Soft Tissue Fillers May Be Causing Blindness in Patients?

The rising popularity of soft tissue fillers has led to a rise in reports of side effects such as blindess.

The FDA approved the use of soft tissue fillers for the correction of moderate to severe facial wrinkles and skin folds (like the nasolabial folds). Some soft tissue fillers are approved for the restoration or correction of facial fat loss in people with HIV.

But according to the Food and Drug Administration, there are risks associated with the use of these fillers.

 Any soft tissue filler can cause long-term side effects, permanent side effects, or both. However, most side effects associated with soft tissue fillers happen shortly after injection and most go away in less than two weeks.

Swelling and pain after hand treatment may last a month or more. In some cases, side effects may appear weeks, months, or years after injection.

Among the rare side effects reported to the FDA are severe allergic reactions which require immediate emergency medical assistance, migration or movement of filler material from the site of injection, leakage, or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection).

There were also rare reports of formation of permanent hard nodules in the face or hand, vision abnormalities, including blindness, stroke, injury to the blood supply, and damage to the skin or the lips.

Recent reports by the American Society for Dermatologic Surgery, Inc. and published by Wolters Kluwer Health, Inc. showed that with the rising popularity of soft tissue fillers has led to a rise in reports of adverse events.

The study conducted a literature review of the reported cases of blindness after the filler injection. The study also examined some prevention and management strategies that may be done.

The results were as follows:

• 98 cases of vision changes from filler were identified.
• The sites that were high risk for complications were the glabella (38.8%), nasal region (25.5%), nasolabial fold (13.3%), and forehead (12.2%).
• Autologous fat (47.9%) was the most common filler type to cause this complication, followed by hyaluronic acid (23.5%).
• The most common symptoms were immediate vision loss and pain and most of the cases of vision loss did not recover.
• Central nervous system complications were seen in 23.5% of the cases. No treatments were found to be consistently successful in treating blindness. 

Even though the risk of blindness from fillers is rare, researchers concluded that it is critical for injecting physicians to have a firm knowledge of the vascular anatomy and to understand key prevention and management strategies.

For more information: http://journals.lww.com/dermatologicsurgery/Abstract/2015/10000/Avoiding_and_Treating_Blindness_From_Fillers___A.1.aspx

Radiesse: FDA Approved For Hand Rejuvenation

Radiesse is now FDA approved for "hand rejuvenation".

Radiesse is an FDA approved dermal filler for smoothening out facial wrinkles and facial contouring. Recently, Radiesse got its FDA approval, making it the only FDA-approved filler for the hands although hyaluronic acid has been used by physicans for years.

The product, according to its website, can hide visible bones and tendons, making the hands look more youthful and smooth. Radiesse utilizes a safe gel formula that contains calcium microspheres (CaHA). These can immediately create added volume and then stimulate the body to produce collagen which results in volume augmentation that can last for around a year.

According to board-certified plastic surgeon Dr. Brent Moelleken, MD FACS:

Radiesse is a great option as a filler for hands. It’s safe for all skin types, and leaves no obvious line between the hand and wrist. The hands are the last frontier, so-to-speak, and often give away the true age of a woman.

Depending on the severity of the volume loss, patients should expect to pay for about one to two syringes of Radiesse at an average cost of $800 - $1,200 per syringe for their hands.

Dr. Moelleken adds that because of the product's pliability and softness, it is a great filler which may also be used for deep filling in the face.

Patients are cautioned to seek out experienced and board-certified plastic surgeon in using the Radiesse hand filler because of the many veins, nerves, and arteries in the hand. During the clinical trials, patients showed swelling, redness, bruising and pain in injection sites.

Because of this recent development, cosmetic doctors may now offer enhancement and rejuvenation for both the hands and faces of their patients.

For more information, you may visit:

https://global.radiesse.com/treatment-options/hands#hands

Stem Cells and Regenerative Medicine - Ready for Prime Time?

The future looks promising for stem cell therapies in aesthetic medicine.

The arguments for and against the use of stem cells for research and medical therapeutic applications have existed for decades and will no doubt increase in volume and intensity for some time to come. Vast amounts of public and private money are currently pouring into the research for these polarizing fields and a Google search on these topics will populate dozens of new articles not only domestically but also globally on a daily basis. The hopes of uncountable patients and their family and friends are intricately entwined on unlocking possible therapeutic applications to cure a myriad of maladies from spinal cord injuries, Alzheimer’s disease, diabetes and heart failure to rare genetic disorders that claim the lives of children daily. In short, stem cell research and regenerative medicine are in the early explosion phase of discovery, application, and no doubt ongoing controversy.

