FDA Issues Public Safety Warning Regarding Potential Risks Of IVC Filters, As IVC Filter Lawsuit Filings Increase

June 27, 2016 – – TheProductLawyers.com reports on IVC filters and the increasing controversy surrounding their use which has increased tremendously in recent years. In 2012 approximately 259,000 implantations of the device have occurred, as compared with only 2,000 in 1979 when the devices were first FDA approved.

The IVC filter is a small cage-like device that is surgically implanted and is designed to capture blood clots emanating in the legs moving toward the heart and lungs, where they could precipitate a pulmonary embolism. The filter retains the clot until it dissipates and according to the FDA is only to be used temporarily until the risk of blood clots disappears.

The filters have become the focus of lawsuits claiming the devices were defectively manufactured by several different manufacturers and that the devices can fracture into pieces. Allegations have been made that the pieces then migrated to other parts of the body that are considered “high risk,” such as the intestines or other organs, thus preventing their removal and causing significant and life-threatening risks to the patient.

The FDA has issued a public safety warning about the devices after the agency received a significant number of patient adverse event reports in excess of 920. The FDA communication was designed to warn patients and medical professionals of the potential dangers of using the devices. The FDA also reminded the public that the devices needed to be removed as soon as feasibly possible when the threat of the development of blood clots was no longer an issue.

The FDA has stated that the adverse reports include claims such as fracturing and migration of the filter, embolization of the pieces, and tearing of the inferior vena cava. The FDA has asked that patients be keenly aware of any symptoms of possible movement of the pieces such as pain in the chest, palpitations of the heart, out of the ordinary heart rhythms or fainting.

To request more information, or to ask questions, please contact the attorneys of Banville Law by calling (888) 997-3792.

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