to get compensated.. at least the amount I paid to have it done.
It is swollen and painful.

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Lindsay Spires

I’m so sorry. We have seen a number of people that have experienced the same thing and have come to us to have it corrected with Smartlipo. I hope they make the process easy for you to get your money back. I can’t imagine how frustrated and disappointed you are. Best of luck to you and please let us know if there is anything we can for you.

Thanks,
Lindsay

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Richard Gaetano

Hello Michael. I had Coolscupling done last year and I have was also diagnosed with PAH. I am working with an attorney on a class action suite. Did Allergan ever compensate you for your claim???

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Judy

Hi, I had it done on my arms, back, inner thighs and stomach, and all areas were affected and have PAH, I was told there’s nothing you can do out side of having plastic surgery, can you give me the information about the law suite. Thanks!

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Holly Sticha

I had coolsculpting and feel I now have PHA. If I do and submit all info and am approved for smart liposuction am I able to have the procedure local or would I have to come to you?

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Lindsay Spires

You should be able to select any facility you would like to have your liposuction done to correct the PAH. We wish you the best and if we can be of any help let us know.

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Bonnie Delgado

I also ended up with PAH just below the bra line in front. My doctor said it would require a tummy tuck to rectify; however, I have since been diagnosed with a-fib and am on blood thinners. I am a young 71 year old. I’m not overweight. What are my options?

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Lindsay Spires

liposuction would help rid you of the PAH. There are many minimally invasive liposuction procedures like Smartlipo. I would consult with your cardiologist. They could put you on an injectable blood thinner for the days leading up to a procedure and the days following. I would start by speaking with your cardiologist to see if you would be able to be cleared for a minimally invasive lipo procedure to correct your PAH. Best of luck to you.

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Richard Gaetano

Hello Holly. I had Coolscupling done last year and I have was also diagnosed with PAH. I am working with an attorney on a class action suite. Did Allergan ever compensate you for your claim???

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Alyssa

Rich,
Where are you located? I am interested in getting in this claim as well. I was told the company “zeltiq” would be compensating me and still nothing! I am so
Horribly depressed.

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Etta Boykin

I had cool sculpting done over a year ago and I believe I have PAH and now my self esteem has went from on a scale 1-10 a 5 to now a 1.my. I can’t even suck in my bulge it’s very noticeable, when before the procedure I could get away with it.😔. Is there an exercise or other home remedy that I can do to get rid of this problem.o could barely afford the first and it was a birthday present 😢 HELP ME SOLVE MY PROBLEM..WILL NOT RECOMMENS THIS..I FELT LIKE THE COMPANY SHOULD BE HELD RELIABLE $

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Lindsay Spires

Etta, I’m so sorry. We have had a number of patients visit us that have PAH. We don’t offer CoolSculpting in our office, but we have corrected many that ended up with PAH as a result from their treatment(s). We use Smartlipo as the corrective procedure, it is a minimally invasive laser assisted liposuction procedure. Honestly I’m not sure if your area(s) effected by PAH could be reduced with any particular exercise, but it would be worth a shot. I’m so sorry this has happened to you, I hope that you are able to get this resolved. Best of luck to you!

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Lindsay Spires

Hi Patricia,

We use local anesthesia when performing Smartlipo. You are awake and aware during the entire procedure. We use a numbing fluid of lidocaine and epinephrine. If you have ever had dental work done, lidocaine is what they use to numb the area. If you are feeling a bit anxious about having this procedure done while you are awake we can prescribe you an oral sedative, but honestly 94% of our patients take nothing and doing really well. Please let me know if you have additional questions, I’m happy to help in any way I can.

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Skinnyguy

Rare, my ass. There’s tons of comments stating they got burned. Rare? Bahaha

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Richard Gaetano

Hello Etta. I had Coolscupling done last year and I have was also diagnosed with PAH. I am working with an attorney on a class action suite. Did Allergan ever compensate you for your claim???

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Carmen A

Will you contact me I need to know how can I contact a attorney I’m having the same problem

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alisha M

Working out will not remove the fat. I am also sad and depressed with how my body looks. My facility said that the company is going to pay for me to have smart lip. Thinking about it since 8/10/2018 when I went in for an exam I want my money back as well.

