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What's in that syringe?

The following was a report by the Associate Press released yesterday. Dr. Walden provides commentary on what is in a “Lipodissolve” injection. Click on the USA Today link here.

WASHINGTON (AP) — The Food and Drug Administration is cracking down on what are billed as fat-melting injections used in spas across the U.S., saying the drugs have not been proven safe or effective.

Lipodissolve injections, a popular nonsurgical alternative to liposuction, are used to dissolve small fat deposits around the legs, arms and belly. The FDA said Wednesday the drugs have not been cleared by federal scientists, as required by law. The agency issued warning letters to a half-dozen spas that offer the injections, citing them for making unsubstantiated claims about lipodissolve therapy.

“The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” states a letter to All About You Medspa in Madison, Ind. Other spas cited by the FDA included: Pure Med Spa of Boca Raton, Fla., Monarch Med Spa of King of Prussia, Pa., and three others.

The website for Monarch Med Spa claims that, “Rather than go through the pain and discomfort associated with liposuction, patients now have the option of a series of injections with very minimal discomfort.” Calls to Monarch Med Spa were not immediately returned Wednesday. FDA regulators called on the spas to stop using such claims and notify the agency within 15 working days of steps they are taking to correct the violations.

“FDA is not aware of any credible scientific evidence to support these claims,” said Kathleen Anderson, an FDA deputy director, on a call with reporters. Spas that offer the injections say they are safe and effective. But public safety advocates have called for proof and urge patients to think twice before paying thousands of dollars for an unproven procedure. FDA said it has received reports of permanent scarring, hard lumps and dark spots on their skin after receiving the therapy. The FDA also issued a warning to a Brazilian company that sells lipodissolve treatments on two websites: zipmed.net and mesoone.com.

Lipodissolve and similar treatments use two chemicals, phosphatidylcholine, or PC, and sodium dioxycholate, or DC. Those chemicals occur naturally in the human body, but that doesn’t necessarily make them safe, said Lenox Hill Hospital plastic surgeon Dr. Jennifer Walden.

“They are used in the metabolic process of our bodies to break down fat, but they were never intended to be extracted, mixed with other ingredients and reinjected to break down fat,” said Walden.

According to Walden, lipodissolve injections are often performed by beauty care specialists who have little or no medical training.

Other ingredients in the cocktails often include the drug Infasurf, which is used to treat respiratory problems in premature infants, according to the FDA.

Lipodissolve formulations are usually mixed at medical spas through a process called compounding, in which a pharmacist combines multiple drugs to create a new formulation, Walden said. The FDA does not regulate the practice of medicine and declined to discuss drug compounding. “We’re not aware of where these spas are getting their drugs, therefore we cannot comment on the issue of compounding this product,” said FDA pharmacist Suda Shukla.

The FDA urged physicians who are using the drugs cosmetically to submit an approval application for regulatory review.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Be sure and watch VH1’s new special, Plastic Surgery Obsession, which will begin airing tonight at 10pm EST! This was a fun special to participate in… I enjoyed working with theVH1 team as they raised some insightful and timely questions on Hollywood’s incessant quest for beauty. Click here to get airtimes and read the following episode summary on the VH1 website:

Plastic surgery. Everyone’s doing it-and talking openly about it, too.

Cutting Edge: What are the some of the ever evolving industry’s newest procedures and secrets?
Younger Faces: The increase in teen plastic surgery: How young is too young?
The Dark Side: Body Dysmorphia, depression, and sometimes even death are just a few of the horrifying dangers involved in looking “amazing.”
Plastic Surgery Disasters: Some of Tinseltown’s most infamous cosmetic surgery calamities

Introducing best actress nominee Gabourey Sidibe at the Oscars, “Precious” producer Oprah Winfrey revealed her as a “true American Cinderella on the threshold of a brilliant new career.” Although questions have arisen of Sidibe’s size being a detriment to her career, the talented new actress has proven many wrong so far. Above is the video clip from the pre-Oscar Strategy Room on Fox News with Dr. Jennifer Walden, Dr. Manny Alvarez, Dr. Cynara Coomer, and other experts with a health perspective on our favorite newcomers.

With Hollywood being such a superficial environment, it is interesting to read editorial on the topic. On ABC.com, New York casting director Bernard Telsey said Sidibe’s size is both a plus and minus: “It’s going to make her not right for the new ‘Romeo and Juliet,’ but it’s going to make her right for the role that needs her for that specificity,” Telsey told ABCNews.com. “There’s room in Hollywood for someone who looks like her,” Telsey said. “Sure, there will be fewer roles, but there’s always less of everything for people who are unique and original and different.”

