Medical Devices – Citizens Report https://citizensreport.org a digital channel commited to health & medical rights. Wed, 17 Jan 2024 09:06:12 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.24 https://citizensreport.org/wp-content/uploads/2016/12/cropped-cr-icon-1-32x32.png Medical Devices – Citizens Report https://citizensreport.org 32 32 High school parents should be concerned about ‘Juuling.’ https://citizensreport.org/2018/04/22/high-school-parents-should-be-concerned-about-juuling/ Sun, 22 Apr 2018 17:22:53 +0000 http://www.citizensreport.org/?p=12257 What Is Juuling? Why Is It Dangerous? Juul is a premium brand of e-cigarette that is often called the iPhone of vaporizers. Unfortunately, the product has become popular among high schoolers, and this is a dangerous trend. The product can be quite addictive. However, many teens have the misconception that premium brands of vaporizers are […]

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What Is Juuling? Why Is It Dangerous?

Juul is a premium brand of e-cigarette that is often called the iPhone of vaporizers. Unfortunately, the product has become popular among high schoolers, and this is a dangerous trend. The product can be quite addictive. However, many teens have the misconception that premium brands of vaporizers are safe to use. You have to make sure that the vape products you’re trying is safe and legit like the ones at the best delta 8 disposables online!

These are some of the most serious vaping dangerous associated with this product:

1. Additives In The Products Could Be Harmful

Many people have a misconception that the products do not contain additives, but this couldn’t be any further from the truth. In fact, there are numerous artificial additives in the product. Some of the additives may have dangers that have not been discovered yet, such as carcinogenic properties.

2. E-Liquids Often Contain High Doses Of Nicotine

The only difference in the nicotine dosage of cigarettes and electronic cigarettes is that electronic cigarettes give a measured dose of nicotine. However, the nicotine dosage in electronic cigarettes can be as high as conventional cigarettes. This means that they have the same addictive potential as cigarettes. This can e juice expire if not used right away after being bought in the vape shop. However, if someone becomes addicted to nicotine, they often suffer from withdrawal symptoms if they attempt to stop consuming it. These are some of the most common nicotine withdrawal symptoms:

Irritability
Headaches
Dizziness
Anxiety
Difficulty concentrating

Each pack of e-liquid contains as much nicotine as a pack of cigarettes. This is the equivalent to 200 puffs of a cigarette.

3. Some Teenagers Are Unaware That They Contain Nicotine

An astonishing 37 percent of teenagers are unaware that these products contain nicotine. Some even identify using Juul e-cigarettes as different than vaping. In fact, around 25% of teenagers do not consider using them to be vaping. They even have their own name for using them. They refer to it as Juuling instead of vaping.

4. The Products Have An Appealing Scent

Many teenagers avoid starting a nicotine habit due to an aversion to the smell of cigarettes. However, this is not a concern of teenagers who are considering using these electronic cigarettes. This is because these products have sweet flavors like mango and creme brulee. As a result, teens may be more likely to use them and become addicted to nicotine as a result.

5. Juul Can Be Easily Concealed

The products are extremely small, and they can easily fit in pockets. In fact, they have an appearance that is similar to a thumb drive. Not only does this make teenagers more likely to try them, but it makes it more difficult for adults to know if they are using them.

6. Nicotine May Impede Brain Development

High schoolers have brains that have underdeveloped regions that are responsible for impulse control and risk assessment. If these areas of the brain never fully develop, an individual may continue to make poor decisions as an adult. It also may increase teenagers’ risk of developing a mental illness in adulthood.

7. They Are Bad For The Entire Respiratory System

Electronic cigarettes can cause progressive damage to the tissue in the lungs. Also, they can irritate other regions of the respiratory system, such as the nose. While they might not appear to be as “harsh” as tobacco smoke, the progressive damage to the respiratory system that can occur from using them can be similar.

8. The Risks Have Not Been Thoroughly Studied By The FDA

E-cigarettes are not FDA regulated. Not only does this mean that the risks have not been fully studied, but it also means that the FDA does not consider using them is a safe way to attempt to quit smoking cigarettes. Furthermore, the lack of regulation means that there are no ways to know for sure what is in a vape juice. Therefore, there could be vaping dangers that haven’t even been discovered.

