Controversial Weight-Loss Device AspireAssist Sparks Outrage Among Physicians, Prompting Planned Lawsuit Against FDA

The incident occurred inMid-June,FDAApprovala novel type ofWeight Loss Devices. However, some doctors have raised objections to this.Among them, oneDoctorEvenJoint Plan4000Famous Doctors File Joint LawsuitFDAInstitution.The incident occurred because physicians believed that the device, which achieves weight loss by pumping recently ingested food directly out of the stomach, poses significant safety risks and may also lead to eating disorders.

This new type ofWeight Loss DevicesSchematic Diagram of Usage

In Pembroke Pines, Florida, with30Endocrinologist and diabetes specialist with years of experience in treating obesityJoseph GutmanSay,“In my long career, this is the first time I haveFDAThe approval of the device was shocking; I simply cannot believe that such a device would be approved.”Gutmanstated that he has currently assembled750Ming Plans to File a LawsuitFDAphysicians, and his ultimate goal is to recruit4000Doctors have joined their ranks. They hope that this device will be banned from the market. They believe that this approval isFDAAs a manifestation of ignorance in clinical medicine, it is nothing more than a poor trick, akin to a frivolous joke with serious consequences.

What Exactly Is This New Weight-Loss Device?

This device is namedAspireAssist, is111After one year of clinical trials, researchers obtainedFDAApproved.FDAIt is pointed out that the target user group for this device is individuals with a body mass index (BMI) at35to55within the specified range, and obese patients who have failed non-surgical weight loss therapies (BMIIt is an index that assesses whether a person is obese by comprehensively considering height and weight factors; a height5Foot9inches, ifBMIIn35to55 range, the converted body weight is approximately236to365lbs).FDAstated that,AspireAssistIt will not be provided for use by patients with eating disorders.

InAspireAssistDuring use, a catheter is inserted through the abdomen into the patient’s stomach, which passes through a“Port Valve”Access: The port valve is located directly above the patient's umbilicus, allowing the patient to open or close the valve to drain gastric contents after meals.20To30minutes for the patient to connect the pump to the valve, allowing the chyme in the stomach to be drained and discharged directly into the toilet. This process takes approximately10minutes.

It is reported that,AspireAssistBased in King of Prussia, Pennsylvania,Aspire BariatricsDeveloped by the company, according to the company'sCEO Kathy Crothallstated that this method of directly expelling ingested food from the stomach can reduce the total caloric intake per meal30%。

AspireAssistDirect evacuation of ingested food from the stomach

Experts' Concerns

1. May cause dietary disturbances in patients

However, in the view of some experts, AspireAssistIt is accompanied by certain side effects, such as the risk of infection associated with the port valve and potential catheter leakage. However, what concerns experts most is its potential to cause eating disorders in patients. This is because the device’s mode of operation bears some resemblance to the symptoms of binge-eating disorder, characterized by uncontrolled binge eating followed by self-induced vomiting; many individuals with obesity also suffer from binge-eating disorder. “Patients with binge-eating disorder vomit food from their throat,AspireAssist...is then expelled via a catheter. This constitutes a mechanized form of bulimia nervosa, and it further enables patients with bulimia to indulge their appetite through an alternative outlet.”Gutmanexplained.

Aspire BariatricsThe company stated that individuals with binge eating disorder cannot achieve this throughAspireAssistto vent their bulimia nervosa. Because food must be completely chewed before it can be expelled through the tube. At Washington University in St. Louis, ShelbyYes17patients underwent procedures on the deviceAspireAssistclinical trials.SullivanIt is stated that if the patient fails to chew food thoroughly, excessively large boluses may become lodged within the catheter and cannot be expelled. Currently aged52-year-old Lotta FriskWhen usingAspireAssistFour years later, lost148pounds, and with each meal, she chews every bite of food55〜75times.Lotta Frisk“I cannot swallow food directly without chewing and then excrete it immediately; I need to chew multiple times for the chyme to pass through.”AspireAssistof the catheter.”

Clinical studies have also shown that, because patients are required to chew food multiple times while using this weight-loss device, their meal duration is prolonged, leading to increased satiety and a relative reduction in food intake compared to baseline. This mechanism contributes to weight loss to a certain extent.

44-year-oldEric WilcoxonFrom2013in use since [year]AspireAssistShe also agreed with the notion of reduced food intake. Because multiple chews are required, when she adopted a dietary pattern of small, frequent meals, she would choose foods that are easy to chew and readily absorbed by the digestive tract, such as fruits, steamed vegetables, and roasted chicken. “If you cannot grasp the importance of chewing, all you can do is chew your food thoroughly; once you cultivate this eating habit, you will come to understand it.”WilcoxonSpeak.

As of now, whose weight once reached as high as389poundsWilcoxonAtAspireAssistwith the help of, has lost128pounds. Three years ago, whenWilcoxonHaving abandoned bariatric surgery and overcome his fear of potential complications associated with the use of weight-loss devices, he decided to pick up the device at the University of Washington’s Clinical Trials Center. Previously, he had witnessed a close friend undergo gastric banding surgery for weight loss, a procedure that reduces the stomach to the size of a golf ball in order to restrict food intake. Compared with such bariatric surgery, it is clearlyAspireAssistYesWilcoxon...more appealing. In addition, he plans to use the weight-loss device for life, as this approach still allows him to enjoy his favorite foods.

