Official Approval for Gastric Band
The Allergan Gastric Band (LAP-BAND ™) is the first obesity device in Europe to receive official approval for weight loss that leads to improvement or remission of Type 2 Diabetes.
Allergan's LAP-BAND™ AP System for obesity intervention has become the first device to receive official European approval for weight loss that leads to improvement or remission of type 2 diabetes. Type 2 diabetes has reached pandemic proportions and the risk of developing the disease has increased up to 10 times in people who are obese. Obesity is defined as having a Body Mass Index of 30 or greater. Alarmingly, the United Kingdom has the fastest growing rate of obesity in the developed world.
Obesity and type 2 diabetes are likely to be the greatest public health problems of the next decade In the United Kingdom, it is estimated that the number of obese people with type 2 diabetes has increased by 1 million over the past 5 years. Recent estimates are that 10 per cent of the National Health Service (NHS) spending goes on diabetes. This equates to GBP9 billion a year - that's GBP1 million an hour. Current lifestyle and pharmacological approaches are only modestly successful in causing sustained weight loss in obese people with type 2 diabetes.
"Type 2 diabetes is becoming an increasing problem as the prevalence of severe or morbid obesity in the population rises. The proven success of gastric banding procedures in these patients is timely and provides us with a powerful alternative to tackle the morbidity and mortality associated with diabesity. Diabesity was coined by Shape Up America to define the direct correlation between diabetes and obesity" said Dr Jonathan Pinkney, Consultant Senior Lecturer and Diabetologist. "The gastric banding procedure is a highly effective option for selected obese patients who are failing to reduce their weight through traditional weight-reduction methods. The recognition of a device such as the LAP-BAND™ AP System by the European health authorities is an important advance for the medical community and obese patients in our efforts to effectively manage type 2 diabetes."
The recent decision by TUV SUD - a European Union notified body responsible for the certification of medical devices - recognizes the LAP-BAND ™ AP System as the first obesity intervention device in Europe officially approved for weight loss leading to improvement or remission of type 2 diabetes. Specifically, the LAP-BAND™ AP System Directions For Use (DFU) or label now states that weight loss associated with the LAP-BAND™ AP System has been shown to improve or lead to remission of type 2 diabetes.
The evidence leading to the expanded product label comes from a landmark two year randomised controlled clinical study which shows that patients who lost weight with the LAP-BAND™ AP System were over 5 times more likely to achieve remission of type 2 diabetes than those receiving conventional diabetes therapy (73% vs 13%). This is the first randomised controlled study to compare surgically induced weight loss with conventional therapy for management of type 2 diabetes in obese patients. These results confirm the findings of previous observational studies.
Gastric banding procedures are a well-established method of achieving significant and sustained weight loss. In 2006, the National Institute of Clinical Excellence recommended bariatric surgery such as gastric banding as a treatment option for people with obesity whose Body Mass Index (BMI) is between 35kg/m2 and 40kg/m2 and have other significant diseases such as type 2 diabetes or high blood pressure, or for those with a BMI greater than 40kg/m2.
The National Obesity Surgery Centre exclusively uses the Lap Band™ AP System gastric band in a number of hospitals throughout the UK and has successfully fitted a number of them in patients suffering from Type 2 diabetes.
