Probable Benefit and Risks – Gastric Electrical Stimulation

Probable Benefits

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

A clinical study (WAVESS – Worldwide Anti-Vomiting Electrical Stimulation Study) 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, 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.

Safety Information

Safety information concerning EnterraTM therapy
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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: 22 Sep 2010

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