What Are The IVC Filter Side Effects?

Legal NewsMedical Devices

Inferior Vena Cava (IVC) filters, also referred to as blood clot filters, are spider-like devices implanted into the vena cava to bar blood clots from entering the patient’s lungs.

An IVC filter is implanted in patients who demonstrate risks of a blood clot inside their lungs—also referred to as pulmonary emboli (PE)—when anticoagulant medication alone is not adequate. The retrievable IVC filters are also implanted in patients who show a high risk of developing life-threatening clots, in particular, those that can’t take blood-thinning medications; or in patients who experience recurring blood clots despite taking blood-thinners.

The filters help prevent any blood clots which may have formed inside the pelvis from getting into the heart or lungs. IVC Filter’s principal purpose is transporting blood from the lower part of the body and back into the heart.

Medical practitioners can consider using a retrievable IVC filter if patients are suffering from recurrent pulmonary embolism. FDA has approved the aid of the IVC filter under the following situations:

• Failed Anticoagulant therapy.

• Anticoagulant therapy contraindications.

• Recurring of pulmonary embolism.

IVC Filters Side Effects

IVC filters are available for use as retrievable or permanent implants as approved by US Food and Drug Administration (FDA) since 1979. Between the years 2005 to 2010, FDA received almost 1,000 complaints connected to the failing of IVC filters removal as well as newer retrievable filters complications. The FDA didn’t report the 34.8% adverse effect report that remained, though a warning was issued regarding increased risks of IVC DVT. Due to these, the agency advised doctors to completely remove the retrievable IVC filters.

Unfortunately, the patients experienced adverse complications after the removal of the retrievable filters, including:

1. IVC Filter Embolization and Migration

While the earlier filters were made of stainless steel and titanium, newer IVC filters are manufactured using various high-tech alloys. Since they become flexible with change in temperature, any fluctuation of the body temperature may alter the configuration of the device, causing the detachment.

When the filter detaches itself from IVC walls, it may relocate to the heart or other body organs. During migration (also referred to as embolization) the IVC filter is moved “upstream” with the flow of blood, across the body, continuously piercing everything along its path. The symptoms may include:

• Chest pains

• Fainting

• Abnormal heartbeat

• Palpitation

Patients having migrated IVC filters happen to be at higher risk of having severe complications such as rapid heart rhythms as well as cardiac tamponade, a possibly fatal emergency whereby the blood escapes in between the outer layer and the heart muscles.

2. IVC Filter Fractures

Numerous sources including FDA, have forwarded reports showing that there is a tendency of some doctors abandoning retrievable IVC filters for very long, thus increasing risks of failure. A study carried out in 2014, reported that the retrievable IVC filters left for long extended periods were associated with higher rates of complications than the permanent filters.

Also, the agency reported adverse events between 2005 and 2010, which included 202 fractures of the filters, 146 cases involved the broken pieces of the IVC filter migrating to the heart. The parts that spread are extremely difficult to remove during the extraction procedure. Some manufacturing companies have faced IVC filter lawsuits due to the sub-standard production of the filters.

3. Perforation

Throughout the whole process of implantation, presence, and removal of IVC filters, these devices have been shown to cause some perforations that may lead to life-threatening situations. The FDA report shows 70 severe effects from 2005 and 2010 whereby perforation had occurred to certain degrees. Once vessel walls are punctured by the strut, the possibility of the organs and the surrounding tissues getting pierced is very high. The most affected organs are the intestines, ureter, kidneys as well as blood vessels in that area. Due to these, the following complications may occur:

• Sepsis – Body reaction due to certain infections that release some chemicals into the bloodstream, which leads to inflammation and also may lead to shock, organ failure, and even death.

• Gastrointestinal bleeding – An IVC filter side effect that may cause low-blood-count and anemia

• Retroperitoneal hematoma – A swollen blood clot within the body tissue in the abdomen cavity.

4. IVC Filter Thrombosis

These filters have also shown to cause blood clots, the very condition they are supposed to treat. When blood clots form inside the IVC, there may be blockage of the deoxygenated blood from reaching the heart, thus causing IVC thrombosis, a DVT subtype. IVC thrombosis is associated with other severe symptoms such as:

• Inflammation

• Fever

• Pulmonary embolism

• Pain in the lower back

• Swellings in the legs that are painful

Other IVC Filter Side Effects

Additionally, other less severe side effects a patient may experience include chest pains, irregular heartbeat as well as shortness of breath, which may cause unconsciousness.

IVC Filter Safety Concerns

Thousands of complaints have been forwarded to FDA, relating the IVC filters. Most of the claims link to the long-term use of IVC filters. For example, patients experience filters breaking and traveling into their bloodstream, while others experienced filter migration from their initial position. These cause severe pain as well as body damage.

IVC Filter Lawsuits

Unfortunately, these filter warnings and studies happen after many patients have experienced severe problems caused by IVC filters. It’s evident that most of the injuries could have been avoided if manufacturers of some particular devices had given better instructions and warnings. Thus, compensation for IVC filter injury should be considered.

Free case evaluation and consultation are adequately provided to help people in the US know whether their injuries are due to the IVC side effects. All these cases are usually reviewed under contingency fee agreement, meaning that the attorney fee is not required unless compensation for IVC filter injury or recovery during the lawsuit.           

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