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Upper G.I. Surgery

Gastroesophageal Reflux Disease (GERD)

Risks and Benefits

A clinical study of 100 patients showed that difficulty swallowing, pain, and stomach bloating were the most common risks associated with the LINX System (summarized below). If you are planning to have the LINX System, your doctor will review these risks with you.

Difficulty swallowing: 68% of patients
Treatment included dilation (stretching lower esophagus with a balloon) or removal of device in 3% of patients. Difficulty swallowing resolved when the device was removed. After dilation, the difficulty swallowing improved but sometimes returned and required having the dilation repeated. See below for more information about difficulty swallowing.

Pain: 24% of patients
Most cases were mild and resolved by 3 months after the procedure. Treatment included pain medications.

Stomach Bloating: 14%
Stomach bloating was mild to moderate and resolved in nearly all patients.

More information about difficulty swallowing
Before and after treatment, patients completed a questionnaire that included a question about difficulty swallowing. Before treatment, 69% of patients reported no symptoms related to difficulty swallowing compared to 55% at 6 months, 64% at 1 year and 59% at 2 years. Before treatment, difficulty swallowing that bothered patients every day or worse was 5% compared to 7% at 6 months, 5% at 1 year and 4% at 2 years. The average number of times per week that a patient had difficulty swallowing was 1 to 2 times per week after treatment.

Other risks of the LINX System reported less frequently included:

  • Painful swallowing – 8%
  • Hiccups – 8%
  • Nausea – 7%
  • Inability to belch or vomit – 6%
  • Decreased Appetite – 4%
  • Increased belching – 2%
  • Flatulence – 2%
  • Weight loss – 2%
  • Vomiting – 1%
  • Food impaction – 1%
  • Lump in throat – 1%
  • Upset stomach or indigestion – 1%
  • Regurgitation of sticky mucus – 1%
  • Uncomfortable feeling in chest – 1%
  • Vomiting – 1%

Other possible risks related to the LINX System may include, but are not limited to:

  • Achalasia (muscles of the esophagus fail to relax during swallowing)
  • Bleeding
  • Death
  • Device erosion (device passes through esophagus wall)
  • Device failure
  • Device migration (device does not appear to be at implant site)
  • Device removal or re-operation
  • Esophageal spasm
  • Diarrhea
  • Infection
  • Impaired gastric motility (ability to move food/liquid through your system)
  • Injury to the esophagus, spleen, or stomach
  • Organ damage caused by device migration
  • Peritonitis (inflammation of the thin tissue that lines the inner wall of the abdomen)
  • Pneumothorax (collapsed lung)
  • Perforation
  • Regurgitation
  • Retching
  • Worsening of pre-operative symptoms (including but limited to difficulty swallowing or heartburn)

Risks of general surgery and anesthesia

Additionally, general surgery and anesthesia carries risk. These risks may include, but are not limited to the following:

  • Adverse reaction to anaesthesia (headache, muscle pain, nausea)
  • Anaphylaxis (Life threatening allergic reaction)
  • Cardiac arrest (Blood circulation stops)
  • Death
  • Diarrhea
  • Fever
  • Hypotension (Low blood pressure)
  • Hypoxemia (Inadequate oxygen in blood)
  • Infection
  • Myocardial infarction (heart attack)
  • Nausea
  • Odynophagia (pain or discomfort with swallowing)
  • Pneumonia (Lung infection)
  • Pulmonary embolism (Blocked artery in lungs)
  • Respiratory distress (breathing trouble)
  • Thrombophlebitis (Blood clot causing inflammation)
  • Vomiting

Benefits of having the procedure done

Benefits of treatment with the LINX System may include:

  • Reduction in acid exposure to your esophagus
  • Improvement in heartburn and regurgitation symptoms
  • Reduction or elimination of GERD medications
  • Less invasive surgery compared to the standard surgical treatment for GERD
  • Ability to resume a normal diet following surgery
  • Discharge the same day or the next day after surgery
  • Minimal side effects, such as being unable to belch or vomit

How to decide about this treatment

When considering the LINX System, it is important to understand the following:

  • The device is a permanent implant, and limited long-term experience is available. Sustainability of effect, as assessed by quality of life scores, has not been studied past 2 years. It is possible that the device may need to be removed or replaced at a later time (for example, in 10 years). If the device fails or breaks, your GERD symptoms may return or you may experience unusual pain.
  • 90% of patients reported improvement in GERD symptoms or elimination of GERD medications in a clinical study at 1 and 2 years after treatment. Every patient is different. There are no guarantees you will have the same results. It is possible you may need to continue GERD medications after treatment.
  • MRI is not allowed while the device is implanted as it may cause serious injury to you and/or the device. This may be an issue if you currently have or may develop a disease or condition where MRI is the appropriate diagnostic test. You should discuss the MRI restriction with your doctor prior to deciding on treatment with the LINX System.
  • The LINX System has not been studied in patients with hiatal hernias greater than 3 cm in size, Barrett's esophagus, advanced esophagitis (inflammation of the esophagus), swallowing difficulties, or motility disorders. Please discuss your medical history with your doctor to determine if you have any conditions for which the LINX System is not recommended.
  • The LINX System is not the only option available. The standard surgical treatment for GERD is the Nissen fundoplication. Your doctor will discuss this option and other options available to you, which may include treatments performed by endoscopy such as radiofrequency applications to the sphincter area and endoscopic sewing devices that sew part of the stomach to the esophagus.
  • Other treatments performed in the area of lower esophagus may not be possible or will need careful consideration if the LINX System is present. These treatments may include surgical or endoscopic interventions for weight loss, Barrett’s esophagus or GERD.

 

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University of Southern California
Upper G.I. and General Surgery

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