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Wayne Parsons
Wayne Parsons
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Hawai‘i defective product alert – some blood clot filters are unsafe

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Hawai‘i has an aging population that, although healthier than the national averages, face the normal health problems of aging including heart problems. As heart problems develop over time one of the greatest risks facing the patient is pulmonary embolism (PE) when a blood clot from the legs travels to the lungs. Untreated the condition can have as high as 30% mortality. Treatment usually starts out with anticoagulation medication (blood thinners) but some patients find that treatment to be ineffective and if the risk of PE is high, one treatment option is to place a filter in the inferior vena cava that will catch the clot before it can do damage to the patient’s heart.

Cross section of inferior vena cava showing filter in place catching blood clot. Locator shows body outline with heart, lungs, kidneys, inferior vena cava, and box to show location of filter in inferior vena cava near heart.

A number of filter devices have been invented, tested and put on the market. Many Hawai‘i residents have received such a device. Some of these devices have flaws that have led to patient death or severe injury.

Judith Walsh, MD, MPH is a Professor of Medicine, Division of General Internal Medicine, Department of Medicine, University of California San Francisco and she wrote an article on this subject entitled “Safety and Effectiveness of Inferior Vena Cava Filters Used to Protect Against Pulmonary Embolus: A Technology Assessment“.

Dr. Walsh explains in her article that “retrievable” IV filters have added risks:

More recently, retrievable filters have been introduced. “Retrievable” filters are filters that can be placed in patients at high risk for PE and then removed later when the risk has decreased. There are different types of retrievable filters, G2 and G2X, manufactured by Bard, OptEase, manufactured by Cordis and Gunther tulip and Cook Celect, manufactured by Cook. Although the devices are designed to be retrievable, retrieval can be difficult and is not always successful. In a recent study of 240 patients who underwent placement of IVC filters, only 73 (30.4%) had documented plans for filter removal and of 62 who underwent attempted filter retrieval, 25.8% of filters could not be successfully removed [Mission, JGIM 2010: (25 (4): 321–5]. The recommended duration of use varies for each manufacturer, but the longer a filter is in place, the more difficult it is to remove. Filters that are not removed stay in place and may be associated with potential complications.

The FDA has been involved since 2005 and before about whether certain devices are safe including the Bard G2 and G2X retrievable filters:

In August of 2010, the FDA reported that since 2005, they had received reports of 921 IVC filter adverse events. The complications included device migration (n=328), embolizations/device component detachment (n=146), IVC perforation (n=70) and filter fracture (n=56). Some of these adverse events were associated with adverse clinical outcomes. Some of the adverse events may also be related to retrievable filters not being removed and staying in past the time when the risk of pulmonary embolism has subsided.

Dr. Walsh reported on a review of patients who had problems with an IV filter:

One important recent study evaluated the potential adverse effects of filter placement and focused on the prevalence of fracture and embolization of the Bard Recovery and the Bard G2 vena cava filters (VCF) Nicholson, 2010.[28] Eighty patients who had filters inserted between 2004 and 2009 had fluoroscopy to assess the filter’s integrity. Patients who had fragment embolization underwent echocardiography and cardiac computed tomography. Of the 80 patients, 13 (16%) had at least one strut fracture. Among the 28 Bard Recovery filters, seven (25%) had a strut fracture with embolization. The strut embolized to the heart in five out of seven cases. Three patients had life threatening ventricular arrhythmias or tamponade. There were 52 Bard G2 filters. Six of them (12%) fractured. Two of the six had embolization to end organs although they were asymptomatic. The results of this study show that there are potentially major complications associated with vena cava filters. Although actual population prevalence cannot be estimated from a retrospective study, the relatively high incidence of complications, some of them life threatening, is concerning.

The FDA sent a Warning Letter to Bard on July 13, 2015 stating that, among other things, the “FDA has learned that your firm manufactures the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h) .. .” In 2014 doctors were made aware that the removable Bard IV filters should be removed from patients to avoid the problem of fractured parts.

Bard 2015-09-02T22-41-27-833Z--1280x720_video_560x315

Noted medical device lawyer Shezad Malik, MD, JD reported in “New York Bard IVC Filter Migration & Perforation Lawsuit” that:

Recently, an NBC News Investigation raised questions about the Bard Recovery blood-clot filter, a medical device implanted in thousands of Americans at risk for blood clots.

The television program, aired in 2 episodes, noted that the device was linked to at least 27 deaths and over 300 other non-fatal injuries. The second report questioned how the filter device received FDA clearance and alleged that a key signature on the application may have been forged.

The two-part NBC News story Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?”