Set in Harlem in 1987, “Precious: Based on the Novel ‘Push’ by Sapphire”, features Sidibe as the heart-wrenching Claireece “Precious” Jones, an obese sixteen year-old African-American girl who is pregnant for the second time by her otherwise absent father. At home, she is always ridiculed and abused by her tragic mother, played by Mo’Nique, who has basically turned her daughter into an indentured servant. With no money or emotional support and falling horribly behind in school, Precious is by all accounts destined to a forgotten caste surrounded by welfare offices and misery. Yet, beneath the hopeless surface, she is a savvy girl who still dreams and believes in herself. She is given a chance at an alternative school taught by a caring yet firm teacher and the emotional nightmare and a supportive social worker, played to a tee by pop diva Mariah Carey.

In October, Sidibe was front and center on the New York Times with a lengthy Magazine story on the film. Indiewire.com wrote: With all of its festival and media attention throughout the year, expectations are obviously heightened, but Sidibe still seems in awe of it all. “It was an honor, I mean, just to be on the cover of anything. I don’t expect to be on the cover of anything,” Sidibe said with a hint of nervous laughter, but then added with a tone that might have been words coming from Precious. “I think people look at me and don’t expect much. Even though, I expect a whole lot.”

What an excellent job she did in the heartbreaking movie, Precious. Now we can’t wait to see Gabourey Sidibe in her next film!

Here is the second part of the Plastic Surgery Gone Awry segment, featuring Dr. Walden and a panel of experts on the “After the Show” Show (watch through the first few minutes to see the panel). Gretchen Carlson and Steve Doocy of Fox and Friends Morning Show ask the questions on their minds about the lack of regulation in the fields of surgery and plastic surgery, as patient safety is in question. The cases of non-medical grade silicone caulk being injected into the buttocks of 7 women in a Newark hotel by a charlatan claiming to be a plastic surgeon are discussed. Also, the case in Florida of a young woman who died after undergoing liposuction at a tanning salon after receiving local anesthetic injections and Propofol (the powerful intravenous anesthetic agent that killed Michael Jackson) is covered. Finding a plastic surgeon who has undergone proper training and credentialing is of utmost importance when selecting a provider, so find out why it is extremely prudent to find a board certified plastic surgeon

The rise of medspas and a recent liposuction death in Florida in a young 37 year old nurse bring to light several issues our specialty is confronted with. Read the news story here.

Liposuction performed by untrained and non-certified doctors and paraprofessionals can lead to detrimental and possibly even fatal outcomes that can be prevented. This case illustrates that point, as a doctor who had only gone to an 18-hour training course in liposuction and was actually an occupational medicine physician performed the procedure on the Floridian woman. The procedure was performed in an unlicensed and non-accredited facility labeled “Tanning Salon” on the outside. Reports show that she likely had seizures from a lidocaine overdose, and she was also given Propofol in the medspa/tanning salon, which is against state law. Propofol is a powerful intravenous sedative and anesthetic agent (the one that killed Michael Jackson), and lidocaine is a local anesthetic that is injected into the subcutaneous fat, often mixed with saline to dilute it, prior to liposuction to cut down on bleeding and for pain control. The dose for a particular human body weight has to be specifically calculated so that overdose and fatality doesn’t ensue no matter what type of case is being performed. It is concerning because an occupational medicine doctor would likely have no specialty training in this particular facet of surgery.

A lack of oversight of medspa facilities has played a part in this young woman’s death after liposuction, as facilities that are not licensed or accredited by state and federal organizations such as JCAHO for hospitals and AAAASF for offices and small facilities should not be able to have practitioners of any kind administering powerful drugs such as Propofol and administering injections of lidocaine. Because this facility had no business performing these procedures, they had no back up emergency crash cart with medications in it to help resuscitate a person who may have complications from these types of drugs and surgeries.

Our state and federal governments are missing the ball in their lack of regulation of physicians, paramedical professionals and technicians performing cosmetic procedures and surgery without proper certification and credentialing. Patient safety is a major issue especially with physicians practicing outside of the scope of their training. Plastic surgery should be done by board-certified plastic surgeons, delivering babies by obstetricians, and workplace injury evaluations by occupational medicine doctors. Surgical training takes many years and requires a vigorous board certification and continuing education process. Israel has laws in place that enforce physicians to practice within their scope of training and advertise in keeping with their training and board certification; the US government should take cues from them.

