A new research study on the long term use of inferior vena cava (IVC) filters has made the Federal Drug Administration (FDA) voice its concerns to the public over these devices and prompted patients to file Cook IVC filter recall lawsuits. Dr. William Nicholson led the research team at York Hospital in York, Pennsylvania and recently posted the results online. For those who are interested in reading a print copy of this important study, the publication will be released in November this year in the Archives of Internal Medicine.
What are IVC filters?
Inferior vena cava filters are used as implants to help patients facing the risk of pulmonary embolism. Designed to keep blood clots from entering the lungs or heart, IVC implants are only intended for short term use. The real problem arises when patients do not have the filters removed once the device’s work is done. Unfortunately, there are many risks affiliated with the long term use of IVC filters. These risks include the possibility that the filters will fracture and cause these pieces to migrate to other parts of the body.
The IVC implants studied by Dr. Nicholson and his team were the Bard Recovery and the Bard G2 vena cava filters. The purpose of their research was to identify if these filters have a tendency to break or fragment. Moreover, the study was to find out if these issues appeared to get worse the longer the implant remained inside the patient. With over 65,000 people implanted with IVC devices, the results from this research are very significant.
The study revealed that the redesigned Bard G2 filter did fracture in about 16% of the patients. More alarmingly though, when a piece of the filter did break away, the broken part traveled up to the heart of the patient around 71% of the time. In addition, the fractured filter pieces could travel in the veins to the liver or other parts of the body. While the second version of the Bard implant was designed to reduce the risk of breaking, both implants showed close results when studied specifically for long term use.
Who is at risk?
Individuals who already have an IVC implant should talk to their physician again about the findings in this new study. Even though IVC filters are used for people who are unable to take anticoagulant medications, the risks associated with these implants should be clearly discussed between physicians and their patients.
What does the FDA recommend?
With the disturbing results revealed in Dr. Nicholson’s study, the FDA is recommending that physicians carefully consider every option before choosing to implant an IVC filter in their patients. Moreover, the FDA is urging doctors to remove any filters from their existing patients once their risk of pulmonary embolism has passed. Leaving IVC filters in longer than necessary has now been shown to elevate the risk of fractured filters and potentially cause severe health problems.
If you have experienced any health issues due to the long term use of IVC filters, please contact our law firm right away for information on your options.