American Society for Metabolic and Bariatric Surgery (ASMBS) Approves Intragastric Balloon

| April 1, 2018

An interview with: Samer Mattar, MD, FACS, FRCS, FASMBS

Medical Director, Swedish Weight Loss Services in Seattle, Washington, President of the American Society for Metabolic and Bariatric Surgery (ASMBS)

Funding: No funding was provided for this article.

Disclosures: The author has no conflicts of interest relevant to the content of this article.

Bariatric Times. 2018;15(4):18–19.

The ASMBS officially approved the intragastric balloon for bariatric surgery. The announcement was made February 5, 2018.

The intragastric balloon was first approved by the United States Food and Drug Administration (FDA) in 2015 for patients with a body mass index (BMI) between 30 and 40kg/m2. The balloon, which is filled with saline, is endoscopically placed into a patient’s stomach with the intention of filling up a portion of the stomach and making patients feel full more quickly. The device remains in a patient for six months before it is removed.

Approximately 5,000 intragastric balloons have been implanted since 2015, a small portion of the total bariatric surgeries that have been completed in the United States. Patients who choose to have a balloon are required to go through a strict diet while the balloon is in their body as well as after it is removed.

The other six ASMBS-approved devices and procedures, thus far, are Roux-en-Y gastric bypass, duodenal switch, sleeve gastrectomy, adjustable gastric banding, bariatric reoperative procedures, and open procedures (when deemed appropriate by the surgeon).

What are your initial thoughts on the ASMBS adding the intragastric balloon to its list of approved devices and procedures?

Dr. Mattar: I am very pleased that we have expanded our portfolio of options, as part of the continuum of care, we can offer our patients. Everyone gains, especially our patients, when additional procedures or devices that have been adequately evaluated for safety and efficacy are added to our armamentarium.

What were the steps for gaining official approval for the intragastric balloon?

Dr. Mattar: The process begins when an application (available on the ASMBS website) is submitted by an ASMBS member advocating for the approval of a procedure or device. The application is then reviewed by the Executive Committee of the Executive Council (ECEC), followed by the New Devices and Procedures Task Force, a group that includes representation from the top ASMBS leadership—Clinical Issues Committee (CIC), Insurance Committee, and Research Committee. Here the topic is deliberated and evaluated for substance and validity. Following a positive recommendation from the task force, the issue is presented to the ECEC in a pro/con debate format (presented by guest experts) along with a brief review of pertinent scientific data from a member of the CIC. If approved, the matter is then released as a survey to solicit opinions from the entire ASMBS membership. The survey results are analyzed by the ECEC, which then votes. A 75-percent majority vote is needed for final approval.

Insurance coverage continues to be a key issue regarding bariatric surgery. Do you think now that the ASMBS has gained momentum in getting other forms of bariatric surgery covered by insurance companies it will be easier to accelerate coverage for the balloon too?

Dr. Mattar: As you can see, the ASMBS approval mechanism is thorough and rigorous, based on scientific data, free and ample deliberation at many levels, and most importantly, reliant on input from the entire membership. Thus the approval of a new device or procedure by ASMBS affords this item the full weight and influence of our society and forges the path to acceptance and validation by many stakeholders, including payers and regulatory bodies.

How quickly do you think the intragastric balloon will be adopted by bariatric surgeons nationwide? Is there any learning curve for bariatric surgeons who haven’t done this procedure before?

Dr. Mattar: Any new technology carries an inherent learning curve, and we are satisfied that the current process adopted by the balloon manufacturers includes a training mechanism before practitioners are provided with the balloons. But, first and foremost, we are firm, adamant, and resolute in our calling that all patients who receive any component of our continuum of care should do so within the confines of a multidisciplinary team that is patient-centric and focused on optimizing the chances for their durable and holistic improvement.

Do you think it will be easier to convince patients that the balloon is the right choice for them since it’s a nonsurgical option?

Dr. Mattar: I think I share the same approach with all my colleagues in the field, in that I don’t really try to “convince” the patient of a particular procedure or device. I have learned that patients do best when they genuinely and actively “embrace” a procedure, rather than passively agree to accept what is offered. I present all the updated information regarding the proven efficacy, safety, risks, benefits, and expectations of a procedure and then help the patient reach an informed decision that we both agree is the most appropriate with regard to his or her particular characteristics.

How popular do you expect the procedure to be for patients compared to more traditional forms of bariatric surgery?

Dr. Mattar: It is difficult to predict how popular these devices will be. Of course, we must bear in mind some of the limitations inherent to these devices. Intragastric balloons are approved for patients with a BMI of 30 to 40, so based on United States Food and Drug Administration (FDA) regulations, not every patient will be a candidate. Moreover, the device is meant to be positioned for a finite duration of six months, after which it is removed (or biodegrades) and is followed by six months of monthly counseling and support. One thing for certain is that while it is evident that intragastric balloons have their recognized place within the continuum of care, they should never be considered of equal efficacy to the more traditional metabolic operations we offer our patients, nor should they undergo head-to-head comparisons with these other procedures. This is unfair and serves no other purpose but to diminish the value of intragastric balloons as one of the many options that we can offer our deserving patients.

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