FDA agrees that Lap Band surgery should be available to more patients
Not sure if you just heard about this ....
WASHINGTON (Dow Jones)--A federal advisory panel backed the use of Allergan Inc.'s (AGN) stomach-shrinking Lap-Band product for a wider group of patients.
The advisory panel to the U.S. Food and Drug Administration said, in an 8-to-2 vote, that the benefits of the device outweighed its risks. But the panel also recommended that Allergan conduct a large, long-term study to look at the device's performance over a period of several years as younger and additional patients may opt to use the product to lose weight.
In a review of Lap-Band prepared for the meeting, the FDA said clinical data submitted in support of the product showed it helped obese patients lose weight and "may have a potential to significantly impact" health problems associated with obesity.
In a statement, Frederick Beddingfield, Allergan's vice president of clinical research and development, said the company was pleased with the panel's decision.
"Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful," he said.
The agency said a study looking at 143 patients showed "statistically significant improvements" in all measures of weight and body mass at 12 months, showing the device worked to help patients lose weight.
The Lap-Band is currently approved to treat severely obese adults with a body mass index of 40 or more or a BMI of 35 with at least one obesity-related condition, such as Type 2 diabetes or high blood pressure.
Allergan is seeking approval to market the device to adults with a BMI of 35 or for adults who have a BMI of 30 and one obesity-related condition.
The FDA said that allowing the device to be used in less obese patients than currently allowed would change current medical practice and is one of the reasons the matter was brought to the advisory panel.
BMI is a measure that estimates body fat by using a person's height and weight in the calculation. Those with BMIs of 25 to 29.9 are considered overweight and those who are considered obese have a BMI of 30 or greater. (A BMI of 18.5 to 24.9 is considered a normal weight for adults.) About two-thirds of Americans are overweight, with one-third considered obese.
The Lap-band is designed to be inserted surgically through a tiny incision and placed at the top portion of the stomach to reduce stomach capacity by creating a small pouch. The band is inflatable and can be tightened or loosened. The company said about 600,000 people have received a Lap-band.
The FDA said the effectiveness of the Lap-band for the treatment of severe obesity "with respect to long-term weight loss is less than that of other bariatric surgical procedures, but substantially better than traditional behavioral or medical therapy." A common type of bariatric surgery involves a procedure that staples the stomach and re-routes food around a section of the small intestine.
FDA didn't raise major safety concerns, but said seven patients had a re-operation after initially receiving a Lap-band. One patient had a re-operation to fix an eroded band while four other patients had the band removed and not replaced. One patient requested that the band be removed after having trouble swallowing, the FDA said. Patients are already warned about the possibility of having an additional operation to fix problems with the device or to remove it.
The agency said most of the weight loss typically happens within the first 12 months but "it appears that the device is able to help a patient maintain a stable weight thereafter and, thus, may have a potential to significantly impact co-morbidities that are frequently associated with obesity."
The study showed that patients entering the study had an average weight of 215 pounds before receiving the Lap-band and lost an average of about 40 pounds one year after receiving the device. The average BMI was 35.4 before surgery and dropped to an average of 28.8 when calculated a year later.
http://abcnews.go.com/Health/WellnessNews/fda-panel-lap-band-expansion/story?id=12308753
http://online.wsj.com/article/BT-CO-20101203-712793.html
http://voices.washingtonpost.com/checkup/2010/12/experts_endorse_obesity_surger.html
http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/23730
http://news.google.com/news/more?hl=en&q=lap+band+bmi&um=1&ie=UTF-8&ncl=dbcbaXFuTaFWEXMLvjyztR5jxuHVM&ei=ZXT5TJfHI4et8Abb1fCxCQ&sa=X&oi=news_result&ct=more-results&resnum=1&ved=0CC8QqgIwAA
WASHINGTON (Dow Jones)--A federal advisory panel backed the use of Allergan Inc.'s (AGN) stomach-shrinking Lap-Band product for a wider group of patients.
