An increasing number of IVC filter cases against Bard are demonstrating just how dangerous its implants can be. In particular, the Recovery implant, G2 implant, and G2 Express implant have all demonstrated dangerous tendencies. What’s worse, it appears the manufacturer may have used underhanded tactics to get the device approved by the FDA in the first place. But with a constant stream of adverse reports flowing into the FDA, it’s clear that the device can cause serious side-effects in patients.
WHY IS THERE A GROWING NUMBER OF IVC FILTER CASES AGAINST BARD?
The company’s implants are designed to be placed in the inferior vena cava, a large vein that transports deoxygenated blood to the heart from the bottom half of the body. It is an exceptionally important circulatory highway, but one prone to ferrying blood clots to the heart, where they can cause life-threatening complications. Normally, anticoagulant medications are prescribed to thin the blood and prevent clots from forming, but sometimes those drugs are not safe to use in a patient. When facing this situation, some doctors will choose to implant a device that catches the clots before they reach the heart, holding them until they dissolve and disappear.
These implants were first approved by the FDA in 2003 and gained in popularity over the years. In 2010, though, the FDA released a safety report regarding the IVC filter, and many cases against Bard cite this safety report in their arguments. The FDA tracks adverse reports with every approved medication and medical device in the hope of catching side-effects before they can cause too much harm. In the implant’s case, the FDA has noted many instances of the device migrating, fracturing, or becoming an embolism itself. In other words, the device can become loose in the bloodstream and act like a clot itself, which can result in a life-threatening emergency if the device reaches the heart. The implant also carries a risk of puncturing through the vessel walls or increasing the chances of developing deep vein thrombosis.
In 2013, the FDA published a decision analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders. According to its analysis, doctors should seek to remove the implant as soon as the risk of pulmonary embolism has subsided. A risk/benefit analysis found that the device is best removed between 29 and 54 days after implantation, a timeframe that many doctors have not adhered to with their patients.
Another troubling element of IVC filter cases against Bard is how the company got their product approved in the first place. The company apparently knew the risks of its implant as far back as 2002, when it hired a regulatory specialist to help push the product through the FDA. The specialist’s name was Kay Fuller, and after independently analyzing the device, she determined it was not safe enough to market. That didn’t stop the company, which may have forged Fuller’s name on an application for the device’s approval. Fuller claims she never signed anything for the company.
Serious civil, and possibly criminal charges, will result from IVC filter cases against Bard. Patients using or considering an implant should talk to their doctor right away about its benefits, and whether or not it is worth the risk.