Some of the Most Commonly asked Questions

 

 

People who used vBloc Therapy lost more excess weight than those who relied on diet and exercise alone.

In the ReCharge study, patients who received an average of 12 hours of vBloc Therapy per day lost an average 28% of their excess body weight in the first year.

If the device needed to be removed, your surgeon will discuss the options and cost at that time.

Yes, you may connect with our vBloc Access team by calling 1-800-MY-VBLOC to discuss your personal financing options.

vBloc may be covered on a case by case basis. vBloc is a new weight loss device and is currently working through processes to achieve broad coverage. Call 1-800-MY-VBLOC to talk to experienced reimbursement case managers that will help you navigate the complex process of applying for insurance coverage with new technologies. Our team will assist in prior authorization and denial of appeals to maximize your likelihood of insurance coverage and access to care.

The cost of vBloc Therapy implant surgery is comparable to other weight loss surgeries.

If you and your clinician decide therapy must be stopped for an emergency or a pregnancy, deactivation is quick and easy.

The Maestro System has a lithium ion battery much like those used in pacemakers and other implantable medical devices. It expected to last up to 8-10 years; however, it is guaranteed to last five years with normal use and recharging. Battery lives can vary.

Your surgeon will assist you in obtaining a replacement device in the event yours is damaged or lost.

Your device should be charged every 1-2 days in order to maintain maximum life and operation of the vBloc battery. If you forget to charge your device and your battery gets very low, you will still be able to charge the device at home but it may take more than one charging session to get the device fully charged. If your battery dies and you do not register any charge at all, you will need to schedule a visit with your clinic to have the device rebooted.

Device Battery
The battery level indicator will show when the battery needs to be recharged. We recommend that you adopt a routine charging pattern of at least every other day to provide optimal charge for the unit. Once charged, the unit can be placed securely in the belt and worn while engaged in morning preparations or on the drive to work. It takes about 20-30 minutes to fully charge the vBloc Therapy device unless the battery is completely out of charge. If the device battery is at zero charge, the re-charge time can take a few hours.

Charging Unit
The charging device must be connected to an AC outlet or an appropriate device to charge. The charger should be placed on the charging unit when not in use.

Although we recommend that you select a surgeon close to your home, we understand that this may not always be possible. Prior to surgery it will be important to discuss your situation with your surgeon. If at all possible, we will work with your surgeon to find follow-up care with a provider close to your home. Additionally, we are working with surgeons and facilities across the nation to bring programs on-line as quickly as possible to allow patients to have the procedure at a location that is close to their home.

Long- term weight loss success with vBloc Therapy requires follow up visits with your surgeon. Your surgeon will provide detailed instructions on the required frequency of visits once your device has been set to help you achieve maximum results.

You may be asked to provide permission to report your de-identified medical data to be used in a clinical registry for the purpose of tracking outcomes and improving quality of care services for your provider.

You will be instructed by your bariatric center to participate in follow-up visits as you start vBloc Therapy. These visits give you the opportunity to:

  • Ask questions, check overall health, weight, device settings and recharging patterns.
  • Review your goals and progress with your bariatric surgeon’s team to support your success.
  • Review battery charging instructions with your bariatric team, and check to see how much therapy you are receiving.
  • Optimize your device therapy settings or change the hours of therapy to adjust to your schedule or lifestyle.

To date there have been no disconnection issues with the device. Your surgeon is trained to handle any issues that may arise with your device and will provide instructions for contacting the office in the rare instance that issues arise. If the device becomes disconnected internally, you would need to have surgery to reconnect the device.

A two week post-surgical follow up visit will be required. Your surgeon will adjust your device to help you achieve the best results. It may be necessary to have additional adjustments over a two to four week period with additional visits as needed, for optimum therapeutic levels.

Some vBloc Therapy patients have described a mild to moderate sensation in the stomach that feels like fullness as new therapeutic levels are introduced. Other vBloc Therapy patients reportedly do not feel any difference. In all cases, the battery level indicator will show the device has been active.

vBloc Therapy is delivered via an implantable device and is not for those who need MRIs.

You should not experience any unnecessary delays as long as you travel with your vBloc ID card. In some airports, security will be able to easily detect the device and no additional action is taken. Other airports may require you to simply present your ID card before proceeding through security.

vBloc Therapy does not alter your anatomy, so it would not affect your ability to get pregnant. You should inform your surgeon if you plan to become pregnant in the near future. vBloc Therapy has not been tested in pregnant women; however, if you become pregnant after the device has been implanted the device can be turned off or adjusted by your surgeon. You cannot have this procedure if you are currently pregnant.

The vBloc Therapy device can be charged again as soon as you have access to a power source.

