Consumer Drug Safety

Recovery Filter Puts Patients at Risk

The Recovery filter, an intra vena cava (IVC) blood clotting filter device, is under scrutiny after being linked to nearly 30 fatalities in recent months. The recovery filter resembles an octopus or spider, and is placed in the vena cava, the largest vein in the body, in an effort to trap clots and prevent them from putting patients at risk for pulmonary embolism and other medical emergencies

Some speculated the device’s manufacturer, C.R. Bard, was aware of the risk before coming to market, and yet still allowed the release of the product. In addition to the fatalities, there is also evidence on record the device has been linked to at least 300 non-fatal health problems.

Dangers of Deep Vein Blood Clots

Deep vein thrombosis (DVT) occurs when a blood clot develops in a deep vein, usually in the leg. In and of itself, deep vein thrombosis can be uncomfortable, and if one of the clots breaks free, the consequences can be fatal. It is possible for the clot to travel from the leg to the heart, lungs, or brain, blocking the blood flow and potentially killing the person.

Deep vein thrombosis is more common when a person suffers from a medical condition that causes his or her blood to clot, or following an accident or medical procedure. When a person’s movement is limited, (such as during recovery after surgery) it becomes more likely clots will form in the legs. In many cases, the risk for post-injury or hereditary deep vein thrombosis can be treated with medication, but not everyone responds to anti-clotting medication. And when the risks is due to a recent surgery, clotting medications must be avoided, in which case the next line of defense the IVC filter.

Dangers of Clotting Filters

If a patient is unable to tolerate clotting medications, his or her doctor might suggest an IVC filter, such as the Recovery filter. These filters have been effective in some cases, but for others, they triggered medical complications as bad as, or worse than, DVT.

One case, involving a 45 year old woman who received her Recovery filter following a 2004 car crash, suffered a medical emergency that put her near death after a piece of the filter broke off and pierced her heart. Doctors were forced to perform emergency open heart surgery and weren’t sure the woman would survive.

In another instance, the filter recipient wasn’t as lucky. She died a week after receiving her Recovery filter, when a blood clot pushed the filter out of place and into her heart, where it punctured the tissue.

Suspicious Behavior by the Bard Company Draws Attention

C.R. Bard hired the large public relations firm Hill and Knowlton to help with bad publicity related to the Recovery filter. The firm created a crisis management plan and told the company “unfavorable press” would affect stock prices and hurt the reputations of those involved in the company.

Bard also conducted a confidential study regarding the filter. In it, an independent doctor found the filter had higher rates of risk for fracture, movement, and death in users. The doctor encouraged Bard to follow-up with further investigation.

Bard failed to heed the advice of the independent study doctor or to act on the negative reports piling up regarding the recovery Filter. The company did not recall the device and sold as many as 34,000 before it was replaced with the company’s modified G2 filter. Bard has been reluctant to speak to the media, but issued a statement claiming its filters have been cleared by the FDA based on accurate information and that when filters are used as directed they provide nothing but benefits.

The FDA clearance of the Recovery filter has also drawn attention. The agency’s first attempt for approval was rejected in 2002, so the company called in a veteran regulatory specialist to assist with the second attempt. Since then, the specialist has called into question how Bard handled the process, stating it failed to give her safety performance test results and that one of the clinical trials raised red flags. She stated that in response to her concerns, she was told she would be removed from the team if she persisted.

Show Sources
  1. http://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/basics/definition/CON-20031922