Retrievable Inferior Vena Cava Filters placed in traumatic brain injury, spinal cord injury and pelvic fracture patients can fracture, migrate, puncture & tilt.

SANTA BARBARA, CA, UNITED STATES, June 22, 2020 /EINPresswire.com/ -- Greg Vigna, MD, JD, physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “Retrievable Inferior Vena Cava Filters (IVC filters) that are placed in traumatic brain injury, spinal cord injury and complex pelvic fracture patients are rarely removed within the FDA recommended time frame. The FDA states these filters should be removed between 29 to 54 days after placement; however, because of the very nature of the at risk population for which they are indicated, this doesn’t happen." Studies indicate that as few as 10% of retrievable IVC filters are actually retrieved.

According to Dr. Vigna, the rationale behind leaving the filters in longer can make sense to a treating physician for the newly injured. “If you are caring for a traumatic brain injured patient with an intracranial bleed who may have undergone emergent neurosurgical procedures, there are often multiple reasons not to use Coumadin or other anti-coagulants. The time frame to avoid anticoagulant therapy may last well after the 54 day period recommended by the FDA to remove the IVC, and therefore it is quite reasonable for a physician to leave the filter in longer. Of course the physicians are told that studies proving safety and efficacy have been performed by the company and that is simply not true. A recent systematic review has shown that there is no quality evidence showing these filters work to prevent pulmonary embolus or mortality. In addition, one of the only randomized controlled trials ever performed and published in the New England Journal of Medicine just last year has shown that they do not work.”

Dr. Vigna, "There is a significant design defect with IVCs. These devices can fracture, migrate, puncture, and tilt, especially when they are used longer than a few weeks. Filters remain in place longer than 54 days in over 90% of patients for a variety of reasons. Seeing patients on a daily basic with traumatic brain injury, spinal cord injury, and multiple fractures, it is exceptionally rare that there is consideration to remove the device prior to 54 days. Patients remain at risk of falls and as such there remains a relative contraindication to anticoagulation, they have impaired mobility putting them at risk for blood clots, and often these patients have future planned surgeries that would prevent anticoagulation. Also, permanent filters have been within the standard of care for over 25 years and severe complications related to the device are exceptionally rare so as far as doctors are told by the companies there is rarely a compelling reason to remove the device early.”

Ben Martin, Esq., of Martin Baughman, PLLC from Dallas Texas, who serves as Co-Lead counsel of the Cook IVC Multidistrict Litigation clarifies, “The retrievable devices such as the Cook Celect and the Bard Recovery Filter are not designed to be permanent devices unlike the prototype permanent devices though that’s how they were marketed, and these devices commonly perforate the IVC into organs, and fracture into pieces causing injury. Both Bard and Cook aggressively marketed these devices to trauma surgeons, and failed to provide mechanisms to follow these patients forward to ensure removal. These companies should have provided safeguards to follow these patients forward to ensure timely removal when medically advisable as they knew their devices would perforate into adjacent organs and fracture in high percentages. Other injuries include inferior caval occlusion leading to chronic pain, edema, and chronic skin ulcers and the need for life-time anticoagulation (blood thinners) as these devices cause blood clots.”

Dr. Vigna is a California and Washington DC national pharmaceutical injury attorney with a focus on catastrophic injuries caused by defective devices . Ben Martin, Esq of Martin Baughman, PLLC is a national pharmaceutical injury trial attorney from Dallas who litigates serious injuries caused by defective devices.
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Greg Vigna, MD, JD
Vigna Law Group
1155 Coast Village Rd., Suite 3, Santa Barbara, CA
1-800-761-9206

Greg Vigna
Greg Vigna, M.D., J.D.
+1 800-761-9206
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