FDA warns of potentially deadly complications associated with blood clot filter implants

Fort Lauderdale women shares nightmare experience

One South Florida woman is sharing her nightmare story about a medical device she says nearly killed her.

The device is called an IVC filter. They're implanted in the main artery beneath your heart and lungs to protect them from blood clots. More patients across Florida and across the country are finding the devices may be more dangerous than the clots themselves. 

“Awful lot of pain, you know, imagine a balloon getting stretched,” says Clare Austin of blood clots cutting off circulation to her arms and legs. She has a blood condition that creates clots for virtually no reason.

“(Doctors) determined that it was safer to have a filter put in place,” said Austin.

Doctors implanted an IVC filter, made by Bard Medical, in the fall of 2010. By 2013 Austin new she had a problem.

“Can you describe the pain at all?” asked Contact 5 Investigator Jared Werksma.

“It's like a knife being pushed into your stomach,” said Austin. Her IVC filter had turned sideways. One of several potential problems with the devices the FDA has warned of since 2010.

“Thankfully my parents were here,” Austin said holding back tears. “They came and took care of me because I couldn't do anything, I couldn't move.”

Austin says the condition continued to worsen, until the filter perforated her artery and punctured her pancreas.

“I was in a position of, you can either leave this (in) and maybe die or you can try doing the surgery,” said Austin, who elected to take her chances in surgery.

After surgery she reached out to West Palm Beach Attorney Joe Johnson.

“By the time Clare reached out to me I had been involved in this litigation against Bard for quite some time,” says Johnson.

“How many people are walking around with these things in their chests?” asked Werksma.

“I believe that there are probably at least 100,000 of those filters that were implanted in people,” said Johnson. “They have a failure rate of more than 50 percent,”

”Where are you getting that number?” asked Werksma. “From Bard's documents,” Johnson replied.

Austin says she still struggles with pain from surgery to remove the IVC filter which was nearly two years ago now. Austin says surgeons had to make, approximately, a 10-inch incision in her belly to remove the filter which had twisted itself puncturing through the walls of the artery where it was implanted

“When I woke up I was in horrendous pain. A few days later when I finally saw the incision that was unbelievable,’ says Austin.

Austin says she can't undo the past but she is hoping her lawsuit against Bard Medical will help to make IVC filters and all medical devices safer in the future.

“They need to take responsibility for what they've done,” said Austin.

We reached out to Bard Medical for response to this story and they sent us the statement below.

“Bard is committed to ensuring the safety of our devices and the patients we serve. Bard filters undergo a thorough battery of testing in compliance with federal law, and are evaluated by the U.S. Food and Drug Administration (FDA) before reaching the market. They are implanted by physicians only after careful consideration of the risks and benefits of the device in light of each patient’s condition. As part of our commitment to safety, we conduct ongoing education and outreach to physicians and hospitals to help ensure the safe and appropriate use of our filters. While we can’t speak to the specific details of individual patient experiences, when used as instructed Bard IVC filters have a safety profile consistent with the medical guidelines published by the American College of Radiology (ACR) and Society of Interventional Radiologists (SIR).”

The FDA now recommends only using IVC filters on a temporary basis to protect against blood clots if medications and other remedies are not effective. Anyone with an IVC filter with questions should consult their physician. 

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