Author Archives: peterdenk

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, 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 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.