Frequently Asked Questions: LINX® system

Massachusetts General

Q: What is the LINX® Reflux Management System?
A: The LINX® Reflux Management System is an FDA-approved device implanted laparoscopically. The system relies upon a flexible bracelet of magnetic titanium beads that, when placed around the esophagus, supports a weak lower esophageal sphincter (LES), the muscle that opens and closes to allow food to enter and stay in the stomach by restoring the body’s natural barrier to reflux.

Q: What are the risks associated with the LINX® procedure?  
A: All surgical procedures have risks, such as the risks associated with anesthesia, risk of bleeding and risk of infection. These risks are small. The most common side effects of the LINX® system are difficulty swallowing, post-operative pain and temporary bloating of the stomach. In the long run, many surgeons have concern that the device might erode into the esophagus and need to be removed. This has not been observed in the clinical trials to date.

Q: How long does the procedure take?
A: Generally the procedure can be completed in approximately an hour. Every case is different, so there is some variability in the time it takes to perform the procedure.
 
Q: Will I be in the hospital after the procedure? If so, for how long?
A: After the procedure, you will be kept in the hospital overnight to be sure there are no complications from the surgery or anesthesia.

Q: How soon after the procedure can I eat?
A: You should be able to eat soft foods with 48 hours of surgery.

Q: How soon after the procedure can I resume normal physical activities?
A: Routine daily activities can begin within a few days of surgery when pain medicine is no longer required. Activities such as sit-ups or weight lifting, which require use of the abdominal muscles, should be deferred for three to six weeks.

Q: Will I have to take acid suppression medication after the procedure?  
A: Based on the clinical trials performed prior to FDA approval of the device, only 10% of LINX® patients required daily medication at one- and two-year follow-up.

Q: Is there any risk the device will be too tight and cause food to get stuck?
A: Yes; about 3% of patients that have had the device implanted had this problem and required removal of the device.

Q: After the device is placed, is there any risk of infection?
 
A: There is always a small risk of infection whenever a foreign object is placed in the body, whether it is LINX®, a pacemaker or an artificial joint. There is not enough data at this time to calculate the percent risk of infection, but the early data suggests it is quite small.

Q: Will the device ever have to be removed?   
A: The intent is for this device to be permanent. But, since there is no 10-year follow-up data available yet, we cannot be sure.  

Q: Why can't I have an MRI with the procedure?    
A: An MRI uses very strong magnets to create images and the LINX® system is susceptible to magnetic force. You could suffer significant injury if the LINX® device were in place while you underwent an MRI.
 
Q: Can I go through airport security with the device?
A: All patients are given a card stating they have an implanted medical device, much like people with a pacemaker or artificial hip.

Q: Is there any chance the LINX® system won’t work as well if I gain a lot of weight after the procedure?
A: The LINX® system works by creating a pressure of approximately 25 mm at the gastroesophageal junction (the place where the esophagus and stomach meet). Weight gain increases the pressure inside the abdomen, so it is possible that significant weight gain can create more pressure than the LINX® valve can counteract, leading to the return of reflux symptoms.

Q: Will my insurance company pay for LINX®?

A: Nearly all insurance companies pay for antireflux surgery. Since the LINX® procedure is a new form of antireflux surgery, insurers are learning about the procedure. We are working closely with them to obtain pre-authorization for these procedures on a case-by-case basis.

Q: If my insurance won't pay for it, how much would the procedure cost?

A: Please contact the Mass General Billing Office at 617-726-4098 or at cs.mgh@partners.org for more information.
 
Q: I have heard that because I had bariatric surgery, I am not a candidate for LINX®. Is it possible this will change and I could be eligible for the system in the future?
A: The LINX® system is not approved for use in patients who have had prior bariatric or esophageal surgery.

Q: If the LINX® device needs to be removed or isn't effective, can I have a standard Nissen fundoplication (NF)?
A: Patients often mention that an NF was suggested to them in the past, or they were considering it when they found out about LINX®. As the screening tests are the same for both procedures, NF may still be considered, providing testing doesn't exclude you. If you cannot or choose not to have LINX®, NF may still be an option.  
 
Q: I know I have GERD and feel better on medications. Why do I need additional testing before the procedure?
A: In order to be sure you will benefit from strengthening the lower esophageal sphincter, it is essential to know and document that the muscles in the esophagus that create peristalsis generate enough pressure to open the LINX® magnetic ring. This is the purpose of Esophageal Motility Testing. Twenty-four hour pH testing is not necessary in all patients, but is frequently needed to prove that your symptoms correlate with actual reflux events.

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