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The FDA is warning medical providers that Absorb dissolving stents may lead to more cardiac injuries than other non-dissolving stents. Recent data from a pivotal clinical trial reveals a much higher rate of heart problems, like heart attacks, once these plastic stents begin to dissolve.
In January 2016 Abbott labs started marketing a product called Absorb, which is a stent made of plastic that is designed to dissolve completely over a three-year period. The stents are larger than traditional metal stents but are intended to dissolve and leave behind a more natural blood vessel.
The FDA granted approval of the device in January 2016 but did so after Abbott submitted one year of clinical data, which means the stents had only partially dissolved. Unfortunately, recent data from a longer two-year clinical trial reveal a much higher rate of heart problems once the stent has more fully dissolved.
Data from the pivotal clinical trial shows that as the stent dissolves there is a higher risk of heart problems. In the clinical trial, 11 percent of the people with a dissolving stent had major cardiac events (cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel). Fewer patients who received a traditional metal stent had these issues.
Additionally, more people using the dissolving stent had blood clots than those using a traditional metal stent.
The FDA is warning doctors of new data that reveals Abbott Laboratories’ Absorb GT1 Bioresorbable Vascular Scaffold (“BVS”) may do more harm than good after two years of use.
The FDA is asking patients to seek medical care if they have a dissolving stent and experience cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath.
The FDA recommends that if someone is injured they report the adverse event to the FDA. Please see our blog on reporting adverse events for information on how you can report an injury.
Because of the significant increase in major adverse cardiac events, the FDA will continue to monitor long-term clinical studies and submitted reports. As more of the Absorb plastic stents are fully absorbed by patients it is likely that more adverse cardiac events related to the device will be reported.
If you believe you have been injured because of an Absorb dissolving heart stent please contact a lawyer to determine whether you have a potential claim against the manufacturer of the stent.
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