Metal Airway Stents Can Cause Problems - U.S. FDA

WASHINGTON (Reuters) - Metal stents used to prop open the airway can cause infections, throat constriction and obstructive tissue if used to treat certain benign disorders, U.S. regulators said in a letter to doctors released on Wednesday.

The U.S. Food and Drug Administration said it alerted physicians after receiving at least 60 reported problems with such stents and was working with makers of the device to change product labels to make sure they "adequately convey the risks."

Boston Scientific and C.R. Bard Inc. both manufacture the device, according to the FDA. Privately held firms including Cook, W.L. Gore, and Alveolus, also produce it.

Boston Scientific spokesman Paul Donovan said the company's label was adequate. "Our existing label language is in agreement with FDA's recommendation," he said.

A C.R. Bard spokeswoman did not return a call seeking comment.

Stents are short mesh-like tubes made of plastic or metal that work like scaffolding to open up arteries and other passageways in the body. Metallic tracheal stents are used to help prop open the airway.

Agency officials said using them to treat patients with disorders from accidents, surgery or other noncancerous causes could lead to complications preventing them from getting other treatments.

The FDA said it came to the conclusion after reviewing reports it received on the device, professional journal articles and information from doctors.

Agency spokeswoman Julie Zawisza said the FDA was still reviewing its own reports but had received about 60 reports, though some included more than one patient "so the real number is actually higher."

About 40 to 50 incidents were reported in the medical literature, she added.

"Although many of the medical device reports received by the FDA are associated with stent fracture, we believe that other complications cited in the literature are a potential risk with both covered and uncovered metallic tracheal stents," the FDA said in a letter to doctors posted on its Web site.

"We recognize that metallic tracheal stents, when used appropriately on carefully selected patients, have benefit," the letter said.

But for benign problems, the FDA said stents should not be used as a temporary measure because they can be hard to remove.

The agency also recommended that all other options, including surgery or silicone stents, are considered before using the metal stents. If they are the only option, the FDA said only doctors trained and experienced to use them should insert or remove them.