Showing posts with label skeptic. Show all posts
Showing posts with label skeptic. Show all posts

Thursday, October 7, 2010

Stem Cell Face-Lifts?

Updated 3/2017--  all links (except to my own posts) removed as many are no longer active and it was easier than checking each one.

It’s been almost a month since the LA Times ran the article by Chris Woolston:  The Healthy Skeptic: Stem cell face-lifts on unproven ground.  It’s well written and presents a fairly balanced view.  While I am a fan of stem cell research, I think the “claims” are often put ahead of the science.  This is one of those times.  I can’t find any decent articles to support the claims of the plastic surgeons doing “stem cell face-lifts.”
My view is echoed in the article (bold emphasis is mine):
Rubin says he's excited about the potential of stem cells in the cosmetic field and beyond. Still, he adds, there are many unanswered questions about the cosmetic use of stem cells, and anyone who claims to have already mastered the technique is jumping the gun. As Rubin puts it, "Claims are being made that are not supported by the evidence."
While researchers in Asia, Italy, Israel and elsewhere are reporting decent cosmetic results with injections of stem cell-enriched fat, Rubin says that nobody really knows how the stem cells themselves are behaving. He points out that fat injections alone can improve a person's appearance, no stem cells needed.
Rubin believes it's possible that injected stem cells could create new collagen and blood vessels — as they have been shown to do in animals studies — but such results have never been proved in humans. And, he adds, the long-term effects of the procedures are an open question.
Stem cell face-lifts could someday offer real advances, says Dr. Michael McGuire, president of the American Society of Plastic Surgeons and a clinical associate professor of surgery at UCLA. But he believes that scientists are still at least 10 years away from reliably harnessing stem cells to create new collagen and younger-looking skin. Until then, promises of a quick stem cell face-lift are a "scam," he says.
The American Society for Aesthetic Plastic Surgery (ASAPS) issued a statement two weeks after the article first appeared --Stem cell therapy 'could offer women natural breast enhancement from stomach fat'
“Procedures with no solid science behind them, stem cells included, give unproven hope to patients and the marketing of them brings dishonor to our entire specialty,” said Felmont Eaves, III, MD of Charlotte, NC, President of ASAPS.  The Aesthetic Society is working together with the other core societies to address this through an evidence based medicine program that will rate any procedure or device on the legitimacy of the scientific evidence behind it.  This program is in its development stage and will be available to the public within the next 12 months”.
“The use of ‘stem cells’ in advertising for cosmetic surgical applications is a global problem," says Doug Sipp, Head of the Science Policy and Ethics Study Unit at the Center for Developmental Biology of RIKEN in Kobe, Japan, who monitors supposed stem cell treatment claims worldwide in all different specialties.  "There have been many cosmetics, nutraceuticals, and device makers who claim either to use stem cells in their products, or to use ingredients that activate the customer’s own stem cells. To the best of my knowledge, none of these has a basis in scientific evidence."
Marketing.  That seems to be the issue here.  And there is much money to be made in promises that may or may not be kept with the use of stem cells.  From the LA Times article:
Stem cell face-lifts: A Sept. 13 Health section story assessing stem cell face-lifts offered by two Beverly Hills doctors said that Dr. Nathan Newman charges between $5,500 and $9,500 for the procedure and Dr. Richard Ellenbogen charges $15,000 to $25,000. The story should have noted that Ellenbogen often performs a surgical face-lift along with his injection of stem cells. —

Thursday, April 8, 2010

Lipodissolve “Too Good to be True”

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

I have long been skeptical of Lipodissolve claims.  Patients would ask about the injections that dissolve the fat without surgery.  How it worked?  How safe is it?  Do you do it?  Do you know anyone who does?
The FDA has finally issued a warning
On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.
The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve
  • are safe and effective
  • have an outstanding safety record
  • are superior to other fat-loss procedures, including liposuction
Notice the “unsupported claims” phrase.  I have never been able to find any good articles regarding lipodissolve so that I could intelligently answer questions regarding it. 
Lipodissolve is a procedure where the patient receives a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body.   This procedure is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.
The drugs most regularly used in the lipodissolve injection procedures are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively).  Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.
None of the drugs or products used have been approved by the FDA for fat dissolving or fat removal.
The FDA wants any potential lipodissolve patients to be aware:
  • None of the drugs/products used in the procedure have been evaluated or approved by the FDA.
  • The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
  • The safety of the substances used in lipodissolve, when used alone or in combination, is unknown.
  • The FDA is not aware of clinical studies to support medical uses of lipodissolve.
In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure.  These side effects include:
  • permanent scarring
  • skin deformation
deep, painful knots under the skin in areas where the lipodissolve treatments were injected

I continue to tell patients that I do not advise the use of these lipodissolve procedures.   For me (and the FDA), lipodissolve is “too good to be true.”

Thursday, June 12, 2008

A Lot of Hot Air?

There is an article in the Cosmetic Surgery Times Vol 11 No 5 2008 on the subcutaneous injection of carbon dioxide (CO2). The treatment is called carboxytherapy.
Subcutaneous injections of carbon dioxide (CO2) can safely and successfully treat cosmetic concerns such as skin laxity and fatty deposits that may remain following liposuction, as well as psoriasis and hair loss, says an expert based here. Additional uses for this treatment — called carboxytherapy — include stretch marks, scars and cellulite, he says.
This is the first time I have ever read or heard of carboxytherapy. So I did a search using carboxytherapy on Medscape -- no articles. I searched the database of the Journal of Plastic and Reconstructive Surgery -- no articles. I changed the search to carbon dioxide/ subcutaneous injections and got this one relevant hit:
  • Carbon dioxide therapy in the treatment of localized adiposities: clinical study and histopathological correlations. Aesthetic Plast Surg, May 2001
I didn't do any better with a google search. At least not for scientific information. So back to the CST article, here is a description of carboxytherapy:
I've been using this technique for more than a year, and getting fantastic results," says Raphael Nach, M.D., a head and neck surgeon in private practice. He estimates that he has treated at least 40 patients for post-liposuction problems such as persistent islands of fatty tissue, skin irregularities and skin laxity. Dr. Nach explains that by adding CO2 gas to the subcutaneous tissues, localized post-operative accumulations of fat can be reduced or eliminated." Alternative forms of treatment have been advised to assist the general recuperate process," he says, "but none have been as successful in eliminating these localized fatty deposits."
TECHNIQUE IN BRIEF The technique requires no anesthesia. First, one sterilizes the skin with Hibiclens (chlorhexidine topical antiseptic; Mölnlycke Health Care U.S., Norcross, Ga.) or its equivalent, he details. "Then a 30-gauge needle connected to the carboxytherapy machine is used to infiltrate the tissues with different volumes of carbon dioxide gas, depending on the condition that's being treated," Dr. Nach explains. A typical treatment site requires about 50 cc to 200 cc of gas, injected either once or twice a week, he says. Each session lasts 15 to 20 minutes. Depending on the treatment area, he says, four to six puncture sites with the 30-gauge needle may be necessary.
I found some references that state that this procedure is FDA approved (including Dr Nach), but according to the ASPRS website (2008) it isn't.
Carboxytherapy
Injection of carbon dioxide for cosmetic purposes, namely to treat cellulite. Not U.S. FDA approved.
I then tried a search of the FDA website and got no hits on carboxytherapy or carbon dioxide/ cellulite.

So for now I would suggest being very skeptical of any claims that carboxytherapy would improve anything. Dr Oliver or anyone else have any information on this? Preferably scientific information.