PURPOSE OF THE DEVICE

The device was introduced in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients. Today greater than 2,000,000 IVC filters have been inserted into patients.

The inferior vena cava is the largest vein in the body, moving deoxygenated blood from the lower legs to the heart and then the lungs. In order to prevent blood clots from traveling to the lungs resulting in a life-threatening pulmonary embolisms (PEs), doctors implant an IVC filter in the vein. Retrievable filters are associated with high potential risks such as fracturing or breaking apart in the vein, damaging tissue, migrating into the heart, or failing to stop blood clots from bypassing the device.

The device is inserted by a doctor using a catheter into a patient’s inferior vena cava through a small incision in the neck or groin. Metal wires that are part of the device are supposed to capture and trap blood clots before they can reach the lungs.

While some filters are permanent, others are retrievable or temporary. Physicians remove retrievable filters in a similar way that they implant them by first injecting contrast or X-ray dye around the device to make sure it is safe to proceed with the removal. Then a catheter-like snare inserted into the vein is used to grab the hook located on the top end of the filter. The filter is then covered by a sheath and pulled out of the vein through the incision in the neck or groin.

WARNINGS

Retrievable filters are associated with high potential risks, such as fracturing or breaking apart in the vein, damaging tissue, migrating into the heart, or failing to stop blood clots from bypassing the device. Serious complications can occur as a result of the implanted filters, like when a device breaks apart and travels to another area of the body, otherwise known as device migration, the most common adverse reaction. The FDA listed embolization as the second most frequently reported complication.

Retrievable IVC filters are only intended for short-term placement, and the FDA reported concern about the devices staying in patients long after PE risks subsided. The FDA updated safety communication in 2014, recommending retrievable devices be removed between the 29th and 54th day after implantation in patients in which PE subsided.

SIDE EFFECTS

Former recipients of retrievable IVC filters filed legal claims against manufacturers for poor design, manufacturing and failing to warn of risks. Faulty filters punctured veins, fractured and migrated to other parts of the body causing complications.

In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters, including 70 filter perforations, 328 device migrations, 56 filter fractures, and 146 embolisms.

HOW DALIMONTE RUEB CAN HELP

Studies have revealed 5 IVC filters prone to failure; Bards Recovery, Bards G2, Bards G2 Express, Cooks Gunther Tulip and Cooks Celect. If you or someone you know has received any of these IVC filters and experienced any adverse side effects, you should speak seek legal counsel immediately.

If you have received an IVC filter your peace of mind is vulnerable because of the risks associated with these devices. The irresponsibility on the part of the manufacturers is egregious, and patients and their families should understand the risks and how to protect themselves.