9. It’s Bad For The Cardiovascular System

It is thought that nicotine is damaging to both the heart and blood vessels. This effect is likely to be a particularly serious concern for teenagers who already suffer from heart problems. Nicotine intake has been shown to increase an individual’s risk of suffering a heart attack or stroke. Vaping is a less harmful alternative to traditional cigarettes, as it doesn’t involve burning tobacco and producing harmful tar and carcinogens. Find your ideal vaping companion with E-Cigs from E-Zigaretteria. As a Swiss online leader, we prioritize quality and customer satisfaction above all.

10. High Schoolers Who Use Electronic Cigarettes Could Become More Likely To Make Other Poor Decisions

Teenagers who begin using electronic cigarettes might become more inclined to try other substances, such as alcohol or even illegal drugs. This could result in addiction and could even be life-threatening. If you or a loved one is facing legal problems associated with illegal drugs, it’s important to talk to this attorney as soon as possible.

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Blood Filters: Are you at risk? https://citizensreport.org/2018/03/18/dsk_blood-filters-are-you-at-risk/ Sun, 18 Mar 2018 19:19:48 +0000 http://www.citizensreport.org/?p=12273 Sponsored content.  Disclosures at bottom. It was 1968. Every boy in America was playing with one of the newly released Hot Wheels toy cars, the Vietnam War was in full swing and movie lovers couldn’t stop talking about the latest Hollywood hit: “Planet of the Apes”. Meanwhile in the University of Miami, a cardiovascular surgeon […]

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Sponsored content.  Disclosures at bottom.

It was 1968. Every boy in America was playing with one of the newly released Hot Wheels toy cars, the Vietnam War was in full swing and movie lovers couldn’t stop talking about the latest Hollywood hit: “Planet of the Apes”.

Meanwhile in the University of Miami, a cardiovascular surgeon called Kazi Mobin-Uddin had just developed the newest medical marvel: The blood clot filter (Inferior Vena Cava Filter).

The device was a first of its kind and immediately received high praise by interventional radiologists, vascular surgeons and cardiologists alike.

What is an IVC Filter?

An IVC filter a small retrievable device designed to break up and filter any clots traveling up the body.  It looks like a tiny metal spider and it is implanted directly in the Inferior Vena Cava (one of the largest veins in the body carrying deoxygenated blood from the lower part of the body, back to the heart).

Doctor Mobin-Uddin called it “The umbrella filter” and personally installed 100 of these filters in patients at risk  of life-threatening pulmonary embolism – with what back then was an acceptable mortality rate of 19%.

In 2003, the FDA approved a new retrievable version of the filter and doctors all across the country have installed thousands of these devices at a rapidly growing rate.

In 1979 alone, 2000 filters were installed.

That number grew to 167,000 in 2007.

And the demand exploded to an estimated 259,000 filters deployed in 2012.

Unfortunately, the  effectiveness of the IVC filters and their safety profile is not well established. In fact, they should only be used in select high-risk scenarios.

However, that’s not what’s happening… and the number of reports and horror stories related to IVC filters has also grown at an alarming rate. So much in fact, that by 2010, the FDA started to issue warnings about them.

The problem with IVC filters

Unfortunately, IVC filters have shown a pattern of failures that may cause implanted patients serious health risks and all sorts of life-threatening complications, like:

  • Filter migration
  • Filter fracture
  • Embolization (movement of the entire filter or a part of it to the heart or lungs)
  • Perforation of tissue, vessels and organs (including the IVC, heart and lungs)
  • Cardiac/Pericardial tamponade (pressure caused by collected blood around the heart)
  • Hemorrhage
  • Sudden death

Even more alarming is the fact that in many IVC filter patients, the risk of deep vein thrombosis and pulmonary embolism are actually increased AFTER the implant of an IVC filter.

The safety concerns over these devices continue to increase, and the FDA recently issued a series of warnings about IVC filters.

An analysis conducted in 2014 by the FDA states that, “the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation”.

And recent studies published in the Journal of the American Medical Association and the Archives of Internal Medicine, show that most of the problems with IVC filters could be prevented if the filter is removed on time – once the risk of blood clots has passed.

Not only that, but it seems filters are sometimes implanted in inpatients that don’t really need them and simple blood-thinning medication would solve the problem.

