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September 9, 2015: Comparative Study Reflects Significantly Higher Perforation Rate For “Celect” Cook IVC Filters

IVC Filter Lawsuit News – Results from a study comparing IVC filter retrieval rates indicate that the Cook Celect IVC filter has a significantly higher incidence of major blood vessel perforation (43%) versus the study comparator, Rex Medical’s Option IVC filter (0%). These findings are of importance to the medical community and patients, as the U.S. Food and Drug Administration (FDA) had previously reported that in some instances, the “cage-like” prongs of an IVC filter may puncture the wall of the vein in which it was placed, or migrate to puncture blood vessels and organs.

An inferior vena cava (IVC) filter is a small, cage-like medical device that is inserted into a patient’s inferior vena cava (the main vessel returning blood from the lower half of the body to the heart) to capture blood clots and prevent them from reaching the lungs where they can result in a life-threatening pulmonary embolism (PE). IVC filters are used in patients who are a risk for developing pulmonary embolism (blood clots in the lungs) when anticoagulants (blood thinners) are not indicated. Although IVC filters are designed to be permanent, some these devices may be removed.

The study, A Comparison of Retrievability: Celect versus Option (Journal of Vascular and Interventional Radiology, June 2015), compared the medical histories of 99 “Celect” IVC filter recipients and 86 “Option” IVC filter recipients whose IVC filters were retrieved about 2 months after the device was implanted. The researchers concluded that retrieval rates for the Celect and Option filters were not significantly different, although retrieval of the Option filter required a significantly increased amount of fluoroscopy time, and a significantly greater usage of adjunctive retrieval techniques compared to the Celect IVC filter. The Celect IVC filter had a significantly higher rate (43%) of strut perforation when compared to the Option IVC filter (0%).

Cook Faces IVC Filter Lawsuits

Bloomington-based Cook Group, Inc., faces over 100 IVC Filter Lawsuits in a multidistrict litigation (MDL 2570) in the Southern District of Indiana. Cook Celect and Cook Gunther Tulip filters have been identified in the product liability lawsuits.

FDA IVC Filter Safety Announcements

On August 9, 2010, the FDA announced that since 2005 it had received 921 medical device adverse event reports involving IVC filters of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. The agency also stated that long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation. It was also recommended that while the FDA is conducting its investigation, physicians caring for patients with retrievable IVC filters should consider removing the filter as soon as protection from PE is no longer needed.

In a second safety announcement on May 6, 2014, the FDA reported IVC filter adverse events and product problems have included:

  • device migration
    filter fracture
  • embolization (movement of the entire filter or fracture fragments to the heart or lungs)
  • perforation of the IVC
  • difficulty removing the device

Some of these events according to the agency, led to adverse clinical outcomes.  Lower limb deep vein thrombosis and IVC occlusion were identified as other possible long-term patient risks.

The FDA recommended that doctors responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.

Obtain A Free IVC Filter Lawsuit Evaluation

The Weinberg Law Firm is currently assisting individuals experiencing IVC filter complications. If you or a loved one has been injured and you would like information regarding an IVC Filter Lawsuit, please contact our personal injury lawyers at 1-877-934-6274. You can also contact our firm by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page.

August 29, 2015: Risk of Fatal Pulmonary Embolism Linked to Television Time

Fatal Pulmonary Embolism Linked To television Time – According to Mr. Toru Shirakawa, a public health research fellow at Osaka University in Japan, those who watch television for prolonged periods are increasing their chance of inducing a life-threatening condition called pulmonary embolism (PE). Five or more hours of television per day may double the risk of fatal pulmonary embolism as opposed to watching less than two and a half hours daily.

For those under 60 years of age, the findings are even more alarming. Those in this age group who watch between two and a half to five hours of television per day are three times more likely to suffer a pulmonary embolism compared to those in the same age group who watch two and half hours or less. Furthermore, those below sixty who watch more than five hours of television per day are six times more likely to suffer a pulmonary embolism compared to those who watch two and half hours or less.

Study Associates Prolonged T.V. Time with Fatal Pulmonary Embolism Risk

Shirakawa shared these findings with the European Congress of Cardiology today, citing the longevity and accuracy of his research; the study had been conducted over an 18-year period, tracking over 86,000 people. Mr. Shirawaka clarified that the study’s conclusion was found after adjusting their results for age at baseline, gender, history of hypertension, history of diabetes, smoking status, drinking status, body mass index, walking and sports habits and menopausal status.

