Dallas Fort Worth Injury Lawyer Blog
As a Fort Worth Product Liability attorney and Bard IVC Filter lawyer, I am writing about this latest FDA warning regarding the Inferior Vena Cava filters.
Patients who suffer from the threat of pulmonary embolism and are contraindicated for anticoagulation therapy may find themselves receiving an Inferior Vena Cava (IVC) filter to prevent pulmonary embolism.
Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism. They are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out like a spider to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs. But, if there is an IVC filter strut fracture, small pieces of the filter may travel to other parts of the body, such as the heart or lungs.
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture.
These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided.
RECOMMENDATION: FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read more here about the IVC Filters.
These IVC Filter devices have recently come under investigation due to a high number of Bard IVC filter fractures which can cause pieces of the devices to travel through the body and damage the heart, lungs and other organs, causing embolisms and possibly death.
In a study published in November in the Archives of Internal Medicine, two Bard IVC filters were found to have a particularly high rate of problems. According to Dr. Rita Redberg in an editorial published by the Archives of Internal Medicine, both of those filters, the Bard G2 and Bard Recovery, were approved with virtually no real clinical data showing they were safe or effective.
Redberg said that researchers suggest that the number of Bard G2 filter fractures is likely to increase as they stay on the market and have been in patients’ bodies longer. She said that data indicates about 62,000 people have received the implants, and as many as 7,000 can expect to experience a Bard IVC filter fracture.
A number of Bard IVC filter lawsuits have been filed against C.R. Bard over the last year alleging that serious injuries or deaths were caused by design defects associated with these filters.