Yes, the vBloc Therapy device can be safely removed by your surgeon.

Your vBloc Therapy device will generally be programmed to deliver 12 hours of therapy each day for optimum therapeutic benefit. Programming adjustments are reversible, and customized to fit your lifestyle. It can also be turned on and off using wireless technology by your surgeon as needed. All adjustments are performed in an in-office setting.

vBloc therapy does not alter your anatomy and not does physically restrict food intake or impact nutrition absorption. You will be able to enjoy a normal diet with a wide range of foods without experiencing uncomfortable and embarrassing reactions.

There is no sound indicating that your therapy system is active. For some people, an outline of the implanted vBloc Therapy device may be noticeable beneath the skin’s surface near the rib cage. Your doctor will discuss with you the optimal placement of your vBloc Therapy device for comfort and functionality.

Some reports of nausea have been reported and were resolved with antacids, but regular regurgitation is not a reported side effect. vBloc Therapy is not a physically restrictive therapy. It works to enhance weight loss efforts by addressing hunger and fullness through brain and body communications, interrupting hunger signals from the stomach to the brain.

At this time, the settings can only be adjusted by your surgeon during an office visit.

No. The only software required for this device is used by your surgeon to adjust the device during clinic visits.

To date there have been no reported adverse allergic reactions associated with the vBloc Therapy device. It is a mostly silicone device with lithium batteries and surgical metals.

The device is made of surgical metals encased in medical grade silicone and contains a rechargeable lithium battery. These components are routinely used in other implanted medical devices.

Yes. Call 1-800-MY-VBLOC and ask to speak with a patient ambassador. Usually, within a week a person currently living with vBloc will give you a call to speak with you about what life is like with vBloc.

vBloc is available at numerous facilities throughout the US. You can use our physician finder or call 1-800-MY-VBLOC to get contact information for vBloc centers available in your area.

vBloc Therapy is available outside the United States in select countries. We are currently working on launching therapy training in the United States and will have more information on world-wide availability and aftercare at a later date.

Currently, vBloc Therapy is not available for use if you have a pacemaker or defibrillator as there is a potential for electromagnetic interference between the devices.

Yes, in order to safely prepare patients for surgery, there are pre-surgical testing requirements and a behavioral health (psychological) evaluation is typically a requirement.

You may be a candidate for vBloc Therapy if you meet these criteria:

  • Have tried to lose weight by diet and exercise in a supervised program within the last 5 years
  • Are at least 18 years of age
  • Have a BMI of 35 to 39.9 with a health-related condition such as:
  • Type 2 diabetes
  • High blood pressure
  • Sleep apnea
  • High cholesterol

Or

BMI of 40 to 45

Weight loss using vBloc Therapy can have a positive impact on obesity-related factors such as high cholesterol levels, blood pressure, glucose levels and type 2 diabetes.

vBloc Therapy is 100% reversible, unlike many other weight loss procedures. It does not change the digestive system nor physically restrict vitamin and nutrient absorption. vBloc Therapy stimulates the vagus nerve, which is a new and unique therapeutic approach to weight loss surgery. It requires minimal intervention from your physician once the appropriate settings are achieved. It is ideal for patients with active or busy lifestyles as it does not require a special diet, supplements, or stringent food restrictions. For optimal results, patients still must make healthy food choices and participate in physical activity.

Common side effects found in the clinical trials were mild or moderate nausea attributed to the therapy or as a result of weight loss. Pain at the implantation site was also a reported side effect. In many cases, these side effects were managed with medications and subsided as people acclimated to the therapy.

In the ReCharge randomized trial (gold standard of clinical research) serious side effects from the surgery, device, or therapy, were significantly lower than other weight loss surgeries and devices.

Any intra-abdominal surgery carries some risks, less than 5% of patients experienced a side effect from the surgery that required overnight hospitalization. All patients should discuss potential side effects in detail with their surgeon prior to proceeding with vBloc Therapy.

vBloc Therapy has been proven safe in clinical trials that included over 600 people worldwide. 8/10 people had their device implanted in the US. 300 in the Empower Study and 290 for the ReCharge study.

vBloc Therapy or “vagal blocking” is the first neurometabolic technology to enhance weight loss efforts by addressing hunger and fullness through brain and body communications. The vagus nerve is the main channel or message center that communicates between the stomach and the brain resulting in one feeling hunger.

vBloc Therapy helps to regulate this communication pathway by intermittently blocking vagal nerve signals. The vBloc Therapy is customized to your needs for hunger control; patients report feeling less hungry between meals and feel full or satisfied much quicker at meal time, making it easier to eat less.

