The FDA has moved in to investigate Boston's Scientific's limited recall of the Taxus drug-coated stent, to make sure that the company has done enough to assure that patients are being adequately protected.
The problem with the Taxus stent has to do with the insertion procedure. Stents are "deployed" by placing them via catheter within a coronary artery plaque, then expanding them against the plaque by blowing up a balloon. Once the stent has been expanded (in order to compress the plaque and hold it into place,) the balloon is deflated and the catheter is removed. Apparently, in some patients receiving the Taxus stent, doctors have been unable to deflate the balloon after expanding the stent - these patients have required emergency bypass surgery.
Originally, Boston Scientific attributed the problem to doctors' insertion techniques. Later, they discovered a problem with the delivery system itself, and recalled 200 stents. Still later, they expanded the recall to over 80,000 stents possibly affected by the problem. Apparently, over 50,000 stents not covered by the recall have been shipped.
In the meantime, several prominent cardiologists and hospitals have either completely suspended the use of the Taxus stent, or have severely curtailed using it, until they are sure the problem has been fully resolved. Some have complained that, given the company's stuttering approach to solving this problem (first "blaming" doctors, then recalling a few stents, then recalling many more stents,) they are not completely confident the problem has been fully characterized and dealt with. The FDA, wishing to resolve the issue once and for all, has now stepped in.
What this means
While it seems very likely that Boston Scientific is fully on top of this issue, one must admit that their step-wise handling of this problem might not inspire confidence, and thus it might not be unexpected that doctors would avoid using this stent until they are sure that no more shoes will drop. (The company's initial and incorrect "take" that the problem was caused by physician error did not do much to encourage docs to give them the benefit of the doubt.) The FDA's stepping in is thus an important move in restoring everybody's confidence in the Taxus stent.
Doctors avoiding the Taxus stent for now will most likely switch back to the Cypher drug-coated stent (Johnson & Johnson). Ironically, the main reason many doctors embraced Taxus when it became available was that it was considered easier to deploy than Cypher.
In the meantime, there is no reason to be concerned if you already have received a Taxus stent. The problem here has been with the placement of the stent, not with the stent itself. Once successfully deployed, the Taxus stent functions as designed.
