FDA Approves ReShape Dual Balloon Device for Weight Loss

 

A new tool in the fight against obesity is now available in the United States.

Image of the device.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: ReShape Integrated Dual Balloon System
PMA Applicant: ReShape Medical, Inc.
Address: 100 Calle Iglesia, San Clemente, CA 92672
Approval Date: July 28, 2015
Approval Letter: Not yet available.

What is it? The ReShape Integrated Dual Balloon System (Reshape Dual Balloon) is a weight-loss system of gastric balloons that occupy space in the stomach. The system consists of two attached balloons that are filled and sealed separately. The balloons are placed into the stomach through the mouth using a minimally invasive endoscopic procedure while the patient is under mild sedation. Once in place, the balloons are filled with about 2 cups of salt water (saline) and a blue dye (methylene blue). If a balloon breaks, blue dye will appear in the patient’s urine. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.

How does it work? The ReShape Dual Balloon takes up space in the stomach to help patients lose weight. The system is temporary and should be removed after 6 months.

When is it used? The device is used in adult obese patients who have a Body Mass Index (BMI) of 30-40 kg/m2 who have been unable to lose weight through diet and exercise. Patients must also have one or more obesity-related conditions such as diabetes, high blood pressure, or high cholesterol. Reshape Dual Balloon is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider.

What will it accomplish? During the clinical study, the group of people who used this device lost more weight than those who did not use it. The study included a total of 326 patients at 8 investigational sites in the United States. Of the 326 patients, 187 received the device and 139 underwent the endoscopic procedure but did not receive the device. All study participants received diet and exercise counseling.

Patients with the device lost an average of 14.3 pounds (25.1% of their excess weight and 6.8% of their total body weight). The patients who did not receive the device lost an average of 7.2 pounds (11.3% of their excess weight and 3.3% of their total body weight).

When should it not be used? The device should not be used in patients who

  • have had previous gastrointestinal or bariatric surgery
  • have gastrointestinal inflammatory disease
  • have potential upper gastrointestinal bleeding conditions
  • have a gastric mass
  • have a large hiatal hernia
  • have structural abnormality in the esophagus or pharynx
  • have serious esophageal motility disorders
  • have severe coagulopathy
  • have hepatic insufficiency or cirrhosis
  • have serious alcoholism or drug addition
  • have serious or uncontrolled psychiatric illness or disorders
  • are pregnant or are breastfeeding or plan to become pregnant
  • have ever developed too much serotonin (serotonin syndrome) and are currently taking any drug known to affect serotonin levels
  • take  use aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants daily
  • are known or suspected to have an allergic reaction to materials in the device
  • are unwilling or unable to participate in a medically-supervised diet and behavior modification program or take prescribed proton pump inhibitor medication for the duration of the device implant

Call GI Surgical Specialists today to schedule your consultation and find out if the balloon is right for you. 239-313-7522

Are Proton Pump Inhibitors the Right Solution for Your Heartburn?

By Peter M. Denk, MD, FACS

As a physician serving residents in the Fort Myers and Naples area, I was very skeptical when pharmaceutical manufacturers began to promote prescription medications on TV. The reason these medications are controlled and require approval is that they are powerful and often can have serious side effects. As an expert on gastroesophageal reflux disease, GERD for short, I am shocked at the frequency of the Proton Pump Inhibitor (PPIs) commercials – even Larry the Cable Guy is now an expert on how to manage your heartburn. But are PPIs right for you? There are important things you should know before you start down that treatment program.

For many, PPI medications are very effective for the treatment of GERD. What I, and most GERD experts believe, is that in order to make an informed decision regarding taking PPIs, or any drug for that matter, one must understand the drug, exactly what it does, why it was prescribed, potential side effects, and other options for treatment. At $14 billion in US sales annually and growing, it is fair to say that PPIs are used indiscriminately in the United States without the above criteria being satisfied.

PPIs are effective in decreasing the production of acid in the stomach, making its contents less irritating when they reflux into the esophagus. However, they do absolutely nothing to decrease the frequency or volume of your reflux. In effect, they make you feel better without addressing the disease itself. That comes at a price:

1) Once you begin, PPIs are likely to be required for life.

