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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Though it requires an intentional effort, properly managing diabetes is key to staying healthy and avoiding complications that can be caused by the disease, such as nerve damage, Alzheimer’s or poor blood flow. 

Regulated by the Food and Drug Administration (FDA), glucose meters allow diabetes patients to measure the amount of glucose in their blood. The medical devices alert patients to dangerously high glucose and provide information on how certain foods and physical activities affect sugar levels.

Glucose meters and test strips can be life-saving, so making sure diabetes management equipment functions properly is essential.  Here are some FDA tips for managing diabetes with glucose meters and test strips.  

Checklist For Blood Sugar Testing

Did you buy a new glucose meter and unused test strips?

When purchasing glucose meters and test strips, it’s important to buy new, unused equipment. While some manufacturers attempt to markdown pre-owned glucose meters as an added incentive, the FDA urges patients to avoid secondhand strips altogether.

Though it isn’t illegal to sell pre-owned test strips, the devices may have been improperly stored, tampered with or expired. Used test strips may also cause infection if blood particles are present. Additionally, some test strips may be imported from other countries, meaning they haven’t been examined for U.S. quality standards.

“Pre-owned test strips can give incorrect results and may not be safe to use with your device,” according to the agency. “So the U.S. Food and Drug Administration recommends that you do not buy or sell previously owned glucose test strips.”

Did you read the instructions and quality check your device?

Each glucose meter comes with instructions, so it’s important to review the package insert to understand how the device functions. The instructions also include information on how to use a control solution to be sure your meter is providing accurate results.

Patients are encouraged to test their equipment regularly. Specifics on how often to conduct the tests are included in the instruction manual.

Do you understand how to test yourself and read the results?

Some test sites may give more accurate results than others. While patients can get a glucose reading from the forearm or palm, pricking the fingertip will provide the most accurate results. The fingertip gives the most immediate results, especially if glucose levels changed rapidly after eating or exercising.

Glucose meters may have different methods of displaying values. Some meters uses a “LO” and “HI” symbol to indicate the blood sugar level has exceeded beyond a number measurable by the device. Patients should familiarize themselves with the display of their individual meter to understand it’s unique messaging. 

Do you clean and disinfect your glucose meter?

For some, blood sugar testing is required throughout the day. It’s important to make sure glucose meters are clean and safe to use. Each meter will come with instructions on how to properly disinfect the equipment, and how often it should be cleaned. 

After reading the instructions, the FDA encourages patients to test themselves in front of their doctors to confirm the device has been used correctly. To make sure the device is working at its highest caliber, patients should go over the entire process of conducting a glucose level test, analyzing the results and then clean equipment with a physician.

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The Food and Drug Administration released a report in March informing doctors that certain scopes were sent to market without undergoing an evaluation. The model, recently identified as the cause of widespread bacterial infections, had been used for years without agency approval.

Devices Marketed Without FDA Review

Patients underwent scope procedures with devices that weren’t submitted to the FDA for approval.
Image: AMS vans

Although Olympus Corporation began selling duodenoscopes in 2010, each model was not individually approved by the FDA. The manufacturer claimed that the models weren’t submitted for careful examination because the design closely matched other products on the market.

But the Olympus TJF-Q180V actually differed from existing models. It was later discovered that the TJF-Q180V included a sealed channel that would be hard to fully disinfect when adhering to current cleaning standards.

In March 2014, the FDA delivered a letter compelling Olympus to apply for approval in order to sell the device. The agency subsequently issued a safety announcement to warn doctors and patients about the device’s potential to spread hidden bacteria.

Sending Out Safety Alerts

The FDA sent out an announcement that showed health professionals are unable to completely disinfect certain duodenoscope models.
Image: CNN

In March, the health department worked to track down 179 people that visited UCLA Medical Center and caught bacterial infections from dirty scopes between Oct. 2014 and Jan. 2015. The agency issued a safety alert to inform medical staff that cleaning “may not entirely eliminate” the risk of infection.

“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the FDA said. “Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection.”

But UCLA isn’t the only hospital where contaminated scopes spread antibiotic-resistant infections. Eleven deaths at a hospital in Seattle, along with four infections at Cedars-Sinai Medical Center and 281 patients exposed to E.coli at Hartford Hospital proves that ineffective scope sanitation isn’t an isolated issue.