Unfortunately, the greed of manufacturers and the indifference of the medical establishment are putting hundreds of thousands of lives at risk.

In short, unsuspecting patients are being put at unnecessary risks.  It. Has. To. Stop.

What can YOU do about it?

If you (or a loved one) has had any complications due to an IVC filter, you may be eligible for financial compensation.

The team at Consumer Alert Services has set up a short online survey to evaluate cases throughout the United States. They provide no-cost, no-obligation review to individuals who have IVC filter implants.

Click the button below and take the 2 minute compensation survey now.


*Citizens Report strives to show you content and advertisements that you find interesting. With some of our advertisers, we receive compensation when you click on a link or advertisement, or send information. We do this so that we can continue providing this publication without having to charge you for access.

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Blood Filters: Are you at risk? https://citizensreport.org/2018/03/15/mob_blood-filters-are-you-at-risk/ Thu, 15 Mar 2018 17:11:36 +0000 http://www.citizensreport.org/?p=12295 Sponsored content.  Disclosures at bottom. It was 1968. Every boy in America was playing with one of the newly released Hot Wheels toy cars, the Vietnam War was in full swing and movie lovers couldn’t stop talking about the latest Hollywood hit: “Planet of the Apes”. Meanwhile in the University of Miami, a cardiovascular surgeon […]

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Sponsored content.  Disclosures at bottom.

It was 1968. Every boy in America was playing with one of the newly released Hot Wheels toy cars, the Vietnam War was in full swing and movie lovers couldn’t stop talking about the latest Hollywood hit: “Planet of the Apes”.

Meanwhile in the University of Miami, a cardiovascular surgeon called Kazi Mobin-Uddin had just developed the newest medical marvel: The blood clot filter (Inferior Vena Cava Filter).

The device was a first of its kind and immediately received high praise by interventional radiologists, vascular surgeons and cardiologists alike.

What is an IVC Filter?

An IVC filter a small retrievable device designed to break up and filter any clots traveling up the body.  It looks like a tiny metal spider and it is implanted directly in the Inferior Vena Cava (one of the largest veins in the body carrying deoxygenated blood from the lower part of the body, back to the heart).

Doctor Mobin-Uddin called it “The umbrella filter” and personally installed 100 of these filters in patients at risk  of life-threatening pulmonary embolism – with what back then was an acceptable mortality rate of 19%.

In 2003, the FDA approved a new retrievable version of the filter and doctors all across the country have installed thousands of these devices at a rapidly growing rate.

In 1979 alone, 2000 filters were installed.

That number grew to 167,000 in 2007.

And the demand exploded to an estimated 259,000 filters deployed in 2012.

Unfortunately, the  effectiveness of the IVC filters and their safety profile is not well established. In fact, they should only be used in select high-risk scenarios.

However, that’s not what’s happening… and the number of reports and horror stories related to IVC filters has also grown at an alarming rate. So much in fact, that by 2010, the FDA started to issue warnings about them.

The problem with IVC filters

Unfortunately, IVC filters have shown a pattern of failures that may cause implanted patients serious health risks and all sorts of life-threatening complications, like:

  • Filter migration
  • Filter fracture
  • Embolization (movement of the entire filter or a part of it to the heart or lungs)
  • Perforation of tissue, vessels and organs (including the IVC, heart and lungs)
  • Cardiac/Pericardial tamponade (pressure caused by collected blood around the heart)
  • Hemorrhage
  • Sudden death

Even more alarming is the fact that in many IVC filter patients, the risk of deep vein thrombosis and pulmonary embolism are actually increased AFTER the implant of an IVC filter.

The safety concerns over these devices continue to increase, and the FDA recently issued a series of warnings about IVC filters.

An analysis conducted in 2014 by the FDA states that, “the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation”.

And recent studies published in the Journal of the American Medical Association and the Archives of Internal Medicine, show that most of the problems with IVC filters could be prevented if the filter is removed on time – once the risk of blood clots has passed.

Not only that, but it seems filters are sometimes implanted in inpatients that don’t really need them and simple blood-thinning medication would solve the problem.

Unfortunately, the greed of manufacturers and the indifference of the medical establishment are putting hundreds of thousands of lives at risk.

