A woman who lives in South Florida says she was the victim of serious complications brought forth by a medical device known as an IVC filter and wants to make other aware of the FDA blood clot filter warning.
An IVC filter is a small cage-like device that is implanted with in the inferior vena cava of the body.
This device is made to “catch” blood clots as they travel from the lower veins of the body, preventing them from reaching the lungs or the heart and causing additional serious damage.
Clare A. has chosen to share her story to inform other patients who have IVC filters as well as those considering implantation of an IVC filter that they should take the blood clot filter warning issued by the FDA seriously.
Clare suffers from a condition where her body creates blood clots for essentially no reason that can be determined.
These blood clots have cut off circulation to both her arms and legs. The blood clots have caused an “Awful lot of pain, you know, imagine a balloon getting stretched,” says Clare.
After visiting her doctor for the pain caused by blood clots, Clare said that the doctors “determined that it was safer to have a filter put in place.”
In the fall of 2010, Clare had an IVC filter implanted, manufactured by C.R. Bard. In 2013, she claims she suffered additional problems as a result of the placement of the device.
When asked to describe the resultant pain she attributed to IVC filter problems, Clare said, “it’s like a knife being pushed into your stomach.”
Clare had suffered the results of having her IVC filter tilt sideways. This complication has been known by the FDA since 2010 when they issued a blood clot filter warning to patients informing them of the possibility of filters turning sideways.
Clare recalls, “Thankfully my parents are here. “Both took care of me because I couldn’t do anything, I couldn’t move.”
She says that her pain kept worsening, and the IVC filter ultimately perforated her artery and caused her pancreas to be punctured.
“I was in a position of, you can either leave this (in) and maybe die or you can try doing the surgery,” Clare says.
She ultimately decided to have surgery to remove the IVC filter and contacted a personal injury lawyer shortly thereafter.
Clare’s attorney said he had been involved in the IVC filter litigation against C.R. Bard for a while.
Based on his research, the lawyer claimed “I believe that there are probably at least 100,000 of those filters that were implanted in people. They have a failure rate of more than 50 percent.”
Following her surgery, Clare says she continues to struggle with the pain of her surgery to remove the IVC filter.
She currently has a ten inch scar left behind from the incision that the surgeons needed to make to retrieve the device.
“When I woke up I was in horrendous pain.” Clare remembers. “A few days later when I finally saw the incision that was unbelievable.”
Although she understands her lawsuit can’t take away her previous pain and suffering, she hopes that it will hold the manufacturer accountable and will force device manufacturers to make safer medical products in the future.
She hopes that her actions will support the seriousness of the blood clot filter warning issued by the FDA.
The blood clot filter warning set forth by the FDA tells physicians and consumers that IVC filters should only be used on a temporary basis.
They should be used as more of a “last resort” to protect patients if other medications and remedies have been tried and are ineffective.
The FDA blood clot filter warning lists a number of adverse events that have been associated with the placement of IVC filters.
The FDA website states, “Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device.”
In general, IVC filter lawsuits are filed individually by each plaintiff and are not class actions.
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