An Abbott Absorb stent lawsuit may be an option for patients who received the devices to treat complications related to heart disease and experienced serious health complications. After several setbacks associated with its dissolvable heart stents, Abbott Laboratories, maker of the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS, is reportedly only making the devices available for use in clinical settings at select institutions. Affected patients and their families may be able to seek compensation with the help of a defective medical device attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Abbott Absorb stent lawsuit attorney who can assist you throughout the legal process.
What is an Abbott Absorb Stent?
Metal stents used in coronary arteries to treat complications associated with heart disease were developed to help alleviate chest pain and to potentially improve survivability in the event of a heart attack. Despite the major benefits of stent-related reductions in restenosis (narrowing of the blood vessel), metal stents have been associated with a number of serious complications, including thrombosis and the lasting impact that a permanent metal stent may have on the artery.
Medical advancements have made possible the introduction of a type of stent that dissolves over time, including the Absorb BVS and Absorb GT1 BVS, manufactured by Abbott Laboratories. Despite data claiming that the risk of stent thrombosis was twice as high as the risk associated with traditional metal stents, the Absorb stent was approved by the U.S. Food and Drug Administration (FDA) in July 2016. Since its approval, the device has faced increased scrutiny as “worrisome” data and an FDA safety alert noted serious risks related to the devices.
As of April 2017, Cardio Brief reports that Abbott Laboratories notified European physicians informing them that the Absorb BVS and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” According to the report, Abbott will begin placing restrictions on the device beginning May 31, 2017, and that the company will work with European Regulatory Agencies and review the situation next summer.
Abbott Absorb Stent Risks
Risks and potential problems related to the Abbot Absorb stent reportedly include:
- Stent thrombosis, or the sudden blockage of a stented coronary artery due to the formation of a blood clot
- Dual antiplatelet therapy (DAPT), or the combination of aspirin and other drugs to reduce the risk of heart attack and coronary stent thrombosis
- Implantation techniques and procedural problems
In October 2016, TCTMD reported what it called “worrisome” data and unexpected results in information gathered over a three-year period from the ABSORB II trail. Notably, the device was associated with “a two-fold increased risk of device-oriented clinical events” as well as an increased risk of stent thrombosis when compared to the XIENCE metallic stent.
Additionally, the FDA issued a safety alert in March 2017 informing health care providers treating patients with the Absorb stent about a potential increased rate of major adverse cardiac events when compared with the XIENCE drug-eluting stent. According to the FDA’s warning, data compiled over a two-year period showed an 11 percent increase in the rate of major cardiac events, including cardiac death, heart attack and the need to re-open the heart vessel.
An additional trial known as the AIDA was terminated early due to an increase in stent thrombosis, including late stent thrombosis. According to Cardo Brief, Abbott Laboratories clarified the status of the device in the U.S. by stating that “Absorb continues to be available to doctors who have completed the required training. Since FDA approval last year, Abbott requires physicians to undergo comprehensive training before they are able to implant Absorb to ensure proper implantation techniques.”
How an Abbott Absorb Stent Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If the maker of the Abbott Absorb stent fails to meet its duty, an Abbott Absorb Stent lawsuit could result.
With the help of an Abbott Absorb stent lawsuit attorney, people injured by a defective Abbott Absorb stent may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
For more information, contact Attorney Group. If you choose to pursue a claim, we can connect you with an Abbott Absorb stent lawsuit attorney who can assist you through the legal process.
After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.