FDA Warning has Some Stent Patients Worried

Web Producer: Brad Maglinger

Patients with coronary artery disease usually get a stent or a sort of metal spring to open up clogged vessels. However, 30 percent would eventually have to get another one because their vessels would become blocked again.

The new cypher stents brought that number down to just five percent. But now, some are hesitating to call it a miracle device.

Joan Welch recently got quite a scare when she read the morning paper. "It says FDA issues a new warning about popular heart stent and I thought, 'Oh no!'"

Joan just had the cypher stent put in last summer and now the FDA is reporting nearly 60 patients have died from it.

Cardiologist Dr. Sanford Schen says, "The numbers are extremely small. So, I don't know that everybody should be alarmed."

The director of St. Mary's cardiac cath lab says 60 people may have died and another 290 have experienced blood clots, but that's not a lot considering more than half a million cypher stents have been distributed around the world.

A stent is a wire coil that's inserted into the arteries to prop them open. The new cypher stents were coated with medication to help reduce the build-up of future plaque or scar tissue.

Because of that innovation, Dr. Schen says some doctors may not have stressed the importance of taking blood-thinning drugs to patients after they had the cypher stents implanted. He suspects that may have led to their deaths.

"I think we plan to continue to use the stents in those specific cases that require this kind of therapy, just as if we had done it before, with or without the FDA warning," says Dr. Schen. "We may be a lot more careful in making sure that everybody gets enough anti-coagulation, but I don't think it's going to change our practice."

Dr. Schen also says Joan shouldn't worry. She's taking blood-thinning medication, and she's had her stent for several months now. Most patients experience complications within the first few days after surgery.

The FDA warning is simply for doctors to be on the lookout for cases of blood clots. The agency stopped short of saying there was a problem with the cypher stent, and emphasized they are investigating the situation.

Dr. Schen says the FDA issues several warnings a day.