Bard IVC Filter Fractures May Impact Thousands of People: Report

Medical experts say that the Bard IVC filter, which may have broken and sent debris into the bodies of as many as 7,000 patients, is a perfect example of what is broken with the FDA’s medical device approval process. 

According to a commentary (pdf) published in August in the Archives of Internal Medicine by Dr. Rita F. Redberg, one of the journal’s editors, the Bard G2 inferior vena cava (IVC) filters were classified as Class II medical devices – the same classification as mercury thermometers – and were approved by the FDA without any clinical data on safety or effectiveness.

The devices have recently come under scrutiny due to a high number of Bard IVC filter fractures which can cause pieces of the devices to travel through the body and damage the heart, lungs and other organs, causing embolisms and possibly death.

In a related study published in August in the Archives of Internal Medicine, two Bard IVC filters were found to have a particularly high rate of problems. Redberg said that both of those filters, the Bard G2 and Bard Recovery, were approved with virtually no real clinical data showing they were safe or effective.

The Bard G2 IVC filter was approved under the controversial 510(k) premarket approval process after the FDA deemed them to be substantially equivalent to the Bard Recovery IVC filter, which the study found had a 16% failure rate. However, the Bard Recovery IVC filter was also approved under the 510(k) process, according to Redberg, and the only clinical data submitted to FDA on the Bard Recovery filter was data supporting that it could be safely removed. The Bard G2 filter has since logged a 12% failure rate, according to the same study.

Redberg said that researchers suggest that the number of Bard G2 filter fractures is likely to increase as they stay on the market and have been in patients’ bodies longer. She said that data indicates about 62,000 people have received the implants, and as many as 7,000 can expect to experience a Bard IVC filter fracture.

The 510(k) program allows quick approval of new medical devices if their manufacturers can show that they are functionally equivalent to devices already on the market. However critics say that the standards of the program and the definition of “functionally equivalent” have strayed over time.

A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

As a result of growing concerns, the FDA has proposed a more stringent application of the 510(k) process.

Inferior vena cava filters are an alternative treatment for patients at risk for a pulmonary embolism. They are often used when an anticoagulant is contraindicated or if such medications have not been effective. They contain a number of legs or struts that extend out like a spider to catch blood clots that may break free elsewhere in the body, such as the deep veins of the legs. However, if there is an IVC filter strut fracture, small pieces of the filter may travel to other parts of the body, such as the heart or lungs.

According to an alert issued by the FDA on August 9, the federal regulatory agency has received 921 reports of problems with IVC filters, with 328 of those cases involving an IVC filter that migrated through the body, 146 involved components breaking loose, 70 involved the IVC being perforated and 56 reports involved an IVC filter fracture. As a result of the problems, the FDA recommended that physicians remove the filters, which are often designed to be retrievable, once the threat of a pulmonary embolism has passed.

A number of Bard IVC filter lawsuits have been filed against C.R. Bard over the last year alleging that serious injuries or deaths were caused by design defects associated with these filters. In addition, as Bard IVC filter lawyers continue to review potential lawsuits for individuals with a vena cava filter implanted since 2003, it is likely that the IVC filter litigation will grow.