Health Canada has issued a safety warning about a controversial device designed to block potentially deadly bloods clots, due to “serious complications” reported in dozens of patients.
As of June 6, Health Canada has received 121 serious incident reports involving inferior vena cava (IVC) filters, which are implanted into the largest vein in the body. Reported complications have included filter fracture, perforation of the vein or the heart, and even death.
The IVC filters are thin, metal devices that extend inside the vein like tiny umbrellas or spider legs. They are used to stop blood clots from travelling toward a patient’s lung or heart.
Lawsuits have already been launched in Canada and the U.S. against certain manufacturers of IVC filters. Some plaintiffs have alleged that the devices broke apart and became trapped in their bodies, causing potentially life-threatening situations.
Health Canada’s warning lists 12 retrievable and permanent IVC filters made by six different manufacturers. It says that many of the reported complications have occurred in patients who have had the filter implanted for longer than 30 days.
John Boehmer, a Gatineau, Que., resident, had a temporary IVC filter inserted to prevent blood clots from travelling through his body following a surgical procedure. But when surgeons tried to remove the filter eight months later, they discovered that it was stuck in the wall of Boehmer’s vein. One of the device’s thin legs had almost punctured his pancreas. Now, doctors can’t get the filter out.
“The source of all this, as far as I’m concerned, is the manufacturer,” Boehmer told CTV News.
“The device was supposed to be retrievable. It wasn’t. What’s your backup plan?”
Boehmer said he’s constantly anxious, wondering how the device that’s stuck in his vein will affect his health.
In light of ongoing concerns about IVC filters, doctors at Toronto General Hospital have become among the first in the country to start searching for all of their patients who may still have the filters implanted in their bodies.
“I think it’s also a duty of care for us to look at these filters that have been put in over the last 10 to 12 years and determine if there are filters out there that should be removed,” said Dr. Graham Roche-Nagle, a vascular surgeon at the hospital’s Peter Munk Cardiac Centre.
A study co-authored by Roche-Nagle showed that only about 41 per cent of retrievable IVC filters were successfully removed from patients at Toronto General Hospital over a 12-year period.
Doctors stress that the use of IVC filters is still essential in some patients with a high risk of blood clots, who cannot take pills to thin their blood.
But the message from Health Canada is clear – the filters should not stay in the body any longer than is necessary.
With a report from CTV’s medical specialist Avis Favaro and producer Elizabeth St. Philip