The FDA is working with the CDC and conducting “reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the [U.S.] — FUJIFILM, Olympus and Pentax.”

The agency advised medical professionals to inform patients about the risk associated with scope procedures. However, individuals who had a medical procedure with a duodenoscopy and caught an infection might be eligible for legal assistance and compensation.

Take a short survey for a free, no-obligation case evaluation.

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A Missouri woman is suing the manufacturer of an IVC filter medical device that fractured, migrated to her back and caused severe pain.

A St. Louis woman began to experience chronic back pain, but she couldn’t find the source. Doctors traced it to a piece of the Bard G2 filter system that had been implanted in her body, broke off and  traveled to her back.

On Nov. 24, 2015, she filed a lawsuit against Bard in the Eastern District of Missouri. She’s taking legal action to gain compensation that will help cover extensive medical expenses caused by complications with the IVC filter.

IVC Filters May Fracture And Migrate

The Bard G2 IVC filter has been linked to increased risk of fracture and migration.
Image: West JEM

In Sept. 2008, the Missouri woman had an IVC filter implanted in her body to protect against pulmonary embolism (PE).

One of the filter’s legs broke off and traveled throughout her body, becoming stuck in her back. After months of pain, she finally discovered the problem and decided to take action.

The Bard G2 filter system was approved through the 510(k) approval process and never underwent safety trials. In 2010, researchers conducted a study and discovered that 16 percent of Bard G2 filters fractured.

In the lawsuit, the woman claimed that she wasn’t properly warned about the high risk of fracture and migration associated with IVC filters. She’s suing for negligence, fraud, failure to warn, design defects and breach of warranties.

In addition to gaining assistance with her mounting medical expenses, the Missouri woman is suing the filter manufacturer in order to get compensation for her pain and suffering.

If you or a loved one experienced complications from an IVC filter, you may be eligible for legal help and compensation. Request a free, no-obligation case evaluation for more information.

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Jerry Woodell filed a legal complaint against the manufacturers of power morcellator devices for their refusal to address known safety concerns.

A North Carolina man named Jerry Woodell is taking legal action against makers of the power morcellator device that allegedly caused the death of his wife.

Woodell is seeking damages on behalf of his late partner Bethann, who developed cancer after undergoing a total laparoscopic hysterectomy procedure.

The Woodell Family’s Story

Jerry and Bethann Woodell.
Image: Ridge Funeral Home

In 2012, Bethann was diagnosed with uterine fibroids. For this painful but common condition, doctors recommended a hysterectomy.

In March of that same year, Bethann underwent a laparoscopic morcellation procedure to have the fibroids removed.

Less than six months after the surgery, Bethann began to experience unusual symptoms. She often felt fatigued and started to suffer from migraine headaches. She was admitted to the hospital, where doctors noticed that she had a growth in her pelvis.

Doctors originally thought the large mass was benign, but it was later discovered that Bethann had developed a high-grade cancer called leiomyosarcoma.

In an attempt to save her life, Bethann was exposed to intensive chemotherapy and underwent multiple surgeries. However, her cancer only continued to grow.

Despite a number of last-ditch treatments, Bethann passed away on Sept. 9.

Fighting The Potential Flaws Of Morcellation

Power morcellation can spread hidden cancer cells throughout the body.
Image: Contemporary OBGYN

On Oct. 22, Woodell filed a lawsuit against high-earning morcellator manufacturers. In his complaint, Woodell listed various injustices. He’s suing for product liability, wrongful death and personal injury.

The lawsuit alleges that the “spinning blades that shred, grind, and core tissue into smaller pieces” can leave behind fragments in the “abdomino-pelvic cavity, or attach to surrounding organs, and cancerous cells can travel to remote areas of the body.”

In his complaint, Woodell argues that device manufacturers were aware of the risks related to the spread of hidden cancer and refused to remedy the situation by altering the design.

“Long before [Bethann] underwent surgery in 2012, defendants knew or should have known that their laparoscopic power morcellators could cause occult malignant tissue fragments to be disseminated and implanted in the body, which, in turn, upstages any cancer present and significantly worsens a woman’s chance of survival,” according to the lawsuit.

