Exciting Breakthroughs in IVC Filter Removal

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Years of product complications and mounting litigation have left an unflattering brand on IVC filters. Patients continue to experience problems with the troublesome medical devices.

Part of what our national litigation team at Hotze Runkle has learned in dealing with the patients affected by IVC filters is that there is often as much trouble with removing these products as there is living with them.

The reasons to consider removal are often the same ones that make extracting an IVC filter so difficult. Whether the filter has torn or blocked a vein, or pieces of the metallic devices have traveled elsewhere, safely removing an IVC filter can be a dangerous undertaking.

Luckily, recent breakthroughs in IVC filter removal look promising for patients living with the pains and medical concerns caused by the devices.

Cutting-Edge Innovations

The fact that these filters break down and inevitably require removal should not be all that surprising. Filters of all sorts need to be replaced in order to prevent potential issues.

What is alarming is that follow-ups to determine the status of IVC filters are not always done, even with the knowledge that most complications arise within three to six months.

#IVC filter complications can begin in as little as 3 to 6 months #Fact Click To Tweet

This urgent need is what motivated a team of interventional radiologists at Rush University Medical Center to develop a safe and effective method of removing the filters.

The Journal of Vascular and Interventional Radiology published the latest techniques developed by the team in November of last year.

Lead author Osman Ahmed, MD, reflected the confidence of the interventional radiologists involved when he stated that they were able to remove any filter with this new method, regardless of the situation.

This innovative system for IVC filter removal centers around catching – or “snaring” – the device during a procedure to ensure that it doesn’t move. This minimizes the chance that additional damage is done to the vein.

Once this is done, the doctors cover the device so that no pieces break off and travel elsewhere in a patient’s body.

An excimer laser is one of the tools utilized by the team to make this technique possible. These lasers are commonly used in the production of microelectronics and eye surgery.

The confidence put forth by Ahmed is well-founded as the Rush staff has successfully retrieved 100 percent of IVC filters with their methods over the last five years.

#RushUMC has 100% #IVCfilter removal rate with new method over last 5 yrs Click To Tweet

Making a Difference Where It Really Matters

While skeptics may be quick to wonder if these are primarily standard procedures, this is not the case.

Many of these procedures were performed on referred patients that required the team to deal with filters that other hospitals had deemed too difficult to remove.

Twilight (conscious) sedation is typically used for these minimally invasive outpatient procedures. If the Rush staff feel that a retrieval may take longer, a patient is given general anesthesia.

The incision made for removing an IVC filter is made either in the neck or the groin. The team uses X-rays to guide the tools they use, such as wires and catheters, to remove a filter.

The necessity to remove IVC filters is because of the inherent dangers associated with leaving the devices inside a patient’s body for too long. The FDA recommends that everyone who has an IVC filter should consult with an interventional radiologist about removing the filter. Regardless of whether removal is recommended, all patients should be evaluated.

#FDA says the length of time left implanted may increase IVC filter complication risks #HotzeRunkle Click To Tweet

If you or someone you know has been harmed by complications with an IVC filter, contact the national litigation team of Hotze Runkle today at 877-919-0830.

Our experienced legal team can help you determine if you are entitled to compensation for the suffering you have experienced.

Don’t let your voice be taken away. We will take care of you and your family by holding those who failed to, accountable.


Alternative Treatments to IVC Filters

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The majority of makers and distributors of IVC filters across the country find themselves entangled in litigation.

These widely-used devices, which are typically used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolisms, have a long-standing reputation for being dangerous and harmful to patients who have had them implanted.

Strangely, these companies have still persist in marketing and selling their products. Even in the face of countless reports of injuries, complications – and even death.

Hotze Runkle knows that these companies have to be held accountable for the suffering they have caused. Their disregard for the wellbeing of patients is both inhumane and criminal.

People should know that even though IVC filters are a common choice to combat DVT and pulmonary embolisms, there are other treatment options available to them.

Potential Alternatives to IVC Filters

Anticoagulants

This is the alternative choice that is most commonly used instead of an IVC Filter. Anticoagulants, or blood thinners, can be given to post-surgery patients to help minimize the risk of strokes and blood clots.

