The individual physician experiences presented should not be considered medical advice. Healthcare professionals should be consulted for all risks and benefits of all treatment options. Trained physicians are familiar with patient selection criteria most associated with positive clinical outcomes and can determine whether the TIF procedure is appropriate on a case-by-case basis.
While clinical studies support the effectiveness of TIF (Transoral Incisionless Fundoplication) in treating chronic GERD (gastroesophageal reflux disease), individual results may vary. There are no guarantees of successful outcome. The TIF procedure may not be appropriate for every individual, and it may not be applicable in every clinical situation.
- United States: EsophyX® Fastener Delivery Devices with SerosaFuse® Fasteners are Class II and 510(k) cleared by the US Food and Drug Administration. Type “EsophyX” into the [Device Name] search box here to get copies of the letters.
- On June 22, 2017, a sentence was added to the EsophyX device indication statement: Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.*
- European Union: The EU granted CE mark to the EsophyX device in 2006.
- adult over 18 years old.
- experiences chronic symptomatic gastroesophageal reflux disease (GERD).
- requires and responds to pharmaceutical therapy.
- has a hiatal hernia less than or equal to 2cm in size. (*see above)
- has a Body Mass Index (BMI) less than 35.
TIF-trained physicians may use additional criteria to determine which patients are appropriate candidates.
- has a bleeding disorder, chronic uncontrollable cough, stricture, severe esophagitis, esophageal diverticulae, an obstruction, a paraesophageal hernia, limited neck mobility, osteophytes of the spine, esophageal varices, esophageal infections or fungal disease, or esophageal stenosis.
- has any kind of normal or abnormal esophageal anatomy which would prohibit insertion of the EsophyX device.
- is unable adhere to the post-operative diet recommended for appropriate healing.
- is under 18 years old.
- has a hiatal hernia greater than 2cm in size.
- has a BMI greater than 35.
Risks of the TIF Procedure
Expected risks or discomforts anticipated as a result of an endoscopic procedure include:
• Sore throat, hoarseness, lump in throat feeling (globus pharyngis)
• Temporary difficulty (dysphagia) or painful swallowing (odynophagia) due to swelling or tissue manipulation
• Nausea, gagging, or vomiting
• Left shoulder pain from C02 insufflation
• Temporary abdominal or other pain which can be treated with standard pain medication
These expected events occur in greater than 25% or more than 25 out of 100 people who have the TIF procedure. They are usually mild in severity and resolve themselves shortly after surgery. Serious adverse events have been reported in less than 0.5% of all commercial procedures.
Potential Adverse Events
Details of foreseeable adverse events (AE) and adverse device effects (e.g., serious / non-serious device related / non-related) are as follows:
- Typical known risks or discomforts anticipated as a result of an endoscopic procedure:
Temporary dysphagia (difficulty swallowing) or odynophagia (painful swallowing), due to swelling or tissue manipulation, hoarseness, gagging, globus pharyngis, or other temporary pain which responds to standard pain medication.
- Unusual risks or discomforts as a result of an endoscopic procedure:
Injury of mouth and/or teeth, bite block related injury, persistent odynophagia or dysphagia requiring intervention, bleeding, perforation, abrasion, hematoma/edema, laceration, esophageal tear, gas bloat, dyspepsia, diarrhea, infection, fistulae between inner organs, vomiting, nose bleeding from nasal intubation, vocal cord nodules due to intubation, hiccups, and limited neck mobility.
- Rare risks as a result of an endoscopic procedure and of this particular procedure: Lockjaw, aspiration, hypoxia, achalasia, nerve damage, focal necrosis, tissue damage, ulceration/abscess, gastrointestinal and pancreatic leaks, pancreatitis, acute abdomen, peritonitis, bowel obstruction, pericardial effusion, capture of other inner organs which may neighbor the suturing site or resulting from adhesions from previous abdominal infections or surgical procedures, potentially resulting in fistulae between inner organs or the inner organs and the abdominal or thoracic cavity, pneumothorax, thoracic, mediastinal, or abdominal abscess, mediastinitis, pneumoabdomen, bleeding requiring blood transfusion, surgery for uncontrolled bleeding and/or perforation, chest pain, cardiac event, ulcer, medical or surgical treatment as a result of the occurrence of complication, procedure related failure requiring medical intervention or surgical conversion, embolism, death.
TIF Procedure is Revisable
It is important to remember that GERD is a chronic disease that requires a lifetime of management to control symptoms. As with laparoscopic procedures, in a minority of patients, additional surgery is sometimes desired for more adequate symptom relief. In a study published in 2014, 28 patients who were previously treated transorally underwent a subsequent laparoscopic Nissen fundoplication safely and effectively.