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Spatz Adjustable Gastric Balloon

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spatz 3 adjustable gastric balloon

The Spatz 3 adjustable gastric balloon was approved by the FDA in the United States in 2021.  It is indicated for patients with a body mass index (BMI) of 35-40, or a BMI of 30-35 with an obesity related medical issue.  Spatz 3 has been available outside the US for some time, and over 100,000 have been implanted.

 

What makes the Spatz unique is that it is the only adjustable balloon system.  This is important for several reasons:

  • One of the most common complications for traditional saline-filled balloons is balloon interolerance.  This means that a small percentage of patients will not tolerate their balloon and will have ongoing issues with vomiting and discomfort.  In the past, if these issues persisted beyond a week or so then the balloon was typically removed early.  With the Spatz however, some saline can be removed from the balloon which will usually cause these issues to resolve without balloon removal.  This does require a repeat endoscopy, however.
  • Another issue with saline balloons in the past is that some patients will only lose weight for the first few months.  These patients will either have a weight loss plateau or even weight gain.  If this occurs with a Spatz, some additional saline can be added to the balloon which will usually lead to additional weight loss.  This also requires a repeat endoscopy.

An additional benefit of the Spatz is that it can be left in the stomach for 8 months, as opposed to a maximum of 6 months for other saline gastric balloons that have been approved in the US.

These advantages have resulted in significantly better weight loss and long-term success for the Spatz balloon in their FDA trial than for any other gastric balloon, whether saline or gas-filled.

Spatz balloon results

As can be seen in the above table comparing all gastric balloons with which we have experience, the Spatz has not only the best weight loss, but also the highest success rate.

Currently, only patients who are able to participate in the Spatz FDA Post-approval Study can have one of these balloons implanted.  Click here if you’re interested to find out if you may be eligible!

How the Spatz Adjustable Gastric Balloon Teaches You to Eat Less!

Plenity-A New, Non-Stimulant Weight Loss Treatment

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Plenity is a new therapy that works like no other FDA-approved weight loss treatment, and is approved for use in patients with a body mass index of 25-40 kg/m 2.  It consists of 2 simple natural ingredients: cellulose fiber and citric acid contained and dehydrated in a gelatin capsule.  After swallowing 3 capsules (around 20 minutes prior to lunch and dinner) and drinking 16 ounces of water, Plenity re-hydrates itself, absorbing more than 100 times its own weight in water.  After this absorption occurs, Plenity expands in the stomach to take up space (see animation below).  The presence of expanded, re-hydrated cellulose in the stomach can reduce hunger and help patients get full earlier.  As it is not absorbed into the body at all, Plenity has actually been classified as as weight loss device, rather than a drug.  Plenity is the first weight loss treatment to be approved by the FDA for patients who are just mildly overweight, with a BMI of 25-27 kg/m2.

In a clinical study, nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. Their average weight loss was 10% of their total body weight (about 22 pounds).  Patients in our Plenity program must come in for monthly office visits and meet with one of our providers and a registered dietitian, as well as following a mindful eating plan and exercising regularly.

One major issue with many weight loss drugs is that they have a significant rate of adverse systemic side effects such as elevation in blood pressure or heart rate, nausea, overstimulation, etc.  A significant advantage of Plenity is that it does not have any major systemic side effects, since it is not absorbed at all into your body at all.

rehydrated plenity

Plenity must be prescribed by a physician, nurse practitioner, or physician’s assistant and can be obtained from their partner pharmacy, GoGoMeds.  In order to receive Plenity, your provider must send a prescription to GogoMeds, and the patient must log on to GoGoMeds.com and register as a patient.  After registering, you will have to add your prescriber in your account.  After payment, GoGoMeds will ship your medication to your home address.  The current 2021 pricing including shipping for a 30 day supply of Plenity from GoGoMeds is $98.