A typical blood thinner therapy plan begins with a patient being given heparin for several days. This will be accompanied by the start of a warfarin treatment that can last anywhere between three to six months.

The reason that these plans begin with heparin is that warfarin usually needs a number of days to reach its peak effectiveness. Heparin helps bridge that initial time gap between surgery and when warfarin reaches its full potency.

However, this alternative is not without drawbacks of its own. People who have medical issues that make them more likely to have severe bleeding incidents can’t take anticoagulants.

Patients with kidney problems and clotting disorders are among those who have to seek out additional treatment avenues as well.

Additionally, if the threat of DVT or pulmonary embolisms is a recurring issue, there is no definite timetable for how long a patient would have to use blood thinners.

Over time, these medications can cause scarring in a patient’s veins and potentially increase the risk of blood clots.

Intermittent Pneumatic Compression (IPC)

If circumstances and medical status prevent the use of blood thinners, a person might consider IPC treatment. In spite of the complex name, this is a relatively simple treatment method.

A patient will have an inflatable sleeve placed over the part of the body where there is risk of blood clots – often times the leg – but not always. That sleeve is connected to an air pump.

The air inflates the sleeve which in turn pushes the blood away from the trouble area to the patient’s heart. When the sleeve deflates, it allows for blood to return to where it started.

The continual process helps facilitate regular blood circulation, minimizing the likelihood of a clot forming.

Thrombolysis & Surgery

These two choices are not used as frequently but should be weighed if a patient is not a candidate for or comfortable with other treatment options.

Thrombolysis is a procedure that involves the use of a catheter to quickly break up a clot and return a vein’s blood flow to normal. There is a relatively high success rate (80%) associated with this type of treatment.

Occasionally, surgery can be employed as a solution to a blood clot. This is only done in very rare and unusual cases involving clots that are very large and blocking important blood vessels.

If you or someone you know has suffered from an implanted IVC filter, Hotze Runkle wants you to know what your legal options are.

As with all medical decisions, Hotze Runkle encourages you to speak with your physician when deciding on how to face issues with DVT or pulmonary embolisms. It is vital that you consider all the alternatives to IVC filters.

Our experienced team of attorneys can help you in your fight against the companies who made your well-being secondary to their bottom line. Contact our national litigation firm today at (877) 919-0830 and let us take care of you and your family.

Disclaimer: THIS SITE DOES NOT PROVIDE MEDICAL ADVICE. The information presented in this blog and on this site should not be interpreted as a substitute for qualified professional medical advice.


The Companies Behind Problem IVC Filters

Statement of personal injury form with patient chart and stethoscope.

While we can sympathize and empathize with the victims who have suffered adverse effects because of the use of IVC filters, the negligent companies behind them seem faceless and nameless.

The national litigation team at Hotze Runkle understands the importance of getting to know the people we are fighting for on a personal level. We also believe it is equally important for us to know about the reckless companies who have put these innocent people in harm’s way by disregarding data that showed their products were dangerous.

By the Names and Numbers

In deciding whether or not to pursue legal action for an injustice suffered, it is natural to ask if there is any precedent or history of similar cases.

For patients who have had trouble with IVC filters, there is an ever-growing body of cases to draw on. There are almost 4000 filed lawsuits currently pending in two separate federal litigations against the two largest makers of these devices.

Nearly 4000 lawsuits against 2 largest IVC makers #HotzeRunkle #NationalLitigation #Fighting4You Click To Tweet

However, these two makers – Cook Medical and C.R. Bard – are not alone in facing potential legal consequences.

Cordis Corporation, a smaller company that also produces the filters, is also involved in around 200 cases of their own. Rex Medical, B. Braun, and Argon Medical are additional companies that distribute IVC filters who are facing lawsuits in federal and state court over the side effects associated with their products.

Still, none of the companies face more penalties and consequences than Cook Medical. The Gunther Tulip and Celect IVC models they market are at the heart of many of the claims levied against them.

The U.S. District Court, Southern District of Indiana, is currently handling all the pretrial steps for the multidistrict litigation on these cases.

