FDA Warns 6 Medical Spas About Lipodissolve Marketing

Lipodissolve (or liposolve or mesotherapy) is a staple in any number of medical spas, but the FDA has just issued a warning letter to 6 clinics that they've crossed the line in marketing lipodisolve to patients.

My own experience with lipodissolve mesotherapy is something of a mixed bag. Clinics that I've been associated with have offered liposolve in the past and I'm aware of one really scary incident where a woman had been treated in Park City over a large area (thights and stomach as I remember) and then went golfing. She colapsed at the golf course and was rushed to the ER at the University of Utah.

She recovered but the administering physician faced some pointed questions from the ER docs about what he'd injected and why.

(The lipodissolve treatment causes fluid accumulation and swelling temporarly. That fluid comes from the blood stream and when there's a large treatment area, that can be a lot of fluid. This can affect the patient's blood pressure and volume, in some cases dramatically. This patient's recent treatment combined with golfing in the sun, walking, and dehydration was enough that she tipped over and (I think) lost conciousness for a few moments.)

If you're offering lipodissolve, leave a comment below and detail your experiences, results and thoughts... especially if you're from one of the 6 medial spas named below.

Anyway, here's the FDA story via USNews.com

FDA Issues Warning on 'Fat-Melting' Spa Injections

There's no proof the procedures work and serious side effects can occur, agency says

Claims by spas that "lipodissolve" injections can melt away fat are unsubstantiated and the procedures' safety also remains in question, according to warning letters issued Wednesday by the U.S. Food and Drug Administration.

The FDA warned six U.S. based medical spas and a Brazilian company to stop making false claims about the drugs used in these procedures.

Sold on the Internet and used by some spas, lipodissolve is a procedure that its proponents claim will eliminate fat. U.S. companies claim that the drugs used in the procedure are safe and effective, but these products have never been approved by the FDA, the agency said.

"We are concerned that these companies are misleading consumers," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal."

Lipodissolve involves several injections that supposedly dissolve and remove small pockets of fat from areas of the body.

Lipodissolve is also known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The drugs most often used are combinations of phosphatidylcholine and deoxycholate.

Sometimes other ingredients such as vitamins, minerals and herbal extracts are added into the mix, the agency said.

However, there is no "credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown," the FDA said.

The FDA has asked for a written response from the U.S. companies within 15 days outlining how they plan to correct the violations and prevent future violations. Failure to correct the violations could result in legal action, the agency said.

Each company has been cited for a variety of violations, including making "unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction," the FDA said.

Also, some of these companies have claimed that lipodissolve can treat certain medical conditions, such as male breast enlargement, benign fatty growths called lipomas, excess fat deposits and surgical deformities.

"The FDA is not aware of clinical evidence to support any of these claims," the agency said.

FDA officials have received reports of negative side effects from people who have tried the procedure, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where lipodissolve drugs were injected.

Warning letters were sent to: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; PURE Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company receiving the warning letter sells lipodissolve products on two Web Sites: zipmed.net and mesoone.com, the FDA said.

The FDA also has issued an import alert against these Internet sites to prevent the drugs from being imported and distributed in the United States.

Well, the zipmed and mesoone sites are both down and have this simple statement.

Due to the current facts, Mesoone.com and Zipmed.net do not sell Lipodissolve vials anymore. Thank you. For more information access www.fda.gov

Leave a comment below.

Nu U Medical Spas Sued By Illinois State Attorney General

Attorney General Lisa Madigan has filed a lawsuit against the Chicago-area medical spas, Nu U Med Spas, for performing unapproved procedures without a physician's supervision and luring patients through deceptive marketing.

This looks like it started with an expose by local Chicago television news.

The seven NuU Medspas in the Chicago area aggressively promote Lipodissolve, a series of injections that supposedly will melt your fat away.

The ads talk about reduced inches with no knives, no tubes, and no pain -- a deceptive ad, patients say.

NuU does not tell clients that Lipodissolve is not approved by the Food and Drug Administration.

"There is no study out there that shows clearly whether it works and what specifically are the risks of it," said Northwestern Memorial Hospital's Dr. Michael Lee.

That's not a problem, said NuU district supervisor Laura Rowsey, formerly a modeling school sales manager.

"This is a soy-based mineral with amino acids," Rowsey said. "Bruising and swelling is like your worst case scenario with this treatment."

But doctors have seen a number of Lipodissolve complications.

Cynthia Sacramento, who went to the Lincoln Park spa, suffered painful scar tissue buildup around her injection site that will require surgery.

Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised.

Sacramento said she's devastated.

Even proponents say Lipodissolve is for treating pockets of fat, not for bigger weight problems.

