FDA Warns Public Of Potential IVC Filter Side Effects As IVC Filter Lawsuit Cases Increase In Number
June 27, 2016 – – TheProductLawyers.com reports on adverse side effects related to the use of IVC filters as outlined in a U.S. Food and Drug Administration (FDA) public safety communication. The FDA has received approximately 920 adverse event reports related to the use of IVC filters and issued its public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include filter fracturing of the device and migration of the pieces, embolization of fractured device or device components, and tearing of the inferior vena cava vein.
Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.
IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.
In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.
For more information on IVC filters, to ask questions or to schedule a consultation, contact an attorney at Banville Law by calling (888) 997-3792.
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