In short, unsuspecting patients are being put at unnecessary risks.  It. Has. To. Stop.

What can YOU do about it?

If you (or a loved one) has had any complications due to an IVC filter, you may be eligible for financial compensation.

The  team at Consumer Alert Services has set up a short online survey to evaluate cases throughout the United States. They provide no-cost, no-obligation review to individuals who have IVC filter implants.

Click the button and take the 2 minute compensation survey now.


*Citizens Report strives to show you content and advertisements that you find interesting. With some of our advertisers, we receive compensation when you click on a link or advertisement, or send information. We do this so that we can continue providing this publication without having to charge you for access.

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NBC Nightly News Publishes Expose On IVC Filters https://citizensreport.org/2018/02/18/nbc-news-ivc-filters/ https://citizensreport.org/2018/02/18/nbc-news-ivc-filters/#respond Sun, 18 Feb 2018 22:40:24 +0000 http://www.citizensreport.org/?p=10674 NBC Nightly News investigated controversial medical devices, known as IVC filters, used to prevent blood clots. The news organization separated their findings into broadcasted segments to show how unsafe filters impact consumers and illustrate that manufacturers knew about design flaws. 27 Fatalities And Other Complications Part one of the investigative series revealed that 27 individuals […]

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NBC Nightly News investigated controversial medical devices, known as IVC filters, used to prevent blood clots. The news organization separated their findings into broadcasted segments to show how unsafe filters impact consumers and illustrate that manufacturers knew about design flaws.

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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What A National Study Says About Blood Clot Filters https://citizensreport.org/2018/02/13/blood-clot-filters-study/ Wed, 14 Feb 2018 04:38:58 +0000 http://www.citizensreport.org/?p=12185 More than 300,000 Americans die from acute pulmonary embolism each year. Pulmonary embolism, treated with blood thinners or a filter, occurs when a blood clot travels to the lungs and causes a fatal blockage. Blood clot filters are implanted in the inferior vena cava (IVC) and used for the prevention of pulmonary embolism. A recent […]

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More than 300,000 Americans die from acute pulmonary embolism each year. Pulmonary embolism, treated with blood thinners or a filter, occurs when a blood clot travels to the lungs and causes a fatal blockage.

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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Safety Reminders For Blood Sugar Testing https://citizensreport.org/2018/02/02/safe-blood-sugar-testing/ Sat, 03 Feb 2018 00:48:04 +0000 http://www.citizensreport.org/?p=12125 1.4 million Americans are diagnosed with diabetes every year. For newly diagnosed patients, blood sugar testing with glucose meters may seem daunting.  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.  […]

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1.4 million Americans are diagnosed with diabetes every year. For newly diagnosed patients, blood sugar testing with glucose meters may seem daunting. 

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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FDA Never Approved Olympus Duodenoscope Model https://citizensreport.org/2016/11/12/olympus-duodenoscope-fda-approval/ https://citizensreport.org/2016/11/12/olympus-duodenoscope-fda-approval/#respond Sat, 12 Nov 2016 18:45:53 +0000 http://www.citizensreport.org/?p=10848 Duodenoscopes are used in ERC procedures to treat cancers, gallstones and other digestive illnesses. The devices assist in performing ERCPs on more than 500,000 patients each year. 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 […]

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Duodenoscopes are used in ERC procedures to treat cancers, gallstones and other digestive illnesses. The devices assist in performing ERCPs on more than 500,000 patients each year.

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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UCLA Superbug Outbreak Caused By Duodenoscope https://citizensreport.org/2016/09/29/ucla-duodenoscope-outbreak/ https://citizensreport.org/2016/09/29/ucla-duodenoscope-outbreak/#respond Thu, 29 Sep 2016 23:44:29 +0000 http://www.citizensreport.org/?p=10536 A number of patients at UCLA Medical Center were suffering from a deadly superbug, but doctors couldn’t identify the problem. After launching an in-depth investigation, the hospital staff uncovered the cause of the infection. The life-threatening bacteria, known as CRE, had crept into an Olympus duodenoscope that doctors reused time and again. Bacterial Infection Continued […]

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Los Angeles County Health Department Investigates Enterobacteriaceae Cases

Doctors linked a deadly CRE bacteria outbreak at the UCLA medical center to a dirty duodenoscope device.

