The device included in the two recent studies (reported on by Bloomberg Businessweek; 10/25/12), is not the same as the St. Jude Silzone heart device. The studies, which were presented at the Transcatheter Cardiovascular Therapeutics conference, found the St. Jude Amplatzer PFO Occluder was no more effective at preventing repeat strokes than drug treatment, although in one study the effectiveness of the device increased when researchers adjusted for dropout rates.
The strokes that patients with the PFO Occluder experienced were not fatal strokes and physicians have said they would still like the option of using the Occluder on patients for whom it could be effective.
In January 2000, St. Jude Silzone mechanical heart valves were recalled after reports surfaced that the silver coating on the valves could leak, potentially causing heart failure. When the recall was announced, St. Jude recommended patients who had the device implanted only have it removed if they suffered complications, because of the risks associated with surgery to remove the valve.
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As recently as July, 2012, the FDA received an adverse event report from a patient who had the St. Jude Silzone valve replaced—for unknown reasons—with another manufacturer's valve. The surgery occurred without complications. It is not known whether the valve was taken out because of adverse effects or because the patient simply wanted a different valve.