Claire Austin describes the pain she experienced from a medical device implanted in her main artery to protect her heart and lungs from blood clots as “a knife being pushed into your stomach.”
The device, known as a Retrievable IVC Filter, is used when blood thinners are not an option. Permanent IVC Filters have been on the market since the 1960s and have a proven track record of safety and efficacy.
In 2003, in an effort to expand market share, manufacturers began marketing Retrievable IVC Filters for blood clot treatment in patients undergoing bariatric, trauma, orthopedic surgeries and other treatments. Since then, the Food and Drug Administration (FDA) has issued several advisory and warnings regarding safety and efficacy of Retrievable IVC Filters.
Risks include migration of the filter from its intended position in the artery, making it difficult to remove. The device can perforate and become embedded in the heart, lungs, other organs, or the spine. They can also embolize to the heart, lungs, liver or other organs.
Claire was diagnosed with a blood condition in which her body produces blood clots for virtually no reason. Her doctors determined that it was safer for her to have a filter. She says she had no idea of the risks the device posed.
In 2010, Clare was implanted with a Retrievable IVC Filter manufactured by Bard Medical. Three years later, she began experiencing extreme pain. Her IVC filter had turned sideways and eventually perforated her artery and punctured her pancreas.
“I was in a position of, you can either leave this (implanted) and maybe die, or you can try doing surgery (to remove the device),” she told ABC 15. She decided to try surgery.
Two years post surgery, Clare says she still experiences pain from the 10-inch incision in her abdomen to remove the IVC filter. She has filed a lawsuit against Bard hoping Bard and other manufacturers take responsibility for their allegedly defective devices.
Source: ABC 15