A number of patients at UCLA Medical Center were suffering from a deadly superbug, but doctors couldn’t identify the problem.

After launching an in-depth investigation, the hospital staff uncovered the cause of the infection. The life-threatening bacteria, known as CRE, had crept into an Olympus duodenoscope that doctors reused time and again.

Bacterial Infection Continued To Spread At UCLA

UCLA doctors unknowingly spread the CRE bacteria when they reused a duodenoscope device that carried the infection.
Image: CBS Local

As patients at the widely respected medical institution grew sicker,  a team of health professionals delved into months of investigation.

Doctors at UCLA were stumped, but Dr. Zachary Rubin, the director of clinical epidemiology and infection prevention, finally discovered the culprit.

Rubin collected a team of 1o professionals to track every patient who had been diagnosed with CRE in the last year. The team found 34 patients affected by CRE, but couldn’t make the connection.

Investigators traced the infections to a potential liver transplant patient who visited the hospital in September 2014. It turned out that she unknowingly introduced CRE, the deadly carbapenem-resistant Enterobacteriaceae, to the institution.

Doctors Linked The Deadly Illness To Dirty Scopes

CRE is an antibiotic-resistant bacteria that killed three people in the UCLA outbreak.
Image: California Department of Public Health

When the duodenoscope entered the patient’s intestine, the bacteria crawled into the crevices of the device. The scope was cleaned and reused on multiple patients, continually spreading the bacteria.

Doctors had disinfected the scope, made by Olympus, and followed the manufacturer’s standard protocol. The hospital had purchased the new scopes, priced at $40,000, only 7 months ago.

The dirty scope, number 47, had infected eight patients. Three of them died. The outbreak sparked a public health outcry, but there is still no mechanism to effectively disinfect duodenoscopy devices.

Restitution for Affected Patients

There is no effective method to completely clean and sanitize duodenoscopes.
Image: International Medical Equipment

It’s possible for individuals to be infected with CRE without experiencing symptoms. The infection, treated for years with antibiotics, has evolved to develop drug resistance.

CRE kills nearly half of infected patients. However, CRE is only one bacteria that could become lodged in the device during one of the 700,000 duodenoscopic procedures performed in the U.S. each year.

Federal attorneys and health professionals are pressing duodenoscope manufacturers, questioning their knowledge of the device’s likelihood to spread infection and examining the effectiveness of their safety measures. In addition, patients and families affected by the UCLA outbreak are taking legal action against Olympus for negligence and fraud.

Patients and families affected by a serious bacterial infection after undergoing an endoscopy procedure may be entitled to compensation.

Request a free case evaluation to learn more.

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Philadelphia Jury Awards $12.5 Million To Woman In Mesh Lawsuit https://citizensreport.org/2016/02/24/12-5-million-awarded-in-mesh-lawsuit/ https://citizensreport.org/2016/02/24/12-5-million-awarded-in-mesh-lawsuit/#respond Thu, 25 Feb 2016 02:21:39 +0000 http://www.citizensreport.org/?p=10502 When Patricia Hammons received a transvaginal mesh implant in 2009, she never expected it to cause so many problems. After dealing with continued pain and incontinence, Hammons had multiple corrective surgeries to repair the mesh. But the issue was severe that she could no longer engage in sex. Hammons’ quality of life began to worsen, […]

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Woman Files Transvaginal Mesh Suit And Gets Millions For Injuries

A Philadelphia court awarded millions in compensation to Patricia Hammons for complications caused by transvaginal mesh.

When Patricia Hammons received a transvaginal mesh implant in 2009, she never expected it to cause so many problems.

After dealing with continued pain and incontinence, Hammons had multiple corrective surgeries to repair the mesh. But the issue was severe that she could no longer engage in sex.

Hammons’ quality of life began to worsen, which prompted her to take legal action against the mesh maker. She shared her story in a Philidelphia courthouse, where she was awarded millions.

Mesh Complications Diminish Quality of Life

Failed mesh can cause severe pain that makes sex unbearable.
Image: Boston Jew

The mesh device, manufactured by Johnson & Johnson/Ethicon, was meant to treat pelvic organ prolapse. Hammons had the device implanted into her body at the age of 58.

