The Elipse Balloon - A new gastric Balloon with Interesting Features

The Elipse Balloon: A new gastric Balloon with Interesting Features

“The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12 month outcomes” a new article published in the current SOARD issue by Dr. Raftopoulos.Dr. Raftopoulos receives consulting fees from Allurion technologies. Allurion technologies, Natick, MA, USA is the developer company of Elipse Balloon. The study is a prospective, nonrandomized and observational analysis of 12 enrolled patients. Elipse Balloon is folded in a vegetarian capsule and attached to a thin catheter via a self-sealing valve. Patients swallow the capsule; an X-ray study confirms position in the stomach before filling the balloon with 550 ml of water. The catheter is disconnected from the balloon by pulling it out. A bio-absorbable film covers the valve and degrades slowly over a 4-month period. Once degraded, the valve is exposed and the balloon empties spontaneously. It is then expected to pass through the pylorus into the intestines and then naturally excreted. In this study, 3 patients vomited the balloon and the rest excreted it in stool with no complications. The authors recommend soft diet and antiemetic towards the end of the treatment to prevent balloon emesis.

As with previous balloon studies the authors find excellent weight loss comparable to other balloon devices on the market like Obalon, Orbera and Reshape. They caution us, however, on “substantial weight regain” if balloon patients “do not take advantage of balloon therapy and transition to a permanent healthier lifestyle”. The authors further add: “these new technologies should be embraced in the context of long-term exercise, diet and behavior modification protocol that will maximize long-term weight maintenance. A balance between practice growth potential by the introduction of these technologies and a commitment to long-term quality care and patient education must be struck to achieve this goal”.

Unfortunately, we continue to read the same wrong rhetoric about diet and exercise to maintain weight loss. Diet and exercise are ineffective in maintaining weight loss unless the underlying metabolic abnormality has been addressed. Gastric balloon, a purely restrictive procedure, unlike sleeve gastrectomy and gastric bypass surgery, does not alter metabolism. Therefore, balloon induced starvation over a 4-month period is unlikely to result in permanent weight loss despite adhering to a healthy lifestyle. This basic metabolic and weight loss concept has been clearly established. The working hypothesis for weight loss surgery is clear. We need to properly use this knowledge to develop new effective weight loss technology rather than ineffective but minimally invasive techniques that are only effective in misleading obese patients struggling to lose weight.

A New FDA Warning Regarding Gastric Balloons

The FDA has recently issued an alert about five reported deaths that have occurred in patients within 30 days following gastric balloon placement. Four reports involve the Orbera Intragastric Balloon SystemTM, manufactured by Apollo EndoSurgery, and one report involves the ReShape Integrated Dual Balloon SystemTM, manufactured by ReShape Medical Inc. 3 patients died one to three days after balloon placement. The intragastric balloon system has been recently approved by the FDA for weight loss in patients whose BMI is between 30 and 40. Both companies Orbera and Reshape have advertised the gastric balloon as “weight loss surgery without the surgery” and as a safe solution for weight loss. Recent reports have surfaced about balloon induced pancreatitis and spontaneous balloon over-inflation. Both conditions may lead to serious consequences. Gastric distention from balloon spontaneous over-inflation can result in aspiration and possible death.

I should mention that the exact cause of death in all 5 reports has not yet been determined, and a cause effect relation between intragastric balloon and death has not yet been established. We will continue to monitor FDA input in the coming few weeks and keep our patients updated. Houston weight loss surgery center does not endorse intragastric balloon as an effective weight loss solution. Gastric balloon procedure is a purely restrictive technique without any apparent metabolic effect. We have learned over the past few years that successful weight loss surgery like sleeve gastrectomy alters several gastro-intestinal neuro-hormonal signals leading to durable weight loss. We hope more research is focused on the metabolic effects and mechanism of action of gastric bypass and sleeve gastrectomy. Only by understanding the mechanism of action of metabolic surgery we can develop newer, safer and more effective solutions for weight loss.

Who Would Have Thought About It: Gastric Balloon and Pancreatitis?

The FDA has recently confirmed that fluid filled intra-gastric balloons used for weight loss can cause acute pancreatitis. It is believed the inflated intra-gastric balloon compresses pancreas tissue resulting in Pancreatitis. Pancreatitis patients typically present with severe back and abdominal pain as well as nausea, vomiting and fever. If not addressed early, pancreatitis may rapidly progress resulting in systemic inflammation that may lead to death.

Patients who have undergone balloon placement need to be aware of pancreatitis symptoms. Should any of these symptoms develop, we recommend gastric balloon patients to contact their bariatric surgeon or present immediately to the nearest emergency room. A simple blood test can confirm the diagnosis of pancreatitis. If confirmed, gastric balloon must be immediately deflated and removed.

We still don’t know the risk factors associated with pancreatitis development in the setting of intra-gastric balloon placement. Obalon, a gas filled intra-gastric balloon has been recently introduced into the Houston area. Obalon requires no endoscopy for insertion. The balloon is rather swallowed as a capsule then inflated in the stomach. The company representative claims that Obalon being lighter than Orbera and Reshape balloons is unlikely to be associated with pancreatitis. Furthermore, Obalon, being a lighter balloon, is thought to cause less nausea, vomiting and discomfort than heavier fluid filled intra-gastric balloons.