Most patients in clinical trials had the procedure done in an outpatient setting and were able to resume normal daily activities after a few days of rest. Because the Maestro device is placed using a minimally invasive procedure, people generally enjoy a quick recovery. The type of work you are involved in will partially determine when you can return to work. vBloc Therapy generally requires less downtime for recovery than traditional surgery is a great option for those who do not have the time or resources for an extended recovery period.

vBloc Therapy procedure is performed by a trained bariatric surgeon in an approved hospital or surgical center using general anesthesia. The surgery generally takes around 60 – 90 minutes. The surgeon will make three to five small incisions in your abdomen placing the Maestro System device near the rib cage just below the skin. Two specially designed leads (wires) are placed around your vagus nerve just above the stomach. Scarring is minimal after this procedure.

Absolutely. Please contact Aspire directly to get connected with a current AspireAssist patient, who can answer any questions you have! Call 877-312-0007 for details on this program.

It’s up to you. It’s intended for long-term use, so you can use it for as long as you’d like. After you reach your goal weight, you might choose to remove the device. It’s important to make significant lifestyle changes, so you can keep the weight off long-term.

Yes! It can be removed in a simple 10 minute procedure.

In the US clinical study, there were 111 people who had the procedure. It has also been available in Europe since 2011, where several hundred people have had the procedure.

The most common side effects are discomfort or pain after the procedure, and irritation around the button area.

Absolutely! You can continue doing all your normal activities.

Although there is a small amount of risk with any procedure, the procedure is very similar to the procedure to place a G-Tube (feeding tube) which is used routinely across the US.

In the US clinical studies, people who completed one year lost an average of 37 pounds, and the most successful people lost over 100 pounds.

The AspireAssist is approved for adults with a Body Mass Index between 35 and 55 who have been unable to lose weight through diet and exercise. People who have had a gastric bypass or gastric sleeve are not candidates. People who have had a gastric band should speak with a physician about whether they are a candidate.

Yes, you’ll receive personalized nutritional coaching with the therapy. You’ll also need to chew very carefully so the food can fit through the tube, which helps give time for the fullness signals from your stomach to reach your brain, before you’ve eaten too much.

The button is attached to the tube, just outside the skin on your belly. It is discreet under clothing, so no one needs to know how you’re losing weight.

Most people are not hungry after using the device, because it only removes 30% of the meal. You’ll also wait 20 minutes after eating, so the fullness signals from your stomach have already started to reach your brain.

Initially, successful patients use it 2-3 times per day, after each major meal. Over time, you may be able to use it less often as you make healthy changes to your lifestyle.

About 20 to 30 minutes after each meal, in the privacy of a restroom, you attach the device (about the size of a smartphone) to the button. The device can remove about 30% of your meal, directly into the toilet. It takes about 5-10 minutes.

The tube is placed into your stomach during a 15-minute non-surgical procedure, usually with twilight sedation instead of general anesthesia. Most patients go home within 1 to 2 hours. You’ll need to take it easy for a few days afterwards.

The AspireAssist works by allowing you to remove about 30% of the food you eat from your stomach through a tube, before your body has a change to absorb it. Because your body still keeps 70%, you’ll lose weight in a gradual, healthy way without nutritional deficiencies.

After your stomach has healed, you may eat most foods that don’t cause you discomfort. However, because you can only eat a little it is important to include foods rich in protein. In general, although a balanced diet is the best diet for most individuals, for patients who are trying to lose weight, avoiding carbohydrates is the most efficient method of weight loss and losing stored fat. In addition, liquids will travel through the band with little difficulty and will defeat the purpose of gastric banding.

Alcohol has a high number of calories and breaks down vitamins. An occasional glass of wine or other alcoholic beverage, though, is not considered harmful to weight loss.

Order only a small amount of food, such as an appetizer. Don’t feel obligated to finish the entire meal and stop as soon as you feel full. Get in the habit of sharing meals with others or bringing home left-overs.

You should be able to take prescribed medication though you may need to adjust their dosage. As a general rule, antihypertensives (medications for high blood pressure), hypoglycemics (medications for diabetes), diuretics (water pills), and blood thinners (Warfarin/Coumadin) will need special attention. Please let both your surgeon and your primary care physician know about your medications, especially around the time of your initial operation.

Since it is possible to not get enough vitamins from three small meals a day, all of our patients are encouraged to take daily vitamin supplements during the period in which they are aggressively losing weight.

Given the overall lower volume of food and beverages, you might find your stools harder after gastric banding. It is important for you to consume an adequate amount of non-caloric beverages (water, unsweetened iced tea, sugar-free/diet beverages, etc.) during the day. But in an effort to avoid helping your pouch empty the food that has recently been consumed, you should concentrate on drinking when your pouch is empty already which is typically just before you are getting ready to sit down and eat your next meal.

