Filter Injuries and Side Effects
The FDA, alongside numerous third-party studies, has issued warnings about the associated risks of IVC filters. The initial warning came from the federal agency in 2010 and stated that in the five years between 2005 and 2010, more than 900 reports had been filed against the filters including: 328 reports about filter migration; 146 reports about detachment of device components; 70 reports about vena cava perforation; and 56 reports of filter fractures.
With more than 250,000 IVC filters implanted in patients throughout the nation, the FDA is concerned that issues with the filters will continue to emerge, especially considering that the market for use of the medical device is continuing to grow. One of the FDA’s primary concerns is that retrievable filters are not being effectively removed, thus prompting them to issue another safety communication to healthcare providers in 2014 in regards to safe extraction once a patient no longer needed them.
Veritably, a study appearing in JAMA: Internal Medicine in 2013, suggested that the retrieval rate of the devices was lower than to 10%. With inadequate warning or instructions to healthcare providers, a growing number of physicians have continued to utilize these filters. The FDA has stated, that for patients with retrievable filters, some complications can be avoided if the filter is removed once the risk of pulmonary embolism has subsided.
Additional studies that call into question the effectiveness and safety of the devices include:
- A 2010 study published in Archives of Internal Medicine that found nearly 50% of implanted blood clot filters may not have been necessary.
- Two studies in 2013 in JAMA: Internal Medicine that found a lack of evidence that validated the effectiveness of IVC filters.
- Another article in JAMA from 2015 raised concerns about the use of filters over the use of anticoagulants.
Numerous studies continue to emerge that essentially contradict the supposed health benefits of these devices.
If you, or a loved one, has suffered physical, emotional, and financial injury, or even death, as a result of IVC Filters, then contact us today at (877) 919-0830.