C.R. Bard has a number of its models that have had injury claims directed against them. The hundreds of lawsuits focus on issues that have arisen with their Denali, Recovery, G2, and Meridian models.

The OptEase and TrapEase filters are the products that have brought suits against Cordis Corporation.

The Role of the FDA

Compounding the indifference from the distributors of IVC filters was the slow response from the FDA. Even after having received reports, in the thousands, for years concerning the negative and deadly effects of the filters, they didn’t issue a warning against them until 2010.

A subsequent warning from the FDA in 2014 advised the removal of IVC filters after a month or two followed their initial warning.

A year later, NBC followed up with a report of their own claiming that C.R. Bard had disregarded these warnings and continued to sell their products, in spite of the injuries and death associated with them.

The events covered in the report highlighted many of the common issues faced by patients who had, for various medical reasons, the devices implanted. These risks included the IVC filters puncturing the vena cava and breaking apart and moving out of place.

In some cases, the metal pieces that broke off traveled to other parts of the body, like the heart and lungs.

C.R. Bard failed to respond to these issues and also failed to pass the warnings along to doctors.

Hotze Runkle’s national litigation firm is here to provide you with the legal guidance you need and to fight for the justice you deserve.

Regardless of whether or not the IVC filter model that you have had implanted appears above, there is a high risk of harm that comes with any version of them.

We here at Hotze Runkle advise you to speak with your doctor or qualified physician on the potential risks you could face while using an IVC filter if you haven’t already struggled with their dangerous failures.

If you or someone you know has been injured because of their use of an IVC filter, contact Hotze Runkle today at (877) 919-0830.

Don’t suffer quietly or alone. These companies must be held responsible for the pain they have caused innocent victims.


Prolonged IVC Filter Use Can Lead to Higher Retrieval Failure Rates

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The U.S. Food and Drug Administration (FDA) has received more than 1,000 adverse event reports involving Inferior Vena Cava (IVC) filters and a growing number of lawsuits are being filed against IVC manufacturers BARD and Cook Medical for several of their products including Bard Recovery, Bard G2, Bard G2 Express,  Cook Gunther Tulip, and Cook Celect.

Allegations against the developers of these IVC filters revolve around the medical devices falling out of place or breaking apart within the body, and the fragments migrating, causing severe internal damages to vein walls and internal organs such as the heart and lungs. Lawsuits also note that the manufacturers failed to warn patients and physicians about the potential hazards of IVC filters.

These issues have been linked to retrievable IVC filters and their surgical removal has been a topic surrounded by much controversy. In 2014, the FDA released a safety communication notifying doctors to remove retrievable IVC filters within two months after a patient was no longer at risk of pulmonary embolism; a medical condition the devices are designed to protect against.

Now, a new study published in Circulation: Cardiovascular Interventions found that it becomes harder to remove the IVC filters the longer they are left implanted, with this further resulting in health problems and the need for more invasive retrieval techniques.

What we already knew about IVC filters.

This isn’t the first time the failing of IVC filters and their removal – or lack thereof – have been scrutinized by reputable organizations. A study published in 2010 in the Archives of Internal Medicine found that the Bard Recovery Filter had a failure rate set at 25% and the Bard G2 at about 12%.

Additionally, JAMA Internal Medicine published in July 2015, a study conducted at a single medical center which revealed that out of 648 procedures, 14.7% required advanced techniques to retrieve the devices after routine attempts had failed.

These studies have only validated concerns set forth by plaintiffs and those injured by the harmful devices.

What the new study warns against.

The newest study published in Circulation: Cardiovascular Interventions was completed by a group of researchers from Northwestern University Feinberg School of Medicine. The group analyzed data from IVC filter retrieval procedures that took place between 2009 to 2015.

One of the most notable points of the research was that out of 762 procedures, the most common filter retrieved was of the Cook Celect variety.

The researchers also uncovered an alarmingly high retrieval failure rate of nearly 41% when the devices had been left in patients for over seven months. The failure to properly retrieve the IVC filters also led to an increased risk of other injuries such as groin hematoma or harming of the inferior vena cava itself.