Becoming pregnant can be easier as you lose weight. Your menstrual cycles may become more regular. Many patients who have failed to become pregnant before losing weight find themselves becoming pregnant after unprotected intercourse. As a general rule, it is neither good for a patient to gain a whole lot of weight nor is it good to lose a whole lot of weight during pregnancy. Accordingly, the decision to empty the band might have to be individualized. It is very important for a patient to let us know if and when they know about their pregnancy so we can closely monitor their weight and their overall health.

Throwing up might become necessary such as when you have eaten “bad” food. Although the band creates a substantial resistance against “passive” movement of stomach acid up into the esophagus, the “active” process of throwing up is often accomplished without much difficulty. Having said that, it might become necessary for us to empty the band when a patient has become ill to make the process of throwing up even easier.

One of the major advantages of the gastric band is that it can be adjusted. If your illness requires you to eat or drink more, the band can be loosened by removing saline from it. When you have recovered from your illness and want to lose weight again, the band can be tightened by increasing the amount of saline.

The gastric band works through a combination of portion control and elimination of hunger. As a result, despite eating very small amounts, a person should not battle hunger throughout the day. One of the components of “healthy eating with a band” is to never “deprive” yourself. Accordingly, when you feel hungry, you should enjoy a “solid” snack which is rich in “protein”. Examples include a handful of mixed nuts, a protein bar, or a hardboiled egg.

This is a fairly common feeling, especially for people with bands that are tight or just after an adjustment. During the day the water content in the body redistributes itself and this may cause the band to feel “tighter” some of the time. Some women have also noticed that the LAP-BAND feels tighter during menstruation.

That is not always the case. The age of the individual, the total amount of weight loss, the pace with which the weight is lost and the amount of exercise and muscle toning during the weight-loss period all contribute to the need for reconstructive surgery. On the average, of all of our highly successful patients, 1/3 will not need any intervention, 1/3 will need it but may choose against it due to concerns about the outcome and the cost of reconstructive surgery and 1/3 go ahead with some kind of reconstructive surgery with very good results.

Although the LAP-BAND System is not meant to be removed, it can be laparoscopically removed in some cases. Following band removal, the stomach generally returns to its original shape. It is important to note that after the removal of the band, many patients may gain some or all of their lost weight.

There are no restrictions based on the access port. It is placed under the skin in the abdominal wall, and once the incisions have healed it should not cause discomfort or limit any physical exercise. The only sensation you may experience from the port occurs when you go in for adjustments. If you feel persistent discomfort in the port area, let us know as soon as possible.

Adjustments are often carried out in the office and will take 5-10 minutes. In some circumstances, your physician might require additional information or assistance from x-rays in which case the procedure might be performed in an x-ray room. Typically, a fine needle is passed through the skin into the access port to add or subtract saline.

The LAP-BAND does not hamper physical activity including aerobics, stretching and strenuous exercise.

Check-ups are a normal and very important part of the LAP-BAND System follow-up. On the average, patients will require a band adjustment every 4-6 weeks during the first year and every 2-3 months thereafter until the desired weight is achieved. Once the desired weight is achieved, the visits are reduced to once or twice a year.

Surgeons have reported that gastric bypass patients lose weight faster in the first year. At five years, however, many LAP-BAND patients have achieved weight loss comparable to that of gastric bypass patients. You should focus on long-term weight loss and remember that it is important to lose weight gradually while reducing obesity-related risks and improving your health.

Weight-loss results vary from patient to patient, and the amount of weight you lose depends on several things. For a patient with a good understanding of the function of the band and a willingness to “work with the band” an average weight loss of 1-2 pounds a week is to be expected. There are no time tables and patients can lose weight indefinitely until they reach their desired weight. Remember that a gradual weight loss is most desirable. Losing weight too quickly creates a health risk and can lead to a number of problems. The main goal is to have weight loss that prevents, improves, or resolves health problems associated with severe obesity.

It takes most patients about a week to return to work and most routine activities including gentle exercise. Patients with extensive medical history might have other restrictions that will need to be considered on a case by case basis.

The LAP-BAND System limits food intake. If you feel nauseated or sick on a regular basis, it may mean that your band is too tight and needs to be loosened some. In general, if you have trouble drinking even beverages, then your band needs to be loosened. Alternatively, it might mean that you are eating more than your adjusted capacity and you need to cut back on the volume that you consume. If you only have trouble with solids and not liquids, then you should try smaller volumes and quit before you get sick. Finally, it is possible that certain foods (bread, pastry, dry meats) are simply too tough to be adequately broken down and pass through the band. If you indeed only have trouble with such foods, then you should not challenge yourself and for the period of time that you are trying to lose weight and your band is kept fairly tight, you might consider avoiding such foods.