FDA Approved Obesity Treatment Devices

For years, some of the hecklers among us have told our obese friends that their fatness and lethargy is permanent. They have been told to quit trying because at the end of the day, even if they lose some mass under their skin it will reappear within the blink of an eye. If this was a decade ago, I would’ve said that those savage lads were true and that there is nothing you can do about obesity. But, why fret about the past? We are living in an age where a spit test can diagnose cancer in just 10 minutes.

Though it is a fact that obesity has take over us like a zombie apocalypse, it has turned us in to The Walking Fats but fear no more because regardless of our hate for manual labor we have done the necessary research and have found out that obesity is in trouble. But to develop the feature we will take you step by step into the world of obesity.

According to World Health Organization, obesity has more than doubled since 2015. In 2014, 13% of adults worldwide aged 18 or above were obese. In recent years, obesity has reached alarming levels, with at least 2.8 million people dying annually around the globe. Hence, this epidemic needs to be dealt with and quickly.

A 30kg/m2 or (30) and exceeding value of BMI is considered obese. BMI is a relative screening tool rather than a diagnostic tool for measuring body fats and that is why its efficacy and credibility is occasionally met with scientific backlash. It is not that BMI is the only tool to determine body fats but other tools include under water body weighing, skinfold thickness measurements with calipers, isotope dilution and DXA (dual- energy x-ray absorptiometry). Since, these tools are far more technique sensitive so we are left with BMI, a simple easy breezy body fat determinant.

A major reason for the obesity crisis is that more and more Americans are opting to eat out, instead of favoring home cooked meals. In 2015 Americans spent, for the first time, more money on restaurants than they did on groceries. Sure, it’s possible to have a small, healthy meal at a restaurant. But researchers have found that people typically eat 20 to 40 percent more calories in restaurants compared with what they’d eat at home.

Another reason is that people have become physically inactive Our sedimentary lifestyle which usually includes sitting in front of a computer for 8 hours a day, 5 days a week, when we are not in the office we are most likely sitting in front of a television screen mindlessly watching a boring movie, only to realize midway, we already saw it last night. It is just what the 21st century’s fast paced environment and technological advancements have resulted in. don’t get me wrong technology is great as it has created for many unique solutions to many of our problems, it has also made us extremely lazy.

Obesity genes are also one big reason for making individuals obese. In that case, the metabolism of fats is altered and hard to control. Whatever the situation may be the fight against obesity is continuous and obese people have to rely on life style modification to win this war.

The best way to control obesity is diet control and exercise and if still you need a medical help, seeking medical intervention is not considered an anathema anymore. Even the next step is surgical intervention, tagged as Bariatric surgery. The obesity devices fall in between the medication and the surgical intervention, although the devices are fixed surgically but they are the temporary means to get rid of extra fats.

By targeting the appetite and satiety on the neural and the capacity level, these scientifically and evidence backed devices are not new, rather they walked in more than 10 years ago. R&D has led to new obesity devices with new targeted actions.

The approval of these devices may have led many people to happiness, but the longer term effects should be kept in consideration. Some of the devices are old enough that they have spent 10 years in the market and has left positive marks. The side effects attached to them is similar to the bariatric surgery like, nausea vomiting and few precautions that must be taken care of. But the latest device which deals with the emptying of food contents from the stomach has been lashed by many experts because of the increased chances of developing bulimia.

Since FDA is an institution where we all look up to, but the approval of device which is attached with a danger of developing another disorder is surprising. According to FDA, it has set 11 criterion check points to gauge the risk benefit analysis, and after close calibration, the device is considered safe if precautions are kept in the mind. However, the obesity experts should keep on working to dig out the truth but for now, FDA’s approval has recommended it safe.

The problem of obesity is looming and there are people who really needs surgical help to fight it off. These devices are not for the people who have not exploited other medical and life style modification. When a disease is in your genes, sometimes it becomes hard to fight it off. These devices are a chance for such people.

FDA Approved Obesity Treatment Devices

After looking at these stats, it’s not surprising that obesity has reached such epic proportions.The situation has become so terrifying that the Food and Drug Administration (FDA) has started approving medical devices that help prevent obesity from reaching pandemic levels.Generally speaking, when diet and exercise are not effective, weight loss treatments can include prescription medications, invasive surgery, and medical devices. All have risks and benefits of their own. In recent years, FDA-approved medical devices have played a significant role in treating obesity. Treatment benefits from these devices may be greater for patients with obesity-related health problems like high blood pressure.

