Intragastric Balloons to Treat ObesityAugust 31, 2015
With an increasing emphasis on the obesity epidemic in the United States, it seems only fitting that we should be adding to our arsenal of procedures able to combat it. Bariatric surgeons and patients alike have been anxiously awaiting the approval of Intragastric Balloons by the FDA and finally that time has arrived. But to call these Balloons “new” would be misleading. While they are new to the United States, they have been available in Europe, South America, Canada and most other parts of the world for over a decade. We have seen an increasing number of patients travel outside of the United States to gain access to this technology but with the recent FDA approval, patients will be able to access them right here at home.
More options to treat obesity
So why are patients and physicians so excited about intragastric balloons? Many reasons. The pace at which we as surgeons have been able to onboard new procedures to treat this disease has been painfully slow. Not since the inception of the sleeve gastrectomy which began over a decade ago, have we been able to introduce something so new to our patients. Furthermore, the fact that we are operating on less than 1% of patients who qualify for surgery suggests that many are not interested in the options we have to offer.
Benefits to Intragastric Balloons
Moreover, the Intragastric Balloon stands out from the current procedures we offer due to several key factors. One, it is by far the least invasive of all current procedures. As an endoscopic procedure, the balloon is placed endoscopically, or through the mouth. This results in no incisions, no scars, and typically a quick 20 or 30 minute outpatient procedure. Once in place, the balloon is designed to take up space in the stomach, reducing appetite and hunger. Furthermore, unlike the other procedures we offer, the balloon is not permanent. It is designed to be removed from the stomach 6 months after its original placement in a similar manner in which it was placed. And finally, this technology gives us a way to better access low BMI patients (the FDA is expected to approve this device for treatment in patients with a BMI of 30-40). The LapBand is the only other treatment modality that has been approved for this low BMI category of patients yet it represents a more invasive laparoscopic procedure that many patients are not willing to pursue.
Since these intragastric balloons have been so readily available outside the United States, we will be able to reference the best practices that they have built and utilize them as our baseline. This should allow us to further boost weight loss for our patients. Recent clinical trial results from Apollo Endosurgery’s Orbera Intragastric Balloon illustrated that patients in this low BMI category (BMI of 30-40) were able to lose upwards of 40% of their excess weight and approximately 10% of their total body weight.
Patients treated with Orbera were able to maintain significantly more weight loss throughout month 12, six months after the removal of the implant, compared to the control group.
Aftercare for Intragastric Balloons
As illustrated by this data, we know that despite the temporary nature of this implant, patients can maintain their weight loss with the appropriate type of aftercare. Pre-procedure education should be mandated as should regular follow-up visits with a dietician/nutritionist and surgeon as needed. A full multidisciplinary approach to this procedure is something patients should look for when selecting a program. It should also be noted, that these patients can expect to have severe nausea and even vomiting within the first few days following this procedure. Procedure teams should onboard appropriate antiemetic cocktails and protocols to implement to help patients avoid dehydration.
Finally, due to the temporary nature of this implant, most insurance plans are unlikely to cover it. Patients should expect to pay cash for this procedure. Established bariatric programs that typically have a relatively low volume of current cash pay patients will need to adapt to this changing landscape. A cash price that incorporates the implantation, explantation, and all affiliated pre-procedure and post-procedure education and aftercare will need to be developed. Onboarding a variety of financing options and educating staff members to effectively discuss these options with patients will also be important.
For all of the reasons discussed here, patients and physicians have a right to be excited about the approval of the Intragastric Balloons. As with all bariatric procedures and weight loss therapies, appropriate attention will need to be given to patient education and follow-up and patients will want to do their due diligence in selecting programs that are well trained and have implemented a true multidisciplinary approach.
ABOUT THE AUTHORDr. Nestor F. de la Cruz-Muñoz is the chief of the Division of Laparoendoscopic and Bariatric Surgery and co-director of the Center of Excellence for Laparoendoscopic and Minimally Invasive Surgery. He is also the Medical Director for Bariatric Surgery at University of Miami Hospital, part of University of Miami Health System. He has focused his practice in general, bariatric, and advanced laparoscopic surgeries. Dr. de la Cruz-Muñoz is renowned nationally and internationally in the fields of bariatric and general surgery.
Photo credit: Apollo Endosurgery