LINX Reflux Management System Lawsuit Overview

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

The U.S. Food and Drug Administration (FDA) approved the LINX Reflux Management System in March 2012. It is specifically designed to treat gastroesophageal reflux disease (GERD) in individuals who do not respond adequately to medication.

In 2018, the FDA announced a LINX device recall for certain models, due to a potential risk that the continuous loop components may detach. The recall was initiated after the FDA identified issues in the manufacturing process, which could allow the magnetic beads to separate from the titanium wire that holds them together, posing serious health risks to individuals.

As a result of the apparent manufacturing defects, individuals who have suffered injuries from a broken device are now filing LINX lawsuits seeking financial compensation for their injuries and the need for removal surgery.

Who Qualifies for the LINX Lawsuit?

Financial compensation may be available through a LINX lawsuit for individuals who underwent a LINX surgery and suffered any of the following complications:

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

Who is the LINX Lawsuit Against?

LINX lawsuits are being filed against the manufacturers of the LINX Reflux Management System including;

• Ethicon Inc. (Johnson & Johnson)
• Torax Medical, Inc.

To determine if you or a loved one qualify for a LINX lawsuit settlement, submit information for review by a LINX lawyer, who will evaluate the circumstances of your potential claim.

Attorneys handle all LINX Reflux lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received.

LINX Device for GERD Treatment

The LINX® Reflux Management System was approved to treat individuals with chronic gastroesophageal reflux disease (GERD) that cannot be effectively managed with medical treatments, including daily proton pump inhibitors (PPIs).

The placement of the LINX device involves a minimally invasive surgical procedure. Under general anesthesia, the device is implanted around the LES through small incisions in the abdomen. The magnetic beads on the device are intended to keep the sphincter closed to block acid reflux, but are flexible enough to expand and allow the passage of food during swallowing.

What is GERD?

Gastroesophageal reflux disease (GERD) occurs when stomach acid frequently backs up into the esophagus, the tube that connects your mouth to your stomach. This acid reflux can cause irritation of the esophageal lining. While many individuals manage their GERD symptoms with over-the-counter medications, others may require prescription medications or surgical intervention.

Common symptoms of GERD include:

• Heartburn
• Chest pain
• A sensation of a lump in the throat
• Regurgitation of food
• Difficulty swallowing

Persistent reflux can lead to chronic inflammation, which may damage the lining of the esophagus, resulting in scar tissue that narrows the esophageal passage. Continual exposure to stomach acid can also lead to the development of ulcers in the esophagus. Approximately 20% of the U.S. population experiences GERD.

Common Side Effects of the LINX Device

Those who have undergone the LINX procedure may experience several side effects, including:

• Difficulty swallowing
• Pain in the stomach after surgery
• Bloating
• Heartburn or regurgitation reappearing

Additionally, there are more severe complications associated with the LINX system, such as:

• The device migrating into the esophagus
• The device being excessively tight, which can obstruct the passage of food.

LINX Device Recall Over Wire Breaks

In 2018, the FDA announced a LINX Reflux Management System Class II recall following concerns over the potential detachment of device components. This recall was prompted by incidents where the magnetic beads were found to separate from the connecting titanium wire, presenting significant health risks to recipients.

Why does the LINX device break?

The LINX device may fail due to manufacturing flaws that have been identified by the FDA. These flaws primarily involve the security of the titanium beads on the titanium wire that forms the device. The beads may not be securely attached to the wire, creating a risk of separation.

The LINX device may separate due to the titanium material failing to hold up well under the combination of stress from esophageal movements and the acidic environment of the stomach. Over time, these conditions can weaken the connections between the beads and the wire, potentially leading to their separation.

This defect can diminish the device’s effectiveness and pose serious health risks, necessitating additional surgeries to repair or replace the malfunctioning device.

