Indications, Safety and Warnings
The LINX Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
Warnings: The LINX® device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or1.5 Tesla (1.5T), depending on the LINX® model implanted. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX® device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures. It is recommended that patients receiving the LINX® device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.
Failure to secure the LINX® device properly may result in its subsequent displacement and necessitate a second operation.
Laparoscopic placement of the LINX® device is major surgery and death can occur.
General Precautions: The LINX® device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include explantation and/or replacement.
The LINX® device has not been evaluated in patients with a hiatal hernia larger than 3 cm. Use of LINX® device in patients with a hiatal hernia larger than 3cm should be considered on the basis of each patient’s medical history and severity of symptoms.
The safety and effectiveness of the LINX® device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification) esophagitis.
The safety and effectiveness of the LINX® device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
- Suspected or confirmed esophageal or gastric cancer
- Prior esophageal or gastric surgery or endoscopic intervention
- Distal esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES
- Symptoms of dysphagia more than once per week within the last 3 months
- Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
- Esophageal or gastric varices
- Lactating, pregnant or plan to become pregnant
- Morbid obesity (BMI >35)
- Age < 21
Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebitis (blood clot). Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting.
Potential risks associated specifically with the LINX Reflux Management System include achalasia (lower part of esophagus does not relax), bleeding, cough, death, decreased appetite, device erosion, device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhea, dyspepsia (indigestion), dysphagia (difficulty swallowing), early satiety (feeling full after eating a small amount of food), esophageal spasms, esophageal stricture, flatulence, food impaction, globus sensation (sensation of a lump in the throat), hiccups, inability to belch or vomit, increased belching, infection, impaired gastric motility, injury to the esophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, ulcer, vomiting, weight loss, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).