NuU in Lincoln Park signed another former client, who preferred to remain anonymous, up for $2,400 in treatments on his belly.

"I think it's a big scam, a waste of money," he said. "The only thing that got thin on me was my wallet."

NuU sales people are pressured to meet sales goals and arrange for many clients to finance their treatments. The money is collected up front and NuU claims it's not refundable.

"Our goal was to get $15,000 a day," said former NuU spa manager Patti Feinstein.

Feinstein recalled how Rowsey scolded her for turning away a skin cancer patient saying, "You are not going to make quota if you don't sell," Feinstein said.

Records show her spa sold made more than $200,000 a month.

Ouch. You have to love how a reporter makes a point of stating that the Nu U spokesperson was fromerly a sales manager for a modeling school. Looks like another slap-down for Nu U Medspas. Madigan's complaint claims that Nu U Med Spas try to lure customers into buying "Lipodissolve, which is an injected therapy used to dissolve fat cells." Here's the full press release:

MADIGAN FILES LAWSUIT AGAINST CHICAGO AREA Nu U MEDICAL SPAS

Attorney General Alleges Nu U Performed Unapproved Procedures Without Physician Supervision And Used Deceptive Marketing to Lure Patients

Chicago — Attorney General Lisa Madigan today filed a lawsuit in Cook County Circuit Court against Nu U Med Spas for deceptively marketing and performing unapproved, unsupervised cosmetic treatments that caused some patients to experience extreme pain and lasting injuries.

“These procedures have yet to be thoroughly researched and sanctioned by the proper medical authorities,” Madigan said. “Despite lacking concrete scientific evidence, Nu U purposefully misleads consumers into believing that their medical spa treatments are safe and effective. I’m very concerned that the health and safety of Illinois consumers who visit Nu U Med Spas are at risk.”

The Chicago-based medical spa chain allegedly uses high-pressure sales tactics based on deceptive marketing claims to induce consumers into purchasing a series of medical and beauty treatments, including Lipodissolve, which is an injected therapy used to dissolve fat cells, according to Madigan’s complaint. Nu U allegedly claims its treatments will “liquefy fat quicker” and can “rid your system of that life long battle of the bulge,” but Nu U fails to inform consumers that its treatments haven’t been approved by the U.S. Food and Drug Administration (FDA) as safe and effective treatments. Both the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons do not recommend using Lipodissolve for fat reduction due to the lack of research that shows its effectiveness.

Further, because Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. In fact, despite its outward claims, Nu U allegedly fails altogether to monitor and evaluate patients by licensed physicians at all seven of its Chicago area locations.

Madigan’s complaint further alleges that the Nu U personnel rush consumers into signing contracts, medical consent forms and financing documentation for treatments but fail to review the documents with consumers. The defendants allegedly pressure consumers to sign up for health care financing but fail to inform consumers that by signing the financial documentation they are authorizing an automatic credit card charge. Nu U allegedly refuses to provide refunds when requested, even in the event that a consumer has not received all of the contracted treatments.

Madigan’s lawsuit charges Nu U with violating the Illinois Food, Drug and Cosmetic Act, the Illinois Medical Practice Act and the Illinois Consumer Fraud and Deceptive Business Practices Act. It asks the court to permanently enjoin the defendants from owning or operating medical or beauty clinics in Illinois and to order the company to pay civil penalties of $50,000, an additional $50,000 penalty for each violation committed with the intent to defraud, an additional $10,000 penalty for each violation committed against a senior citizen 65 years of age or older, and the costs associated with the investigation and prosecution of the lawsuit.

To be honest, this looks like some grandstanding on the part of the Attorney General. Lipodissolve is used in perhaps thousands of medical spas and cosmetic practices around the country without 'painfull scar tissue build up' and complications.

And what does it actually mean when. "Dr. David Song of University of Chicago Hospital said the entire injection area will have to be excised."? An entire treatment area excised from needle sticks? Seems fishy to me. Might well be something of a hatchet-job.

Anyone have thoughts on this?

IPL Burns

The Independent newspaper in the UK has an article today in their Health & Wellbeing section from a reporter who was badly burned by an IPL treatment at a 'Top London Med Spa'.

The photos show the reporter with large uneven red welts on her chest and areas of redness on her face also. According to the story the correspondent was seduced by the promise of a `fast and effective way of removing the visible ravages of time without surgery’.

This is the second high profile newspaper report in recent times (see also News anchor gets burned by photo facial). I wish this were even less common than it is, but I've seen a number of IPL & laser burns before. These are often the result of rogue operations (Mesotherapy Lipodisolve Horror Stories) poorly trained staff AND physicians who intimidate their staff.