2) PPIs have immediate possible side effects of headache, diarrhea, and abdominal pain.

3) Long-term side effects are now becoming well recognized, including increased risk of hip fractures, an increased risk of a serious colon infection called C. Difficile colitis, low magnesium levels which can lead to heart rhythm problems, pneumonias, and interaction with other drugs.

4) We also now know that almost 40% of people on PPIs continue to have symptoms.

5) Finally, research has proven that over 30% of PPI users do not have reflux disease.

Given those issues, what else can you do? First, confirm that you have reflux disease. Diagnosing via symptoms or reduced improvement on PPIs is not a good means to diagnose GERD. See a physician that can perform the necessary diagnostics to validate a GERD diagnosis. If you are found to have reflux disease, there are many other things you can do to reduce your GERD symptoms:

Lifestyle – With proper education, lifestyle changes can reduce or eliminate the need for such potent medications in many patients.

Diet – Knowing your “trigger” foods and avoiding them can result in significant symptoms reduction.

BMI – Those extra pounds put pressure on your diaphragm causing an increase in GERD symptoms. Target a BMI of 25 or lower not only to manage your heartburn, but for your general health as well.

Medications – If you need medication to control your symptoms, there are several other drug categories that are available with much fewer side effects, such as H2 blockers (including Zantac, Tagamet, and others), and antacids like Tums and Mylanta. Unfortunately, these preferred options have been “forgotten” with the promotion of PPIs. It is also important to point out that if any of these medications are needed, they do not necessarily need to be taken daily. Remember, they act to control symptoms, so taking the least potent medication only as needed to control symptoms is recommended.

Surgery – Surgical and procedural alternatives directly address the underlining cause of GERD by restoring the barrier between the esophagus and the stomach. When performed by an experienced surgeon, these procedures can be highly effective at stopping reflux and reducing/eliminating the need for medications.

Finally, the most important thing you can do is to learn more about your heartburn. Reflux disease is a long-term chronic condition that can progress, leading to many complications including Barrett’s esophagus and adenocarcinoma, esophageal cancer. I recommend our patient with reflux disease to learn as much as they can at www.refluxmd.com, an Internet healthcare community dedicated to GERD. I also suggest that you visit my website to learn more about my practice, and if surgery is the right option for you, at www.GISurgical.com. Educate yourself, know all your treatment options, build your support team including a GERD expert, and build your plan to symptom relief and good health.

Peter M. Denk, MD is a board-certified, fellowship trained surgeon specializing in minimally invasive and noninvasive Bariatric, Endoscopic GI and General Surgery. Offering two convenient locations in Ft. Myers and Naples, Dr. Denk is dedicated to providing a modern, friendly approach to complex surgical problems.

Slow Down, Lose Weight

The pace at which you eat is just one eating behavior that might influence your weight loss progress.

Slow Down, Lose WeightEating behavior refers to the habits that influence the way you eat. Changing the types of food you eat makes up half of the healthy dieting equation. To lose weight, behavioral changes are also necessary.

It’s likely that you engage in a collection of eating behaviors without much thought. Eating behavior incorporates actions and thoughts toward food, like:

  • Willingness (or unwillingness) to try new things
  • Preference for soda or high-sugar juice instead of water
  • Constant snacking throughout the day
  • Serving oversized portions
  • Misunderstanding hunger cues
  • Desire to always clean your plate
  • Eating too fast

Each of these behaviors has the potential to negatively affect your health and wellness goals, and may even interrupt your weight loss process. While only one of the potential factors that may be interfering with your weight loss efforts, eating too fast is something that many people are guilty of—and it is a behavior that you can start changing today.

Eating Slowly Encourages Weight Loss

In 2010 researchers from Athens University Medical School in Greece and Imperial College in London conducted a clinical research study to determine the influence eating fast or slow might have on a person’s ability to lose weight. After giving two groups of participant’s identical snacks, they found that those who took 30 minutes to eat their ice cream became more satiated than those who ate their entire treat in just five minutes.