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Devastated on the West Coast

Hello all,
I had Cool Sculpting well over a year ago and I KNOW I am experiencing PAH. The area under my chin (double chin) is now much larger than the original area I was attempting to treat. Now I have quadruple chin! Likewise, my upper arms are also larger than they were prior to Cool Sculpting and I have not gained any weight. I contacted the company and I received the run around “please contact the treating provider”. Unbelievable.

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Lindsay Spires

I’m so sorry! We hear this same story from many patients. I would continue to make some noise about what you are experiencing. Hopefully you can get somewhere with the manufacturer of Coolsculpting if you aren’t making any progress with the facility that you went to for treatment. We wish you luck.

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Richard Gaetano

I had Coolscupling done last year and I have was also diagnosed with PAH. I am working with an attorney on a class action suite. Did Allergan ever compensate you for your claim???

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Claire Marie

Hi, how long after you got it done did you notice your chin getting bigger? I’m experiencing it also and am worried it’s PAH

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Rob McIntosh.

Please supply me a contact number for Allegan if you can.

Clinic refuses.before and after pictures clearly show pah.

Thanks Rob McIntosh.

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Marie Walker

I need help. I had Cryolipolysis on my inner thighs 18 months ago. I now have PAH, it’s so depressing. I had the Cryolipolysis done in the UK, but I now live in Australia. I have contacted the UK clinic to ask for the manufacturer details but they won’t even acknowledge my emails. What do I do? I really want to correct the PAH on my legs. Can I have corrective treatment done in Australia? And is the manufacturer responsible for this?
Any advice would be greatly appreciated. I honestly thought I was the only person to suffer from this and I’m so relieved to hear that there could be hope of getting it corrected.
Thanks.
Marie

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Lindsay Spires

So sorry to hear you are dealing with this. We don’t perform CoolSculpting in our office, however we have performed Smartlipo on many patients that have come to see us as a result of PAH. So it can be corrected with Smartlipo (liposuction). I hope you can get somewhere with the practice that performed your original procedure otherwise you could try reaching out to the manufacturer of the device. We wish you the best and keep us posted.

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Jacqueline Thomas

I have PAH under my chin after 2 cool sculpting treatments in early 2016. I could tell by October 2016 that there was a serious problem. The little pocket of fat under my chin that caused a slight double chin is now triple-quadrupled in size and I am ten pounds lighter than back then…. 35yo / 5’4″ / 140lbs

I completely regret getting cool sculpting done. I would take my little tiny double chin back in a heartbeat! Had I really done my research (however back then there was a lot less research/ reports on this), I would have just handled it down the road with smart lipo, or just continued living with it!

The place that treated me did tell before starting my first treatment that there was a very tiny chance that I would have an adverse reaction and that the company would pay for me to have little lipo to zap it away if needed…. but from the looks of the comments, it seems very slim to none that the parent company will admit you have PAH and compensate you.

I have heard that PAH fatty tissue is not the same as regular fat and that even after lipo/smart lipo removal, and no change in weight, the cells in that area continue to grow back fat and that one would potentially have to continue getting ongoing lipo treatments in the area.

What are your comments and experience with that?

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Lindsay Spires

I’m sorry to hear that you are struggling with PAH. We have corrected a large number of PAH cases with Smartlipo and they do really well. We have not had anyone with PAH that we corrected with Smartlipo return saying the fat has returned. It is our experience that once those fat cells are removed the problem is corrected.

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Terry

Can PAH be diagnosed with a CT scan? I had Coolsculpting 3 years ago and I was in tremendous pain on the areas treated for many months and I can take a lot of pain. I had scheduled a CT scan because I was thinking I might have a hernia but upon further reflection and research I now believe i have PAH. It has been extremely stressful and disappointing that the areas (quad around my belly button) is larger now and I have pain above my belly button which is why I’m getting the CT scan done tomorrow and then have an appointment with my provider in a week and a half.

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V.F.

I had cool sculpting in dec last year. It’s been 9 months, waiting to hear back about my case. Does anyone know what options we have?

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MaryEllen Smith

I have been thinking of doing this procedure, so I did some research looking to see if there are any trending issues; unsatisfied results and PAH seems to be the ones that keep coming up.