LINX Reflux Failures Lead to Severe Injuries

Leading up to the recall, and afterwards, there there have been a growing number of reports concerning the failure of the LINX devices. Recipients reported incidents where the device either broke down within the esophageal environment or migrated from its original position, leading to exacerbated symptoms or new complications.

According to the FDA, at least 526 adverse events associated with the LINX devices had been reported to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database by the time of the recall, many of which included reports of the devices breaking and migrating.

Some of the most common LINX problems reported in the FDA’s MAUDE database include;

• Detachment of Device or Device Component
• Material Separation
• Migration or Expulsion of Device
• Material Erosion and Deformation
• Defective Components
• Breaks
• Disconnections
• Mechanical Problems

Side Effects of Broken LINX Devices

If a LINX device breaks inside the body, the consequences and necessary interventions can be serious:

Immediate Effects and Health Risks

• Pain and Discomfort: Individuals may experience sudden, sharp pain in the chest or abdominal area as the device fails. This pain could be exacerbated by swallowing or esophageal movements.
• Increased Acid Reflux: The primary function of the LINX device is to prevent stomach acid from entering the esophagus. If the device breaks, its effectiveness is compromised, leading to an immediate increase in acid reflux symptoms.
• Foreign Body Reaction: If the beads detach from the wire, the body may react to these loose components as foreign objects, potentially leading to inflammation or infection.
• Internal Injury: The detached beads or broken wires could migrate, causing damage to the esophagus, stomach lining, or other internal organs. This might include scratches, punctures, or more severe internal injuries.
• Aspiration of Device Parts: There’s a risk that small parts of the device could be aspirated into the respiratory tract, leading to coughing, infection, or even more severe respiratory issues.

Broken LINX Removal Surgery

The removal of a broken LINX device generally requires surgical intervention. Here’s how it is typically handled:

Diagnosis and Imaging: The first step involves confirming the breakage through diagnostic imaging, utilizing methods such as X-rays, endoscopy, or magnetic resonance imaging (MRI) to accurately locate the broken parts and assess the extent of any internal damage.

Surgical Removal: Removal usually involves a laparoscopic procedure, which is minimally invasive. Surgeons make small incisions in the abdomen to access the esophagus and carefully remove the broken pieces of the device.

Repair or Replacement: Depending on the condition of the LINX device and the individuals health, the surgeon may replace it with a new device during the same procedure or might opt to use a different treatment strategy for acid reflux.

Recovery and Follow-up: After the removal, individuals will likely need follow-up appointments to monitor their recovery and manage their acid reflux symptoms with alternative treatments.

Examples of LINX Lawsuits

LINX Reflux Failure Lawsuit: Stephen Tilghman filed a product liability lawsuit in the U.S. District Court for the District of Minnesota on June 3, naming Torax Medical, Inc. and Ethicon, Inc. as defendants, indicating that the LINX reflux device was defective and failed only a few years after it was implanted in his body.

Tilghman’s complaint states the LINX devices are defective and have an “out of specification condition” leading to a bead component separating from the wire link, requiring surgical removal.

LINX GERD Device Removal Lawsuit: Mengying Zhang filed a LINX lawsuit in the U.S. District Court for the District of Minnesota on May 22, 2024, stating the 13-bead LINX reflux management system implant she received in 2017 failed, requiring her to undergo revision surgery in April 2024.

Zhang’s lawsuit claims the LINX devices were defectively manufactured by Ethicon Inc., and Torax Medical, Inc., and that the manufacturers owed a duty of care to ensure the medical device was safe.

Contact a LINX Recall Lawyer

LINX Reflux lawyers offer free consultations and claim evaluations to assess whether individuals may be eligible for financial compensation and settlement benefits related to health issues, injuries, or adverse effects resulting from a defective LINX device.

If you or a loved one have been injured or impacted by a LINX Reflux device and wish to explore the possibility of pursuing a lawsuit, request a free consultation and claim evaluation by providing details about your potential claim for review by a lawyer.