What are IVC Filters and how can they result in an IVC Filter Injury?
An IVC filter is a small medical device, shaped like a tiny cage with spider legs, which is implanted into patients to decrease the chances of a blood clot. Unfortunately, in a significant number of patients, IVC removable filters are not removed in a timely fashion, causing serious IVC filter problems. As of 2015, IVC retrievable filters had been on the market for approximately a dozen years, and the FDA had received more than 1000 adverse event reports regarding IVC filter FDA safety concerns. In fact, only about a third of removable IVC filters are ever removed, placing patients across the nation at serious risk.
What is the FDA Stance on IVC Filters?
Regarding IVC filters and the Food & Drug Administration, the first retrievable IVC filters received FDA approval in 2003 and 2004, yet between the years of 2005-2010, the FDA received 921 adverse event reports related to retrievable IVC filters. Of these adverse event reports sent to the FDA, 328 were for migration, 56 involved filter fracture, 146 involved embolisms and 70 involved IVC filter perforations. The FDA stance on IVC filters held that these adverse events may have been linked to a retrievable IVC filter being left in a patient’s body far past the time when an embolism risk was present, and their recommendations are that the filters be taken out as soon as the risk for blood clots has passed.
Have there been any IVC Filter Injury FDA Warnings and are these Warnings Adequate?
In 2010, IVC Filter FDA warnings were issued which noted concerns that filters which were intended for short-term placement were not being removed in a timely fashion. Many believe these IVC Filter FDA warnings are simply not adequate when you consider the number of patients who have suffered serious injury or death from an IVC Filter. (According to an NBC News report, twenty-seven deaths have been associated with IVC retrievable filters).
When you consider the deaths and injuries associated with IVC removable filters, you may wonder why the FDA approved the filters in the first place. Like many drugs and medical devices, IVC filters seemed to offer patient benefits during the FDA approval phase, then later were found to potentially harm patients, perhaps resulting in more adverse events than positive results. Among the IVC filters approved by the FDA are: Boston Scientific’s Titanium Greenfield, Cook Medical’s Cook Celect, C.R. Bard’s, G2, Boston Scientific’s Stainless Steel Over-the-Wire Greenfield, and Cook Medical’s Gunther Tulip.
Have there been IVC Filter FDA Notices and IVC Filter FDA Safety Communications?
In 2014 an IVC Filter FDA safety communication was issued which cautioned patients with retrievable IVC filters to have their IVC filter removed as soon as the risk of blood clots had subsided. An IVC filter FDA warning letter to Bard came after FDA inspectors visited the Bard facilities in Arizona and New York. The FDA told Bard in the letter that failure to correct the noted violations (reporting of deaths, serious injuries and malfunctions related to the IVC filters) could result in injunctions and other penalties.
Have there been any IVC Filter Clinical Studies?
A confidential study was commissioned by Bard, which concluded the Bard Recovery IVC filter had higher rates of filter fracture and death than those of all Bard’s competitor’s IVC retrievable filters, and the doctor hired by Bard to conduct the study wrote, “further investigation is urgently warranted.” Despite this, Bard did not recall the Recovery IVC retrievable filter from the market, but rather replaced it with a similar G2 series model after it had been sold for more than three years.
Unfortunately, the hundreds of adverse event reports sent to the FDA show the G2 series failed to solve the filter’s many problems.
In 2013, The Journal of Vascular Surgery: Venous and Lymphatic Disorders published an article on IVC retrievable filters which stated the risk/benefit profile would be greatly enhanced if the retrievable filters were actually removed as they should be from between 29 and 54 days following implantation. Some IVC filter manufacturers are currently participating in a study known as PRESERVE, which examines the use of IVC filters to prevent pulmonary embolism.
In December 2005, a Bard vice-president noted in a confidential memo that “problems with…migration, tilting and perforation,” existed in the G2. A later document showed the G2 series retrievable filters had more problems, including fractures and migrations, than any of the competitor’s models. An independent study asked the question: What is the evidence basis for using IVC filters?
The study, published in JAMA, involved 400 patients with proximal DVT who were considered to be at a high risk of pulmonary embolism. Among the patients who received an IVC filter it was found there was no significant benefit in terms of mortality or in symptomatic pulmonary embolism. There was an increase in recurrent DVT noted in patients who received a filter, and there was a 43 percent rate of IVC filter thrombosis among study patients.
What About an IVC Filter Potential Recall?
Many wonder, in light of IVC Filter Clinical Studies and IVC Filter FDA warnings, whether there will be an IVC filter potential recall. While an IVC filter potential recall has certainly been called for—and some IVC manufacturers have been forced to pay IVC filter settlements—there is no indication the FDA has plans to remove IVC retrievable filters from the market. It appears the FDA’s stance on IVC filters is that the safety of the filters can be improved through tighter regulations and stronger warnings. If you or a loved one have IVC filter safety concerns, and questions about whether your injuries are related to an IVC retrievable filter, it could be beneficial to speak to an IVC filter injury attorney.