Beginning in 2009, and over the following 7 years, SmartShape Weight Loss Centre was one of the largest surgical clinics to recruit patients for the HERO (Helping Evaluate Reduction in Obesity) research project, set up to examine explant rates for the LAP-BAND® AP Adjustable Gastric Band (LAGB).
A total of 671 subjects were enrolled (June 4, 2009 to March 19, 2011) in the study at 17 sites across the United States and Canada. The study was completed and results published in November 2016.
The reason for this study was to provide updated data to the Food and Drug Administration in the US and give more relevant and current data for the LAP-BAND® procedure.
During the 5-year period of the study, fifty-seven LAGB devices were removed (8.74%). This is significantly lower than the previously documented rate of 36.35% (from the FDA trial data). This data indicates a significant improvement in this metric indicating that patients can expect a low band removal rate in clinics that are experienced in the implantation and care of LAP-BAND® patients.
Over the 5 years of the study, a sustained mean weight loss of 18% of total body weight was seen. Also, and importantly, there were significant improvements in all parameters of chronic disease such as diabetes, hypertension and heart disease.
The conclusions drawn from this rigorous and long-term scientific study were that explant rates of the LAP-BAND® are much lower than an estimate previously set by the FDA, and are consistent with more recent literature.
The LAP-BAND® remains a recommended weight loss device by the FDA for helping obese and morbidly obese people to lose weight. An experienced and dedicated clinic is critical in allowing LAP-BAND® patients to lose weight, which leads to control of Type 2 diabetes. Lap Band surgery is considered the least invasive bariatric surgical procedure.
The LAP-BAND® ‘s proven success as well as it’s minimally invasive and completely reversible surgery is an attractive option for many patients.
Placing the LAP-BAND® is not the end, but the start of the process, which when combined with a healthy diet and regular exercise allow a path to achieve the goals of the treatment. When patients follow the plan, LAP-BAND® surgery can help not only to lose weight, but also improve overall health.
One of the lead investigators, John Olsofka, M.D., stated, “This study demonstrates that continued patient interaction and adherence to good LAP-BAND® aftercare principles by the surgeon’s practice will produce an effective, safe, and durable outcome for patients who suffer from obesity.” Vincent Lusco, M.D., another lead investigator commented, “As the HERO Study shows, the key to success with LAP-BAND® is for it to be viewed as a therapy as much as a surgical procedure. When delivered by bariatric surgeons who have the required aftercare program, laparoscopic adjustable gastric banding with the LAP-BAND® is an excellent alternative for patients looking to gain control over obesity.
The SmartShape Team are proud of our 5-year Aftercare Program for LAP-BAND® patients – learn about our Program at http://bit.ly/SmartShapeProgram