Stomach Balloons: A New Alternative to Surgery for Obese Patients?
Although childhood obesity rates have recently declined, obesity remains a significant problem in the US, with 34% of the adult population considered obese today. The American Medical Association officially recognized obesity as a disease in 2013. Since then, the FDA has approved several weight loss drugs. Recently, it approved 2 stomach or intragastric balloon weight loss devices for obese patients that may be attractive alternatives to surgical treatment.
Gastroenterologist or Surgeon Place Balloon in OP Procedure
The 2 newly approved devices are the Orbera Intragastric Balloon by Apollo Endosurgery and the Integrated Dual Balloon System by ReShape Medical. The purpose of these devices is to occupy enough space in the stomach so that when patients eat, they will get full faster and, therefore, eat less. There is no malabsorption of food or nutrients associated with this type of device (this differs from some surgical procedures that intend to elicit malabsorption and may pose a risk for some patients). The devices are designed simply to reduce the available capacity of the stomach and thereby limit the amount of food eaten. They are intended to remain in the stomach for about 6 months.
The deflated balloon is placed into a patient’s stomach with the aid of an endoscope and inflated with a saline solution after placement is confirmed. Either a gastroenterologist or a surgeon with endoscopic training and expertise can perform the procedure. It can be performed in the outpatient setting under light or moderate sedation, and typically takes 15 to 20 minutes. Since there is no incision, the patient can go home the same day and can easily resume normal activities without restriction by the next day.
Clinical trials have proven the efficacy of this approach, with patients using the device losing 2 to 3 times as much weight as the control group at 6 months, with a mean of 30% to 40% of excess weight loss (EWL = current body weight – ideal body weight), or about 15 to 20 pounds per patient. The complication and risk profile of the procedure is also very good, with minimal complications and a large pool of patients (200,000+) who have successfully undergone it worldwide.
Large Patient Pool May Gravitate to Alternative to Surgery
Eligible patients include adults with a body mass index (BMI) between 30 and 40. In the US, this is estimated to be 45 to 50 million people. This procedure will appeal to many of these patients who are seeking alternatives to surgery.
The first bariatric surgical procedures were performed almost 65 years ago. The popularity of bariatric surgery exploded about 15 to 20 years ago with the advent of the Roux-en-Y gastric bypass procedure, which is now performed laparoscopically in most cases. The sleeve gastrectomy, Lap-Band procedure, and duodenal switch procedure are operations that are also performed for weight reduction for severely obese patients. However, all of these procedures require patients to undergo general anesthesia and incisions.
The number of patients undergoing some type of surgical procedure in the US appears to be plateauing, somewhere just under 200,000 per year, suggesting that the ceiling for the surgical market may be in sight. Hence, a procedure that does not require general anesthesia or surgical incisions will be very attractive to many patients, especially those who are fearful of an operation.
Payment May Be Problematic
Currently, the procedure is not reimbursed by commercial payers or Medicare. Payers may be reticent to reimburse given concerns about the long-term outcomes or durability of the procedure for weight loss. Thus, patients are currently footing 100% of the bill. The cost of the procedure is in the $5,000 to $8,000 range, which includes 1 year of dietary and weight management. Clearly, that price will be prohibitive for many patients and, as such, it is difficult to forecast how much traction the intragastric balloon will gain for the treatment of obesity in the near future.
However, ease of use, convenience and avoidance of surgery are very attractive to patients and, if costs are reduced and/or reimbursement is established, this intervention will be an important part of the weight management arsenal.
Lay Foundation With Comprehensive Weight Management Program
We at Sg2 recommend that this procedure be considered as one part of a comprehensive weight management program. Key elements of a comprehensive program should include:
- Staff: physicians and surgeons, dietitians, nutritionists, exercise physiologists and psychologists
- Dietary and exercise programs as a staple offering
- Surgical, nonsurgical and pharmaceutical treatment options for obese and severely obese patients, as needed/applicable
- A process (led by the program director) for assessing and incorporating new technologies or procedures as they become available
As mentioned previously, 34% of the US populations is clinically obese. Given the millions who are affected, we anticipate that additional innovative obesity treatments will continue to be developed and marketed. Health care organizations with comprehensive weight management programs will be best suited to assess and incorporate these new treatments and provide a robust set of offerings to their patients.