The Coolsculpting manufacturer is Zeltiq (acquired by Allegan), and this is consider to be a medical device registered and approved by the FDA. I have seem many complaints about PAH online. However when I researched the FDA between 3/18 and 2012 for medical device reportable events (MAUDE adverse event report database), I found almost 70 reports and a good chunk are for PAH. For the number of procedures done in a year, this is a very small number.
With this being said, the only way for the FDA to take a closer look at the manufacturer regarding to this issue is if reports are being made. Usually reports are made by facilities or manufacturers (required) from complaints received from their clients/patients, but as an individual you can (and should) fill out a report as well. There is no time limits on when to report as long as you have evidence that the incident/damaged was caused by that medical device during or as a result of the of the treatment/use.

I have worked in medical devices quality and compliance for post marketing for almost 20yrs, and the FDA takes notice of spikes in the numbers of reports received for a particular issue on a device. The safety of the patient is very important and if a device is causing harm that needs to be repaired with other procedures, it’s a higher risk than originally anticipated and registerd with the FDA. Additionally, no matter how low the number is, PAH is a possible side effect that should be disclosed.

If you are interested in looking at these reports here is the link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=zeltiq&brandname=&eventtype=&reportdatefrom=05%2F01%2F2012&reportdateto=05%2F31%2F2018&pagenum=10

A

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Boob man

I had cool sculpting done on my pectoral area and now, 3 months later I have large ManBoobs. I was told that the procedure of cool sculpting was safe and effective. After returning to the location that preformed it, they have suggested having a second round of cool sculpting done. Im afraid this will not help and make it worse. Any suggestions of if this is a good or bad idea?

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Pam

Do NOT have multiple treatments if you’re already having PAH. I had 3 treatments at the recommendation of my plastic surgeons office manager. OMG how stupid! Nothing got better, only worse. I was 12 pounds lighter when we did my “after” photos, but my stomach was considerably larger than in the “before” photo

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Danna Combs

I believe I too am suffering from PAH after cool sculpting. My stomach is way bigger than the rest of me. It is extremely out of proportion. From the rest of my body. I am miserable. I can’t suck it in & it sticks out so far. Sine I’ve been dieting & losing weight it is staying the same size. Very very frustrated & worried.

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Lisa Gardner

I am experiencing the same visible problems with my abdomen after Coolsculpting treatment 6 mo ago. Cellulite looking , hard feeling tissue on my upper and mid abdomen area. Unable to suck in my stomach anymore. Abdomen is extremely distended. I am being told by my provider that the company requires another treatment before they will cover liposuction because my pictures don’t show the exact marks of the machine on my stomach which is their indicator of PAH. I know the area affected Is a result of PAH. I don’t think I should risk another treatment as the company is recommending , do you ? I think I need to consult with a plastic surgeon and an attorney instead .

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Angel Taylor

I had Coolsculpting done April 6, 2018. I never really saw positive results and felt I was actually gaining weight instead. I had my 22 year old saline Breast Implants removed due to a Facebook Group Breast Implant Illness and Healing by Nicole. I have several autoimmune diseases and many women are getting better after removing their breast implants. There’s over 50,000 women in this group.

Anyhow, I decided to have my implants removed July 31, 2018 and to have fat transfer to the breasts. Being excited about using my own fat and getting lipo from my problem areas including my stomach was thrilling to me. However, I did tell my surgeon about the Coolsculpting only 4 months earlier and not to use that fat because it’s probably not good and I told him about my stomach becoming larger. He told me about PAH which I had read about shortly before.

As I was recovering from my Lipo and surgery I started taking pictures to watch changes in my body. My surgeon informed me that he didn’t do lipo in the abdomen because he believed I had PAH. Of course being very disappointed, I watch over the next several weeks my stomach start to form more and more into the exact shape of the two Coolsculpting areas on each side of my belly button.

I got written diagnosis from my surgeon but of course had to go back to the facility that did my Coolsculpting. She took pictures to compare to my original picture and agreed I definitely looked like I had PAH especially on my right side. She also said I’m only the second patient she’s seen this in and she submitted my pics to Allergen. Surprisingly I received a call from her yesterday and said she heard back from Allergen and that I need to go back in to have their surgeon do a final diagnosis and then submit the claim and go from there.

However, after reading all of your comments I’m now worried that Allergen won’t follow through??? I mean I had the Coolsculpting and Lipo in the flanks and my mid section looks worse than it did before. My husband is so mad I even did this to myself and then to have to go through more procedures which I had hoped were done after removing my implants and doing Lipo which I never thought I’d do.

