A little over a year ago, the FDA approved the first new obesity device since 2007. What led to its approval? When a patient is diagnosed with obesity (having body mass index (BMI) of 30 or higher), the risk for medical complications such as diabetes, high blood pressure, or sleep apnea is heighted. As the number of adults in the U.S. who are obese continues to increase, the need for more options for providers to help patients with weight loss has grown. Recent reports calculated that 78.6 million adults are obese, and the yearly medical costs are near $147 billion. Obesity remains a major public health concern, but healthcare providers have an increasing range of options to help patients improve or prevent health problems related to obesity.

Many patients achieve successful weight loss through increasing physical activity, making dietary changes, and modifying behaviors. If these approaches do not achieve the desired results, prescription weight-loss medications may be effective. Commonly prescribed weight-loss medications include Xenical (orlistat), Belviq (lorcaserin), Qsymia (phentermine and topiramate), Suprenza (phentermine), Contrave (bupropion and naltrexone), and Saxenda (liraglutide). Though pharmacotherapy can be very effective for some patients, some barriers exist that can interfere with the benefits of the drugs. Adverse reactions like oily diarrhea, increased blood pressure, depression, problems sleeping, nervousness, headache, nausea, and constipation may occur with some of these medications. Sometimes weight loss medications may not be covered by insurance. Some patients who do achieve successful weight loss while on medications (usually between 5 to 10 pounds) may experience the frustrating result of regaining the weight, unless they have also implemented lifestyle changes such as improved diet and exercise programs.

Not all patients are able to lose weight on medications. Weight loss surgery may be the right choice for some patients, but as with any surgery, there are serious risks. Common weight-loss surgeries include:

• Gastric bypass surgery
• Laparoscopic adjustable gastric banding
• Biliopancreatic diversion with duodenal switch
• Gastric sleeve

Another treatment for obesity is a vagal nerve blockade (ie, vagal blocking therapy, or VBLOC therapy), where a device is implanted under the skin of the abdomen. The device sends electrical pulses intermittently to the abdominal vagus nerve, which signals feelings of stomach emptiness or fullness to the brain. The FDA approved this new technology in 2014 for use by adults with a BMI of 35 to 45 and at least one obesity-related condition, and who have not been able to lose weight with a weight-loss program. The Maestro Rechargeable System (which received FDA approval in January 2015) delivers VBLOC therapy and is intended for adults who are obese with a BMI of 40 to 45 or a BMI of 35 to 39.9 and one or more obesity-related health condition. Possible side effects of the device include pain at the neuroregulator site, heartburn/dyspepsia, abdominal pain, nausea, dysphagia, eructation/belching, or chest pain.

Another medical device used for treating obesity is the ReShape Integrated Dual Balloon System (Reshape Dual Balloon). Available internationally since 2011, the system consists of two attached balloons filled and sealed separately and placed in the stomach via an endoscopic procedure. By filling space in the stomach, the system helps patients lose weight. The device is indicated for adult obese patients with a BMI of 30 to 40 and who have at least one obesity-related health condition, and who have been unable to lose weight through diet and exercise. The maximum placement period of the system is six months. To remove the balloons, they are deflated then removed using another endoscopic procedure. In the pivotal trial, the group who used the device lost 2.3 times more excess weight at 6 months than those who did not use it.

Unfortunately, regardless which obesity treatment method is implemented, patients often regain weight. Patients working to overcome obesity will need continued support from healthcare providers to encourage adherence to weight-loss medications and to exercise and healthy eating plans.

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Salvatore Volpe, MD, FAAP, FACP, CHCQM
Chief Medical Officer
PDR