The United States (US) Federal Drug Administration (FDA) is joining Australia in the battle of the bulge by approving the gastric band for use in obese adults with a Body Mass Index (BMI)* as low as 30 and one obesity-related condition.
Australia was the first in the Asia-Pacific region to recently approve the gastric band for use in people with a BMI over 35 or a BMI greater than 30 with at least one serious, obesity-related condition. For the first time, adults across the whole obesity spectrum who have failed conventional weight loss measures (diet, exercise and medication) can access this clinically effective, long-term, weight loss option.
According to Professor Paul O’Brien, Head of the Centre for Obesity Research and Education (CORE) at Monash University, Melbourne, broader use of the gastric band among obese adults will have a significant and positive effect on health in Australia and the US.
“We know that serious, obesity-related health complications have already begun by the time a BMI of 30 is reached, which is the lower limit of obesity.1
“The gastric band was previously available to those with a BMI of at least 35 and one serious, obesity-related condition. Until now, obese people with a BMI under 35 who carry significant health risks have had limited options to improve their health when other conventional weight loss measures, such as diet and exercise, have failed,” said Prof O’Brien.
“If left untreated, research shows that these people will likely remain obese,2 placing themselves in danger of developing serious health conditions, such as diabetes, high blood pressure and heart disease.
“While these simpler, non-surgical options should certainly form part of all initial weight loss attempts, we know with confidence from our Australian clinical data, that gastric banding is a viable, effective option for people unable to maintain weight loss with conventional methods,” Prof O’Brien said.
Data reveal that approximately one-in-four3 – or 3.24 million4 – Australian adults are obese. If this trend continues, it is estimated that 7.2 million Australians will be obese by 2025,4 underscoring obesity as a growing health epidemic in Australia and the need for additional, effective treatment.5,6 Given its known correlation to life-threatening conditions (such as type 2 diabetes, heart disease, high blood pressure, stroke and some cancers),5 obesity is a disease that requires medical treatment.
In Australia, the first gastric banding procedure was performed in 1994, and last year more than 11,000 procedures were conducted.7 In total, more than 600,000 procedures have been performed internationally.8
“In one of our landmark studies that contributed to the FDA’s decision to expand the indication for the gastric band, those who had mild-to-moderate obesity (BMI 30-35) showed very clear benefits with the gastric band compared to a matched group who received the best conventional weight loss treatment,” said Prof O’Brien.
At two years after entry into the study, the gastric banding patients had lost an average of 87 per cent of their excess weight compared to those who followed a conventional program and lost just 21 per cent of their excess weight through diets, improved eating habits, and increased exercise and lifestyle changes.9
Dr Roy Brancatisano from the Institute of Weight Control, Sydney, cautions that gastric banding is not a quick fix to weight loss but rather, one part of a person’s lifetime commitment to shedding excess weight and leading a healthier lifestyle.
“Obesity is a complex disease. We all have different messages from our brain about food. It is sometimes assumed that those who over-indulge in food must have a lack of self-control. However, the spectrum of pressure to eat can range from minimal to an overwhelmingly persistent hunger that can never be satisfied.
“The new indication is a welcome relief for people struggling to lose weight who want to improve their health and quality of life when other options fail,” Dr Brancatisano said.
“Gastric banding addresses an unmet treatment need and provides effective, sustainable weight loss.
“The broader indication for the gastric band across the whole adult obesity spectrum will allow Australia and the US to lead the way in the fight against obesity,” said Dr Brancatisano.
About the FDA announcement
The FDA has approved the laparoscopic adjustable gastric banding (LAGB) procedure for people with a BMI greater than 30 and at least one serious, obesity-related condition, and who are unable to lose weight through conventional weight loss methods.
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Landmark Australian research contributed to the FDA’s approval of the gastric band for use in adults within the lower limits of obesity. A world-first study, conducted at the Centre for Obesity Research and Education (CORE) at Monash University, compared the effectiveness of LAGB to non-surgical treatment (diet, exercise and medication) in obese adults with a BMI between 30 and 35. The research found that LAGB resulted in a loss of 87 per cent in excess body weight, compared to 21 per cent with non-surgical treatment; a greater reduction in obesity-related health conditions for LAGB; greater improvements in quality of life across all measures with LAGB. 9
A second Australian study also conducted at CORE, that formed part of the FDA submission, revealed that gastric banding surgery is five times more likely to reverse type 2 diabetes than simple lifestyle changes.10 The study revealed 20 per cent of average body weight loss with LAGB compared to 1.4 per cent average body weight loss with conventional diabetes care; an 80 per cent improvement to normal limit blood sugar (glucose) levels with LAGB, compared to 20 per cent with conventional diabetes care; a greater reduction in the use of diabetes medication with LAGB and a greater reduction in associated health conditions, including use of blood pressure and lipid lowering medications. 10
About the LAGB procedure
The laparoscopic adjustable gastric band (LAGB) is a buckle-design band placed laparoscopically (keyhole surgery) around the stomach that compresses the top of the stomach and reduces appetite.11 The band has a soft lining that can be inflated by injecting saline into an access port, just beneath the skin in the side of the abdomen, allowing for tightening of the band for further control over appetite, without surgery.11
The LAGB procedure does not require cutting or stapling of the stomach and there is no bypassing of parts of the digestive system.11
The LAGB procedure is suitable for severely obese adults, or obese adults with weight-related health complications, who have unsuccessfully tried other weight loss methods, such as diet and exercise.11
Complications associated with gastric banding surgery include risks from the medications and methods used in the surgical procedure, the risks associated with any surgical procedure, and the patient’s degree of intolerance to any foreign object implanted in the body.11
Australia’s first gastric banding procedure was performed in 1994, and last year more than 11,000 procedures were performed in Australia.7 More than 600,000 procedures in total have been performed internationally.8
About obesity
Obesity is a disease in which fat has accumulated to the extent that one’s health is impaired.9 Obesity can also be linked to genetic, perinatal and socioeconomic factors.3 Weight status is often measured using the body mass index (BMI); measured by body weight (in kilograms) divided by height (in metres squared). A BMI of 25–30 is considered overweight, while a BMI greater than 30 is obese.3
People who are obese are at higher risk of premature death and many health complications including type 2 diabetes, heart disease, osteoarthritis and some cancers.12 More than 3 million adult Australians are obese, costing the community more than $58 billion each year.12
Obesity accounts for approximately 7.5 per cent of the total disease burden in Australia, just behind high blood pressure and tobacco,3 and is the highest contributor to the the burden of disease for those in the 35-44 age group (8.6%) and 45-54 age groups (13%).3 Obesity places a significant burden on the health economy.4 As the trend grows, so will the prevalence of obesity-related health risks to the community.
* BMI – Body Mass Index expressed in kg/m2