Blood Clot Filter Device is Dangerous for Patients and Suspicions Surround its FDA Application
The Recovery filter is a device shaped like a spider which is inserted into the vena cava to prevent blood clots from reaching the heart or lungs. It is often inserted in people at high risk for clots or after patients have undergone certain surgeries or medical procedures. Blood clot filters are often implanted in patients who cannot tolerate blood thinners. About a quarter million blood clot filters are implanted in patients in the U.S. each year.
Over the course of ten years this device, manufactured by Bard, has been linked to as many as 27 deaths. Similar devices are manufactured by ten other companies in the U.S. Questions are now being raised about whether or not Bard told medical providers and patients about what it knew to be potentially fatal flaws.
Other data shows about 300 non-fatal issues have been reported from patients implanted with Recovery. Some patients have developed serious and life threatening injuries from the device. The spider-like metal pieces of Recovery have broken off inside the vein and, like a clot, either traveled to the heart or lungs, or have pierced patients hearts. Such a problem can cause death or require immediate life-saving open heart surgery. Also, instead of stopping a clot, the device can be pushed into the heart along with a clot which can puncture patients’ hearts and cause death.
Once problems with the Recovery device were being reported, Bard hired a public relations firm and developed a crisis management plan. Bard noted “unfavorable press” could damage their stock prices and run their reputation. Bard also hired an outside doctor to conduct a confidential study. The outside doctor found Recovery had higher rates of risk of death, filter fracture, and movement than all of its competitors. The doctor also suggested Bard to do further investigation immediately.
Bard, however, declined to recall the Recovery device. Bard continued selling Recovery, about 34,000 over the course of three years, before modifying the device and giving it a new name, G2, in 2006. The device was approved by the FDA in 2002 but questions are also being raised about how Bard got the clearance. Kay Fuller, who Bard hired to assist them in obtaining FDA approval, says the company did not tell her about safety performance test results and a small clinical trial that raised concerns. Fuller refused to sign the FDA application until the concerns were resolved. Bard ignored her and submitted its application to the FDA with what appears to be her signature. Fuller now says the signature is not hers and it was put onto the application without her knowledge. Fuller resigned from Bard and has reported her concerns to the FDA. The FDA has not confirmed or denied whether it has acted on Fuller’s reports.
According to NBC news, health officials have advised patients to check with their doctors to determine what brand of device they have and determine with their doctors whether or not it should be removed.
If you have been harmed by a dangerous device, contact The Poppe Law Firm® at 502-895-3400.