Following is a summary of safety information related to the TIF procedure.
Risks of the TIF Procedure
While the TIF procedure with the EsophyX device is less invasive than conventional laparoscopic antireflux surgery and has an excellent safety profile, it is important to note that it is still a surgical procedure.
All surgeries have risks, and it is important to understand the risks associated with any procedure before deciding to undergo surgery. Speak to your surgeon in detail about the risks and complications that may arise before committing to the TIF procedure or any surgical solution.
Anticipated risks or discomforts from endoscopic procedure may 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 events are relatively common for any endoscopic procedure and occur in slightly more than 25% of patients who undergo the TIF procedure. They are usually mild in severity and resolve themselves shortly after surgery.
Infrequent risks or discomforts may include…
- Oral or dental injury
- Bloating sensation
These infrequent events, which are associated with any endoscopic procedure, occur in 1-10% of patients who have the TIF procedure. They are usually mild in severity.
Rare risks may include…
- Perforation, laceration, or tear of the esophagus
- Aspiration, hypoxia, or achalasia
- Nerve damage
- Abnormal heartbeat
- Collapsed lung or chest pain
- Abdominal gas
- Infection of the space around the esophagus
These events can be associated with any endoscopic procedure and occur in less than 0.5% of those who have the TIF procedure. Rarely, additional surgery may be needed to repair an adverse event from the first procedure.
Additional risks may include…
- Additional surgery after a failed procedure (e.g., if there is insufficient symptom relief)
- Moving and fastening of tissue other than gastric tissue
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. 
Indications for TIF Surgery
The TIF procedure, using the EsophyX device, may be right for you if…
- You are at least 18 years old.
- You regularly experience troublesome symptoms of symptomatic chronic GERD.
- You no longer respond adequately to, or are dissatisfied with, antireflux medicines.
- You are concerned about the adverse long-term effects of taking proton pump inhibitors and other medicines.
- You have a hiatal hernia but it is no larger than 2 cm in size.
- You have a Body Mass Index (BMI) less than 35.
Your physician may have other criteria he or she uses to determine whether you are an appropriate candidate. Ask your physician to discuss those criteria with you.
Contraindications for TIF procedure
The TIF procedure may not be right for you if…
- You are under 18 years old.
- You have a BMI greater than 35.
- You are pregnant.
- You have a hiatal hernia greater than 2 cm in size.
- You cannot adhere to the post-operative diet recommended for appropriate healing.
- The anatomy of your esophagus would prohibit insertion of the EsophyX device.
- You have suffered from any of the following esophageal-related concerns:
- abnormal, enlarged veins in the lower part of the esophagus
- infections or fungal disease in the esophagus
- unusually narrow diameter of the inside of the esophagus
- severe inflammation of the esophagus
- sacs or pouches (diverticula) in the wall of the esophagus
- narrowing of the esophagus
- an obstruction or hernia next to the esophagus
- You have suffered from any of the following health concerns:
- bleeding disorder
- chronic uncontrolled cough
- limited neck mobility
- bone spurs in the spine
Your physician may have other criteria he or she uses to determine whether you are an appropriate candidate for the TIF procedure. Ask your physician to discuss the criteria, as well as any other safety concerns, with you.
Regulatory and labeling information can be found here.
 Bell RC, Kurian AA, Freeman KD. Laparoscopic anti-reflux revision surgery after transoral incisionless fundoplication is safe and effective. Surg Endosc. 2014 Nov 8. [Epub ahead of print].