FDA Clot Device Advisory
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
The FDA sent out an advisory to doctors and patients about a medical device that is used to prevent blood clots from traveling to the lungs. These devices, which are medical filters, can move and break posing a life threatening risk to patients. These filters can be either permanent or intende only for short term use. The FDA has advised doctors to consider removing the filters if the risk of clot has subsided.
About 200,000 people each year are treated for blood clots each year. Most of these people are treated with blood thinning drugs, however when that is not an option the alternative can be these filters. About 30,000 people are treated with these filters annually.
In a study done of patients at York Hospital in Pennsylvania there were 80 patients that had a filter made by C.R. Bard. Of those with newer implants by Bard 16% had a filter break. Of older filters that were studied, 25% had a filter break.