Currently thousands of patients and medical experts are questioning the safety of inferior vena cava (IVC) filters and if manufacturing companies were aware of problems before they became a public concern.

At least 27 deaths have been reported associated with the Recovery Filger, C.R. Bard’s inferior vena cava filter, after patients allegedly suffered from the design defects of the products.

Inferior vena cava filters are small cage like devices directly implanted in the patient’s inferior vena cava, the largest vein in the body.

These devices trap and resolve blood clots forming in the legs and pelvis, preventing them from traveling to the patient’s heart or lungs. Initially only permanent models were available, but temporary models meant to be later removed soon became available and grew in popularity.

Several medical manufacturers have their own line of inferior vena cava filter models, most of which have come under fire for adverse inferior vena cava filter side effects.

Government data showed 300 other reports of inferior vena cava filter complications associated with the Recovery.  One of these reports include patient Dodi F.

Dodi had the inferior vena cava filter implanted after a car accident in 2004 had put her at high risk for blood clots. However, the device almost killed her. Just four months after the device was implanted, Dodi says she suffered inferior vena cava filter side effects and passed out from a severe headache.

Diagnostic testing revealed the IVC filter had broken apart, with a piece of it piercing Dodi’s heart. She required emergency open heart surgery to retrieve it. Even though Dodi’s life was saved, many who suffer inferior vena cava filter complications are not as lucky.

Overview of Inferior Vena Cava Filter Problems

After injury reports for the The Recovery IVC filter became commonly reported, Bard hired public relations company Hill and Knowlton for crisis management and to help level “damaging press” that could influence stock prices and reputations.

Bard also reportedly hired an outside doctor to conduct a confidential study of the The Recovery IVC filter, which was later obtained by NBC News.

The study found that the Recovery IVC filter had a higher risk of death, filter fracture and movement compared to other inferior vena cava filter models. The doctor concluded that further investigation was needed, and “urgently warranted.”

Instead of recalling the product, Bard reportedly sold 34,000 Recovery inferior cava filters over the course of three years and eventually replaced them with a modified version under a different name, the G2 IVC filter model.

Even with all of the information collected by NBC, Bard maintained that its inferior vena cava filters had been “appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate “significant benefits to patients.”

The FDA first warned against inferior vena cava filter complications in August 2010, with the agency reporting over 921 injury reports. At the time, the agency noted a trend in the growing number of inferior vena cava filter injury reports in conjunction with their growing popularity.

This issue was further explored in an updated warning from the FDA in May 2014, stating that temporary IVC filter models should be removed soon after the blood clots are resolved to avoid inferior vena cava side effects.