It was understood that the longer the medical device had been left implanted within the patient, the more difficult the retrieval process, which would ultimately require patients to obtain services at a more advanced facility.

What are some of the risk of retrieving IVC filters?

While having the medical devices implanted within the body is risky enough, the removal of IVC filters come with their own potential concerns including:

  • Damage to the vena cava
  • Damage to internal organs
  • Migration of IVC filter pieces to the heart or lungs
  • Loss of the filter in the body
  • Source of a new clot

In scenarios where patients cannot have their IVC filter removed because of its dangerous proximity to organs or arteries, they must commence a blood thinning treatment – the same type of treatment the IVC filters were meant to help them avoid.

Let the national litigation team of Hotze Runkle help you take legal action against the manufacturers of defective IVC filters.

If you or a loved one has suffered physical, emotional, and financial complications due to an IVC filter, Hotze Runkle is here to help. Contact us today at (877) 919-0830.

Our team of experienced and knowledgeable attorneys is dedicated to fighting for the justice you deserve. Allow us to review your experiences and determine if your case qualifies for compensation.


What You Should Know About IVC Filters and Multidistrict Litigation

If you or a loved has fallen victim to severe injuries caused by dangerous drugs or medical devices like Xarelto, IVC Filters, or Taxotere then you may be aware that there are thousands of lawsuits all across the nation involving the manufacturers who have developed and marketed these products.There are some vital differences to note, however, between a traditional lawsuit and what is known as multidistrict litigation (MDL) case.

Hotze Runkle is a national litigation law firm dedicated to providing top tier legal advice and assistance to individuals and families during the most troubling times. We believe that by making the most out of informing our clients, we are better able to develop a trusting environment and clear lines of communication.

We would like to educate the reader on how MDL may affect you.

What is multidistrict litigation?

Multidistrict litigation (MDL) is a special civil procedure that occurs when a complex legal issue begins to affect a large quantity of people. In the cases of Xarelto, IVC filters, and Taxotere, for instance, thousands of claims have been made against the creators of these individual products.

Generally, cases that fall under MDL have a common issue and common parties.

In order to better manage the multitude of cases that occur all around the country, the federal court system will transfer all of them into a single district court. One court will manage all the discovery and pretrial processes for the lawsuits.

The first lawsuits of an MDL are known as bellwether cases and their rulings can greatly affect litigation for the remaining cases. These initial cases are specifically chosen to represent the circumstances of the majority of the other cases.

What is the purpose of multidistrict litigation?

There are a couple of reasons that the MDL system was established.

The intent of merging all of these cases into a single district court is to conserve court resources, allow litigation to be more efficient and also move forward more quickly. Additionally, this also saves time, money, and effort for the plaintiff (as well as the defendants).

As previously mentioned, a single court will go through the discovery process, which is the investigation that both parties conduct prior to going to trial. The court will set guidelines and rules that must be followed during the discovery process but which will allow for the parties to carry out depositions of witnesses, gather official documents, and submit interrogatories.

Another important element of the MDL is that it helps develop a consistency in rulings. If a single plaintiff is facing individual lawsuits all throughout the nation, then there is a high likelihood that a variety of different rulings will occur, which can negatively affect plaintiffs in the long run.

What companies are facing MDL for IVC filters?

There are two major IVC filter producing companies that are currently facing MDL because of filters that were defective and caused serious – and sometimes deadly – injury to patients.

One of those companies is Cook Medical, which has nearly 1,600 claims filed against it in the Indiana federal court. The lawsuits allege that the Cook Celect IVC Filter was sold to patients even as its potential to break apart and damage internal organs and veins was known by the company. While a number of these cases have been recommended for settlement, if the settlements do not occur, the bellwether cases will begin later this year.

Another IVC filter manufacturer facing litigation is Bard for a number of its products including the G2 IVC filter, Recovery IVC filter, Denali, Eclipse, and several others. Individuals who have had these medical devices installed have dealt with heart or lung perforation, internal bleeding, hemorrhaging, punctured vena cava veins, chest pains, shortness of breath, and other serious medical issues.

