December 10th, 2010
The Lap-Band device is a popular surgical product used to shrink the stomach so that obese patients can cut back on their eating. made by manufacturer Allergan, the Lap-Band was approved for sale in 2001 and is currently approved for use in adults with a BMI of at least 40 or at least 35 plus another health problem.
Allergan is looking to gain approval for a wider group of patients. They would like it to be used for patients with a BMI of 35 or higher or at least 30 plus another health problem. A BMI of 30 is considered obese.
Clinical trials showed that the adjustable silicon stomach band improved health-related quality of life in people who aren’t as heavy as current users, according to regulators.
A FDA report showed that no deaths or “unanticipated adverse effects” occurred with the device.
Allergan is looking to sell Lap-Band for treating people who have a body mass index of 35 or even 30 for those with other complications
Allergan conducted a study and found that patients had a “significant decrease in all measures of weight loss,” wrote FDA reviewers in a summary to be reviewed by an outside group of advisers. There were no unexpected complications and about 2% of device-related problems were considered severe.
UPDATE
The advisory committee to the Food and Drug Administration voted 8 to 2 that the benefits of Lap-Band surgery exceeded the risks for patients in the lower range of obesity. It voted 8 to 2 that the device was safe, and 8 to 1, with one abstention, that the device was effective.
The F.D.A. usually agrees with its advisory committees, but it was not clear when a decision would be made
Tags: LAP BAND
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August 27th, 2010
Gastric banding and other weight loss surgical procedures have soared tenfold within the decade
The British Medical Journal reports operations such as gastric banding and bypasses rose from 238 a year to more than 2,543 in 2007.
Researchers from Imperial College London said more obese patients were now aware that surgery could help them.
Data for 2003/04 showed there were 480 procedures, rising to 4,246 in 2008/09.
Tam Fry, from the National Obesity Forum, said: “These figures just show how bad things have got with the obesity epidemic.
“We have alternative ways of losing weight but when people realise this is a possibility, they could go for it.
“A lot of doctors are also starting to skirt around the rules and not insist on months of lifestyle change and pharmaceutical treatment – instead they are going straight for surgery.”
Peter Sedman, bariatric surgeon and spokesman for the Royal College of Surgeons, said: “The number of morbidly obese patients in the UK is increasing rapidly and we need to continue to put even more resources into what is proven to be a successful and cost-effective method of treatment.
Bariatric surgery is performed on people who are dangerously obese and who need to lose weight for medical reasons. The National Institute for Health and Clinical Excellence (NICE) recommends bariatric surgery for people with ‘morbid obesity’, which means a body mass index of at least 40 or of at least 35 if accompanied by another disease (such as diabetes) which could improve if the patient lost weight, and for whom all non-surgical treatments for weight loss have failed.
Bariatric surgery usually involves:
Reducing the size of the stomach with a surgical band ( gastric banding)
Re-routing the small intestines to a small stomach pouch ( gastric bypass)
Removing a portion of the stomach
Tags: obesity surgery
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August 16th, 2010
Results of a large national study show that nearly three-quarters of obese patients with type 2 diabetes who undergo weight-loss surgery are able to stop insulin and other antidiabetes drugs within six months.
In the Johns Hopkins study of insured, obese, diabetic patients, researchers also found that in the third year following surgery, average annual health care costs per patient decreased by more than 70 percent. The study is published in the Archives of Surgery this month
Makary and his colleagues studied 2,235 adults with Blue Cross/Blue Shield insurance from throughout the United States who had type 2 diabetes and underwent bariatric surgery during a four-year period from January 1, 2002 to December 31, 2005. The average age of those in the study was 48 years old and 74.5 percent were women. More than 23 percent of participants were insulin dependent while more than 50 percent took metformin hydrochloride to keep their diabetes in check.
Makary and his colleagues found that within one year following surgery, the number of patients dependent on insulin dropped from 524 (23.4 percent) to 101 (5.5 percent). Those on metformin dropped from 1,129 (50.5 percent) to 156 (8.4 percent).
Makary says that while bariatric surgery has been shown to result in long-term weight loss, improved lifestyle and decreased mortality in many patients, its impact on diabetes has not been widely studied
Tags: Weight Loss Surgery .DIABETES
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