Bard Recovery and G2 IVC Filter Defective Products

There are serious and fatal complications of the widely used Bard inferior vena cava (IVC) filters, the models Bard Recovery and G2 IVC Filter. 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.

Bard G2 IVC Filter Lawsuits
G2™ Filter System Lawsuits allege that the G2 Filter System possesses manufacturing and design defects which resulted in device failure. The injured plaintiffs experienced fracture and migration of the G2 Filter.

In 2005, Bard Peripheral Vascular began selling its G2 IVC filter. This replaced the Recovery IVC filter. Despite the "enhanced fracture resistance" and "enhanced migration resistance" advertisements by Bard Peripheral Vascular, the device has still been shown to fracture, fail and migrate.

Recovery IVC Filter Lawsuits
The Recovery IVC filter was approved by the Food and Drug Administration in 2002. It was placed on the market for use in 2003. Its manufacturer, Bard Peripheral Vascular withdrew the Recovery IVC filter from the market in 2005 and replaced it with the G2 IVC filter. The G2 IVC filter is the "second generation" of the Recovery IVC filter.

Medical experts report that the Bard IVC filter, may be defective and subject to fractures and sent debris into the bodies of as many as 7,000 patients. According to a commentary (pdf) published in August 2010, in the Archives of Internal Medicine by Dr. Rita F. Redberg, the Bard G2 inferior vena cava (IVC) filters were classified as Class II medical devices and were approved by the FDA without any clinical data on safety or effectiveness.

The devices are being investigated because of many complaints that the Bard IVC filter fractures, that 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 another study published in November 2010, in the Archives of Internal Medicine, two Bard IVC filters were found to have high rate of problems. Redberg said that both of those filters, the Bard G2 and Bard Recovery, were approved without any real clinical data showing they were safe or effective.

The Bard G2 IVC filter was approved under the 510(k) premarket approval process after the FDA considered them to be substantially equivalent to the Bard Recovery IVC filter, which the study found had a 16% failure rate. 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. But critics say that the standards of the program and the definition of “functionally equivalent” have deviated over time.

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. 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, 2010, 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.

Summary
According to researchers, 25% of all Bard Recovery IVC filters and 12% of Bard G2 IVC filters fractured. These fractured filters have the potential become dislodged and cause serious and fatal injury. 71% of the broken pieces migrated through the veins of the patient to the heart. The FDA has received more than 900 reports of adverse events, including:

* Deep Vein Thrombosis (DVT)
* Filter Fracture, Migration or Embolization, leading to Injury to the Heart, Lung or Vena Cava
* Cardiac or Pericardial Tamponade
* Severe Persistent Chest Pain
* Shortness of Breath
* Death