Anyhow, that’s my story and I’ll keep everyone posted if I’m lucky enough to get Allergen to actually approve my claim. My surgical surgeon even said it’s more common than we all hear about. Good luck everyone!

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HateMyBodyAfterCoolSculpting

I had CoolScuplting done back in 2015. I was sure that both my abdominal wall and inner thighs were both larger after. My husband completely agreed that CoolScuplting messed me up. I have been working out 6-7 days a week wearing compression belts and doing 100 of abdominal work outs to try and correct what is now a huge problem area, when before I honestly thought I would do CoolSculpting to help with the little bit of of excess fat from having kids. I never hated my stomach before. And my Inner thighs never touched before. The technician just talk me into doing them because I had a free area. This has been a huge nightmare. And until know I every time I looked up complication I thought I was alone. Until know! Can someone send me the information about lawsuit. Amylynneolson@gmail.com

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Kym Nutting

I would also like to join the lawsuit. I paid almost $4000 to treat one area and it has enlarged significantly. I’m not happy.

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Mary

I went for a CoolSculpting consultation and they told me that PAH has only been seen in patients that had the old applicators (the ones that take an hour). They said the new ones that only take 30 minutes haven’t caused PAH. Not sure if this is true?

If it is, it might give you some ammunition against the location you went to. If they willingly chose to not upgrade their applicators aren’t they in part responsible along with allergen?

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KK

i am a CoolSculpting provider. I am only commenting to be sure everyone has correct and good information on how to handle this if you get it.
It is ALL applicators and ALL parts of the body and ALL people that can potentially get PAH after CoolSculpting. It’s a relatively small risk less than 1% but if it’s YOU, that doesn’t matter, it’s terrible.
The clinic where you were treated is responsible for handling your possible PAH claim. The first step is you are seen by a physician that does CoolSculpting for an official diagnosis that the appearance and feel of the area are consistent with PAH.
The clinic then needs to start a review by the Allergan medical board by sending in your before and after photos, details of your treatment (what applicators, what areas, etc) and then they upload the data from the CoolSculpting machine to Allergan and they review that as part of the process.
All this goes to an indenpendent group of physicians trained to identify PAH. Once the diagnosis is confirmed and validated by the medical review board, Allergan turns that over to their insurance company and they process a claim for you. You will need to have a consultation by the surgeon that will do the liposuction or tummy tuck or whatever surgery they deem best for you to correct the PAH. That quote for surgery is what Allergan will use to pay you for the claim. You will be signing a release with them once they pay for the first surgery that is all that will be compensated. So make sure you are working with a reputable surgeon that has treated PAH before. It’s not a simple liposuction surgery, it is more complex as this site and Dr. Kulkin have mentioned on this page already. Don’t just choose anyone, find a surgeon specifically that has experience with this.
You should wait 6 to 9 months for the area to soften and also to verify that the process of the PAH growing has stopped and stabilized before surgery. The waiting isn’t easy because of the body changes but if you don’t wait, it could come back after surgery and then YOU are responsible for any additional surgery costs.
If the clinic you went to will not help you, call Allergan directly. Go through your clinic first they should be helping you 100%! Its their job to help you. Allergan needs a lot of information from them to process this. If they won’t help you then call Allergan clinical directly yourself. 1-888-935-8471 They will start the process for you and reach back out to your CoolSculpting provider to get what they need. It is not the most ideal way to handle it but as a provider I am more than angry reading comments from those of you that are getting NO SUPPORT from the place that treated you. I would NEVER leave anyone without helping them that has this complication that we treated. I am remaining anonymous because this isn’t about me, it’s about those of you that have been treated and are not being taken care of the way you should be.
I am a high volume CoolSculpting provider center and I find this behavior by other treatment centers ridiculous and just plain mean and unnecessary.
It is in the consent form that this complication is a risk from the procedure. It is rare, I have 3 people out of the over thousands I have treated that have developed PAH. I have helped them all and every one has been treated and the surgery paid for by Allergan with NO ISSUES AT ALL.

I wish everyone the best and hope you find a solution to the complication that lets you find peace and happiness in the way you look again. I know how terrible this can be and am sorry for each of you having to experience this.

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