Lawsuit Alleges LINX Device Bead Separation Required Removal Surgery

Woman alleges she was implanted with a LINX device months after it had been recalled, due to the same risk of bead separation problems that caused her reflux management implant to fail.

A Washington state woman says she was unknowingly implanted with a recalled LINX reflux management system, which her product liability lawsuit claims was defectively designed and manufactured, leading to the need for revision surgery.

Janett Wingett filed the complaint (PDF) in the U.S. District Court for the District of Minnesota on February 10, naming Torax Medical Inc. and Ethicon Inc. as the defendants. The lawsuit accuses them of manufacturing a defective medical device, failing to warn consumers about the potential risks and not fully removing the devices from the market after the recall.

The LINX Reflux Management System was released in 2017 by Torax, before the company was absorbed by Johnson & Johnson’s Ethicon division. It consists of a small ring of magnetic beads connected by titanium wires, which is placed around the lower esophageal sphincter to help keep stomach acid from flowing back up into the esophagus, a condition commonly known as gastroesophageal reflux disease (GERD).

Despite being marketed as a safe alternative for patients with GERD who do not respond to proton pump inhibitors, like Nexium or Prilosec, problems have emerged that suggested the magnetic beads can become disconnected from the titanium wires.

Following the reports of bead separation, Torax announced a LINX device recall in May 2018, after the U.S. Food and Drug Administration (FDA) determined that a manufacturing defect could cause the problems, potentially resulting in migration of the device, damage nearby organs or other serious complications.

Wingett’s complaint joins a growing number of LINX bead separation lawsuits filed over the past few years, each raising similar allegations that the reflux management device is prone to break inside the body and cause serious injuries. The complaints contend the manufacturer knew or should have known about the defect and failed to provide doctors and patients with accurate information about the risk of device failure.

According to the complaint, Wingett was surgically implanted with the LINX system in August 2018, unaware that the devices, including hers, had been recalled at the end of May.

The device later failed, allegedly due to the same bead separation defect identified in the recall. According to the lawsuit, the malfunction led to additional complications and ultimately required surgical removal in December of last year.

“Plaintiff alleges that Defendants Torax and Ethicon manufactured the LINX which was implanted in Plaintiff and subsequently failed due to a manufacturing defect.”

– Janett Wingett v. Torax Medical Inc. et al

The lawsuit indicates the manufacturer was clearly aware of the LINX bead separation defects before Wingett underwent the procedure to implant the device. She presents claims of manufacturing defect, negligence, negligence per se and strict liability.

LINX Device Bead Separation Lawsuits

Following the 2018 recall, the manufacturer removed the LINX device from certain foreign markets in September 2025, which has led to questions as to whether more patients will experience LINX device bead separation complications that could result in lasting or permanent injuries.

Due to the seriousness of the reported problems, attorneys are reviewing LINX injury claims and pursuing compensation for those who experienced complications, including:

• The need for revision surgery or removal of the device
• Device breakage or mechanical failure
• Migration of the implant
• Organ punctures or tissue damage