In 2000, the FDA approved Gastric Electrical Stimulation, Enterra, as a way to treat those who suffered from intractable chronic nausea and vomiting. The Humanitarian Device Exemption came into place to treat this condition that is secondary to a condition that is the result of diabetes called gastroparesis. Enterra utilizes a low energy but high frequency stimulation of the pacemaker that is naturally in the curve of the stomach. This procedure is achieved with two electrodes that are positioned using an open technique or laparoscopic technique.
What Is a Gastric Pacemaker?
A gastric pacemaker is the device used to stimulate the nerves in the lower portion of the stomach. The device is called Enterra and is an FDA approved Gastric Electrical Stimulation technique that is used to relieve chronic vomiting and nausea. The electrical stimulation pulsates to get the stomach to contract which in turn helps to alleviate the vomiting and nausea. The procedure to implant the stomach pacemaker is almost non-invasive as it is placed just under the skin in the abdomen right below the rib cage. Implanted into the stomach are two lead intramuscular wires that have electrodes on it to send out regular pulsations to help ease the stomach problems. You can turn this therapy on and off when you want to and you can even reverse it and have it removed when you feel you no longer need it.
What Can a Stomach Pacemaker Do?
The purpose of the stomach or gastric pacemaker is to use electrical stimulation through a device that is placed in the lower portion of the abdomen in order to relax the muscles in the stomach and help eliminate vomiting and nausea.
Some people who have these symptoms have what is called gastroparesis. This condition centers on the muscles and nerves in the stomach and causes the stomach to delay the release of food into the small intestine. The cause of gastroparesis is usually diabetes but there are some disorders that stem from the nervous system that could also be the culprit. The gastric electrical stimulation is used primarily for diabetic patients or those who cannot find any relief through prescription medication.
How Is a Gastroparesis Pacemaker Implanted?
If you are in need of a gastroparesis pacemaker, what is involved in putting one in? If nothing else has worked for you so far to eliminate your nausea and vomiting, consult a gastroenterologist to see if he can recommend Enterra Therapy. The physician will perform the procedure using general anesthesia in two parts – implanting the device and post-implant.
The gastroparesis pacemaker is very much like a heart pacemaker in size. The operation can take from one to three hours to complete and the electrodes are attached to the stomach wall using laparotomy or laparoscopy. Once the electric stimulator is in place under the skin in the abdominal wall, the lead wires are attached to the neurostimulator. The patient will usually remain in the hospital anywhere from one to five days depending on how well they are responding to the procedure and any of their pre-existing health conditions.
The post-implant procedures involve ongoing adjustments to the electrical device to keep it working at an optimal level. These adjustments can be performed in a non-invasive manner in an outpatient facility. The follow up for this procedure is from 6 to 12 months.
What Are the Possible Risks and Complications?
Before signing on for a gastric pacemaker, you should be fully aware of all of the possible side effects and complications.
Risks of Surgery
As with any surgical procedure there are always going to be risks. With this procedure, you are looking at the following risks, side effects, and complications:
- Pain where the surgery was performed
- An allergic reaction to the materials that were implanted
- Neurologic complications that could be temporary or permanent
- Bruising where the device has been implanted
Possible Side Effects
- Pain in the abdomen
- Problems swallowing
- Gastrointestinal reactions
- Complications from the feeding tube
- Complications from the diabetes
- The device may stop working on your symptoms
Possible Device Complications
- You could suffer from an infection, pain or healing may be delayed in the area where the gastric electrical stimulation device has been implanted.
- The parts from the device could come through the skin in your abdomen resulting in an infection and/or a scar.
- If the neurostimulator is or becomes defective, a second operation would be required to remove it and replace it with another device.
- Your body could reject the device as being a foreign object or you may suffer from an allergic reaction.
- Some of your tissues could become damaged from the settings of the stimulation or if any of the parts of the device do not operate properly.
- You could suffer from a perforation to your stomach from the lead; this would require additional surgery.