The presiding judge is looking to narrow down the bellwether trials to about six cases and hopes to begin litigation in late 2017.

Let the experienced national litigation team of Hotze Runkle help you take action if you or loved one has been injured by an IVC filter.

Hotze Runkle law firm is committed to helping those have been harmed by others find the justice they deserve. Don’t hesitate to reach out to us immediately.

If you or a loved one has suffered physical, emotional, and financial complications due to the implantation or retrieval of an IVC Filter, we are here are to help. Contact us today at (877) 919-0830.

We can help you recover damages to cover medical expenses, lost earnings, earning capacity, physical and emotional pain, and more.


Dangerous Medical Devices, Prescription Drugs, and the FDA

Test tubes in clinic, pharmacy and medical research laboratory with male scientist using pipette

We as a nation, we have become familiar with news stories and exposés on dangerous medical devices and prescription drugs. Every years hundreds, if not thousands, of individuals suffer through life threatening situations because of products that have been marketed to consumers as safe and effective to treat their illness or health condition. From medical devices like IVC filters, to prescription anticoagulants like Xarelto, patients are often the last to learn that their treatments may be dangerous, or sadly, even fatal. While there are certain federal departments designed to regulate the approval of medications and medical devices that make it into the market, flaws within these systems allow for pharmaceutical companies and manufacturers to sell products that are not always thoroughly studied or understood.

At the law offices of Hotze and Runkle, we believe that the safety and physical well being of patients should be of the utmost importance to these various medical devices and drug creators. However, the reality is that the primary focus of many of these pharmaceutical companies is simply profit.

To understand how these dangerous medical devices and prescription drugs make it through governmental approval processes, there is some vital information that you should know.

The Gatekeepers: The Food and Drug Administration

The Food and Drug Administration (FDA) is the federal department tasked with regulating the approval of medications and medical devices that the public is able to purchase, including prescription and over-the-counter products.

Unfortunately, the FDA does not actually test the products, but rather analyzes clinical trials and data to make a decision on whether or not a product will be approved. This system is rather flawed and allows for many drugs and devices to make it to the market without undergoing adequate studies or trials.

To begin with, medications and medical devices are generally tested by the same companies that make them. This means that the FDA must rely on the accuracy and integrity of studies done by the same individuals who are seeking to make a profit off of the devices and drugs. As pharmaceutical companies cannot make a profit from products that do not have approval, it is in their self-interest to only report information that is suited to their own needs. Essentially, pharmaceutical companies will only report the data that will grant them FDA approval.

To make matters worse, the Government Accountability Office (GAO) has warned that the FDA lacks reliable resources to adequately staff, study, and track drugs and devices before they reach the market. This is further exasperated by the FDA’s impaired oversight of postmarket medications and medical devices.

More Than Just an FDA Problem

To make matters worse, there is an unsettling trend amongst federal legislatures that is providing the FDA with even less oversight abilities and further enabling pharmaceutical companies to release products that are not adequately studied.

One of the most recent examples of this has come in the form legislation known as the 21st Century Cures Act.

One of the last pieces of law signed by Obama, the Cures Act outwardly appears to be a landmark bill that would fund a number of health initiatives. The downside, however, is that the bill also cuts into the powers of the FDA, further deregulating the pharmaceutical and medical device industry.

One of the means by which this will occur is by allowing the FDA to quickly approve new technologies and drugs with even lower standards of evidence than what is currently set in place. While the FDA currently relies on clinical tests and randomized samples to ensure the safety and effectiveness of new products, the Cures Act would now allow them to approve an item based on observations, safety and side-effect claims, and post market clinical studies, rather than pre-market analysis and thorough consideration.

Proponents of the bill argued that the FDA system was ineffective and did not allow for growing medical technologies and medications to emerge on the market quickly enough. Now, the companies can bypass the entire process and submit documentation after patients have been subjected to the medication or medical device. These post market clinical studies often take place years after approval and few are ever completed.

Additionally, the 21st Century Cures Act would require the FDA to utilize a third party to review the safety of a product if a manufacturer makes changes to it. This would allow manufacturers to select and pay the third party for approval. This could obviously lead to huge conflicts of interests.