FDA has clearly stated that Before a medical device is recommended, doctors will probably want their patients to have tried lifestyle changes that include healthy eating and increased physical activity. Even if a person is prescribed an obesity treatment device, he or she still must make lifestyle changes.

fda-approved-obesity-devices-2

The FDA regulates medical devices in the United States and evaluates certain devices for safety and effectiveness before they can be marketed. When FDA-approved medical devices are implanted inside a patient, some can be extracted from the body or adjusted in case of adverse reactions, but it’s important to be aware of the risks they carry.

At the moment 4 types of devices are approved to treat obesity in adults age 18 years or older:

  • gastric bands
  • gastric balloons
  • electrical stimulation system
  • gastric emptying system.

Patients with these devices should be monitored by a healthcare provider.

Each device carries its own risks. These risks can include everything from vomiting, bleeding, diarrhea, nausea or infections. One extremely important thing to keep in mind always is that unfortunately, Some patients who receive treatment and make lifestyle changes (such as increased physical activity and healthy eating) still may not be able to lose weight or keep weight off. There are 11 criterions on which FDA will gauge the devices for determining benefit- risk management.

So let us take a look at some of these medical devices that treat obesity approved by the FDA.

  1. Gastric Balloons

These obesity fighting devices include one or two balloons which are temporarily placed in a stomach using surgery, that fill space in the stomach. They’re placed using an endoscope, a long flexible tube with a small camera and light at the end, which the doctors can use to view stomach on a monitor.  the process is known as endoscopy. After that the balloon is filled with salt water (saline) and sealed. gastric balloons are removed after six months in another surgical procedure.

Evidence for its efficacy: A recent study looked at the efficacy and effectiveness of gastric balloons in reducing obesity. The researchers found that swallowing a balloon-filled capsule can help fight obesity more effectively than orthodox methods such as diet plans.

The treatment, called the Obalon 6-Month Balloon System, involves individuals swallowing the balloon-filled capsule, after which the doctor inflates it with nitrogen gas through a catheter tube attached to the capsule. Once the balloon is filled with gas, it reaches a volume slightly larger than that of a 237 ml cup, which makes the individual feel fuller sooner.

The study was conducted on 185 obese people whose body mass index (BMI) was between 30-40. The process involved swallowing a total of three balloons (a new one every three weeks), and then removing all the balloons after three months.

gastric-balloons

Device approved by FDA: One of the devices approved by FDA in recent times was Reshape Dual Balloon System, a balloon based obesity treatment, which was approved back in 2015. The good thing about this device is that it is non-surgical, but is invasive however. ORBERA intragastric balloon system is also another drop in the pond of gastric balloon devices.

The company recommends the ReShape Integrated Dual Balloon System to be used in conjunction with exercise and proper diet in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions and is meant for use in adult patients who have failed weight reduction with diet and exercise alone.

This device works by gastric banding and a vagal nerve stimulation. Vagus nerve is the gate keeper of the gastric system by effecting the release of Ghrelin and leptin hormones.

Patients who are looking to get this surgery done have to be aware of the fact that The maximum placement period for the ReShape Integrated Dual Balloon is 6 months. Periods longer than that have a higher risk of adverse reactions in patients.

Placement of the ReShape Integrated Dual Balloon requires an endoscopic procedure with sedation. Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), infection, pneumonia, and respiratory distress. Potential risks associated with the ReShape Integrated Dual Balloon include ulceration, perforation, abdominal pain, nausea, vomiting, bloating, belching, heartburn, dehydration, and sore throat.

These complications may be severe enough to require early removal of the ReShapeIntegrated Dual Balloon. Although the ReShape Dual Balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction. The risk of intestinal obstruction is increased if the device is not removed after 6 months. If intestinal migration occurs, surgical or endoscopic removal may be required.

Precaution: Patients with gastric bands should eat less food in one sitting otherwise they will feel sick.

  1. Gastric Emptying Device

The most recent gastric emptying obesity fighting medical device to get approved by the FDA is AspireAssist.

AspireAssist is marketed as a minimally-invasive and reversible procedure that can be done under twilight-sedation, a mild anesthetic technique.  It works rather unconventionally- the device uses an external pump that extracts about 30% of the stomach’s contents before they are absorbed from the intestine into the bloodstream, and dumps them into the toilet. To begin the process, a thin tube is placed in a person’s stomach with an endoscope via a small incision in the abdomen, which connects the stomach to a small button on the skin. After each meal, the device attempts to empty about 30% of the stomach’s contents via the tube by connecting a small, handheld device to the button.

gastric-emptying-system

The procedure is performed twenty minutes after the meal has been consumed and takes about 5 to 10 minutes to complete. The procedure is performed in a restroom, and the food is drained directly into the toilet. The process called aspiration only extracts about a third of the stomach’s contents and the body still gets its required calories. This therapy is most effective when used in conjunction with lifestyle counseling. The program enables one-on-one counseling with support programs that encourage healthier eating and an active lifestyle.

