Deep vein thrombosis and pulmonary embolism are serious health risks for older people. DVT usually occurs when a blood clot forms within the leg or pelvis. When this blood clot breaks free, it can travel through the vein to vital organs like the lungs and cause a blockage. This is called a pulmonary embolism (PE). The Centers for Disease Control and Prevention estimate 60,000-100,000 people die from DVT or PE each year. To prevent PEs, doctors will often implant a device into the inferior vena cava (the largest vein in the abdomen). This instrument, known as an IVC filter, is a cage-like device that traps blood clots before they can travel to your lungs and other organs. Unfortunately, IVC filter risks may outweigh their benefits.
Observing this device at face value, it appears as though it would benefit any patient who uses it. However, many patients have experienced adverse side effects after having the instrument implanted. If a temporary IVC filter’s left in too long, it can cause complications that make device retrieval more difficult. Other possible IVC filter risks and side effect complications include:
- Device migration
- Tool fracture
- Inability to retrieve appliance after use
When using terms like device migration and perforation, people don’t always understand the full impact they can have in a patient’s body. Here’s what consumers need to know about IVC filter risks and quality violations.
IVC Filter Risks
When a device migrates, it moves away from the point of initial implantation. The IVC filter, which is meant to stop blood clots from traveling to vital organs, will sometimes migrate to those organs. In one case, a 69-year-old man’s filter migrated to his right ventricle, reported the Texas Heart Institute Journal. This caused non-sustained ventricular tachycardia in that patient. The journal Medical Clinics describes NSVT as three or more consecutive ventricular complexes greater than 100 beats per minute. NSVT is one early warning sign for increased cardiac arrest risks or other major health problems. Luckily, doctors identified the device and promptly removed it.
Among the more serious IVC filter risks is device perforation. When perforation occurs, one or more of filter prongs can puncture the inferior vena cava. One 27-year-old man experienced incessant abdominal pain after implantation. He later had it removed when doctors discovered the filter punctured his vein, causing gastrointestinal bleeding, the International Journal of Angiology reported.
Since winning the U.S. Food and Drug Administration’s approval in 2003, the agency issued many warnings about IVC filter risks. On top of these warnings, many people filed lawsuits against various IVC filter manufacturers.
IVC Filter Risks Linked to Quality System Violations
C.R. Bard manufactures IVC filters. Plaintiffs injured by IVC filters are filing personal injury lawsuits are underway against Bard for their pain and suffering. The FDA issued Bard a warning letter about device manufacturing violations on July 13, 2015. One of these infractions broke the FDA’s Quality System regulation. This system monitors good manufacturing practice requirements, production methods, facilities, etc. This process also examines how businesses evaluates consumer complaints, and the FDA discovered major errors with Bard. According to the FDA letter, Bard failed to establish proper procedures for receiving, reviewing and evaluating complaints. This means Bard’s customers reported concerns, yet the company never addressed them.
If Bard implemented stricter procedures, they may have identified dangerous device issues much sooner. Bard also could’ve provided better warnings about IVC filter risks to the public.
What You Can Do
The harmful side effects associated with IVC filters have caused a lot of pain for people, physically and emotionally. When a device migrates to a different location, punctures the IVC or breaks apart, you may need surgical removal. Surgery is dangerous for older patients, as is having a medical device floating through the body, both of which can cause premature death. A lot of the time, it is also difficult for these devices to be removed, requiring either multiple surgeries or the instrument to be left in, increasing risks. Extra surgeries are not only dangerous, they’re also extremely expensive. If you or a loved one has adverse IVC filter side effects, you may qualify for compensation. Contact an attorney today to discuss your options for getting justice and the pay you deserve.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.