It remains to be seen if this medication can be used in patients who have had prior surgical weight loss procedures and at this point we would recommend against it, unless under the close supervision of a bariatric surgeon.

Wegovy

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semaglutide

Wegovy (generic: semaglutide) is a new injectable weight loss medication that is in the same family as Saxenda (GLP-1 receptor agonist).  Unlike Saxenda, howver, Wegovy only needs to be injected once a week!  Like Saxenda, this medication is approved by the FDA for patients with a BMI of 27-30 if they have weight-related medical problems, or any patient with a BMI over 30.

Wegovy works by interacting with GLP-1 receptors in your body.  GLP-1 (glucagon-like peptide) is an appetite hormone that is naturally produced in humans that helps to regulate hunger.  Saxenda works like GLP-1 by regulating your appetite, which leads to decrease calorie consumption and therefore weight loss.

Wegovy comes in a single-use pen that makes injections very simple.  The dosage is adjusted over 5 months, starting at 0.25 milligrams in the first month and going to 2.4 milligrams in month 5. Each dose comes in 1 pack of 4 pens and contains only the specific dosage for that month.

The manufacturer, Novo Nordisk, offers a savings program where eligible patients will pay $25 fo a 28-day supply of Wegovy with up to 6 refills.  Go to GetToKnowWegovy.com for more information! You will need a Wegovy savings card (or a Kit number) which we can provide at all JourneyLite Physicians offices.  You must know your financial responsibility for Wegovy before you come in for a consultation!

Wegovy is typically injected in the skin of the lower abdomen.  Make sure to clean the injection site with an alcohol swab or soap and water first.  Simply insert the tiny needle all the way into the skin and press the button on the end of the syringe.  You will hear 2 clicks – after the second click keep holding down the button until the yellow bar stops moving.  You can get further instructions and watch a video on how to inject at StartWegovy.com.

Pens must be disposed of in an FDA-cleared sharps disposal container, or a sturdy household container with a tight-fitting lid.

COVID-19 and Obesity: CDC Guidelines

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scaleThe impact of the COVID-19 pandemic has been felt around the world, and is causing people to think hard about their overall health.  The reason this is happening is that there is a wide spectrum of severity of COVID-19 infections.  Healthy, young, normal-weight patients tend to have minimal to no symptoms, while older patients and/or those with multiple medical issues tend to present with much more aggressive cases that carry a higher risk for death.

The CDC has weighed in on what conditions can increase the severity of COVID infections.  In addition to older adults in general, people of any age with the following conditions are at increased risk of severe illness from COVID-19:

With regard to obesity and severity of ilness, nearly 40% of Americans have a BMI of 30 or higher, so this puts A WHOLE LOT OF PEOPLE at increased risk.  Although we don’t yet have reliable statistics, there is a good chance that the risk of severity doesn’t just go up at a 30 BMI and stay put, it most likely continues to rise with BMI. So patients with a BMI of 50 likely have a significantly higher risk of death than patients with a BMI of 30.

If you are overweight or obese, now is the time to act, as it is a tragic event to think of a potential COVID-19 fatlity in a young, otherwise healthy but obese patient from COVID-19.  We have surgical, incisionless, and medical-only options that can help patients lose weight and hopefully reduce the risk of severe ilness or death in a patient who contracts coronavirus.

If you are interested in learning about weight loss options, try our online weight loss navigator to learn what programs for which you might qualify.

New Columbus Location 8/1/2020!

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We are excited to announce that we will be moving our Columbus office into a larger space!  We will be in the new office beginning 8/1/2020, so any appointments scheduled at the Parkmead Drive office after 8/1/2020 will actually occur at the new location, which is less than a mile away at 2041 Stringtown Road Grove City, Ohio 43123.  It’s located in a medical office complex directly behind the Sherwin Williams store that is visible on the south side of Stringtown Road, in between I-75 and the old location on Parkmead.