The difference in hunger levels wasn’t just perceived, either. The researchers took blood samples and evaluated insulin and gut hormones, and found that after taking 30 minutes to eat a snack, the hormones signaling fullness were more pronounced.

A 2008 study from the University of Rhode Island found something similar. That eating at a slow pace reduced the desire to continue eating and helped participants to feel more satisfied.

Having a reduced stomach capacity after weight loss surgery makes it even more important that you slow down your eating style. Here are a few ways you can accomplish this:

  • Set a timer and practice pacing your meals to use the entire time allotted
  • Focus on engaging in conversation with your family or friends
  • Put your fork down between bites
  • Chew food more thoroughly

Eating slower gives your body and brain a chance to communicate during the eating process. As you eat your stomach sends signals to the brain to let it know how much it’s had, and how much more will be necessary. The brain gets these signals and that is how we know to either keep eating or pack it up.

When you eat too fast, your stomach falls behind in sending these signals to the brain. By the time the brain knows we are full, we’ve already taken a few more bites. This leads to overconsumption, stomach aches and if you aren’t careful after weight loss surgery it could cause your smaller stomach pouch to stretch.

As you transition to a more traditional diet following weight loss surgery, do your best to slow down as you eat. Quickly eating your food takes away from your ability to savor and appreciate each bite, and may cause you to eat more than you intended.

Using a Journal to Lose Weight

Using a Journal to Lose WeightMost people have their own notions of what it means to keep a journal, and sometimes these preconceived notions are enough to prevent someone from giving it a try. Images of the words “KEEP OUT!” scrawled across the top of a marble notebook, or thoughts of a teenagers diary hidden under the bed behind a lock and key are just a few impressions many people hold of journals. But times have changed, and so has the art of journaling.

Keeping a weight loss journal is a proven strategy that can boost your efforts to lose weight. When you keep a journal it becomes easier to maintain a workout schedule and stay accountable for your goals. When you look back through your journal you’ll be able to see habits and trends and the impact your actions have had on your weight loss efforts.

Technology makes it easy to journal with fun resources, like:

Phone apps: You can either download a weight loss inspired app like Lose It, or try out one of the many journaling applications for your smartphone provider. Chances are you always have your phone on you, why not use your phone to stay accountable to your goals.

Blogs: This is a great way to log your thoughts and maintain a sense of external accountability. You don’t need to tell your friends and family about it, either. Consider blogging your weight loss journey to connect with total strangers out there who might benefit from your learning process.

Word documents: You can either keep a file with documents on your computer, or use an online open document, like through Google Docs. This way you can type up anything you might log in your journal without having to pull out pen and paper.

What do I write?

There are absolutely no limits as to what you can journal about, especially when it comes to using a journal to promote your weight loss efforts. Consider logging things like:

  • Exercise habits
  • Food choices
  • Hunger
  • Headaches
  • Stomach aches and other digestive symptoms
  • Water consumption
  • Cravings
  • Temptations
  • Stress factors
  • Weight loss goals

Every day as you update your journal you are free to provide as much detail as you like. This might mean a vague description of what you did the day before, or you may choose to get specific and long details like how many steps you took yesterday, how much you weighed this morning and what your plans are for the next day.

Journaling is a great habit to develop as you try to lose weight, and best of all it is absolutely free. Try starting your own weight loss journal and see how it goes. You might be surprised by how much you like it.

Setting Healthy Goals to Lose Weight

Setting Healthy Goals to Lose WeightHow do you measure weight loss success? Is it a number? A pant size? A feeling? Success is dependent on your own expectations. The goals that you set for yourself at the onset of your weight loss program will have a direct effect on how you’ll interpret your own success. You want your goals to be challenging, but not so out of reach that they aren’t worth pursuing.

A great goal can become a guiding force as you lose weight. It becomes something for you to work towards and focus on as you encounter challenges and fight fatigue. A goal like this can be among your greatest assets following weight loss surgery, and you are the only one who can create it for yourself.

