Probable Benefits and Risks – Gastric Electrical Stimulation

Probable Benefits

Gastric electrical stimulation uses mild electrical pulses to stimulate the smooth muscles of the lower stomach. This may help to control the chronic nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin when drugs haven't worked.

A clinical study (WAVESS – Worldwide Anti-Vomiting Electrical Stimulation Study¹) using the Enterra^® neurostimulator for treating nausea and vomiting has shown that most, but not all, patients have some relief of their vomiting symptoms.

Risks of Surgery

Implanting the gastric electrical stimulation system carries the same risks associated with any other gastric surgery. Risks may include:

Infection
Allergic response to implanted materials
Temporary or permanent neurologic complications
Pain at the surgery site
Bruising at the neurostimulator site
Bleeding

Possible Side Effects

Side effects of gastric electrical stimulation of the stomach may include the following:

Gastrointestinal (GI) symptoms
Abdominal pain
Feeding tube complications
Difficulty swallowing
Dehydration
Acute diabetic complications
Loss of therapeutic effect

Possible Device Complications

There may be pain, lack of healing, or infection where the gastric electrical stimulation system parts are implanted.
The gastric electrical stimulation system parts may wear through your skin, which can cause an infection or scarring.
The Enterra neurostimulator could stop because of mechanical or electrical problems. Either of these would require surgery.
Your body may have an allergic reaction to the gastric electrical stimulation system. Your body could also reject the system (as a foreign body).
The lead may perforate your stomach, or device components may become entangled with or obstruct other internal organs, requiring surgery.
There is the possibility of tissue damage resulting from the stimulation settings or a malfunction of one of the parts of the gastric electrical stimulation system.

Please discuss any concerns you have about potential risks, side effects, and complications of neurostimulation with your doctor.

Reference

Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. August 2003;125(2):421-428.

Next: Questions and Answers

Humanitarian Device: The Enterra^® Therapy system for gastric electrical stimulation is authorized by Federal law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 4 Jan 2012