Insurance Exclusions and Weight Loss Surgery

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Insurance

Many times patients who do not have coverage for weight loss surgery will ask us to file an appeal.  Will this work?  The short answer is no.  Read on for the long answer…

If your insurance does not cover weight loss surgery, this is called an “exclusion.”  This means that the employer who provides the insurance chose to exclude surgical weight loss from coverage in order to purchase a cheaper plan.  Once you understand this fact, it’s easier to understand why you can’t file an appeal and get them to cover it, no matter how severe your obesity might be.

If insurance companies were to allow this, then no employer would ever opt for the more expensive plans that do cover bariatric surgery. They would just buy the bare bones coverage and then tell their employees to all file appeals to get it covered anyway.

Unfortunately, when patients call their carriers, someone on the other end of the line (who actually works for the insurance company) will tell  you that you can file an appeal.  This is technically true, as you can file an appeal for anything your insurance denies.  However, in this case the appeal will never work because the issue is not one of medical necessity; in otherwords the insurance company is not saying that you don’t need the operation, they are denying it because you do not have the right type of coverage.  It would be somewhat like having a tree fall on your house and asking your car insurance to pay for it.  Or, perhaps more appropriately, asking your homeowners to pay for flood damage when it is specifically excluded from your homeowners policy.  It simply isn’t going to happen.

Also unfortunate (at least in Ohio, Kentucky and Indiana) is that marketplace policies purchased by individuals under the Affordable Care Act also exclude weight loss surgery.  Medicare, Medicaid, and most managed-care Medicaid plans such as CareSource, do cover weight loss surgery, however.

We wish that all Americans had access to life-saving surgical weight loss procedures, and maybe some day that will happen.  In the meantime, patients with exclusions essentially have two options:

Frequently Asked Questions (FAQ) about Bariatric Weight-Loss Benefit Exclusions:

  1.     Why do I have a bariatric weight-loss benefit exclusion? When employers decide on a policy to offer their employees, they determine if they want to include or exclude bariatric weight-loss benefits. It is an addition to a plan; it is not an automatic benefit for a medical health plan.
  2.     What happens if the practice submits a pre-authorization when my insurance policy has a bariatric weight-loss exclusion? If the practice submits a pre-authorization and gets approval for medical necessity, it may seem the patient is approved for surgery. But when the patient’s policy does not have bariatric weight-loss benefits, the insurance company will not pay the claim. This will make the patient responsible for the entire billed amount, possibly over $50,000.00. If the pre-authorization is denied, you would have to possibly complete extra insurance policy requirements, which you did not need when you have a bariatric weight-loss exclusion. Some insurance policy requirements are but not limited to, a body mass index (BMI) of over forty (40), 5-year weight history, and a twelve-month physician-supervised diet.
  3.     Why does the practice maintain a Self-Pay Financial policy not to submit a pre-authorization for a policy with an exclusion? When a practice submits a pre-authorization to an insurance company, they are checking to see if the patient is approved, medically, for surgery.  This is called medically necessity. The insurance company pre-authorization department does not always verify if a policy has bariatric weight-loss benefits. Therefore, we do not submit for medical necessity when a patient has a bariatric exclusion.
  4.     Why do I not have to meet my insurance bariatric weight-loss policy requirements when I have a bariatric exclusion? Each insurance company has a bariatric weight-loss policy with requirements to meet medical necessity; this is to qualify the patient medically. When you are not using your insurance for bariatric weight-loss benefits, you do not need to meet their guidelines.  You do have to meet the JourneyLite Physicians Self-Pay guidelines.  
  5.     Why am I waiving the right to file a claim? If you have a bariatric weight-loss exclusion, your claim will be denied, and you will be financially responsible up to $50,000.00.
  6.     Why should I continue as a Self-Pay patient? JourneyLite Physicians is a bariatric specialty group. Each and every day we work hand in hand with insurance companies to review their bariatric weight-loss policies and guidelines. We have created a partnership with them and would like to create this partnership with you also. If you have an insurance bariatric weight-loss exclusion, we want to help you through having surgery. It is very important for us to guide you or your loved one that is having surgery. We are here for you!

