July 26, 2016 — Health Canada has issued a Safety Warning about IVC filters and the risk of serious complications.
As of June 6, the agency has received 121 reports of serious complications associated with IVC filters. Many of these complications occurred with long-term use (greater than 30 days). Reported side effects include:
- Vena cava perforation
- Blood clots
- Filter fracture and embolization of fragments
- Migration to the heart
- Heart perforation
- Cardiac tamponade
Only two randomized controlled studies have investigated the safety of IVC filters. These studies did not show that IVC filters reduced the risk of venous blood clots or death, according to Health Canada.
The agency reminded doctors that IVC filters should only be implanted in patients with acute pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who cannot take a blood-thinner.
Health Canada also said temporary IVC filters are only intended for short-term use and they should be removed as soon as the risk of blood clots has passed. Hospitals are encouraged to identify all patients who have a retrievable filter and develop a strategy to asses these patients for filter removal.
In the United States, thousands of people have been injured by IVC filters. Over 1,500 lawsuits are now pending against C.R. Bard and Cook Medical, with the first trials scheduled for early 2017.
|ALN Vena Cava Filter||Retrievable||A.L.N|
|Denali Vena Cava Filter||Retrievable||Bard Peripheral Vascular|
|G2 Filter System||Retrievable|
|Simon Nitinol Vena Cava Filter||Permanent|
|VenaTech LP Vena Cava Filter System||Permanent||B. Braun Medical|
|Optease Vena Cava Filter||Retrievable||Cordis Cashel|
|Trapease Permanent Vena Cava Filter||Permanent|
|Option Retrievable Vena Cava Filter System||Retrievable||REX Medical, LP|
|Cook Celect Platinum Vena Cava Filter||Retrievable||William Cook, Europe APS And Cook, Inc.|
|Cook Celect Vena Cava Filter||Retrievable|
|Gianturco-Roehm Birds Nest Vena Cava Filter||Permanent|
|Gunther Tulip Vena Cava MREye Filter Set||Retrievable|
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