Initial shockwaves of fear and objection arose partly from the need for using embryonic stem cells for this research.  Fortunately, it is looking more promising that we can use easily obtainable cells from existing and abundant adult tissues and engineer highly selected cells from these tissues to become culturable and guidable stem cells. Ideally, this would negate the use of embryonic stem cells and eliminate at least this one-of-many passionately debated aspects of controversy (there are many!). To date, cells from bone marrow, skin, and adipose amongst others are being used to isolate adult stem cells, and from these it is hoped that we can “reverse engineer” them into pluripotent cells that can be used to generate selected tissue types for clinical use. How many of us don’t have an extra area or two of excess fat that could potentially be used to save our life at some point in the future?  While we don’t have proven reliable human applications as yet, the future does look promising. I am seeing more and more presentations at our plastic surgery meetings on stem cell research and regenerative medicine and the buzz and excitement are palpable. It is important to note that all involved seem to share a sense of cautious optimism and emphasize the need for careful control over the research and applications.  The FDA is very involved with all aspects of clinical use of stem cells as the field evolves and becomes more complex.

The future is exciting for stem cells and regenerative medicine. I fully agree with careful oversight and deliberate planning and control as research progresses. I follow the fields closely and am hopeful that in the near future we can offer hope to those patients with difficult illnesses and medical conditions that are currently not largely treatable. And all the better if we can obtain easily available and harvestable tissues to affect the research and clinical applications. Now I invite a lively and constructive discussion from the readers!

Fairwarning: The LipoTron 3000 FDA UnApproved $85k Massager

According to a new story on Fairwarning.org, RevecoMED claims that their LipoTron device is really being marketed and sold as an $85,000 massager.

I just got off the phone with Myron Levin or Fairwarning.org who contacted me about Advanced Aesthetic Concepts attempts to have comments and reviews about the Lipotron 3000 and their business removed from Medical Spa MD claiming that some negative comments were costing them sales. It was an intersting discussion and Myron filled me in on some of the background that went into the story which has some interesting twists including anonymous calls to the FDA and secretive meetings with criminal investigators.

Read the entire article here: Fat-Melting Device a Weighty Matter for FDA on Fairwarning.org

From the Fairwarning.org article: 

According to interviews and records, Reveco first sought a green light from the FDA in 2007. It chose the FDA’s market clearance procedure, which is less demanding than the formal approval process.

To get a new device cleared this way, the manufacturer must show it is similar in safety and effectiveness to products that are already on the market.

However, Reveco’s bid failed. The company’s initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”

According to interviews and a document reviewed by FairWarning, the FDA then told Reveco that the device could not be marketed.

LipoTron sales continued, however. Rosen wouldn’t disclose how many of the devices have been sold, but the number is believed to be in the low hundreds.

In 2011, Reveco took another tack with the FDA. It classified the LipoTron as a massager used for relief of minor pain. That would make it, in FDA parlance, a Class 1 device — a category that includes such simple, low-risk items as elastic bandages and examination gloves.

The advantage for Reveco is that massagers can be sold without a green light from the FDA. They automatically are exempt from FDA review and can be put on the market once a notice is filed.

Yet doctors and med spas have been promoting the device on the Internet not for massages but for removing fat.

Rosen said that was not Reveco’s responsibility, stating that the company can’t dictate what doctors do or “police everything out on the Internet.”

Asked who would pay $85,000 for a massager, Rosen replied: “Anybody that wants to buy it.”

Wow. It would take some really big cajones to claim that you're selling an $80k+ device named LipoTron to cosmetic clinics from a company named RevecoMED but you're only marketing it as "a massager for minor pain" and that it's the doctors who are running around uncontrolled promoting it for fat-melting. I'm actually somewhat impressed. I guess the real lesson is that if you can't get your device approved by the FDA as a medical device the first time, reclassify it as a band-aid and declare yourself in full compliance. That seems simple enough. 

Of course it also seems fairly clear from the article that if you have one of these devices and you're promoting it as FDA approved or as a treatment for anything other than a 'massager' you might not be in lock-step with the FDA, a fact that might be exacerbated by the fact that this story has been picked up by major media outlets like MSN.com.

I'm curious; Does anyone have one of these Lipotron devices that they're using as a massager for minor pain? You might want to see if it works on yourself because I'm guessing you have a headache about now.

Update on 2012-07-19 14:46 by Medical Spa MD

More bad news for LipoTron, RevecoMED (the manufacturer of LipoTron), and probably for it's resellers... as well as all the physicians and clinics who are offering LipoTron treatments.

Public Citizen, a consumer watchdog organization with 300k members, has contacted the FDA urging, among other things, that all LipoTron devices should be seized immediately.

Here is what Public Citizen is asking for; from their letter to the FDA:

Immediately seize all LipoTron devices that have been manufactured by RevecoMED and either (a) are being held in inventory by the manufacturer in the U.S. or (b) have been sold and distributed to user facilities in the U.S.

(2) Immediately order RevecoMED and any distributors of the LipoTron device to cease and desist all activities involving the distribution, sale, and promotion of the LipoTron device.

(3) Expeditiously complete its criminal investigation of the distribution, sale, and promotion of the LipoTron device and take appropriate legal action against those individuals, companies, and user facilities that are found by the agency to have engaged in any illegal marketing or promotion of this device

This can not be good news for any of the medical spas and clinics who already have this device.

Read the entire letter to the FDA

View attachments regarding the letter

View the Public Citizen press release

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.