A recently issued letter to healthcare providers by the United States Food and Drug Administration (FDA) reveals a link between the use of paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of peripheral arterial disease (PAD) and the risk of mortality. The FDA’s letter was released following the publication of data in the Journal of the American Heart Association (JAHA) that suggests an increased risk of mortality in PAD patients two years after implantation of a paclitaxel-coated balloon and paclitaxel-eluting stent as compared to patients without implantation of such devices. The FDA has not identified a specific cause for the increased risk of mortality and is informing doctors to be aware of the link and to consider alternative treatment options for patients with PAD.
What Are Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents?
Paclitaxel-coated balloons and paclitaxel-eluting stents are Class III medical devices that require premarket approval (PMA) by the FDA. Such devices are considered life-saving, and as such, the FDA has stringent requirements that medical device manufacturers must meet to ensure the devices are safe and effective for their intended use. Paclitaxel-coated balloons and paclitaxel-eluting stents are marketed for the treatment of peripheral arterial disease (PAD), which is narrowing of the arteries that limits blood flow to the limbs. The balloon and stent are implanted to open the arteries and allow blood to flow more easily. The paclitaxel medication is released from the balloon and stent to ensure there is no scar tissue formation which can lead to re-obstruction (or re-narrowing) of the arteries.
The Failure of Life-Saving Medical Devices
When a medical device is used to treat a potentially life-threatening condition, such as PAD, patients and doctors trust that the medical devices will be safe for their intended use. When evidence comes forward that a life-saving device may cause more harm than good, doctors and patients are rightfully concerned. If patients have had a paclitaxel-coated balloon and stent used for treatment, they may be in fear that they will suffer fatal injuries two or more years following implantation of the product, fear that no patient deserves to experience.
Our legal system allows for injured patients and representatives of fatally injured patients to bring forward lawsuits against medical device manufacturers to hold them accountable for defective products they place on the market. After all, these medical device manufacturers are making billions of dollars, and money is often the primary goal. While there are responsible medical device manufacturers that care about safety, many products are pushed to market without safety being a number one concern. When safety falls by the wayside, patients suffer the consequences. The recent FDA letter to healthcare providers should help to ensure patients are fully aware of the risks associated with paclitaxel-coated balloons and paclitaxel-eluting stents, helping them to make an informed decision about whether alternative treatment options would be more beneficial in the long run.
Contact Parker Waichman LLP Today to Schedule a Free Consultation
If you have learned that you have a potential legal claim concerning a paclitaxel-coated balloon or stent for the treatment of PAD, you should consider speaking with a Defective Medical Device Lawyer right away to discuss your situation. At Parker Waichman LLP, our team of legal professionals has extensive experience handling complex defective drug and medical device cases. To schedule a free consultation, contact Parker Waichman LLP today by calling (800) YOUR-LAWYER (968-7529).
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