Research shows that 1 in 350 women undergoing power morcellation procedures may have hidden cancer cells in their uterus. The FDA warns that if these women have surgery with a power morcellator, it “will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

If you developed cancer after having your uterine fibroids removed with a power morcellator, you might be entitled to compensation for this medical side effect.

Request a free, no-obligation case evaluation now to see if you qualify.

The post Man Files Suit Against Morcellator That Caused Wife’s Death appeared first on Citizens Report.

Although inferior vena cava filters can help prevent blood clots from traveling through the body, the devices are associated with a variety of complications.

Blood clots serve an important purpose. They’re able to stop bleeding and prevent excessive spillage after a cut or injury.

Unfortunately, blood clots can also form when they aren’t needed. Unnecessary clotting has been linked to heart attack, stroke and other serious medical problems.

Inferior vena cava (IVC) filters are meant to keep blood clots from traveling through the body. However, research shows that these devices may be dangerous.

The Potential For Complications

IVC filters have been linked to deep vein thrombosis, a condition that causes painful swelling of the leg.
Image: Seconds Count

IVC filters are specifically recommended for patients with a high risk of pulmonary embolism (PE), but many health professionals claim the device lacks an established safety profile. Although IVC filters decrease the risk of PE, they may cause a condition called deep vein thrombosis (DVT).

The National Center for Biotechnology Information (NCBI) published a study from the University of Chicago Hospitals that divided IVC filter complications into three categories: “procedural complications, including those related to both venous access and filter deployment; delayed complications, including filter fracture, migration, IVC thrombosis, and recurrent PE; and complications of filter retrieval after implantation of temporary IVC filters.”

According to NCBI, “certain complications are beyond the control of physicians.” For this reason, it’ is important to be aware of the possible risks associated with IVC filters.

Procedural Complications

• Venous access issues include bleeding, hematoma, inadvertent arterial puncture, and infection
• Malposition
• Defective filter deployment

Delayed Complications

• Filter migration
• Filter fracture
• Vein/organ perforation
• Infection
• Deep vein thrombosis
• Difficult or impossible retrieval

IVC filters are marketed as a permanent or temporary alternative to anticoagulant treatment. However, IVC filters are only recommended for use in patients unresponsive to anticoagulants.

Many patients will have the devices implanted regardless. If you experienced complications with your IVC filter, you may be entitled to compensation.

Click here to take a short survey and learn more about compensation eligibility.

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An international transvaginal mesh maker increased its lawsuit budget by $448 million after being ordered by the U.S. government to prepare for litigation.

Transvaginal mesh lawsuits are on the rise as more women claim to have been injured by the medical implant. The number of lawsuits against mesh makers nears 80,000 as these women step into the arena to fight for their own justice.

Manufacturers of transvaginal mesh are bracing themselves for big payouts by increasing their settlement budgets. One Danish mesh maker has recently expanded the company’s litigation finances by $448 million to provide additional funding for the growing number of legal settlements in the U.S.

What’s The Trouble With Transvaginal Mesh?

Transvaginal mesh may come with complications, such as erosion and organ perforation.
Image: Escubes

Transvaginal mesh is a net-like device implanted into a woman’s body to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, mesh products may cause a slew of additional medical problems.

The implantation of transvaginal mesh can lead to infections and cause issues with organs and tissue. The device may cause pain, nerve damage, bleeding, pain during intercourse, scarring and much more.

The transvaginal mesh can deteriorate, migrate, or fuse to surrounding organs and tissue, which creates the need for a revision surgery. Because the mesh is meant to be a permanent solution, it often takes multiple surgeries to remove the device.

Danish Company Prepares for Serious Payouts

Coloplast, a Danish manufacturer of transvaginal mesh, has allocated millions to cover settlement costs in the U.S.
Image: Holscher Design

Coloplast is an international manufacturer of medical devices headquartered in Denmark. The company supplies products for ostomy care, wound and skin care, incontinence and urology in addition to transvaginal mesh.

Coloplast markets its products to hospitals, retailers and patients worldwide. With such an extensive reach, it seems that the company is bracing itself for a long haul of litigation. In fact, there are 2,000 lawsuits against Coloplast in a multidistrict litigation in the Southern District of West Virginia alone.

In 2014, Coloplast settled 400 lawsuits with a $16 million distribution. However, the United States government has made it clear that Coloplast won’t be getting off that easy.

