It’s been less than two years since the FDA approved the use of Absorb stents, the first stent designed to dissolve on its own within three years of implantation. The stent was designed to do its job, opening a blood vessel long enough for the blood vessel to heal or for an occlusion to resolve, then break down naturally in the body.
Absorb stents were hailed as the next step forward by many cardiac surgeons and were greeted with glowing reviews in the medical press. But after less than two years of actual practical use, it is becoming clear that these stents might, in fact, be a step backward.
So far, the risk of a significant event is nearly one and a half times as high with an Absorb stent as with the control group, which used existing cobalt-chromium stents. The FDA has announced its intention to probe further into the issue.
The manufacturer is offering early denial, trying to ensure potential patients that the design or manufacturer is not at fault, instead of blaming surgeons for not following implantation protocols. Though it is certainly possible that choices made by medical professionals are increasing the risk of a significant cardiac event, it is always difficult to accept the word of the manufacturer trying to place blame on another party.
This would not be the first time that dangerous stents were used on cardiac patients. Drug-coated stents were seen as a major breakthrough for years until too many patients died due to complications of the device. The designers of those products also denied there was anything wrong with their stents. With this history in mind, suitable caution is appropriate in regard to the Absorb stent as well.
If you or someone you love suffered a significant cardiac event after the implantation of a stent, determining what role the stent played in causing that event is important. The FDA needs to be pressured into investigating these products to determine if they increase the risk of adverse outcomes, and manufacturers must be held accountable for dangerous designs. Please contact a qualified attorney who can help you make your case.