Weight Loss Surgery In Lower BMI Patients

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Unfortunately in the field of weight loss surgery we use the phrase “NIH criteria” frequently.  What does this mean?  If refers to a 1991 National Institute of Health consensus statement on which patients should qualify for weight loss surgery.  That’s right folks, in many cases we are basing our decisions today on a loose set of mandates from 30+ years ago, when all procedures were open surgeries with 12 inch incisions, were mostly all gastric bypasses, and had a mortality rate of 1-2%.

Nowadays the gastric sleeve is the most commonly performed procedure, and nearly all procedures are done with a laparoscopic, minimally invasive technique.  Therefore both the short-term and long-term risk of bariatric surgery is a least an order of magnitude lower than in 1991.  Yet most insurance companies still follow these outdated guidelines.

The truth is that lower BMI patients suffering from  class I or II obesity have an increased risk of weight-related medical issues and mortality.

Weight loss and metabolic surgery in lower BMI patients who continue to struggle with class 1 or II obesity, in the setting of failed attempts at lifestyle modification & weight loss programs is proven effective at leading to significant weight loss and an overall reduction in comordities and cardiovascular risk.

Also, it has been shown that diet, exercise, and weight loss drugs are largely ineffective for achieving durable weight loss, even in lower BMI patients. In this setting, weight loss surgery is reasonable and is supported by the recent American Society of Metabolic and Bariatric Surgery’s position statement in 2018 (Surgery for Obesity and Related Diseases 14 (2018) 1071-1087).

Obesity is probably the only disease where we make patients wait until they are sicker and a higher operative risk to offer them the most  successful treatment option, which is weight loss surgery. We need a change in thinking here as lower BMI patients often times have a higher success rate and are almost always a lower operative risk. Waiting until a patient is heavier and sicker is not the best strategy!

Weight loss 1 month after surgery predicts long-term success!

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Recently I attended a lecture by Dr. Dana Portenier, a respected bariatric surgeon from Duke University.  He spoke about a study published by their practice showing that a patients success after weight loss surgery can be predicted as early as at the 1 month post-op visit.

In the graphs below, you can see that for a patient with a BMI under 50, if they have lost 6% of their excess body weight at the 1 month visit, they will be in the bottom 5th percentile at 36 months.  A patient who has lost 26% of excess body weight, on the other hand,  will be in the 95th percentile!

Weight Loss At First Post-operative Visit Predicts Long-Term Outcome Of Roux-en-Y Gastric Bypass Using Duke Weight Loss Surgery Chart

Surgery for Obesity and Related Diseases 8 (2012) 556-550

EWL-followup graph for BMI under 50
EWL-followup graph for BMI over 50

This is something that I’ve always suspected but have never seen presented in such an elegant fashion.  You might ask, what is percent excess body weight loss?  In order to know this, you must first know what your excess body weight is.  This is simple: your excess body weight is your current weight minus your ideal body weight.  You can look up your ideal body weight multiple ways, such as here.

So let’s say you weigh 250 lbs and your ideal body weight is 150 lbs. This makes it easy, as your excess body weight is 100 lbs! If you lose 50 lbs then you have lost half (or 50%) of your excess body weight. Surgeons will often abbreviate as 50% EWL or 50% EBWL.

Here is an excellent article that will help you figure out what your excess body weight loss is, and you can refer to the graph above to see where you fall on the curve.

One of our goals at JourneyLite Physicians is to provide the best outcomes for our patients, and given this data we want patients to adhere to the follow-up schedule of:

  • monthly visits for the first year after surgery
  • visits every 3 months during the second year
  • visits every 6 months starting in the third year and beyond

We feel that more closely-spaced appointments will help patients stay on track better and give them every opportunity to succeed!

Click here to request a follow-up appointment.

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