Don’t let the negligent and deceitful practices of IVC filter manufacturers scare you. Your injury and pain deserve justice. Let the legal representatives of Hotze Runkle serve your needs and provide you with the commitment of a team that can get the job done.

If you or a loved one has suffered adverse effects as a result of an IVC filter implantation, contact a team that fights to earn your trust—contact Hotze Runkle.
Our team of experienced and high qualified lawyers has the ability to make IVC filter manufacturers pay for the damaged they have caused. Reach us today at (877) 919-0830 to learn more about how we can put our years of experience to work fighting for you and your family.


The Decline of IVC Filters

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Inferior vena cava (IVC) filters are designed to prevent blood clots in patients who cannot use blood thinners. While they have enjoyed widespread use for some years, there is a good deal of controversy that surrounds them as well.

To date, there have been thousand of reports of issues arising from the use and removal of these devices. IVC filters are susceptible to migration within the body and the procedure to remove even the most modern versions can still be very dangerous and difficult to perform.

The attorneys at Hotze Runkle take great pride in staying current on news related to the various legal services we provide so that our clients can be well-informed as well.

Recent information shows that the use of IVC filters is a medical topic that is under considerable scrutiny, and because of this, professionals in the medical field are beginning to reexamine the use of the devices and the frequency in which they are implanted in patients.

Decreases in Use

One encouraging sign regarding the potential health and safety hazards associated with IVC filters is that there continues to be a decline in their use. This drop in the number of IVC filters in use began in 2010 shortly after the FDA issued a safety alert about devices that had been implanted for an extended period of time.

This overall decrease, however, has not been uniform across the country. The Northeastern U.S. has seen the bulk of the reduction, due in part to a medical environment that sees more disputes find their way into the courts. Western states have also seen decreases, but the legal atmosphere of their medical world does not have such a contentious streak.

Southern states have not experienced the same cutbacks in IVC use, largely due to tort reforms. These changes have made it harder for plaintiffs in these cases, not only to win settlements but the size of the settlements has been capped as well.

Regardless of what part of the country you find yourself in, there is likely to be a facility specializing in the removal of IVC filters. As the use of IVC filters began to decline, the number of places a patient could go to have one taken out rose greatly.

Instances of Pulmonary Embolism (PE)

Another factor that may contribute to the decline of IVC filters is that new studies are calling into question the effectiveness the devices have had in reducing the rate of PE. One particular study, published in JAMA Surgery, documents how the sharp decline in IVC use in trauma has not resulted in a rise in PE rates.

This relationship calls into question how useful these devices are in helping prevent blood clots. The possibility that they do not have much influence over the number of PE cases is something that has become hard to ignore for many physicians across the country.

While the authors of the study do not advocate the complete discontinuation of IVC filter use, they do acknowledge that there is still research to be done into their implementation.

Finding the safest ways and situations to employ IVC filters is still something that eludes even the most inquisitive and well-intentioned medical minds, which is probably as telling as recommending they not be used.

There continue to be many positive signs regarding the removal of IVC filters from medical use.

Future patients deserve to be treated with alternatives that do not come with as many safety questions.

If you or your family are seeking help with IVC filter litigation, the attorneys at Hotze Runkle are here to find the solutions to your problems and get you the justice you’ve been searching for.

Unfortunately, there are still many in need of legal aid because of the medical and health complications they have faced due to the use of an IVC filter.

The attorneys at Hotze Runkle are committed to helping those have been harmed by IVC filters.

If you or a loved one has suffered physical, emotional, and financial complications, or even death as a result of an IVC filter, Hotze Runkle is here to help.

Contact us today at (877) 919-0830.

Please be aware that there is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us today for a free case evaluation to review your legal options and ensure proper legal guidance in your time of need.


Symptoms of a Malfunctioning IVC Filter


Inferior Vena Cava (IVC) filters are small, cage-like devices implanted in the IVC vein of patients who are at risk of bloods clots, but cannot use anticoagulants (blood thinners). The devices are designed to stop a rising blood clot before it reaches the heart or lungs of a patient.