At Houston Weight Loss Surgery Center, we remain hesitant to recommend gastric balloons for weight loss. Purely restrictive procedures are not associated with durable weight loss. Gastric balloons do not alter the metabolic signals that control energy metabolism weight and appetite. For patients, however, interested in loosing few pounds before a wedding or a trip to the beach gastric balloon may be a great yet expensive, temporary solution.

Patient Education: Gastric Balloon and Portion Control

Pamela sent us this question regarding intra-gastric balloon mechanism of action: I am looking into getting a balloon placed into my stomach to learn portion control. I eat healthy and exercise regularly but I have failed to lose weight over the past few years.

Thank you, Pamela, for your question and interest in our comprehensive weight loss program at Houston Weight Loss Surgery Center. Your question is very important, and in my opinion it underlies a central concept in weight loss and bariatric surgery mechanism of action. Indeed, there is more to bariatric surgery than simple calorie restriction and herein lies it effectiveness and durability.

Weight loss surgery like gastric sleeve procedure is also called metabolic surgery because it alters several hormones in your body. Hormones like Ghrelin, Leptin, PYY and GLP-1 control your energy metabolism, appetite, hunger and weight. Thus, following gastric sleeve surgery, Roux-en-Y gastric bypass, or duodenal switch surgery, altered hormone secretion leads to increased metabolic rate, decreased hunger and appetite, and increased satiety. You are now satisfied with a small meal not only because your stomach volume has decreased but also because your satiety has increased. Procedures like gastric balloon and lap Band are purely restrictive. This means that your gastric volume is reduced forcing you to eat less without altering any of the hormones that control your weight and appetite. Thus, you are not satisfied with a small meal even though you are making every possible effort to learn and apply portion control.

Weight loss is not a will power or behavioral problem. Weight loss is a hormonal problem. Bariatric surgery resets your energy hormones allowing you to be satisfied with small portions. Enforcing portion control by itself, leads to starvation. Starvation leads to increased hunger and decreased metabolism. Hunger is not easy to ignore and low metabolism trigger fat cells to absorb and hoard too many calories. The result of calorie restriction is eventual weight regain and frustration. A phenomenon that you and most Houstonians experience daily.

“Overeating doesn’t make you fat. The process of getting fat makes you overeat,” per David Ludwig, a practicing endocrinologist at Boston Children’s Hospital and a professor of nutrition at the Harvard School of Health in Boston. In his book, “Always Hungry”, Dr. Ludwig emphasizes that body weight is about biology rather than willpower. The key to weight loss is not discipline but getting your metabolism to work correctly. Gastric balloon and Lap Band procedures do not correct your metabolism. You may be forced to eat small meals while the balloon is in place and loose around 20 pounds. However, once the balloon is removed 6 months after placement, you are most likely going to regain the weight back despite your best efforts.

What In The World?

The FDA has just approved, yet another stellar device for weight loss, called AspireAssist.  AspireAssist is, you guessed it, an endoscopic and reversible procedure. I don’t think they are calling it weight loss surgery without the surgery, yet. I am sure, however, that the description will surface at some point. The procedure is being advertised as very safe. Indeed, it is much safer than those “invasive and irreversible surgeries like gastric sleeve and bypass”. According to the company website, the one year complication rate of gastric sleeve surgery is 24% compared to 3.6% for AspireAssist. It is also very effective with 37% loss of excess weight during the first year after implantation according to information I read on the company website www.aspirebariatrics.com. The device will bridge the huge treatment gap that currently exists between medical and surgical management of obesity. Continue reading “What In The World?”

The FDA Approves A New Device For Weight Loss: Reshape Dual Balloon

The U.S. Food and Drug Administration (FDA) has just approved a new device for weight loss called the Reshape Dual Balloon. The procedure is indicated for patients with BMI ranging between 30 and 40. The balloon is placed in the stomach through the mouth using endoscopy. The balloon is inflated in the stomach thereby preventing the patient from eating large meals. It is thought that the balloon increases satiety and controls appetite thus leading to weight loss. The balloon must be removed 6 months after insertion. Otherwise, the balloon may rupture inside the stomach and pass into the intestines causing obstruction.

A randomized study of 326 patients showed 14.3 pound average weight loss in those who received the balloon versus 7.2 pounds in the control group. After balloon removal, patients gained weight. An average of 4.4 pounds over 6 months following balloon retrieval. The study did not extend beyond one year.

The American Society for Metabolic and Bariatric Surgery (ASMBS) is very pleased with the approval because “the ReShape Dual Balloon offers a bridge between medications and surgery similar to a cardiac stent in cardiac disease.”

I am not sure what the ASMBS statement really means and why would the society be pleased with such a device. The weight loss is transient and small. Obesity is a chronic disease that results from disrupted interaction between the gastrointestinal tract and ingested food. Consequently, the digestive process including gastrointestinal motility, nutrient absorption, neuro-hormonal gastrointestinal signals and other substances secreted by the digestive system like bile are not properly functioning. We barely understand this complex physiology, and in the face of the obesity epidemic we come up with “silly” devices like bands and balloons as weight loss solutions and “bridges to nowhere.”

Personally, I would recommend the balloon as a temporary cosmetic procedure for an individual interested in loosing a few pounds before a wedding or a trip to the beach. ReShape Dual Balloon is not a weight loss procedure by any stretch of the imagination. Let us stay honest and stop marketing the device as “weight loss surgery without the surgery.”