Baron & Budd Attorney and Shareholder Burton LeBlanc to Speak on Opioid Epidemic at American Association for Justice
BATON ROUGE, La. – November 17, 2017 – The national law firm of Baron & Budd is pleased to...READ MORE
The U.S. Food and Drug Administration (FDA) has actually had quite a bit to say over the last few years regarding the use of IVC filters.
In 2010, the FDA reported 921 incidents of adverse effects suffered by patients who had an IVC filter implanted to reduce the chances of blood clots traveling to their lungs, a condition known as a pulmonary embolism (PE). Of those events, 328 were linked to migration of the device to another area of the body. As a result, the FDA recommended that doctors consider taking the filter out as quickly as possible after the threat of a PE subsides. In May 2014, the agency updated that warning to recommend doctors remove IVC filters between 29 and 54 days after implantation, or as soon as possible after protection from a PE is no longer needed.
The FDA then sent a warning letter to IVC manufacturer C.R. Bard in July 2015, stating that the company’s IVC filter retrieval system had been neither cleared nor approved by the agency. The letter also alleged that Bard had committed several violations regarding the marketing and manufacturing of its filters. These violations included:
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