The weapons in the war on obesity are increasingly creative. One of the most interesting is the so-called gastric pacemaker, developed by IntraPace; the device emits electrical pulses said to create a feeling of fullness in the recipient. Then there’s the pill that when taken before meals to swell up the stomach and leave, in effect, less room at the inn. There is also an experimental device that slows the movement of food out of the stomach, as well as tubes that line the inside of the small intestine, letting food slide through without being absorbed.
And just this past November none other than the Cleveland Clinic began investigating a new weight-loss surgery described enthusiastically (and prematurely it turns out) as “one of the top 10 medical innovations expected this year”. The procedure shrinks the stomach by using a stapler-like device that is inserted through the patient’s mouth, rather than through the five incisions needed for laparoscopic LAP-BAND, currently the least invasive of the weight loss surgeries proven effective at helping obese patients lose excess weight.
Sounds great, right? Even the name of the developer, Satiety Inc, seemed perfect – venture capitalists thought so, sinking more than $80 million into the company over a period of ten years before shutting the company down when results clinical trial revealed the so-called “transoral gastroplasty” procedure was not sufficiently effective: patients who had the procedure shed far fewer pounds than hoped for. resulted in the shedding of far fewer pounds for patients than the company had hoped. Venture capitalists who had invested $86 million in Satiety over a decade shut the company down.
The findings are particularly disappointing to device makers like Satiety Inc because the advantages of going through the mouth – lowers the risk of infection and eliminates the need for general anesthesia, which in turn lowers the cost of the procedure from the current average price of $30,000 to ~$12,000 – would likely significantly increase the number of people who would have weight loss surgery.
Although an estimated 20 million Americans are heavy enough to qualify for bariatric surgery, only a small proportion – 200,000 – have the procedure every year.
With Satiety’s transoral gastroplasty out of the picture, it appears that an incision-less weight loss surgery procedure will not be available to the many millions of Americans who are overweight or obese.
With all of these new devices under investigation it would seems that more would be approved, but as it happens, the digestive tract is a challenging environment to place a medical device, and for nearly every device that has ballyhooed itself as the next big thing, there are 2-3 companies going out of business: Satiety, LeptosBiomedical, ReShape Medical, EnteroMedics and Transneuronix, just to name a few.
There is good news. Bariatric surgery has become less invasive and lower risk than ever before. Recently, the Food and Drug Administration lowered the weight requirement for Allergan’s Lap-Band, a move that makes more than 26 million additional people eligible to have it implanted with the silicone device. And recently gastric imbrication or plication – very similar to reflux surgery, accomplishing the restriction through invagination of the stomach and suturing it int place, a technique that does not require a device of any kind, even stomach staples.
Bariatric surgery is also more accessible financially than ever, thanks in large part to Allergan, following a common tradition among US medical device makers, introduced its LAP-BAND system abroad more than five years before it finally made it through the sluggish US FDA approval process. As a result, tens of thousands of weight loss seekers crossed the border to Mexico, where they were able to have their bands installed by an Allergan-certified gastroenterologist surgeon at top private hospitals like the state-of-the-art Hospital Angeles Tijuana (home of world-renowned obesity surgeon Dr. Juan Lopez Corvala, featured on CNN) for $5,000.
The FDA recently lowered the BMI requirement for LAP-BAND, responding to the guidance of members of the Gastroenterology and Urology Devices Panel, a quorum of which agreed to low the BMI requirement from 35 to 30 for people with weight-related health issues. Under the new proposed guidelines, a person who is five feet, eight inches tall would qualify for the device at a weight of 197 (the previous, higher BMI guideline required this same height person to weight 230).
Will BAI replace BMI as the measure of obesity?
Dr. Robin Blackstone, the President-elect of the American Society of Metabolic and Bariatric Surgery approved the move, noting that people with a BMI that falls between 30 and 35 “have a significant burden of medical problems associated with their obesity,” including Type 2 Diabetes, which can lead to serious health complications.