Unfortunately, IVC filters have gained a high level of notoriety, as the FDA has received more than 1,000 adverse event reports involving the metal devices. There have been a substantial number of patient injuries and deaths from IVC filters malfunctioning within the patient’s body.

Alarmingly, reports suggest that a leading manufacturer of IVC filters was aware of the potential complications, yet still marketed and sold the devices.

Severe complications include:

  • Filter fracture
  • IVC perforation
  • Damage to vital organs (i.e. lungs and heart)
  • Heart blockage
  • Death

At Hotze Runkle, we are committed to helping those who have suffered harm at the hands of negligent and deceitful manufacturers. Your injury and pain deserve justice. Let our legal representatives serve your needs.

Potential Symptoms of IVC Malfunctioning

If you are the recipient of an IVC filter and have been experiencing pain in various regions of your body, the following symptoms may suggest that the filter is malfunctioning or has been clogged with a blood clot.

Abdominal or Back Pain

The potential symptoms of a malfunctioning IVC filter vary from patient to patient with some cases having asymptomatic complications and others undergoing heart rhythm problems.<

One of the most commonly occurring signs of a IVC filter migration is abdominal and back pain. This can occur as a result of the IVC traveling throughout your blood vessels and lodging itself in an organ or other vein.

If the pain correlates with specific bodily movement, then the patient should visit a doctor and get examined to ensure that the filter has not moved from its intended location.

Pain in Lower Extremities

IVC filters help to reduce the risks associated with deep vein thrombosis (DVT) and are intended to prevent clots in the legs and pelvis from traveling up to the lungs and causing pulmonary embolism.

Because of this, patients may interpret pain in the legs as an issue of their DVT, but extreme pain should not rule out filter migration or perforation.

Furthermore, painfully swollen legs may show that the filter has become clogged.

Patients should visit their primary care provider if the issues continue for some time.

Symptoms in the Heart Area

If the filter has fractured and one of its struts has traveled into the heart, symptoms patients should watch for to include:

  • Chest pain
  • Neck pain
  • Confusion
  • Lightheadedness
  • Nausea
  • Shortness of breath
  • Abnormally rapid heart rate

If the IVC filter remains embedded in the heart, then the following severe conditions can arise:

  • Cardiac tamponade
  • Hole in the heart
  • Heart rhythm problems
  • Stroke
  • Hemorrhaging
  • Internal bleeding

If the IVC filter has caused severe damage to the heart, then open heart surgery may be required to remedy the issue.

Asymptomatic Concerns

In many cases, the migration of an IVC filter may not be accompanied by any symptoms. As blood vessels to have any nerve endings within them, internal injuries may be asymptomatic—meaning producing no sign or symptoms.

These scenarios can be just as dangerous as patients may not even recognize they have a problem until receiving an x-ray or CT scan.

A minor movement by a IVC filter can lead to slight tears in major veins that can continue to grow over time until major issues arise and emergency invasive surgery is required.

Dealing with pain and medical complications as a result of an IVC filter? Let Hotze Runkle fight for you.

The attorneys at Hotze Runkle are committed to helping those have been harmed by IVC filters.

If you or a loved one has suffered physical, emotional, and financial complications, or even death as a result of an IVC filter, Hotze Runkle is here to help.

Contact us today at (877) 919-0830.

There is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us for a free consultation to review your legal options and ensure proper legal guidance in your time of need. Hotze Runkle will review your experiences and determine if your case qualifies for compensation.


Retrieval of Inferior Vena Cava

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The removal of inferior vena cava (IVC) Filters has been a topic of great distress for doctors who are now attempting to remove the implants and for the patients who have undergone the procedure with hopes of it being temporary. IVC Filters are spider-like medical devices that were designed as a solution for those who cannot use blood thinning medications but who are at risk of a blood clot. The inferior vena cava is the large vein that supplies deoxygenated blood from the lower half of the body to the heart. Reports involving severe and disabling complications, including incidences in which the device migrated, titled, or became fractures and traveled through the body, have shed light on the dangers of IVC filters.