In addition, chewing is not the patient'sAspireAssistThe sole behavioral change observed during use. Studies have shown that individuals using this device opt for healthier food choices, as they have directly witnessed the appearance of chyme expelled from their stomachs, leading them to carefully reconsider their dietary selections. Users reported that healthy foods appear less repulsive when transformed into chyme, resembling their original state prior to ingestion, merely broken down within the stomach. In contrast, junk foods such as hamburgers and french fries look extremely disgusting when expelled through the catheter.

2. Concerns about the long-term sequelae this weight-loss device may cause in patients

UponFDAPrior to approval,AspireAssistThe clinical trial period lasted only one year. This has led some experts to worry about potential long-term sequelae. “Although, from a long-term perspective, there is currently no scientific basis to determine what side effects it may cause.”GutmanSpeak. ““But the study is incomplete. It is also difficult to determine how patients will respond once they stop using this device. Will their weight rebound immediately?” said the President of the American Society for Metabolic and Bariatric SurgeryRaul RosenthalIt is believed that if patients are usingAspireAssistAfter sudden discontinuation one to two years later, patients will experience98% may rebound to their original weight. This is because most people are unable to maintain self-control and revert to unhealthy eating habits.

Some scholars are concerned that such weight-loss devices may create a misconception among patients that they can eat without restraint, believing that regardless of how much they consume, the excess can be mechanically eliminated. However, scientifically sound treatment of obesity necessitates changes in dietary habits. Patients should be advised to reduce their food intake, engage in regular physical activity, and maintain a healthy diet. “I find it difficult to accept this approach, which appears deceptively simple and allows patients to eat more while avoiding calorie absorption as a means of weight loss,” said a professor at the Brody School of Medicine at East Carolina University.Konstantinos Spaniolassaid.

Previously,FDADuring the review of its clinical trials, participants usingAspireAssistwhile also providing nutritional and exercise counseling. On average, they lost a percentage of their initial body weight12%weight, while those who only received nutrition and exercise counseling lost an average of4% by weight. Although it appears on the surface that usingAspireAssistThe weight-loss efficacy is superior to that of diet and exercise alone; however, when the invasiveness of the device implantation procedure is taken into account, the outcome appears less satisfactory.Spaniolassaid. When conducting clinical trials,AspireAssistTime required for the insertion procedure15minutes, but without general anesthesia.FriskandWilcoxonAll stated that during the initial two weeks of gastric catheter insertion, they only adapted after enduring significant pain.FDAIt also warned them that the process carries risks of symptoms such as gastric infection, bleeding, vomiting, nausea, and ulceration.

In fact, bariatric surgery can help obese patients achieve better weight loss outcomes. For example, sleeve gastrectomy removes a portion of an individual's80%of the stomach, which can help patients lose weight30% or so; gastric bypass surgery can basically make food“Bypass”Most of the stomach is bypassed, with food entering the intestine directly, which can help patients lose weight.35%. However, these two procedures are irreversible and carry the risk of causing serious complications.

“Weight Loss for Patients with Obesity12“% is a good target. However, this device invades the human body by inserting a tube into the stomach, thereby creating a direct connection between the skin and the stomach. To me, this approach does not seem like a safe and effective method for treating disease; rather, it sounds more like a risky gamble.”SpaniolasSpeak.

In fact, the treatment of obesity is not solely dependent on weight loss; traditional surgical interventions also offer significant advantages. However, bariatric surgery may lead to certain complications, such as diabetes, hyperlipidemia, and hypertension, or cause changes in hormone levels.

2012year, when he was still living in SwedenFriskObtainAspireAssist, at that time her weight was320pounds, and suffering from hypertension,2Type 2 diabetes and depression. ForFriskFor such patients, weight loss alone is sufficient to improve their physical health. She uses it once daily, and her weight has now decreased to172lbs.FriskShe claims to be in good health without taking any medications for hypertension or diabetes, and her depression has also improved significantly; she no longer feels depressed, sad, or hopeless about life every day. She currently resides in Delray Beach, Florida.Friskbelieve that,“"I feel like I've truly been reborn; everything has changed, and I am happy every day."”

Over 500 people worldwide have used it.AspireAssist

Aspire BariatricsofCEO Crothallaspects indicate that there are currently approximately worldwide500The devices have been used by humans and proven to be safe and effective. (Already in use across Europe)AspireAssist, with plans to rapidly expand into Australia, Canada, New Zealand, and South America. The device bears a strong resemblance to the esophageal catheters we have utilized for decades.AspireAssistIt merely drains food out rather than infusing it in, yet the underlying design concept is identical. Furthermore, they firmly believe that leaving this catheter in the abdomen for a period of time causes no harm to the human body.

But such rhetoric is insufficient to letGutmanThey are actively preparing to seek legal aid and file a lawsuit.FDAconvinced the physicians. They unanimously agreed that,AspireAssistcan lead to various complications, such as infection, bleeding, and leakage,Gutmanhas also provided toFDAHe wrote a letter of complaint. He said, “I find this device utterly illogical. I do not believe it holds any medical or physiological significance. It is even more absurd than Trump running for president.”

Today, the United States has7900Millions of people suffer from obesity, accounting for35%. Therefore, it is crucial and urgent to develop new devices for market introduction and to propose additional treatment options for patients. However, each new device requires time to demonstrate its true efficacy. Members of the American Society for Metabolic and Bariatric Surgery RosenthalObjectively speaking,“In fact, throughFDAapproval merely indicates that a certain device or drug is considered safe, but it should never be regarded as the optimal treatment. In other words, even if obtainedFDAapproval, nor does it imply that the therapy is suitable for every patient.”

Original Source:www.theverge.com