Clinical trials indicate that the device could provide another option for those who are severely overweight but can not undergo other weight loss surgeries.
The Food and Drug Administration (FDA) is reviewing an implant that is meant to help with weight loss in individuals who have not been able to lose weight using traditional methods. The implant is called Maestro Rechargeable System and it functions by inhibiting nerves in the stomach, helping to control digestion and curb hunger.
The implant is meant to help people who are considered to be significantly overweight, specifically people with a BMI over 40. It is proposed as an alternative to other, more invasive weight loss interventions and, if approved by the FDA, would give people a new option if they could not or would not undergo surgeries required for other procedures.
There are currently few options available for treating obesity, which the American Medical Association has recommended be treated as a chronic disease. Clinical trials indicate that this implant could help people lose more weight, as well as maintain their weight loss more successfully.
When compared with people who were given non-operating implants, participants in trials were shown to lose 8.5 percent more weight. This equaled an average of 24 percent loss of excess weight achieved by the experimental group compared to an average of 16 percent loss of weight by the control.
In the six months following the trial, the group that had not received real implants was shown to have gained back an average of 40 percent of the weight they had lost. Those who had the working implants seemed to maintain their weight with greater success.
Drawbacks to the implant appear not to outweigh the benefits. So far clinical trials have revealed a four percent occurrence of health complications related to the implant. It is also not safe to use while receiving an MRI and must be removed from the patient in order for them to safely undergo this scanning procedure. The FDA is considering these issues as a committee determines if the device will be granted endorsement or not.
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