Mr Shirakawa summarized, “We showed that prolonged television viewing may be a risky behavior for death from pulmonary embolism.” Shirawaka continues to explain, “Leg immobility during television viewing may in part explain the finding. To prevent the occurrence of pulmonary embolism, we recommend the […] preventive behavior […] That is, take a break, stand up, and walk around during the television viewing. Drinking water for preventing dehydration is also important.”

Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT)

A pulmonary embolism (PE) is a sudden blockage in a lung artery. The blockage is actually a blood clot or blood clots that have traveled to the lungs from another part of the body. These traveling blood clots commonly form in the deep veins of the legs, and are called a deep vein thrombosis (DVT). Because a PE can block the flow of blood to the lungs, it can be disabling or fatal.

Some pulmonary embolism victims may experience PE symptoms while others may experience no symptoms at all. In addition, some PE victims experience DVT symptoms only. Because a PE is a medical emergency, it is important to seek medical attention if you experience any PE or DVT symptoms.

Symptoms of pulmonary embolism may include:
•Chest pain
•Sudden shortness of breath or trouble breathing
•Cough or cough with blood
•Wheezing
•Irregular heart beat (arrhythmia)
•Dizziness, lightheadedness, or fainting
•Bluish tint to skin, or paleness
•Anxiety
•Sweating
•Increased or rapid breathing
•Increased heart rate
•Fever

Obtain a Free Pulmonary Embolism Lawsuit Case Evaluation

The Weinberg Law Firm is currently assisting pulmonary embolism or DVT patients who may be entitled to seek compensation for their injuries by filing a Medical Malpractice Lawsuit. Our firm also represents individuals who have suffered a blood clot or pulmonary embolism related to medication use, including for example, testosterone and Yaz. For a free pulmonary embolism lawsuit evaluation, please call our firm 24/7, toll free at 1-877-934-6274. Please see New Jersey Personal Injury Lawyers to learn more about our legal services.

June 19, 2014: FDA Requires Testosterone Labeling To Include Testosterone Blood Clot Risk Warning

FDA Mandated Testosterone Blood Clot Risk Labeling – The U.S Food and Drug Administration (FDA) will require manufacturers of all approved testosterone products to include a warning regarding the risk of venous blood clots with testosterone use in the product labeling.

Testosterone labeling currently includes the risk of venous blood clots as a possible consequence of a medical condition known as polycythemia (an abnormal increase in a person’s red blood cell count). The FDA stated that because it has received reports of venous blood clots unrelated to polycythemia, the agency will now require testosterone product labeling to carry a broader warning regarding testosterone blood clot risks.

Blood Clots – Deep Vein Thrombosis (DVT) Can Result In Life Threatenting Pulmonary Embolism (PE)

Blood clots forming in the deep veins are referred to as a deep vein thrombosis (DVT). If a DVT breaks free (often from the deep veins of the legs ) and travels to the lungs, it can cause a sudden blockage in a lung artery called a pulmonary embolism (PE). Because a PE can block the flow of blood to the lungs, it can be disabling or fatal.

The new testosterone blood clot risk warning is not related to the FDA’s ongoing evaluation of the potential risk for heart attack, stroke and death in patients using testosterone products. Heart attack, stroke, and death are cadiovascular events related to blood clots in the arteries, and are described in the FDA Drug Safety Communication posted on January 31, 2014. FDA asks health care professionals and consumers to report any testosterone adverse drug reactions to MedWatch.

Contact Weinberg Law Firm For A Free Testosterone Blood Clot Lawsuit Or Testosterone Pulmonary Embolism Lawsuit Evaluation

Since 1984, Attorney Eric Weinberg has represented personal injury and product liability victims, including those injured by pharmaceutical drug products, obtaining over $800 million in recoveries on behalf of clients. If you or a loved one has suffered injuries related to the use of testosterone, including blood clots, pulmonary embolism, heart attack, stroke, or death you may be entitled to financial compensation. For a free and non-obligatory testosterone lawsuit evaluation, please call the personal injury lawyers at The Weinberg Law Firm 24/7, toll free at 1-877-934-6274.

October 8, 2014: Cook Medical IVC Filters MDL Cases Transferred to Southern District of Indiana

IVC Filter Lawsuits – In the matter of Cook Medical IVC Filters Products Liability Litigation, the Judicial Panel on Multi District Litigation (“JPML”) ruled in favor of centralization of plaintiffs’ cases into an MDL (Multi District Litigation). The litigation consists of 27 actions pending in eleven districts. Plaintiffs in 12 of 27 of IVC Filter suits against Cook Medical were centralized into an MDL, and transferred to the Southern District of Indiana.