If your a plastic surgeon or dermatologist running a skin clinic, med spa, or laser clinic and your staffs first reaction is not to tell you somethings going wrong or they're not sure about an IPL or laser setting, you're just setting yourself up to have problems.

These types of IPL and laser burns are almost invaraibly the result of a physician who has medical estheticians or laser technicians who are afraid of confronting them with a problem or question. The doctor's defense? They were told what to do... but problems always arise and doctors who don't want to be hassled are the ones putting both their patitent and their laser clinic at risk. It's just a numbers game. If you treat 1000 patients at least some of them will have problems. Your staff should never be repremanded or belittled for ANY question.

The technician told me she would use a strong setting to get better results. As she passed the handpiece across my face the feeling grew hotter and hotter. By the time the device reached my neck, I could barely imagine continuing with the burning sensation. When she started on my chest the pain was intolerable and I had to ask her to stop repeatedly before continuing with what felt like torture. I'd thought of "no pain, no gain" and I soldiered on.

I got dressed, with a burning hot chest and a face that looked as if I'd been pulled out of a forest fire.

I was scheduled to return in two weeks for the next IPL treatment, in a course of six that costs £1,200. I went to a make-up shop and was dusted with a mineral powder, suggested by the spa, to camouflage the redness of my face.

A woman at the same counter asked me what the hell I'd had done. When I proudly informed her I'd had an IPL photo facial – she looked at me with total horror. "I don't mean to worry you, but I've had a course and it never looked like that." I largely shrugged off her words of warning. Why would I question the skill of a technician at the high end of the market? It's not as if I'd taken a chance and visited a high-street beauty parlour.

When I got home and looked in the mirror at my chest for the first time since the treatment - only an hour later – I was horrified. Angry red rectangular burns covered my chest in a random grid. Little did I know when I'd set off that morning that I would return after my first exciting treatment scorched and traumatised. What made no sense to me was that the treatment had not been done uniformly which was more obvious on my chest where I looked like I'd been branded with a hot iron.

The next day, on the advice of a friend, I called a top dermatologist – Dr Nick Lowe – known as the god of dermatology. He is also the man the rich and famous depend on when they need to be fixed, without resorting to the knife.

Dr Lowe saw me as a medical emergency the following morning. He works at the Cranley Clinic, off Harley Street, London, has a private practice in Santa Monica, California, and is clinical professor of dermatology at the UCLA School of Medicine, Los Angeles. He has his own skin care range and is the author of many books, including, most recently, The Wrinkle Revolution.

He was horrified by what he saw and concerned that no doctor was present at the IPL treatment – but it didn't surprise him. Along with other doctors, he is lobbying to get these types of treatments regulated in the UK. He believes treatments including Botox, line fillers, laser and light should only be conducted by doctors or administered under a doctor's supervision.

"The UK is one of the few countries in Europe that does not have sound legislation. It is much more regulated in France, Spain and Italy where only trained doctors can administer these treatments. The UK has failed totally to protect the public in this arena," says Dr Lowe.

Lipodisolve: Mesotherapy Horror Posts!

These posts about mesotherapy were taken from discussion threads on this site.

 
The individual comments have been removed from the discussion threads for obvious reasons but are reposted here:

Yono writes: I am a nail salon owner and learned it from a friend. It works great and you do not need a prescription ! Go online for the best prices and instruction. Mesotherapy is great for anyone and you don't have to go to France!

JJlin writes: Anyone can perform mesotherapy. I tell people its cheaper to inject yourself in the comfort of your own home. You can purchase sterile needles and mesotherapy injectables online, compounding pharmacies, just about anywhere. Instructions online as well.

Aestheticianspa writes: I perform manicures, mesotherapy, botox, and laser hair in my garage transformed into a spa like office. I think anyone can do it as long as you have a doctors lisc. Just send em the check every month. :)

And Cosmo: Its pretty safe and effective. You can pick up the solution at any compounding pharmacy or online and inject it yourself. I tried it many times on a friend. Real easy for anyone. Go for it.

JJlin again: I agree w/ Cosmo. Who cares if it works or not? Everyone should get into Mesotherapy. Its cheap, easy and good cash.

Where to begin. It seems hard for me to believe that this kind of activity is actually happening let alone there are those who are posting that injecting yourself or others in the comfort of your home or garage is a good idea. The stupidity is overwhelming.

If you are injecting anyone and are not a licensed medical provider you are practicing medicine without a license, a felony in every state. If you are injecting yourself you are just plain stupid and should be removed from the gene pool as fast as possible. It's no wonder that mesotherapy has a hit-and-miss reputation for being pseudo-garage-science.