Controversies attached to it: This is a controversial technique, since the clinical trial of AspireAssist had seen some participants suffering from adverse reactions such as occasional indigestion, nausea, constipation, vomiting and diarrhea, despite patients using AspireAssist lost an average of 12.1% of their total body weight compared to only 3.6% of the control group patients.

There are also risk involved with the surgery ie accidental gastric line puncturing, allergic reaction and internal bleeding etc. also Patients who undergo the procedure have to frequently pay medical visits to their physicians who monitor device use and weight loss and provide lifestyle therapy counseling. Patients have to be constantly monitored by physicians to shorten the length of the tube as they lose weight.  Hence there is a bit of nuisance involved with the process.

The most significant that comes with gastric emptying device, however is people who are bulimic or have a binge eating disorder or suffer from night eating syndrome or have uncontrolled hypotension or a history of mental or cardiovascular illnesses are at a higher risk of surgical complications. The most significant shortcoming of the device is that it can encourage healthy people to pick up unhealthy eating disorders such as bulimia, which is an eating disorder characterized by binge eating followed by purging or over-eating as a shortcut for weight loss.

Precaution: people with this device should look at their life style modification strictly, otherwise there are high chances of development of eating disorder.

  1. Electrical Stimulation Devices

The electrical stimulation device is implanted into the abdomen and electrical signals are blocked from the place of origin, in this case the abdomen, to the brain.It includes nerve electrodes, wire leads, and a rechargeable electrical pulse generator that delivers electrical signals to electrodes. External controllers let the patient charge the device and let health care professionals adjust settings. How electrical signals work, the science and physics behind it is well understood but how exactly removing electrical stimuli fights obesity is yet to be figured out exactly.

Device approved by FDA: The first device of its kind to fight obesity in such a way, approved by the FDA since 2007 is the Maestro System. is approved to treat patients aged 18 years or older who have not been unsuccessful at losing weight using a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes mellitus.

The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.

electrical-stimulation-system

External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects.

Evidence for its efficacy:The safety and effectiveness of the Maestro Rechargeable System were evaluated in a clinical trial that included 233 patients with a BMI of 35 or greater. The weight loss and adverse events of 157 patients who received the active Maestro device (the experimental group) were compared to 76 patients in the control group who received a Maestro electrical pulse generator that was not activated. The study found that after 12 months, the experimental group lost 8.5 percent more of its excess weight than the control group. More than half, 52.5% to be exact, of the patients in the experimental group lost at least 20% of their excess weight, and 38.3 percent of patients in the experimental group lost at least 25 percent of their excess weight.

However, as part of FDA’s approval process, the manufacturer, in this case EnteroMedics of St. Paul, Minnesota must conduct a five year post approval study that will follow at least 100 patients to determine additional side effects, weight loss figures, and surgical revisions etc.

The adverse reaction observed in the clinical study included all the adverse reaction that are common with bariatric surgery including vomiting, nausea, pain at the surgery site and surgical complications.

  1. Gastric Bands

Gastric bands are placed surgically at the upper end (pyloric end) of the stomach and this way the entry point of stomach is constricted and resulting the person to reduce its eating capacity.

gastric-bands

FDA APPROVED DEVICES:  Lap band gastric banding system it was approved for people with minimum age of 18 years and have BMI of 40. But people with 30 BMI with co-morbid diseases like hypertension, diabetes and sleep apnea can also take benefit of this device too.

The Realize Band was approved in 2007 for people with BMI of 40 but exception is for the people with 35 BMI and co-morbid diseases. It is a surgically implanted device used to help adults (18 years of age or older) lose weight. The Realize Band consists of a silicone band, tubing, and an injection port. The band helps a person eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested.

The Band is indicated for use only in adult patients who have failed non-surgical weight-loss alternatives, such as supervised diet, exercise and behavior modification programs.

Precautions: patients with this device should eat less in one sitting or else they will feel sick.

The adverse reaction observed in the clinical study included all the adverse reaction that are common with bariatric surgery including vomiting, nausea, pain at the surgery site and surgical complications.

Co-Author: Fazeel Ashraf

1 Comment
  1. Shoaib Amjad says

    A man should be in shape, Round is a shape. Right?

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