Philadelphia Defective Medical Device Lawyers

IVC Filters

An IVC filter is a medical device that is inserted into the inferior vena cava, which is a large vein that carries deoxygenated blood into the heart, in order to catch and prevent blood clots from reaching the lungs. Oftentimes, patients who are at risk for pulmonary embolisms, which are blood clots present in the lungs, have the device placed if anticoagulant therapy in the form of blood thinners proves ineffective or cannot be used.

Since 1979, when the FDA originally approved its use in preventing blood clot migration, doctors have recommended IVC filters for patients who have sustained serious injuries or recently endured surgery. The following cases are situations in which a doctor may recommend IVC filter insertion in a patient: car accidents, gunshot or stab wounds, dialysis treatment, cancer diagnosis and/or treatment, spinal cord injuries, serious falls, voluntary or emergency surgeries, individuals who are immobile, and mothers who just gave birth. In these cases, a blood thinner may instigate uncontrolled bleeding; therefore, the use of IVC filters is introduced as an alternative.

Unfortunately, the FDA concluded from several different studies that IVC filters present dangers to patients using the product. In 2010 and again in 2014, the FDA issued safety alerts citing product complications including device migration; filter perforation; filter fracture; and device embolization, which means that the device’s components have detached from the point of insertion.

Side effects endured by patients using the IVC filters are numerous.

IVC Filter Insertion

Upon insertion, there may be bleeding, bruising and/or blood vessel puncturing at the access site; incorrect placement of the device; and defective deployment of the filter.

IVC Filter Retrieval

When the doctor attempts to retrieve the device, blood vessels could be perforated; large blood clots may develop during filter prevention removal; longer and more intensive surgeries may occur due to difficulties in retrieving the device; and scars may be made when removing the device.

IVC Filter Complications After Insertion

After the insertion of the IVC filter, severe complications may arise including migration of the device to another part of the vena cava, heart or other adjacent organs; the development of deep vein thrombosis, which is a blood clot located in the legs; fracture or breakage of the filter; blockage which may cause swelling in the legs; and the development of an embolization, which is a blood clot or air bubble, surrounding the filter.