A study published in the New England Journal of Medicine has prompted the Food and Drug Administration and cardiologists to warn about the risk of tiny blood clots in aortic heart valves.
Analyzing data from more than 185 patients in a clinical trial of patients with a trans catheter aortic-valve replacement, it was revealed that the valves do not open and close properly. The issue may arise because of the formation of a blood clot that could raise the risk of stroke.
The valves, created from pig and cow tissue, have been used for more than 30 years in patients with malfunctioning heart valves.
Evidence from the study suggests that these small clots may lead to restricted motion. When the valves do not move properly, it can cause the opening for blood flow to narrow.
Although doctors suggest that anticoagulant drugs, such as warfarin, can dissolve the clots, research has shown that these drugs can also be dangerous.
Tissue valves have become popular over the years, mainly because they can be implanted without surgery, through the use of a catheter. Last year, a different study revealed that tube-placed valves were not working correctly. The study initially only impacted valves from St. Jude Medical, but the problem has now been noticed in other brands.
Six of the 187 patients in the study suffered a stroke or mini-stroke. Data did not verify if the stroke occurred in patients whose valves were not working properly.
While doctors and the FDA are saying the products remain reasonably safe and effective, some patients have already suffered injuries as a result of the heart valve implants.
At O’Connor, Acciani & Levy, we believe that medical device manufacturers should be held responsible if they fail to warn consumers about potential product risks. If you or someone you know has been hurt by a defective medical device, contact our experienced personal injury attorneys. You may be entitled to file a lawsuit for your medical expenses, lost wages and more.