FDA Nester and Tornado Coil Warning

Internal Damage from Nester and Tornado Coil Defects

Cook, Inc., is facing touch questions and a wave of lawsuits as FDA embolization coil reports mount. FDA Nester and Tornado coils injury reports indicate the embolization coils have a tendency to move or migrate within the body, causing internal damage and a variety of serious side effects. Additionally, Cook, Inc. has a history of manufacturing negligence, shedding light on reports of foreign body reactions and autoimmune complications from Nester and Tornado coils.

Cook Group, which is a medical supply company based in Bloomington, Indiana, chose repeatedly to prioritize profits over product safety and put countless Americans at risk. Meanwhile, the CEO of Cook Group, Carl Cook, has a net worth of over $10.2 billion.

Attorneys handling Cook Tornado and Nester coil lawsuits believe persons and the family members of persons who have suffered from embolization coil problems may be eligible for significant compensation. This page provides an overview of FDA Tornado and Nester coil warnings and reports.

Cook Nester and Tornado Coils for Embolization

Cook, Inc. received FDA approval for Tornado and Nester coils for embolization in 2016 via a fast track approval process. Known as 510(k), this rapid approval process skips premarket testing for products deemed substantially similar to others already approved for use.

Tornado and Nester coils from Cook are intended to block blood flow into a weakened wall area in a vein or artery. Composed of platinum metal coils affixed with synthetic fibers, Nester and Cook coils create a partial block that prompts the body to form a blood clot plug.

Nester and Cook coils are placed with a catheter and then released into place. Nester and Cook coils are intended to be permanent without migrating, breaking or corroding; the metal coils are designed to lodge the small device into place.

FDA Nester and Tornado Coil Warnings and Reports

While federal regulators have not yet issued an FDA Nester and Tornado coil warning, a number of adverse event reports have already been filed through the agency's MAUDE reporting system. FDA Tornado and Nester coil reports highlight a number of incidents in which patients implanted with embolization coils developed severe and life-threatening complications.

These FDA Nester and Tornado coil reports have two main themes: The dominant set includes patients for whom the implantation was at first deemed a success. Yet over time, the Nester or Tornado coil migrated from the implantation site to another part of the body, resulting in the metal coil pushing through organs, nerves, or other internal tissues. Migration of Cook Tornado and Nester coils results in severe and chronic pain; bleeding and clotting problems such as emboli, hematomas and hemorrhage; ischemia and tissue necrosis; and death. Many of these patients require surgery to remove the defective embolization coil(s).

Specific FDA Nester and Tornado problems reports include coils that unraveled, stretched or migrated, causing damage to renal veins, bowels, blood vessels and pelvic floor nerves. In another case, a metal coil piece broke off an implanted coil and had to be retrieved via surgery.

A second set of FDA Tornado and Nester complaints are related to the metallic content of the devices. Some patients experience a more immediate reaction including infection, foreign body reactions, and autoimmune problems. While the device's label states the embolization coils are 100% platinum, allegations have surfaced that Nester and Tornado coils also contain Tungsten. In fact, Cook, Inc. received an FDA warning letter for failing to properly test and monitor the content of incoming raw materials in its manufacturing facility in 2014.

Embolization Coil Lawsuits Allege Cook Neglected to Warn of Nester and Tornado Coil Dangers

Anyone who has been implanted with a Tornado or Nester embolization coil is at risk for developing these serious and life-threatening side effects, yet Cook, Inc. has neglected to warn consumers of the risk.

When Cook's Nester and Tornado coils were approved, the company included a warning and instructions for surgeons using the device that indicates the company was aware of the tendency for its embolization coils to cause damage in the body. Yet the company did not warn consumers of Tornado coil dangers and Nester coil problems. Marketing a device without appropriate warning information yields a device defective.

Each company has a responsibility to monitor safety and product risks and to warn both consumers and medical professionals of any potential dangers. Cook, Inc. has allegedly failed to state known risks on the product's warning label or conduct post-market testing. As a result, thousands of Americans have been implanted with Nester and Tornado coils completely unaware of the risk of severe and life-threatening complications.

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Nester and Tornado Coil Lawsuits

Filing a lawsuit will allow you to hold the manufacturer accountable for damage it has caused you or a loved one, while also providing real compensation for your medical expenses, suffering and loss. Contact us today for a free consultation.