Boston Scientific Stents have been known to cause serious or even fatal side effects when the balloons used to insert the stents failed to deflate. If you or a loved one have been injured by Boston Scientific Stent malfunction you may be entitled to compensation.

Boston Scientific Stent Recall:

In July and August of 2004, Boston Scientific issued a recall of 99,200 stent systems after three people died and dozens were injured when balloons used to insert the stents failed to deflate.

At the time, the company said it was getting deflation complaints at a frequency of approximately one in every 10,000 stents. Boston Scientific said it identified and fixed the manufacturing flaw that led to the defect and that its goal was to lower "complaint rates for no deflates" to less than one in 100,000.

Then in August of 2004 Boston Scientific and the Food and Drug Administration (FDA) issued a recall of the "Express" and "Taxus" stents. The recall was issued as a result of several deaths and dozens of injuries.

Since the 2004 recall doctors have continued reporting injuries during the implantation of cardiac stents made by Boston Scientific Corp., many of them linked to a problem that preceded a voluntary temporary recall of the devices last year.

Balloons used to deploy the stents -- small, wire-mesh tubes inserted into clogged arteries to open them up -- failed to deflate or were so hard to remove that three people died and dozens more were injured during operations performed after the 2004 recall, according to Food and Drug Administration records.

A review of the FDA data shows that between last Oct. 1 and April 1, the agency received at least 45 reports of deflation difficulties with Boston Scientific stent balloons. In 86 other cases, doctors reported that the balloons became stuck or otherwise were difficult to withdraw from a patient's body.

The problems leading to injuries were detailed in "adverse event" reports submitted to the FDA voluntarily by doctors. In most cases, those reports came through the company, as often happens. A spokeswoman for the FDA said the agency had conducted a "preliminary" assessment of Boston Scientific's post-recall stents and concluded "the level of adverse events reported" during the period was "consistent with our expectations for this type of product." The spokeswoman said the recall last year was tied to a specific manufacturing flaw, but the recent reports "represent a wide variety of causes" and that the agency is monitoring the reports.

Of the 45 recent deflation problems reported to the FDA, 43 occurred with the Taxus Express, the most widely used of the two Boston Scientific stents recalled last year. The stent system in question, a Taxus Express, was assembled after last summer's recall, in December 2004. The others occurred with the Taxus Liberte, a newer model sold outside the U.S. , which wasn't recalled.

What are Stents used for?
Stents are inserted during procedures in which doctors thread a thin tube, or catheter, down a patient's groin or arm artery. When the clogged area is reached, the stent, located at the tip of the tube, is expanded into place by streaming liquid into an inflatable balloon that sits inside. Once the stent is deployed, the balloon is deflated within seconds and removed. If the balloon doesn't deflate properly, blood flow can be impaired, causing problems.

Boston Scientific Stent News

If you or a loved one have been injured as a result of a Boston Scientific stent malfunction you need to know your legal rights as you may be entitled to compensation. Contact the Boston Scientific Stent attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Boston Scientific stent recall, a possible Boston Scientific stent class action lawsuit, or any other type of Boston Scientific stent litigation.

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