Nearly 13 years later, Hammons found herself in a courtroom describing the severity of pain she experienced when attempting to have sex. Additionally, Hammons deals with incontinence, a condition that makes her unable to control her bladder.

Doctors attempted to repair the mesh issues with corrective surgeries. During one of the operations, it was discovered Hammons’ mesh had “bunched up” and perforated her bladder.

In December, a jury awarded Hammons $12.5 million as restitution for all that she had been through.

Court Assists With Medical Expenses

Mesh complications can require additional surgeries that would substantially increase medical costs.
Image: Antimicrobial Resistance Learning Site

Hammons is 65 years old. She works at an Indiana Wal-Mart stocking shelves, earning a small income that couldn’t begin to cover her medical expenses.

A number of experts testified on Hammons’ behalf, proving that Johnson & Johnson knew about mesh failures since 2005. The court also heard testimony from a former product engineer who said device manufacturers lacked a solid backup plan to address potential complications.

A Philadephia jury believed Hammons was entitled to $5.5 million to assist with mounting health care costs. The award will also act as compensation for the loss of sexual function.

Additionally, the court awarded Hammons $7 million to Johnson & Johnson, sending a message to health care manufacturers who market unsafe products.

Women implanted with transvaginal mesh may need multiple corrective surgeries. Even with corrective treatment, mesh complications may persist.

Request a free case evaluation to learn more about compensation.

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Mississippi Man Files Lawsuit Over Irremovable IVC Filter https://citizensreport.org/2016/02/18/irremovable-ivc-filter-lawsuit/ https://citizensreport.org/2016/02/18/irremovable-ivc-filter-lawsuit/#respond Thu, 18 Feb 2016 20:26:33 +0000 http://www.citizensreport.org/?p=10479 Mississippi man Alec Caldwell had a blood clot filter implanted in his inferior vena cava. It seemed the device was working well until he started to experience severe pain. Caldwell attempted to have his filter taken out and discovered that the device was not only impossible to remove, but also had rotated and damaged his […]

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Inferior Vena Cava Filters Are Difficult To Remove And People Can File Lawsuits Against The Medical Device Manufacturer

A Mississippi man filed a lawsuit to obtain monetary awards as compensation for pain and suffering caused by an irremovable IVC filter medical device.

Mississippi man Alec Caldwell had a blood clot filter implanted in his inferior vena cava. It seemed the device was working well until he started to experience severe pain.

Caldwell attempted to have his filter taken out and discovered that the device was not only impossible to remove, but also had rotated and damaged his essential IVC vein.

He has since taken legal action and filed a product liability and personal injury lawsuit against the device manufacturer, who allegedly knew about the risk of perforation and difficulties with removal.

Complications With Perforation And Removal

IVC filters may shift and become tilted, situating the device in a position that would lead to vein perforation and extended medical problems.
Image: Research Gate

Caldwell had the Eclipse model IVC filter implanted in his body on Sept. 29, 2010. It was meant to stop blood clots from traveling to the lungs, which could cause pulmonary embolism to occur.

Bard, the makers of the IVC filter, allegedly knew about the device’s risks and didn’t inform the consumer. The lawsuit states that Bard was aware of the product’s “serious design and manufacturing flaws causing it to have inadequate stability and structural integrity, as well as a high propensity to perforate the vena cava.”

On Dec. 9, Caldwell decided to file a lawsuit against the manufacturer of the medical device that caused him serious pain and suffering.

In the lawsuit, prosecutors argue on Caldwell’s behalf, claiming that he “suffered and will continue to suffer significant medical expenses, pain, suffering, emotional distress, loss of enjoyment of life, psychological trauma, anxiety, hedonic damages, lost wages, loss of earning capacity, the need for medical monitoring of the Eclipse filter, and any other form of damages under the law of the subject forum.”

The prosecutor intends to hold Bard liable for manufacturing, information and design defects, negligence due to failure to recall products and warn consumers, breach of warranty, fraudulent misrepresentation and concealment. The goal is to provide Caldwell with enough financial restitution to cover his medical bills, lost income and more.

If you experienced difficulties removing your IVC filter, you may also be entitled to compensation.

Take the next step and request a free case evaluation to learn about your legal rights.

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