LINX Implant Lawsuit Claims Recalled GERD Device Failed Due to Manufacturing Defects, Requiring Surgical Removal

More than 9,000 individuals who received a recalled LINX reflux device could be at risk of injuries and the need for removal surgery, lawsuit alleges.

A Pennsylvania woman has filed a product liability lawsuit indicating she received a beaded LINX implant to treat her gastroesophageal reflux disease (GERD), which failed and had to be surgically removed several years later, due to a manufacturing defect that may also impact thousands of other individuals who still have the recalled device in their body.

The LINX implant lawsuit (PDF) was filed by Denise Tamborski in the U.S. District Court for the District of Minnesota on August 30, seeking damages from the manufacturers of the acid reflux device, Torax Medical, Inc. and Ethicon, Inc., who were named as the defendants.

The device consists of a small ring of magnetic beads, which are linked by titanium wires. The LINX is surgically implanted around the lower esophageal sphincter (LES) to prevent the backward flow of stomach acid, which is the primary cause of acid reflux symptoms and GERD.

LINX Device Recall Over Bead Separation

While the LINX Reflux Management System has been advertised as a safe treatment for those with chronic GERD symptoms, who 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.

It was not until April 2018 when Torax issued a LINX implant recall, impacting approximately 9,131 devices. At that time, the manufacturer acknowledged that an out of specification condition may allow the titanium bead components to separate.

As a result of the complications, multiple LINX recall lawsuits have been filed in recent years by individuals who have suffered injuries from the device migrating into the esophagus or requiring additional surgeries to remove the broken LINX implant devices.

In this recent complaint, Tamborski indicates she had a 14-bead LINX implanted on January 6, 2020, and the device failed only a few years later, resulting in the need for the device to be surgically removed in May 2024.

In addition to the return of her GERD symptoms after the LINX esophageal implant failed, Tamborski claims she has, and continues to live with disfigurement, physical pain and mental anguish. The lawsuit further claims Tamborski has incurred significant medical costs and lost wages, due to her injuries and the need for surgery to remove the LINX Reflux system.

Tomborski alleges that Torax and Ethicon failed to establish and adhere to a quality system to ensure the safe manufacture of the devices, resulting in an unreasonably dangerous design that has placed thousands of individuals at risk of injuries and the need for removal surgery.

LINX Implant Lawsuits Being Investigated Nationwide

The complaint filed by Tamborski joins a number of similar lawsuits already pending in the U.S. District Court for the District of Minnesota, which is the state where the headquarters are located for Torax Medical, which originally developed the device.

As the recalled esophageal implants continue to age and become prone to failure, 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, product liability lawyers are actively investigating LINX implant lawsuits 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