The advisory panel to the U.S. Food and Drug Administration said, in an 8-to-2 vote, that the benefits of the device outweighed its risks. But the panel also recommended that Allergan conduct a large, long-term study to look at the device's performance over a period of several years as younger and additional patients may opt to use the product to lose weight.
In a review of Lap-Band prepared for the meeting, the FDA said clinical data submitted in support of the product showed it helped obese patients lose weight and "may have a potential to significantly impact" health problems associated with obesity.
In a statement, Frederick Beddingfield, Allergan's vice president of clinical research and development, said the company was pleased with the panel's decision.
"Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful," he said.
The agency said a study looking at 143 patients showed "statistically significant improvements" in all measures of weight and body mass at 12 months, showing the device worked to help patients lose weight.
The Lap-Band is currently approved to treat severely obese adults with a body mass index of 40 or more or a BMI of 35 with at least one obesity-related condition, such as Type 2 diabetes or high blood pressure.
Allergan is seeking approval to market the device to adults with a BMI of 35 or for adults who have a BMI of 30 and one obesity-related condition.
The FDA said that allowing the device to be used in less obese patients than currently allowed would change current medical practice and is one of the reasons the matter was brought to the advisory panel.
BMI is a measure that estimates body fat by using a person's height and weight in the calculation. Those with BMIs of 25 to 29.9 are considered overweight and those who are considered obese have a BMI of 30 or greater. (A BMI of 18.5 to 24.9 is considered a normal weight for adults.) About two-thirds of Americans are overweight, with one-third considered obese.
The Lap-band is designed to be inserted surgically through a tiny incision and placed at the top portion of the stomach to reduce stomach capacity by creating a small pouch. The band is inflatable and can be tightened or loosened. The company said about 600,000 people have received a Lap-band.
The FDA said the effectiveness of the Lap-band for the treatment of severe obesity "with respect to long-term weight loss is less than that of other bariatric surgical procedures, but substantially better than traditional behavioral or medical therapy." A common type of bariatric surgery involves a procedure that staples the stomach and re-routes food around a section of the small intestine.
FDA didn't raise major safety concerns, but said seven patients had a re-operation after initially receiving a Lap-band. One patient had a re-operation to fix an eroded band while four other patients had the band removed and not replaced. One patient requested that the band be removed after having trouble swallowing, the FDA said. Patients are already warned about the possibility of having an additional operation to fix problems with the device or to remove it.
The agency said most of the weight loss typically happens within the first 12 months but "it appears that the device is able to help a patient maintain a stable weight thereafter and, thus, may have a potential to significantly impact co-morbidities that are frequently associated with obesity."
The study showed that patients entering the study had an average weight of 215 pounds before receiving the Lap-band and lost an average of about 40 pounds one year after receiving the device. The average BMI was 35.4 before surgery and dropped to an average of 28.8 when calculated a year later.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected]
Other links:http://abcnews.go.com/Health/WellnessNews/fda-panel-lap-band-expansion/story?id=12308753
http://online.wsj.com/article/BT-CO-20101203-712793.html
http://voices.washingtonpost.com/checkup/2010/12/experts_endorse_obesity_surger.html
http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/23730
http://news.google.com/news/more?hl=en&q=lap+band+bmi&um=1&ie=UTF-8&ncl=dbcbaXFuTaFWEXMLvjyztR5jxuHVM&ei=ZXT5TJfHI4et8Abb1fCxCQ&sa=X&oi=news_result&ct=more-results&resnum=1&ved=0CC8QqgIwAA
Good Luck on your Journey !!
Tom
“Nothing I will ever eat will give me the feeling I get as when I lose weight” The views expressed are based on my own experiences - and should NOT BE FOLLOWED IN LIEU OF DOCTOR’S ADVICE/INSTRUCTIONS. Only your Doctor knows your condition, and make sure you talk to them before making any changes to your diet
Tom
“Nothing I will ever eat will give me the feeling I get as when I lose weight” The views expressed are based on my own experiences - and should NOT BE FOLLOWED IN LIEU OF DOCTOR’S ADVICE/INSTRUCTIONS. Only your Doctor knows your condition, and make sure you talk to them before making any changes to your diet
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