Question: Calcium Hydroxylapatite For Collagen Stimulation - Which technique is best?

What Calcium Hydroxylapatite injection technique is best for collagen stimulation?

It is well known, that CaHA stimulates collagen production. Which is the best-in-class injection technique to maximize the desired effect and ho much risk should you take?

Mesotherapy with CaHA? Linear threading with blunt tip Cannulas after having effected subcision?

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.

Non-Invasive Fat Melting Devices: Sail or Sink?

There’s a lot of buzz about the new wave of non-invasive fat melting devices like Zerona™ (635nm low level laser), Lipo-Ex™ (radio frequency) and UltraShape® (selective focused ultrasound) who all lack the illustrious FDA clearance desperately needed to make a huge impact in the body sculpting arena.

Sure they possess FDA clearances for safety, but not yet efficacy in the key category of actual fat reduction. What’s the FDA’s hang up? Apparently it has to do with fat metabolism. Specifically, the FDA wants to know what happens to the fat that is expelled from the liposome after treatment, it’s ingestion by macrophages, the transportation to the lymphatic system, and the final excretion by the kidneys. The FDA wants to ensure no harm will come to a patient by this natural process of foreign body elimination. They also want to prove they work as a stand-alone therapy.

I’ve talked with many physicians at ASLMS and The Aesthetic Show and have read posted discussions by fellow MAPA members like, Dr. Lornell Hansen who is extremely proficient in the development of lasers in the U.S. and is highly regarded for his opinions. If I may quote Dr. Hansen, he states every time he asks physicians who have used, specifically the Zerona™ by Erchonia, over the last few clinical trial years if the device actually works, the answer he receives is they “think it does”. For many physicians that answer doesn’t quite cut the mustard when you're thinking of investing time, money and your reputation on a device. On the other hand, if the technology is proven to be clinically advantageous for your patients, and they finally do receive the FDA’s approval in the next few months as all companies are claiming, are you willing to “miss the boat” and sit idly by on the shore watching everyone else sail into a sea of opportunity? Or, will you get into the boat too early and risk having it sink? It’s a gamble and timing is everything.

Well, our medical spa has thought long and hard on this technology and we have come to the conclusion that if the device is positioned in the right practice and for the right patient, it can be advantageous for both our practice and the patient. Many patients we see during complimentary consultations don’t want to have a minimally invasive surgical procedures, or the multiple injections of lipodissolve. They diet and exercise regularly, but can’t seem to lose those pockets of fat that seem impenetrable by their current regimen. Our practice offers SmartLipo™, SlimLipo™, VASER® Lipo, lipodissolve and VelaShape™. Body contouring is 80% of what we do. We believe this device has a place in our practice either before or after laser lipo, or combined with the lymphatic drainage abilities of the VelaShape™. Of course, with all body contouring procedures, optimal patient selection is a must for success.

Our decision was influenced in the faith and belief in technology and also the fact that the Zerona™, unlike the UltraShape® and Lipo-Ex™, is at least FDA market cleared for laser assisted liposuction. And just think, a few years ago even laser lipolysis was scoffed at. And, who would’ve even dreamed that fractional technology would exists and prove to be beneficial? Technology will continue to advance. Sometimes it works they way you hoped it would, other times your dreams fall a little short.

So, we are very excited to take the leap of faith into the Zerona™ low level laser and look forward to only positive results for our patients. If it works like we trust it will, we all win and score one more for technology! If it falls short, the worst that could happen is that the technology will need a little more “tweaking” and we’ll sail out boat back to shore.

We’ll keep you all posted on our travels.

Author: Paula D. Young RN runs internal operations and training at Young Medical Spa and is the author of the Medical Spa Aesthetics Course, Study Guide, and Advanced IPL & Laser Training course for medical estheticians and laser technicians.

Submit a guest post and be heard.

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.

Kansas State Board of Healing Arts outlaws Lipodissolve

Kansas State Board of Healing Arts outlaws Lipodissolve except in drug trials

By JULIUS A. KARASH - The Kansas City Star Story

 
In a first for the nation, the Kansas State Board of Healing Arts on Saturday greatly restricted the use of Lipodissolve, the controversial fat-dissolving injection.

The board said patients may not receive Lipodissolve unless it is authorized by a physician as part of an investigational drug trial.

“We have to protect the public from the potentially disastrous effects of unproven drugs,” said Mark Stafford, the board’s general counsel, who noted that Lipodissolve is not approved for treating fat by the Food and Drug Administration.

