LINX Acid Reflux Device Recalled From Foreign Markets

J&J denies that the recall is linked to increasing reports of device failures, which can lead to device migration and punctured organs.

Johnson & Johnson has decided to withdraw its LINX Reflux Management System from international markets, while continuing to offer the implant in the United States despite growing reports of failures and complications.

Approved in the U.S. in March 2012, the LINX implant consists of a small ring of magnetic beads connected by titanium wires that is surgically placed around the lower esophageal sphincter (LES). The device is marketed as a treatment to reinforce the LES, preventing the backward flow of stomach acid that causes acid reflux and gastroesophageal reflux disease (GERD).

Although the LINX Reflux Management System has been advertised as a safe treatment for those with chronic GERD symptoms, which cannot be effectively managed with daily proton pump inhibitors (PPIs), the device has been linked to a growing number of incidents of the bead components detaching from the connecting wire.

These problems led to a LINX recall in the U.S. in April 2018, after it was determined that some of the devices were failing due to manufacturing problems, leading to reports of device migration, punctured organs and other injuries.

As a result of the complications, a number of LINX lawsuits have been filed in recent years, often involving failures that occurred years after the acid reflux implant was placed in the body. Those lawsuits have been filed in the U.S. District Court of Minnesota, where the manufacturer, Torax Medical is located.

According to a September 23 report by Bloomberg News (subscription required), Johnson & Johnson announced the latest LINX recall on September 17 in a letter to doctors, indicating it will withdraw the device from certain markets, but not the U.S. The company claims it is still confident in the device’s safety and efficacy.

While the letter did not list which countries would be impacted by the market withdrawal, various news sources indicate the recall ends sales in all global markets except the U.S. The recall comes about a year after the FDA expanded the label for the LINX implant, allowing it to be used on patients with Barrett’s esophagus who are also experiencing GERD symptoms.

Some surgeons warn that if the implant is removed from the market, there is no device to replace it. However, the device is widely considered an alternative treatment to addressing GERD through medications and other means.

LINX Reflux Implant Lawsuits

As Torax LINX implants continue to age and fail, there are growing concerns that more individuals may encounter issues where the implants break, potentially leading to permanent injuries in the future.

As a result, LINX injury lawyers are actively investigating these additional cases as they arise, seeking compensation for individuals who have suffered any of the following injuries caused by a defective LINX device:

• LINX device failures (breaks)
• LINX device migration
• Organ punctures or scratches
• Surgical removal of LINX device
• Other injuries caused by LINX failures

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