Safety Information

Risks of the TIF Procedure

While the TIF procedure is less invasive than conventional laparoscopic fundoplication and has an excellent safety profile, it is important to note that TIF is still a surgical procedure. All surgical procedures have risks. Therefore, it is important to understand the associated risks. Before you decide on a procedure, speak to your surgeon in detail about the risks and complications that may arise.

Expected risks or discomforts anticipated as a result of an endoscopic procedure include:

• Pharyngolaryngeal pain (sore throat)
• Musculoskeletal pain (left shoulder pain)
• Temporary epigastric or abdominal pain which can be treated with standard pain medication
• Temporary dysphagia (difficulty swallowing) due to swelling
• Nausea or vomiting

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.

Infrequent risks or discomforts as a result of an endoscopic procedure include:

• Oral or dental injury
• Bleeding
• Bloating sensation
• Bruising

These infrequent events occur in greater than 1-10%, or more than 1-10 out of 100 people who have the TIF procedure. They are usually mild in severity.

Rare risks as a result of an endoscopic procedure and of this particular procedure include:

• Esophageal perforation, laceration or tear
• Aspiration, hypoxia or achalasia
• Nerve damage
• Arrythmia (abnormal heartbeat)
• Pneumothorax, chest pain
• Pneumoabdomen
• Fistula
• Infection of the mediastinal space

These events occur in less than 1%, or less than 1 out of 100 people who have the TIF procedure. Rarely, additional surgeries may be needed to repair an adverse event from the first procedure including: operation to repair an above-mentioned adverse event. These adverse events can be moderate to severe.

Additional risks include:

• Reoperation after a failed procedure (insufficient symptom relief)
• Retraction and fastening of tissue other than gastric tissue

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 2011, 9 patients who were previously treated transorally underwent a subsequent laparoscopic Nissen fundoplication safely and effectively.^[1]

Indications

The TIF procedure, using the EsophyX device, may be right for you if:

• You are an adult (at least 18 years old).
• You have symptomatic chronic gastroesophageal reflux disease (GERD).
• You require and respond to pharmacological therapy.
• You have a hiatal hernia less than or equal to 2cm in size.
• You have a Body Mass Index (BMI) less than 35.

Your surgeon may have other criteria he or she uses to determine whether you are an appropriate candidate. Ask your surgeon to discuss those criteria with you.

Contraindications

The TIF procedure may not be right for you if:

• You have a bleeding disorder, chronic 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.
• You have any kind of normal or abnormal esophageal anatomy which would prohibit insertion of the EsophyX device.
• You cannot adhere to the post-operative diet recommended for appropriate healing.
• You are under 18 years old.
• You have a hiatal hernia greater than 2cm in size.
• You have a BMI greater than 35.
• You are pregnant.

Your surgeon may have other criteria he or she uses to determine whether you are an appropriate candidate. Ask your surgeon to discuss those criteria with you.