December 22nd, 2011 by John Di Saia, M.D. in News, Opinion
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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
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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*
November 23rd, 2011 by John Di Saia, M.D. in Health Tips
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About ten years ago plastic surgery had a nice little advance- the advent of the disposable pain pump. Breakthroughs in medicine are far fewer than advertising copy would have you believe, but this one is real. Unfortunately some practices use them like a marketing ploy in all cases and really don’t spend the time to make them work well or minimize their risk. Others don’t see the benefit and don’t use them at all.
Pain pumps are quite useful in some cases when used correctly. Plastic surgery is a technical specialty and some surgeons are more adept at making things work than others. There are risks with them and cases in which the benefit is harder to measure.
How Does a Pain Pump Work? Read more »
*This blog post was originally published at Truth in Cosmetic Surgery*
November 13th, 2011 by Toni Brayer, M.D. in Research
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Remember the 1991 Gulf War between the United States and Iraq (aka: “Operation Desert Storm”)? A new study has been published in the American Journal of Epidemiology that assessed the health status of 5,469 deployed Gulf War veterans compared to 3,353 non deployed veterans. At 10 year follow up, the deployed veterans were more likely to report persistent poor health. The measures were functional impairment, limitation of activities, repeated clinic visits, recurrent hospitalization, perception of health as fair or poor, chronic fatigue syndrome illness and post-traumatic stress disorder.
From 1995 to 2005, the health of these veterans worsened in comparison to the veterans who did not deploy to the Persian Gulf. A study done in the United Kingdom that compared Gulf War veterans to UN peacekeepers who served in Bosnia and other non-deployed Gulf War soldiers found Read more »
*This blog post was originally published at EverythingHealth*
October 19th, 2011 by Steve Novella, M.D. in Health Tips, Research
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The discovery of various vitamins – essential micronutrients that cause disease when deficient – was one of the great advances of modern scientific medicine. This knowledge also led to several highly successful public health campaigns, such as vitamin-D supplementation to prevent rickets.
Today vitamins have a deserved reputation for being an important part of overall health. However, their reputation has gone beyond the science and taken on almost mythical proportions. Perhaps it is due to aggressive marketing from the supplement industry, perhaps recent generations have grown up being told by their parents thousands of times how important it is to take their vitamins, or eat vitamin-rich food. Culture also plays a role – Popeye eating spinach to make himself super strong is an example this pervasive message.
Regardless of the cause, the general feeling is that vitamins Read more »
*This blog post was originally published at Science-Based Medicine*
October 2nd, 2011 by DeborahSchwarzRPA in News
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Ventricular Assist Devices (VADs) are small pumps that take over the work of the heart in pumping the blood through the body. Patients who need a heart transplant, but for whom there is no donor heart available, might be given a VAD for what’s called a bridge-to-transplant while they wait for a donor.
PediMag, the pediatric version of the adult device, CentriMag, is an external device designed for short-term use in infants with heart failure. PediMag can also be used to support children after heart transplant surgery if they experience organ rejection and need time for their hearts to rest and heal, according to Jonathan M. Chen, MD, Surgical Director of Pediatric Heart Transplantation at Morgan Stanley Children’s Hospital of New York. Dr. Chen has extensive experience treating children with heart failure and has recently authored an account of his first successful use of the PediMag as a biventricular bridge-to-transplant in an infant.
The PediMag ventricular assist device is Read more »
*This blog post was originally published at Columbia University Department of Surgery Blog*