Decision for the MDL

In making this decision, the JPML found “that these 27 actions involve common questions of fact,” such as shared “factual issues arising from allegations that defects in the design of Cook’s inferior vena cava (“IVC”) filters makes them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.”

The JPML also maintained that centralizing the cases into an MDL in the Southern District of Indiana would be more convenient for involved all parties, and would “eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel, and the judiciary.”

CONTACT THE WEINBERG LAW FIRM FOR IVC FILTER LAWSUIT HELP

If you are a loved one has suffered an IVC filter injury and you would like information regarding an IVC Filter Lawsuit, please call The Weinberg Law Firm toll free at 1-877-934-6274 for a free legal case evaluation. You can also contact our firm online by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page.

IVC Filter Information

IVC filters,or inferior vena cava filters, are inserted into the inferior vena cava (the main blood vessel that returns blood from the lower half of the body to the heart) to filter and prevent blood clots from reaching the lungs, where the clots can cause a pulmonary embolism (PE), or blockage in a lung artery. Since a PE can block blood flow to the lungs, it can be disabling or fatal. IVC filters are placed in patients at risk for PE when anticoagulant therapy cannot be used or is ineffective.

While these devices may be beneficial to most patients, in some cases the “cage-like” prongs of the IVC filter may puncture the wall of the vein in which it was placed, or migrate to puncture blood vessels and organs. Any of these occurrences could lead to internal bleeding, cardiac tamponade, deep vein thrombosis, pulmonary embolism, or death, according the U.S. Food and Drug Administration (FDA).

Contact The Weinberg Law Firm For Personal Injury Lawsuit Help

Since 1984, Attorney Eric Weinberg has assisted personal injury victims, including those injured by medical malpractice and defective medical devices. Please see Pulmonary Embolism Lawsuit and Duodenoscope Lawsuit to learn more about our legal services.

April 10, 2012: FDA Concludes Birth Control Pills Containing Drospirenone, Including Yaz and Yasmin, May Increase Blood Clot Risks

FDA Concludes Drospirenone-Containing Birth Control Pills May Increase the Risk of Blood Clots; Yaz Blood Clot Risks – In a Safety Communication dated April 10, 2012, the U.S Food and Drug Administration (FDA) reported that following a review of observational studies that examined the risk of blood clots in women taking drospirenone-containing birth control pills, it had concluded that these birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. The FDA has required manufacturers to add information from these the studies to the labels of drospirenone-containing birth control pills, including Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

According to the FDA, the labeling for Yaz, Yasmin, Beyez, and Safyral should be revised to reflect that epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing birth control pills when compared to products containing levonorgestrel or some other progestins. The revised labeling will also reflect that some epidemiological studies found no additional risk of blood clots with drospirenone-containing birth control pills.

Yasmin and Yaz are combination birth control pills containing two types of hormones known as estrogen and progestin. The estrogen component, ethinyl estradiol, is common to many combination birth control pills, however, the progestin component, drospirenone, is unique to Yasmin and Yaz. Yasmin contains a higher concentration of ethinyl estradiol per tablet than Yaz.

Deep vein thrombosis (DVT) and pulmonary embolism (PE) Are Serious Conditions and Potentially Fatal

A blood clot that forms inside of a vein is referred to as a deep vein thrombosis (DVT). A DVT is a serious medical condition. DVT that form in the extremities, including the lower leg or thigh, can break free and travel to other areas of the body such as the lungs. A blood clot that has traveled to the lungs is called a pulmonary embolism (PE). Because a PE can block a lung artery and stop the flow of blood, it can be disabling or fatal. Venous thromboembolism (VTE) is a term that applies to both the DVT and resulting PE.

According to the FDA “The symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain, and sudden shortness of breath. Women experiencing these symptoms should contact a healthcare professional immediately because VTEs can be life-threatening.”

Please visit our homepage to learn more about DVT and PE, and The Weinberg Law Firm legal services related to pulmonary embolism lawsuits.

Contact Attorney Eric Weinberg for a Free Yaz Blood Clot or Yaz Pulmonary Embolism Lawsuit Evaluation

If you or a loved one has suffered a blood clot or pulmonary embolism after taking a drospirenone-containing birth control pill and you would like to learn more about your legal rights, please call the New Jersey Personal Injury Lawyers at The Weinberg Law Firm toll free at 1-877-934-6274. For more than 30 years Attorney Eric Weinberg has represented personal injury victims,recovering over $800 million on behalf of the firm’s clients.