Thousands of people across the nation have undergone inferior vena cava (IVC) filter surgery to prevent blood clots from entering the lungs — known as pulmonary emboli. An IVC is a type of vascular filter implanted by vascular surgeons or interventional radiologists to prevent life-threatening pulmonary emboli. The inferior cava, a large vein in the middle of the body, is an important blood vessel that brings oxygen-poor blood and waste products back to the heart. Deep vein thrombosis (DVT) is a blood clot that forms in a vein within the body. DVT happens when the blood thickens, forming a clump. More often than not the blood clot forms in a deep vein of the lower leg or thigh. Because a DVT may damage or weaken a vein, the blood clot may move and enter the lungs. This results in a pulmonary embolism — an extremely dangerous medical condition. One way to help prevent pulmonary embolisms is to surgically implant an IVC. When the IVC filter, which is a small and wiry device, is placed in the inferior vena cava the blood flows through the filter which catches the blood clots and prevents them from moving into the heart and/or lungs.
The Need for IVC Filter Placements
There are many reasons why a patient may need placement of an IVC filter. One reason is if you have a DVT or pulmonary embolism — or have had either in the past. Another reason for an IVC filter is if the patient is at a high risk of suffering a DVT. Because anything that slows the flow of blood through your veins increases the risk of DVT, there are several medical conditions that could increase a person’s risk. These include, but are not limited to:
- Treatment for cancer;
- Long periods of travel that limit mobility;
- An injured deep vein in the leg(s);
- Older age;
- Recent surgery;
- Mobility-limiting medical conditions; and
- Inherited blood disorders.
Anticoagulants — commonly referred to as blood-thinning medicines — such as warfarin are also used to treat patients who are at high risk of pulmonary embolism. That being said, studies show that blood thinners, in and of themselves, are not enough to prevent this. Sometimes, physicians treat their patients with anticoagulants in addition to an IVC filter. Patients who have medical conditions that prevent them from safely taking blood thinning medication may have an IVC filter as their only choice to prevent against pulmonary embolisms.
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IVC Risks to Patients
While all medical procedures carry some type of risk, IVC filter implantation surgeries have known to result in the following medical risks:
- Excess bleeding;
- Allergic reactions;
- Serious infections;
- Filter migration to the heart or lungs;
- Placement issues;
- Continued risk of blood clots;
- Blocked blood flow of the vena cava; and
- Damage to the blood vessel at the insertion site.
Health risks from an IVC filter implantation can vary based on the patient’s overall health, his or her age, the severity of the condition, and other risk factors. Notably, the International Journal of Anthology (IJA) analyzed the medical literature and found penetration of the inferior vena cava — a potential risk in IVC filter implantation surgery — has been linked to several injuries including the: first section of the small intestine (duodenum), the body’s main artery (aorta), small and large intestines, pancreas, renal vein, kidneys, the portal vein, diaphragm, genital and urinary system, and spinal column.
Increased Risk Over Time
While IVC filter implantation surgeries have likely helped thousands of patients, if the medical device is left inside the patient for too long — or, at least, longer than necessary — a number of medical complications may arise. Moreover, removing an IVC filter can be more complicated than other medical devices. The U.S. Food & Drug Administration has recommended that IVC filters should be removed within two months of implantation. The longer the IVC filter is in place, the FDA warns, the more susceptible the patient is to complications. In fact, IVC filters have been linked to dozens of deaths and nearly 1,000 FDA-reported adverse events. Issues include filter migration from its original placement, device fractures that result in metal fragments floating in the body and piercing other organs, among other issues. Initially, the FDA approved IVC filters as permanent medical devices that could remain in patients indefinitely. In 2010, however, the FDA advised — after receiving hundreds of adverse incident reports — the device should be removed once the filter is no longer necessary for the patient’s health.
Now, the FDA recommends temporary retrievable IVC filters should be removed between 29 and 54 days after insertion for patients who are no longer at a high risk for blood clots. The international peer reviewed medical journal, JAMA Internal Medicine, conducted a study that showed a majority of physicians are not following up with patients who have had IVC filters implanted. Furthermore, JAMA’s study found that only 24 percent of patients with IVC filters underwent retrieval surgery. Less than nine percent of IVC filter retrieval surgeries were successful. Current statistics show, however, that less than one-third of IVC filters are retrieved after implantation on average.
Medical Device Litigation
Not surprisingly, the potentially fatal complications associated with IVC filters have triggered hundreds of products liability lawsuits by injured patients and their loved ones. The majority of these cases are against manufacturing giants C.R. Bard (Bard) and Cook Medical (Cook), alleging the manufacturers knew of the IVC filters’ safety risks but hid these facts from consumers to make a profit. In fact, class action lawsuits against Bard and Cook have been filed in California, Florida and Pennsylvania. The suits seek compensation to offset costs of ongoing safety monitoring for patients living with IVC filters in a special fund. Multidistrict litigation (MDL) lawsuits have also been filed regarding IVC filters against Bard and Cook in Indiana and Arizona, respectively.
If you or someone you love suffered an injury due to an IVC filter, contact the knowledgeable attorneys at the Roger Ghai Law Offices. These skilled attorneys can evaluate your case and explain whether you can move forward with legal action. While a monetary compensation cannot change the past, it can help pay for medical expenses, pain and suffering, lost wages, and more. Click here today to schedule your initial case evaluation.