Approved Use
Vibrant is approved for the treatment of chronic idiopathic constipation in adults who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least 1 month.
Safety
You should not use the Vibrant System if you
- have a history of complicated/obstructive diverticular disease (small sacs in the colon).
- have a history of, or have suspected, obstruction in your small intestine or colon.
- currently have significant gastroparesis (stomach is unable to empty itself).
- have a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is okay if you have been treated and no longer experience signs or symptoms), and/or anal fissures and fistulas.
- have a history of Zenker’s diverticulum (pouches in the lower part of the throat), dysphagia (trouble swallowing), esophageal stricture (abnormal tightening or narrowing in the throat), eosinophilic esophagitis (allergic condition in the throat), or achalasia (nerve damage in the throat that prevents swallowing).
- are pregnant or lactating (breastfeeding).
Side effects
Based on clinical testing, potential side effects associated with the use of this device may include abdominal pain, abdominal distension (swollen abdomen), abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence (passing gas), and proctalgia (pain due to a spasm of the pelvic floor muscles). In rare cases, obstruction may occur.
Warnings
- The Vibrant Capsule is magnetic resonance (MR) unsafe. If an MRI is required, verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.
- The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
For the full list of warnings, contraindications, and potential side effects, please click here to read the full Instructions for Use.
