IVC Filter Medical Device Risks May Outweigh Benefits

An inferior vena cava (IVC) filter is a small cage-like device designed to catch and dissolve blood clots. These devices are implanted in patients who have a higher risk of blood clots but for various reasons, cannot take anticoagulants. An IVC works by trapping blood clots before they migrate to vital organs such as the heart or lungs and cause life-threatening situation.

What seems like an optimum solution for patients who are unable to take blood thinners, has unfortunately various potentially serious, if not life-threatening, side effects.

Inferior Vena Cava Filter Background

The inferior vena cava is the main vein in the body and the IVC is implanted in certain patients to prevent blood clots from traveling around the body, should blood clots occur. Blood clots from the lower body can be common after knee or hip replacement surgeries. If a blood clot travels to the lungs, it can cause extensive damage with dangerous complication such as difficulty breathing, chest pain, heart attack, pulmonary embolism (PE). The IVC filters are designed to catch these clots before serious damage can occur.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from alleged defective medical devices, including inferior vena cava filters.

IVC Concerns

In 2010, the U.S. Food and Drug Administration (FDA) warned against the long-term use of IVC filters, as the medical device was designed as a temporary solution. When the IVC filters are left in the body for an extended period of time, serious life-threatening complications may occur. The FDA noted that they had nearly 1,000 adverse event reports in the previous five years.

Over 300 reports involved IVC filter migration, almost 150 reports involved the detachment of components, 70 reports revealed perforation of the inferior vena cava, and 56 IVC filters were fractured.

Four years later, the FDA updated its warning and announced that once the patient’s risk for pulmonary embolism has passed, the IVC filter should be removed between 29 and 54 days after implantation, in order to avoid IVC filter damage.

Basically, IVC filters are only approved for use when anticoagulant therapy is not an option, when anticoagulant therapy fails to work, (for example, during an emergency after a massive pulmonary embolism), or for chronic recurrent pulmonary embolism when anticoagulant use has failed or is contraindicated.

Typical Types of IVC Filter Damage

The FDA notes that the most common IVC filter damage complications are: IVC thrombosis, deep vein thrombosis (DVT), access site thrombosis, filter migration, caval penetration, and IVC filter fracture.

Legal Issues Regarding IVC Filters

A Florida women had an IVC filter implanted in November 2010. In March 2011, doctors attempted to remove the filter, but determined that it could not be removed. The plaintiff developed debilitating gastrointestinal symptoms, including bowel inflammation, diarrhea, vomiting, fatigue, and abdominal pain. A colonoscopy revealed that the IVC filter had perforated her vena cava and migrated into her intestines. The filter had migrated to the duodenum, the first part of the small intestine. A different hospital was successful in removing the filter.

An Illinois man had an IVC filter inserted in April 2011. The filter perforated his vena cava and caused him severe pain and shortness of breath. The filter remains in his body because doctors deemed it too dangerous to remove the filter.

An IVC manufacturer is facing a wrongful death lawsuit over its Option Inferior Vena Cava filter. The family of the Florida man alleges that the device, caused a pulmonary embolism and subsequent respiratory failure. The man died in October 2014. His family alleges that the IVC filter was defectively designed and accuses the manufacturer of failing to disclose the risks to patients and the medical community.

Multidistrict litigations (MDLs) have been created for many IVC filter lawsuits. The U.S. Judicial Panel on Multidistrict Litigation creates MDLs when there are many lawsuits with common allegations. MDLs centralize lawsuits to one court before one judge, making proceedings more efficient.

Plaintiffs in many IVC filter litigations point out that IVC filters were approved through 501(k), which allows devices to be approved without clinical testing. Manufacturers only need to show that devices are “substantially equivalent,” or similar enough, to a previously approved device.

IVC Filter Medical Device Risks May Outweigh Benefits

IVC Filter Medical Device Risks May Outweigh Benefits

A general list of manufacturers facing IVC legal action include Bard, Cook Medical, Cordis Corporation, Rex Medical, and Boston Scientific.

The FDA as well as researchers indicate that IVC filters may become more dangerous than beneficial to a patient when they are left in the body longer than two months.

Legal Help for Inferior Vena Cava Filter Recipients

Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free legal case evaluations to anyone with questions about filing a lawsuit over adverse effects from medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).

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