“We have been ordered by the judicial system in the U.S. to take preliminary steps towards actual litigation on 200 specific cases,” CEO Lars Rasmussen said in a press release. “This means that our costs in relation to the litigation will increase. As a consequence, we have found it necessary to increase our provision.”

If your vaginal mesh failed and required additional surgery, then you might be entitled to compensation for receiving a faulty medical device.

Complete a free, no obligation case evaluation now to see if you qualify.

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A couple comprised of two medical professionals has made it their mission to ban power morcellator surgery.

Cardiothoracic surgeon Dr. Hooman Noorchashm and anesthesiologist Dr. Amy Reed have experienced the dangers of power morcellation surgery firsthand.

After the procedure to remove her uterine fibroids spread undetected cancer in her body, Reed and her husband launched a campaign to ban the device once and for all.

The Birth of the Campaign

Power morcellator surgery can spread fragments of cancerous tissue, leading to a worsened prognosis.
Image: Contemporary OBGYN

Laparoscopic power morcellation is a medical procedure that is used to remove painful fibroids from the uterus. Through small incisions, the morcellator device breaks and clears fibroids embedded in uterine tissue.

In October 2013, doctors at Brigham and Women’s Hospital in Boston removed Reed’s uterine fibroids with a power morcellator.  No one expected that a minimally invasive procedure could come with life-changing consequences.

As the device destroyed the fibroids, it spread hidden leiomyosarcoma cancer cells throughout Reed’s abdomen. Reed and her husband were outraged, and they began searching for answers.

The couple set out to discover how frequently undetected leiomyosarcoma was released and spread by power morcellation surgery. After consulting with doctors and other women who developed cancer as a side effect of surgery, the two took to the internet to start a Change.org petition that urged the FDA to put an end to the procedure.

“I basically used the same intensity I brought to work and focused it on this,” Noorchashm told ABC News. “What you’re seeing here is a large volume of time and non-stop sustained [work] in order to make a change.”

Reed and her husband were successful in altering the ways that doctors at Brigham and Women’s Hospital regulate power morcellator procedures, but the duo won’t stop until it has been banned altogether. The real goal is to save other women from an avoidable fate.

“We want the American College of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this ‘standard of care’ by ending the needless waste of life caused by spreading cancer with morcellation,” Noorchashm wrote on Change.org.

FDA Defines Risk Associated With Power Morcellators

Currently, there is no way for doctors to test if a mass in the uterus is a benign fibroid or a malignant uterine cancer.
Image: Medscape

Power morcellation surgery can cause pain and infections, but the most serious side effect is the possibility of developing uterine cancer. Although Reed and Noorchashm haven’t reached their ultimate goal of banning the surgery, the campaign has been successful in drawing attention to the issue.

The FDA has released figures that show 1 in 350 women are at risk of developing uterine cancer from power morcellation surgery. The regulatory agency is still looking into the procedure to determine what should be done to mediate this risk.

In the meantime, women are still suffering as a result of power morcellation surgery. Those who developed cancer after undergoing a uterine fibroid removal procedure with a power morcellator might be entitled to compensation. 

Complete a free, no obligation case evaluation now to see if you qualify.

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Doctors have known for several years that some hip devices, in which both the ball and cup are made of metal, were failing at faster rates than other hip implants. Research to be presented Wednesday, at the annual meeting of the American Academy of Orthopaedic Surgeons in San Francisco, shows that debilitating problems from all-metal implants can persist for years. Last year, the Food and Drug Administration ordered 21 manufacturers to study patients who received metal-on-metal implants, after issuing a recall of one of the devices in 2010.

“This is a serious problem in the USA,” said Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City. “Some implants have a worse record than others, but almost all the metal-on-metal implants have issues.”

Bostrom said metal-on-metal hip implants were sometimes used in younger patients who wanted to remain active in sports.

If you have had side effects from a hip replacement surgery performed after 2003, click here!

Read more of this article.

Click here to learn more about the side effects of metal-on-metal hip replacements, as well as the lawsuit settlements victims receive for their injuries.

$56 million awarded to injured metal-on-metal hip replacement patients

To learn about other drug side effects, their subsequent lawsuits and settlements, as well as other personal injury cases, CLICK HERE.

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