Crafting Great Goals

The first step to creating a great weight loss goal is determining what you want. Think long and hard about what it is you want to accomplish through weight loss surgery. Are you ready to improve your health? Do you want to feel able to move easier? Lose weight you’ve gained in recent years?

The best goals are personal ones. There are things in your life that will drive you to succeed, and this makes your goals different from anyone else’s. Once you know what you want, you can turn this desire and drive into a well-crafted weight loss goal.

The best goals are SMART. That means they are:

  • Specific
  • Measurable
  • Attainable
  • Result-focused
  • Time-bound

When creating a weight loss goal, try your best not to let it be too vague. Simply saying you want to lose weight is a great start, but it isn’t enough. Talk to your weight loss surgeon and decide on a number. Then, set a date you hope to reach that number by. Make sure this number is attainable—setting it too high is only going to lead to discouragement as you set yourself up for failure. But setting it too low won’t motivate you to keep going, either.

Things like wanting to feel better, having more energy, moving around easier—these are all great goals to have, but they are difficult to measure and that can make it hard to know where you stand in the weight loss process. By creating a SMART goal you are giving yourself something to measure up against and an opportunity to track your progress as you take steps to improve your health.

Find Accountability to Lose Weight

Find Accountability to Lose WeightWeight loss isn’t a short term affair. To lose weight and to keep it off you will have to make long-term, sustainable changes in your exercise habits and diet. A strong source of accountability can make this process a bit easier.

Even after weight loss surgery, accountability plays a big role in the weight loss process. Your weight loss procedure helps you gain control of hunger and cut your portion sizes, but at the end of the day the food choices, the exercise habits and other lifestyle changes are yours to make or break.

There are several avenues through which you may find weight loss accountability. Family, friends, co-workers and your weight loss center may all function as strong external sources of accountability, while personal goals and expectations may drive you to stay on track as internal sources of accountability. There are also tools freely available to help you track your progress, offering an additional form of accountability to your weight loss goals.

Weight loss accountability comes in all sorts of formats. Here are a few suggestions of accountability resources you may want to check out:

  • Talk to a friend: Find a friend who wants to become your new weight loss buddy and make a commitment to each other. You can work out together, hold each other accountable for diet choices and encourage each other through difficult times.
  • Weight loss journal: This is a form of self-accountability, but it works on the same principal of external motivators. Write your progress in your journal every day. Jot down details like how long you exercised, what you ate and other healthy habits you practiced. You can use this as a resource to track your progress and to hold yourself accountable.
  • Internet tools and apps: Consider signing up for an online program or using a smartphone app to hold yourself accountable even more. Earndit is a website that gives you points every time you log a workout or check in at the gym. The popular phone application Lose It encourages you to log everything you eat and every bit of activity you engage in, kind of like a cyber-weight loss journal. There are many other similar programs out there that use other incentives to help you stick with your goals, as well.

How you choose to keep yourself accountable will have a large impact on your weight loss program. There are resources all around you that you can turn to as you lose weight. Take advantage of the different forms of weight loss accountability available to you in Ft. Myers and use them as resources to push your weight loss efforts to the next level.

Eat Local and Lose Weight

Eat Local and Lose WeightHow many miles did your last meal travel before reaching your plate? There is a good chance the number might top 1,500 miles. The average meal has ingredients that come from at least five different countries. Highly processed foods, fresh produce and even meat is packed onto trucks and transported for days before reaching your neighborhood grocery store. A lot of people don’t realize how far every bite of food they take has traveled before reaching their lips, and for some this is pretty disconcerting.

Weight loss surgery will likely encourage you to make healthy changes in your diet. What you choose to eat, how often you are eating and how much you eat at once will all undergo changes as you gain greater control over hunger and eating habits. Connecting with the source of the food you eat is a great way to increase awareness within your own diet as you undergo these changes.

Shopping at the farmers market can do more than just increase healthy aspects of your diet. By encouraging your family to go to the market with you and incorporating fresh, healthy ingredients into your weekly meal plan you can increase the health of your family’s diet altogether.

