If the risk is higher, the reward should be, too. That's an FDA panel's opinion on anti-obesity devices seeking regulatory approval, MassDevice reports.
The gastro-focused panel of the FDA's Medical Devices Advisory Committee met last week to discuss obesity-treating devices. Implantable obesity fighters, like Allergan's ($AGN) Lap-Band, pose a higher health risk to patients than most weight-loss drugs, the panel pointed out, so, if they're to be approved, they also need to outstrip the effectiveness of those drugs. By that same token, less risky devices should be held to a lesser standard of effectiveness, according to the panel.
The questionable benefits of obesity-treating devices has been a hot topic of late, with Allergan getting a subpoena from the Department of Health and Human Services over Lap-Band. While the company didn't disclose the nature of the probe, nearly half of the patients who received the device experienced no weight loss or had the implant removed, while 40% endured complications, Bloomberg has reported.
This could also affect EndoSphere's planned Lap-Band competitor, Satisphere. The company received a CE mark in Europe for the implantable last month, but it has yet to file for FDA approval and could face stiffer criticism if the agency adopts the opinion of the panel.
- read the MassDevice story