This story recounts the experience of one person who is receiving Enterra™ Therapy (gastric electrical stimulation). Medtronic invited her to share her story candidly. Please bear in mind that the experiences are specific to this particular person. Not everyone who receives Enterra Therapy will receive the same results as the person in this story.
Karen, a 47-year-old mother of three, loves to participate in activities with her large extended family – from school events to church functions to birthday celebrations. In fact, her family often depends on her to plan and organize multi-generational gatherings.
In late 2001, however, complications from Karen's diabetes led to gastroparesis*, a condition characterized by chronic nausea and vomiting. The condition left Karen bedridden.
"The nausea was so bad, day and night, that I had to stop all activities," Karen recalls. "I could not sit up or converse with people. I couldn’t even cry about it, because crying made me feel sicker. A simple activity like watching television became impossible."
Karen tried prescription and over-the-counter drugs in search of relief, but nothing helped. Behavioral therapy and breathing techniques failed too.
"I could never be far from a bathroom," explains Karen. "My diet consisted of a little yogurt, crackers, and a food supplement. Occasionally, I sucked on a lemon to relieve the nausea."
After a year of symptoms, Karen met with a team of physicians whose testing indicated that gastric electrical stimulation might relieve her chronic nausea and vomiting symptoms.
"I was thrilled to have an option that might give me my life back," Karen says. "The gastric emptying test and endoscopy before the implant were tolerable compared to other procedures I’ve had. In fact, the only discomfort I felt was my chronic nausea."
Unfortunately, Karen’s excitement met with a major obstacle. Her healthcare insurance company considered neurostimulators to be experimental devices, and wouldn’t cover it under her plan. With support from her physicians and family, Karen won her fight to gain reimbursement for the implant after an 18-month delay.
Karen underwent a procedure for a neurostimulator in 2004. While the effectiveness of gastric electrical stimulation hasn’t been shown, and results differ for each patient, it has helped Karen. "Since receiving Enterra Therapy, I’ve gone from focusing on coping with my gastroparesis to living a regular life," she says.
"I was able to eat a normal diet again and participate in family activities, including our regular cook-outs," Karen says. "One of my greatest thrills was being able to eat a hamburger again."
Karen credits her family for bolstering her courage, and her physicians for teaching her how to care for herself properly. "If I still run into problems, it’s because I’ve made poor dietary decisions," she explains.
"Ultimately, the responsibility of what goes into your stomach lies with you."
Surgical complications are possible and may include infection, bleeding, bruising, and pain at the implant site. Once implanted, the system may become infected, devices may move or wear through the skin, the lead may perforate the stomach, the lead may entangle with or obstruct the bowel, irritation/inflammation over implant site may occur. The therapy system could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return and some can be life-threatening.
For a list of adverse events that have been associated with the therapy, please refer to Important Safety Information.
*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?
This story reflects one person's experience. Not every person will receive the same results. Talk to your doctor about your treatment options.