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FDA Sends Warning Letters To California Surgical Centers For Misleading Advertising Of The Lap-Band

The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.

Source: fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm283455.htm#.TueG3YY1aZY.facebook

We have blogged on 1-800-Get-Thin and Lap-band surgery in general before. Read more »

*This blog post was originally published at Truth in Cosmetic Surgery*

Woman Loses Hearing Following The Birth Of Her Child

Can you imagine giving birth and then immediately discovering that you couldn’t hear anyone? That you were completely deaf? That’s exactly what happened to Heather Simonsen, a mother of three who lives in Utah. Simonsen noticed after each previous pregnancy that sounds would come and go and her ears felt clogged. She saw an ear, nose and throat specialist who advised her that she was gradually losing her hearing in the left ear. She also began to hear a ringing in her ear.

Simonsen didn’t realize that she was developing a condition called Otosclerosis, a disease of the bones of the middle ear. The bones of the middle ear (the maleus, incus and stapes) are usually flexible and transmit sound but with Otosclerosis, this is not possible because the bones become fused together. Simonsen is one of the Read more »

*This blog post was originally published at Dr. Linda Burke-Galloway*

Video Describes Procedure To Determine The Cause Of Your Snoring

Our office has produced a new video describing “where” snoring comes from determined by a simple procedure known as sedated or sleep endoscopy. At its most basic definition, snoring is noise produced from a vibrating mucosal surface in the upper airway.

Though snoring can be defined simply, the tough question is WHERE are these vibrating mucosal surfaces? Because unless one can define WHERE the snoring is coming from, successful treatment can’t be pursued definitively.

An office exam performed while a patient is awake is suboptimal as the patient is awake… and not snoring. As such, it is an educated guess where the snoring problem is stemming from.

To this end, Read more »

*This blog post was originally published at Fauquier ENT Blog*

Man Dies In An Attempt To Remove His Own Pacemaker

A 47-year-old Chicago man died after trying to remove his own pacemaker. He’s not the first to try self-surgery, as it turns out.

The Chicago Tribune described this most recent attempt at self-surgery:

“Chicago Fire Department paramedics were called after the man told a worker in the home that he was experiencing chest pains and asked them to call an ambulance.

“The man returned to his room, where he remained until paramedics arrived, police said. When they did, he complained to them about chest pains and was taken to the ambulance where he fell unconscious, police said.

“As paramedics were trying to revive him, they discovered Read more »

*This blog post was originally published at ACP Internist*

The Vocal Strength Of A Lion Helps Us Understand The Weak Voice In Some Humans

Researchers in Iowa have discovered what makes a lion or tiger roar so effectively. Apparently, there is a layer of fat within large feline vocal cords that makes the vocal cords especially prone to vibrate easily with minimal exhalation effort.

What import does this have to humans?

Well, there are patients who have a very weak voice due to vocal cord atrophy as well as vocal cord paralysis. Standard interventions include voice therapy as well as surgical procedures using an implant or injectable material in order to “bulk” up the vocal cord.

In fact Read more »

*This blog post was originally published at Fauquier ENT Blog*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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