The Food and Drug Administration (FDA) has approved an unusual device that is designed to remove food directly from the stomach and deposit it into the toilet. While the device aims to fight obesity, many critics are calling it “assisted bulimia.”

The device is called the AspireAssist and is manufactured by Aspire Bariatrics. The minimally invasive device has a tube that connects to a port on the outside of the abdomen, which can then be attached to a pump. The pump can remove nearly one-third of the stomach’s contents at a time.

In the FDA’s statement regarding use of the device, the FDA said the device “is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.”

While the news of this device might have many people running to their doctor’s office, it’s important to understand that medical devices are sometimes approved by the FDA before all of the side effects and risks are known.

Devices like IVC filters, power morcellators, and Essure contraceptives were all discovered to have serious and life threatening complications years after their approval by the FDA.

IVC filter manufacturers are now facing hundreds of lawsuits from patients who had the device fracture, migrate, perforate, or embolize inside their bodies. These patients suffered chronic chest pain, internal bleeding, hemorrhaging, and other serious complications. For some patients, the device has been impossible to remove.

If defective medical devices have taught consumers anything, it’s that choosing a medical device or medication is serious decision, and patients need to know all risks and side effects to make an informed decision about use. The AspireAssist is currently on sale in Europe and is expected to arrive in the United States soon.