Here are a few tips to consider when heading to the farmer’s market:

  • Bring your own bag: Some of the farmer’s may have plastic bags, but most will expect to just hand you the produce. You can either bring a standard re-usable grocery bag or an insulated cooler bag to keep your produce cold.
  • Ask about storage techniques: As you buy produce, ask the farmers how they would suggest storing the items you are buying, and how long you can expect the produce to last. Most produce is okay for about a week, so try not to buy more than your family will eat in that amount of time.
  • Bring cash: Some farmers are now starting to accept credit cards thanks to the advancement of smartphone applications, but most keep to cash-only. At most farmers markets you can buy a substantial amount of fresh produce for just $10 to $20.
  • Ask for a taste: Farmers are there to sell their harvest, so don’t treat yourself to the display for a taste. Many farmers will keep a few items to the side to offer tastes of, especially for in-season produce. If you are unsure about something, ask if you can sample before buying.

If you’ve never been before, try out a farmer’s market near your home. The River District Farmers Market is located under the Caloosahatchee Bridge in Ft. Myers. This market features produce, baked goods, local honey and more. It is open on Thursdays from 7am to 1pm.

Adjusting to Exercise after Weight Loss Surgery

Adjusting to Exercise after Weight Loss Surgery in Ft. MyersTo create your ideal workout plan, you have to first figure out where you need the most improvement. Once your body is ready for exercise after sleeve gastrectomy or gastric band surgery, you can put yourself through a short personal fitness assessment to figure out your ideal starting place.

Take out a notebook and log your results for the following challenges:

  • How far can you walk in 10 minutes?
  • How many times can you do a simple bicep-curl with a five-pound weight?
  • Stand in front of a sturdy chair. How many times can you stand up and sit down before becoming short of breath?
  • Bending at your waist while sitting, how far can you reach your fingers? Your knees, toes, thighs or somewhere in between? Try this activity from a chair if you do not yet feel comfortable on the ground.
  • What is your pulse before working out, and what is your pulse after 10 minutes of activity?

Answers to these tasks will give you a strong starting point to work from and will help you create realistic fitness goals. Keep the answers to these questions and track your progress periodically to see how far you’ve come.

Finding Exercises for You

Once you know where you need improvement, you can find activities that will target that area of physical fitness.

Strength Training

If bicep curls were difficult with five-pound weights, you need to focus on building upper-body strength. Your local gym is equipped with many weight training machines that reduce risk of injury by guiding motions and making it possible to work out without a reliable spotter.

In lieu of free weights, you can start building strength by using resistance bands, or try lifting full water bottles.

Cardiovascular Activity

If you had trouble walking for 30 minutes, it’s time to focus on cardio. This form of exercise increases your heart rate and promotes blood circulation.

Examples of cardio activities include:

  • Walking: Don’t push yourself too far at first. Start out by walking in 10 minute increments, and push yourself farther and longer as you feel able. Treadmills are a great resource for increasing your distance.
  • Water aerobics: Exercising in the water removes a lot of resistance and can help you improve strength and flexibility as you improve your endurance.
  • Biking: Riding a bike may be difficult at first, but in time this may prove to be a valuable form of fitness for you. Try using stationary bikes to engage your legs without worrying about balance. Incumbent stationary bikes may be more comfortable when you are starting out.

Flexibility

Flexibility influences every aspect of physical fitness. It improves strength and range of motion, making every exercise a bit easier. You can do simple stretches at home, or you can go to a class for some guidance on basic stretches.

Some classes combine strength, cardio and flexibility training, helping you improve all three at once. Examples include:

  • Yoga: This is great for beginners and advanced athletes. Tell your instructor it is your first course and he or she will be happy to offer extra guidance.
  • Pilates: This exercise uses aspects of yoga but adds resistance and some other devices to encourage strength building.

Basic yoga and Pilates poses call for mild knee bends and arm extensions. You can also use a sturdy chair to modify poses as you get started.

Once you find an activity that is both challenging and enjoyable, set up a schedule and stick to it. Aim to work out every day you can, and try to incorporate a variety of activities to keep yourself interested.

