FDA approves temporary, non-surgical device to treat obesity

The Fierce 15 company’s device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach “or by other mechanisms that are not yet fully understood”, according to the FDA. New patients easily and effortlessly consult online with one of their doctors who will review the system and assess past history and weight loss needs to identify the real reason for weight gain.

It has shown promise as a minimally invasive procedure and vast improvement over a similar design created in 1992, which ruptured and caused artery blockage in patients.

The FDA approved the ReShape Dual Balloon based on a study of 326 obese people, aged 22 to 60, who had at least one obesity-related health condition. The weight loss balloon is temporary and is typically removed after 6 months. “The approval of ReShape opens up a new opportunity for these patients or patients who are not ready for surgery, by providing an effective nonsurgical treatment to help them with their weight loss and a path to a healthier lifestyle”.

The balloon is removed after six months, during which time patients are advised to follow a medically supervised diet.

The Food and Drug Administration spokesman, Deborah Kotz, has stated that the ReShape Dual Balloon device is meant for obese people who have already tried the traditional diet and exercise regime, but with little results. They urge those of all shapes and sizes, who have been unsuccessful in the past, to call today to schedule a confidential, no-cost consultation.

It is inserted in the stomach endoscopically and filled with saline and remains in the body for six months. Although the balloon takes up volume, it’s important to note that it does not alter the stomach’s natural anatomy.

He says, “For those with obesity, significant weight loss and maintenance of that weight loss often requires combinations of solutions including efforts to improve diet and exercise habits”. Patients can lose as much as 17 percent of their total body weight with banding devices, such as the LAP-Band, although about 20 percent of patients regain almost all the weight within three years.

It is estimated that almost one-third of the American population is obese.

FDA cautioned that side effects during the placement procedure include headache, muscle pain, and nausea, and in rare cases severe allergic reactions, heart attack, esophageal tear, infection, or breathing difficulties.

“Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers and feelings of indigestion”, the FDA added. Pylori infection, nor is it for those who use aspirin daily or who are pregnant.