Prospective patients also need to wise up and educate themselves by doing research on their treating physician. The discount that people get for untrained professionals to do their surgery or procedure is quickly offset by the complications that can be extremely costly, even to their life. Things to look in a plastic surgeon are for are board certification by the American Board of Plastic Surgery, experience with the procedure being performed, and hospital privileges at a local tertiary care center should complications arise that need to be expeditiously treated.

Now you may be able to find out! Here you can see Dr. Jennifer Walden featured on an educational DVD for the Natrelle Pre-consultation Kit on Breast Augmentation and Breast Reconstruction. As you may already know, Dr. Walden specializes in Breast Augmentation and Reconstruction in New York, NY and recommends this product for anyone who is looking to get surgery and is unsure about size. This kit was inspired by Dr. Elizabeth Kinsley, who is a plastic surgeon in Covington, LA. On Dr. Kinsley’s website she says, ” After trying on the implants and seeing themselves with a totally different look, many women who said they never considered augmentation changed their minds.”

The Natrelle Pre-consultation Kit was created for patients to find their ideal size for for breast implants. We’re all built differently and sometimes it can be hard to make such a big decision when you’re unsure about the outcome. This kit is the only home breast implant sizing kit designed to educate you about breast augmentation. And, the Natrelle kit is meant to educate people about implants and how to choose the size you desire without being disappointed after surgery. Dr. Walden has been quoted, “Why wonder about what breast enlargement can do for you when you can take a test drive with the Natrelle Pre-consultation Kit?” She also says, “However it’s the implants and sizing bra that make the kit by helping women visualize and get excited about what they’d look like after a breast enhancement”.

The Natrelle™ Collection offers over 140 breast implant combinations from type of filler and volume to base width and profile—to help you find the fit you want. The entire Natrelle™ Collection is FDA-approved, and produced by Allergan (makers of good stuff like Botox and Latisse!). This kit is available on the Natrelle website for $39.95 plus $5 shipping and handling and includes rebates for Botox, Juvederm, and Latisse. Search it on Natrelle.com!

Watch the above YouTube video!

Heidi Montag was featured on People Magazine’s cover this month regarding her “addiction” to plastic surgery. She has recently undergone 10 cosmetic procedures, in what seemingly is an endless quest for beauty or a publicity stunt in a naturally gorgeous young lady. Too often young women undergo multiple procedures in hopes for a transformation to an idealized or unattainable version of themselves or someone whom they idolize, which a surgical procedure can never bring. The Hollywood quest for fame and beauty in our culture today among young women adds to the pressure to look the same. Check out Inside Edition’s segment on Heidi Montag’s plastic surgery procedures, and see Dr. Walden interviewed on the topic.

Above you will see the latest updates from this week’s medical news on the first Medical Rewind of 2010 on Fox and Friends! Topics include the effect of ginkgo biloba on memory, an update on causes of chest pain, and the herbal supplement Kava and how it is being used in relaxation drinks for all those who want to put down the Red Bull! Dr. Walden is interviewed by Dave Briggs and Clayton Morris on morning’s top-rated news show.

Check out Dr. Walden on this week’s Medical Rewind on Fox and Friends. She is interviewed on the breaking health news this week including tap water contamination, several interesting things that may decrease the risk of prostate cancer, and public school meal quality and safety.

Watch the above video as Neil Cavuto interviews Dr. Jennifer Walden, Manhattan Plastic Surgeon, on Fox Business News on the proposed cosmetic surgery tax in the Senate version of the health care bill. Many plastic surgeons and surgical societies oppose this tax as discriminatory, arbitrary and ineffective.

As Dr. Walden explains, about 90 percent of cosmetic surgery patients are female so
elective surgery taxes unfairly target women. Contrary to popular belief, cosmetic surgery is no longer an
exclusive luxury reserved for the very wealthy – the vast majority of patients are women who work.
Research by the American Society of Plastic Surgeons targeting those who plan to have cosmetic surgery
within the next two years reveals that 60 percent of the respondents report an annual household income of $30,000-$90,000. Most importantly, 40 percent of those report income of
$30,000-$60,000. Only 10 percent of the respondents report
household income of more than $90,000.

It would be an inappropriate position for physicians to be put in to be tax collectors, and the government is in no position to determine medical necessity. A similar program in NJ is about to be repealed as it failed in that state with a huge administrative burden and budget shortfall. We hope the politicians come to their senses on this proposed tax and do not set this precedent of taxing patients and physicians to solve their budget crisis in healthcare reform.