The Kansas restrictions are expected to take effect in mid-to-late September, Stafford said. The board’s unanimous action covers the most common form of Lipodissolve, consisting of phosphatidylcholine and sodium deoxycholate.

The action drew criticism from Matt Taranto, owner of Leawood-based Aesthetic Consulting Group, which manages AesthetiCare Medi-Spa & Lipo Dissolve Center in Leawood.

Taranto said in a phone interview that 10,000 to 50,000 such treatments are administered every month to patients throughout the United States.

“I have yet to hear of a serious reaction or side effect from Lipodissolve,” Taranto said. “It’s an effective way to address localized deposits of fat. The majority of people who have it are happy.”

But Stafford said the board has received at least half a dozen complaints about facilities that give the injections. He said the complaints, which are under investigation, involve problems with business practices and patients suffering side effects such as nodules, infections and nausea.

Lipodissolve is a trademark name. The injections are not designed to treat obesity, but rather to flush out fatty deposits from various parts of the body when patients can’t get rid of them through diet and exercise.

In May, the American Society for Aesthetic Plastic Surgery warned against the use of Lipodissolve and similar treatments. “We do not have definitive information on injection fat loss treatments,” Foad Nahai, president of the society, said in a May 14 statement. “The bottom line for patients is this: Don’t allow yourself to be injected with an unknown and untested substance.”

A placebo-controlled study of Lipodissolve is being sponsored by the Aesthetic Surgery Education and Research Foundation. The study, which will be conducted under FDA supervision, will follow 20 patients for 46 weeks to evaluate the efficacy of the procedure and collect data on reactions and complications.

It is not clear how many Kansas businesses will be impacted by the new restrictions and to what degree. Stafford said the board did not have firm numbers on Kansans who have received the injections or the number of Kansas facilities that administer Lipodissolve.

However, Stafford said the Kansas City area has had one of the heavier concentrations of Lipodissolve clinics, and the board has been aware of perhaps a dozen such facilities on the Kansas side of the metropolitan area recently.

Taranto estimated that Lipodissolve is dispensed by about 20 facilities in the Kansas City area on both sides of the state line.

The Kansas board in April passed a temporary regulation that required a physician to perform a physical exam, record the patient’s medical history and write a prescription before a patient was injected with Lipodissolve.

The board held a public hearing on Lipodissolve last month.

“Other states have been watching to see what we’re doing, and some are contemplating taking action,” Stafford said.

Mark Tucker, president of the Missouri State Board of Registration for the Healing Arts, has said that Missouri might consider stricter regulation of Lipodissolve if necessary.

Hat tip to Ron for sending this to me. 

Lipodissolve, Mesotherapy & Fat Melting Injections.

The plastic surgery community has come out strongly against physician injectable mesotherapy treatments that are often referred to as Lipodissolve and main stream media's taking a look. Is this quackery? Is it medical fraud? Will it effect liposuction incomes?

 
I know a number of plastic surgeons who regularly use Lipodissolve in conduction with their liposuction surgeries. Why? There are inherent problems with liposuction that lipodissolve can address.

The plastic surgeon societies state that it's not 'proven'. True enough. But unlike treatments like featherlift, lipodisolve ends up with happy patients. The market is validating it as 'wanted' and the plastic surgery societies are trying to sweep back the ocean with a broom. Anyone know if there are studies ongoing?

Disclaimer: Surface performs Liposolve.

The Wall Street Journal weighs in on Mesotherapy: Popular Treatment That Aims To Melt Fat Draws Scrutiny

Last month, the American Society for Aesthetic Plastic Surgery warned that the shots are "scientifically unproven, lacking any objective data on safety and efficacy." The surgeons' group, which is sponsoring human tests to evaluate one such treatment, urged the public "to steer clear" until more data come in.

Physicians who offer lipodissolve say the injections can be effective in skilled hands. Diane Duncan, a plastic surgeon in Fort Collins, Colo., cites a 2006 retrospective study that she co-authored in the Aesthetic Surgery Journal, based on data submitted by 75 physicians in 17 countries from 17,376 patients. The study found that roughly 12% of patients expressed disappointment with the aesthetic result. The authors concluded that the treatments have a good safety record; complications included temporary hyperpigmentation, pain and allergic reactions.

Hat tip to PS 101 

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.