FDA Approves New Obesity Device

 Posted on February 02,2015 in Arlington Heights Defective Medical Device Attorney

In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It's the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes. The system consists of a rechargeable electrical pulse generator, leads, and electrodes that are implanted surgically into the abdomen. Safety trials consisted of 233 patients, in which 157 received the device and 76 in a control group who did not. Though there were some adverse effects observed, the FDA sponsored a survey that found that patients with severe obesity would be willing to accept the dangers for the weight loss it promised.

There are several devices to help fight obesity that have been on the market for years, including those that tie off the passageways to the stomach. Some of these devices require that the patient eat very slowly, or that he takes very small bites. Many of these devices came under fire by the FDA for safety concerns. One well-publicized event was the discontinuation of the manufacture of one of these devices for teenagers after two percent of patients who were using them experienced severe side effects. According to the National Institutes of Health, a significant number of patients surveyed in a trial of obesity-reducing devices experienced negative side effects.

Only time will tell if the recently approved device will have a similarly bad track record. If you or someone you know has experienced negative side effects or long-term health problems because of an obesity device, you may be eligible for compensation. Do not go through it alone. Contact an experienced Chicago defective medical device attorney today.