IVC Filter Lawsuit Plaintiffs Claim Devices Have Life-Threatening Side Effects, As FDA Issues Public Safety Announcement

June 27, 2016 – – TheProductLawyers.com reports on a U.S. Food and Drug Administration (FDA) Safety Communication related to the high number of adverse reports it has received about IVC filters and their potential to fracture with pieces migrating to other parts of the body. The FDA reminds medical professionals and patients of the risks involved in using the filters. The filters are meant to be used in patients at risk for development of blood clots and that cannot take traditional blood thinning medications. The FDA report also reiterated the filters were only to be used temporarily and needed to be removed as soon as the risk of blood clots had passed.

IVC filters are surgically implanted into patients’ inferior vena cava veins with the intent of capturing blood clots from the lower body, thus preventing them from reaching the heart or lungs, which could precipitate a pulmonary embolism. The filters allegedly hold the clot until they dissipate naturally.

The FDA noted that in a 5–year period between 2005 and 2010 it received in excess of 920 adverse reports focusing on side effects such as perforation of the inferior vena cava, filter migration and fracturing, and embolization of the fractured device or its parts. The agency’s safety communication recommended that patients be keenly aware of any possible symptoms that the filter had migrated, such as chest pain and heart palpitations, dizziness, fainting, light-headedness and out of the ordinary heart patterns. Patients that have experienced issues are at a higher risk of pulmonary embolism or cardiac tamponade.

Many lawsuits have been filed against the various makers of the device with plaintiffs claiming they have are defective and that they can break apart with the pieces migrating to other parts of the body. In some cases, the pieces have embedded in high-risk areas where they cannot be surgically removed, or they have done damage to veins and organs.

For more information on IVC filters, to ask questions, or to schedule a consultation, contact an attorney at Banville Law by calling (888)-997-3792.

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