Managing Time for Weight Loss

Managing Time after Gastric Band Surgery in Ft. Myers

“Slow down and everything you are chasing will come around and catch you.” –John De Paola

When was the last time you excused yourself from something important because you were “too busy?” If you are like most people, you can think of an occasion within the past week when this happened. Busyness is more than a packed schedule; it can be a debilitating mindset. If we aren’t busy, we may feel like we aren’t doing enough. Saying you are too busy for something reasserts your priorities, making it clear that you have way too much going on in your life to fit in whatever was just asked of you.

The problem is that all too often the things getting pushed off in the name of busyness are the very tasks that we should be prioritizing.

After weight loss surgery, do your best not to let healthy habits fall by the wayside as a result of busyness. Once you have sleeve gastrectomy or gastric band surgery, you have to maintain your commitment to a healthier lifestyle.

This means finding time for a number of things like:

  • Planning healthy meals for you and your family
  • Exercising every day
  • Getting eight hours of sleep every night
  • Managing stress levels to keep a good attitude for weight loss

Fitting these healthy habits into your lifestyle takes work. Instead of throwing these new commitments on top of your existing schedule, try taking a step back and evaluating what takes up the most time in your life right now. Ultimately, the things you commit the most time to every day should be the biggest priorities in your life.

Here are a few time management tips to help you add healthy habits to your lifestyle without succumbing to busyness:

  • Create time slots. Don’t just write a list—allocate specific periods of time to get tasks done. This will help you stay on track of your responsibilities and ensure that you use every moment efficiently.
  • Schedule in “you” time. Time to relax, work out and unwind should be penciled in on your calendar. Because these habits will help prevent fatigue and mental burnout, they should remain priorities.
  • Delegate tasks. As you look at all that needs to be done, ask yourself what needs to be done by you. Consider asking for help where you need it.
  • Learn how to say “no.” Don’t take on any extra tasks that you don’t need. Doing favors is a kind gesture, but if you really don’t have time to do one without it affecting your weight loss habits, then say no.

There are all sorts of convenient tools available to you to help you manage your time. Download a calendar or to-do list app on your smartphone or tablet and let it keep track of what you have to do. Keep a notebook on your desk at workout or in your car to jot down reminders as they cross your mind. Strategies like these can help you stay organized as you continue on your weight loss journey.

 

Hydration and Your Health after Weight Loss Surgery

Hydration and Your Health after Gastric Band Surgery in Ft. MyersWater is essential to survival. Your body depends on it to keep organs functioning properly, including your heart and brain. Every cell, tissue and muscle in your body is supported by water. It lubricates your joints, pushes waste through your body and maintains internal temperature. Without enough water your body will struggle to remain healthy.

After sleeve gastrectomy or gastric band surgery, you’ll have to make a concerted effort to drink enough water every day. This will involve taking small sips regularly throughout the day, as your smaller stomach pouch will make it impossible to take large gulps without filling up quickly.

You should aim to drink at least 64 ounces of water daily. While it is true you can meet this quota by drinking other fluids, none will hydrate you as effectively as water. This is why at least half of your daily water intake should be good old H2O.

If you don’t drink enough water, you will become dehydrated, which can cause all sorts of problems.

Symptoms of dehydration include:

  • Decreased or darker urine
  • Dry mouth
  • Chapped lips
  • Headaches
  • Fatigue
  • Extreme thirst
  • Confusion
  • Dizziness
  • Lack of tears

After weight loss surgery your stomach capacity will be greatly reduced. You won’t be able to take large gulps of water to reach your fluid intake goals. Instead, you’ll have to drink water regularly throughout the day.

Carry a water bottle with you and practice taking very small sips. To learn the right size of a sip, practice drinking two ounces at a time using medicine caps, like the type that come with cough syrup bottles.

Try finding a water bottle with ounces marked on the side—this way, you can track your progress and know how much water you consume throughout the day. If you are missing some flavor in your beverage, try adding a drop of lemon or lime juice, or adding a sprig of mint to your water for some extra zest.