27 Fatalities And Other Complications

Part one of the investigative series revealed that 27 individuals died from IVC filter problems in the last decade. In addition, there were 300 reports of other complications. The device in question, C.R. Bard’s Recovery filter, is implanted in the inferior vena cava vein to stop blood clots.

One of the thousands of people implanted with IVC filters, a 45-year-old woman named Dodi Froehlich, nearly died when a part of the IVC filter broke off and moved to her heart. She had the device implanted after a car accident that made her more susceptible to clotting, NBC reports. If this will lead to an unfortunate outcome, you can talk to Houston wrongful death lawyer if you have lost your loved one due to someone’s else negligence.

Another woman, 55-year-old Gloria Adams, died after a powerful blood clot propelled the entire spider-like IVC device to her heart. The filter was meant to protect her after a brain aneurysm.

One of the main components of the investigation is an attempt to find out if C.R. Bard knew about the device failures and health risks.

Hiding Study Results To Sell Products

Patients began to speak out about complications. Instead of issuing a recall, C.R. Bard hired a public relations firm for damage control. Simultaneously, the device manufacturer privately researched IVC filter complications.

The study showed that the IVC filter Recovery model was associated with a greater risk of fracture, migration and early death. C.R. Bard kept the results hidden and continued to sell thousands of rebranded filters, NBC reports.

Despite initial difficulties with FDA clearance and insufficient clinical trials, the company claims that the product meet federal safety standards. Representatives from C.R. Bard issued a statement that IVC filters offer “significant benefits to patients.”

Kay Fuller, a regulatory affairs specialist hired by Bard to help get FDA approval the second time around, noticed safety issues and reported them to the FDA. NBC investigators discovered that Fuller’s signature on the FDA application appears to be forged, which she confirmed in an interview with the news organization.

NBC reports that more than 20,000 people are implanted with IVC filters. Individuals who experienced complications may be entitled to a lawsuit.

Request a free case evaluation to learn more about compensation opportunities.

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Blood clot filters are implanted in the inferior vena cava (IVC) and used for the prevention of pulmonary embolism. A recent analysis of national data, published in the National Library of Medicine, shows that blood clot filters may come with serious side effects.

Are Blood Clot Filters On The Rise?

IVC filters were introduced in the 1960s and approved by the Food and Drug Administration (FDA) through the agency’s 501(k) expedited process.  As the population ages, blood clot filters placement has increased as an alternative to anticoagulant medications. Trends illustrate more patients receive temporary, rather than permanent, IVC filters.

National data from Medicare and a National Discharge Survey indicates blood clot filter placement has markedly increased in the last two decades.

Data shows the placement of inferior vena cava (IVC) filters have been expanding, despite a lack of clear directing evidence. When IVC filters were approved, there was minimal data about blood clot filters, along with inconsistent recommendations across societies about how blood clot filters should be used.

Study Data On Blood Clot Filters 

Researchers examined how well blood clot filters work, measuring complication rates and national trends. The study data comes from a 9-year period at Einstein Medical Center in Philadelphia, PA. The researchers also assessed national trends using the Nationwide Inpatient Sample. 

The patients had an IVC filter implanted between 2003 and 2013. They were likely to elderly and high-risk for bleeding complications when using blood thinners.

Though temporary filters are becoming increasingly popular, the researchers found that only 7 percent of filters designed for retrieval were successfully removed. Researchers discovered many patients qualified for filter removal after receiving an IVC filter, but hospitals discharged patients with the device still in place. They suspect the reasoning could be “an increased reimbursement rates when filters are retrieved in an outpatient setting and an under-appreciation of the potential harms of leaving filters in place for extended periods.”

Although temporary IVCFs are becoming increasingly popular, their timely removal remains a significant challenge.

In 2010, the FDA issued a safety warning to inform physicians to remove IVC filters as soon as the risk of pulmonary embolism had subsided. The filters, though minimally invasive, have been associated with”clear evidence for filter-related complications even several years after placement.”

Some patients may experience complications early on, while others develop no symptoms. Potential complications, though varied, include: 

• Access site hematoma
• IVC thrombosis
• IVC perforation
• Air embolism
• Pneumothorax
• Filter migration
• Filter fracture

More temporary IVC filters are placed for prior falls and bleeding complications. In order to avoid exposing patients to unnecessary risks with little benefits, researchers acknowledge that filters should be removed as soon as possible. 

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While testosterone therapy allows older men to reap benefits similar to a revived youth, there may be consequences associated with the drug. Men using testosterone have nearly five times the number of cardiovascular problems, including heart attacks and strokes.

In 2014, nearly one in 25 men over the age of 60 was prescribed testosterone. However, some doctors believe that it’s possible to increase testosterone naturally and without potentially dangerous prescriptions.

Holistic Alternatives To Prescription Testosterone

Doctors recommend consuming less sugar to avoid decreasing testosterone in the body.
Image: WebMd

Dr. David Samadi, Chairman of Urology, Chief of Robotic Surgery at Lenox Hill Hospital and Professor of Urology at Hofstra School of Medicine, is one of those doctors.

In an article published in the Huffington Post, Samadi described seven holistic alternatives to testosterone medication:

1. Limit alcohol intake: Even drinking moderate amounts of alcohol can cause testosterone levels to plummet.

2. Reduce stress: be mindful of factors in your life that create stress. Mental or physical stress can quickly depress your levels. The stress hormone cortisol suppresses the body’s ability to make testosterone.

3. Cardio: High-intensity exercise can cut stress in half but don’t overdo it. Injuries and fatigue are sure signs that your workout may lower testosterone.

4. Zinc: The mineral zinc is important for testosterone production. Look to protein-rich foods like meats and fish. If you decide to supplement zinc, stick to a dosage of less than 40mg per day.

5. Vitamin D: This is a big secret when it comes to healthy testosterone levels. Foods like shellfish, tuna, salmon, egg yolks, beans and others work great. You can also look into taking vitamin D supplements, 1,000-2,000 IU per day (that’s what I personally do) and monitor your levels after that. Vitamin D levels should be between 30-60.

6. Limit Sugar: When in doubt, say no to sugar. Testosterone levels decrease because sugar leads to a high insulin level.

7. Healthy fats: Foods like olive oil, raw nuts, coconut oil, grass-fed meats and avocados are essential for building testosterone — 50-70 percent of your diet should include healthy fats.

Help For Men Suffering From Testosterone Side Effects

Testosterone therapy has been linked to heart attacks, among other complications.
Image: Home Remedies Station

Studies show that testosterone therapy can increase the risk of cardiovascular issues, such as heart attack, stroke, blood clots and early death. Many men using testosterone have already experienced these complications.

If you experienced side effects while using testosterone, you may be eligible to file a lawsuit. Request a free case evaluation to learn about compensation today.

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