Most of these problems have been linked to the retrievable IVC Filters, or the devices designed to be removed after the risk of blood clot or pulmonary embolism has passed. Some of these removable IVC Filters have made the retrieval process difficult for doctors and their patients.

Identified Risks of Retrieving IVC Filters

Attempts to removal the IVC Filter can result in life-threatening health risks, such as:

  • Damage to the vena cava
  • Damage to internal organs
  • Migration of IVC filter pieces to the heart or lungs
  • Loss of the filter in the body
  • Source of a new clot

The benefits of retrievable IVC Filters over permanent filters has been touted by manufacturers, but the very design of these filters may make them difficult to remove. In 2014, the FDA released a safety communication urging doctors to remove retrievable IVC Filters within two months after the risk of pulmonary embolism cleared. Doctors were finding that IVC Filters were too dangerous to attempt a removal or the filters simply could not be found.

In cases where individuals were told they could not have their IVC Filter removed due to close proximity to vital organs or arteries, these individuals had to start a life-long blood thinner regimen. They were also made aware that the device would pose a continuing threat as it could dislodge at any time and cause severe injury or death.

When a doctor is unable to successfully retrieve a filter via routine attempts there are four options available, all of which pose significant safety risks for the patient. The curved catheter technique, loop-and-snare technique, balloon-assisted technique, and forceps technique are all options to remove the IVC Filter. However, these pose risk of massive internal bleeding, migration of broken filters to the heart, and sudden death.

In July 2015, JAMA Internal Medicine published a journal which revealed data from a single medical center about IVC Filter removal. Of 648 procedures conducted, 14.7% of the cases required advanced techniques after routine attempts to retrieve the device failed. In that same year, the Journal of Vascular Surgery, another medical journal, published a study that noted in some cases of IVC Filter retrievable, the device simply could not be removed because it was moved from its original position.

IVC Filter Retrieval Complications and Complaints

Yannis B, an implant recipient from Athens, Greece had his Option™ ELITE Retrievable IVC Filter placed in February of 2016 in Massachusetts. The surgery took place prior to his leg amputation as a prevention against blood clot complications. Just four months later, Yannis returned to his doctor to have the filter removed. His doctor found the device to be tilted with the retrieval hook embedded in the wall of his IVC. The doctor was unable to remove the filter from its delicate and dangerous position. Yannis was able to have the filter removed after consulting with another doctor in January of 2017. The patient took legal action against Rex Medical for selling a defectively-designed medical device. Not only was the company accused of selling defective products, they were found to be negligent of warning about possible side effects. Many doctors have come forth with complaints about the challenges of removing IVC filters and finding that the devices tilt or become embedded in veins or vital organs.

Susan Karnstedt received a permanent Greenfield IVC filter in 1992 due to a history of blood clots. Over the years, she began to feel intermittent pain in her abdomen. In her case, the legs of the filter eroded through the IVC and punctured her intestines. These types of complications are believed to increase the longer the implant remains in place. After years of pain and unexpected medical results, Karnstedt sought out medical experts at Stanford Hospital. It was interventional radiologist William Kuo, MD at the hospital who discovered a creative way of safely removing the permanent device. After a non-invasive laser procedure, Karnstedt was IVC Filter-free. This may not be the case for many others who lack access to these specialists or who have already suffered the detrimental effects of IVC filters.

Hotze Runkle Takes Action Against IVC Filters

We are committed to helping those have been harmed by others find the justice they deserve. Don’t hesitate to reach out. If you or a loved one has suffered physical, emotional, and financial complications due to retrieval of an IVC Filter, Hotze Runkle is here are to help. Contact us today at (877) 919-0830.

There is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us for a free consultation to review your legal options and ensure proper legal guidance in your time of need. Hotze Runkle will review your experiences and determine if your case qualifies for compensation.


Studies Suggest IVC Filters Are Overused and Ineffective

IVC Research
Concern continues to grow in the medical community as numerous studies have emerged to suggest that IVC filters are overused, ineffective, and place unnecessary risks to the health of patients who have been fitted with the devices. The FDA has received 100’s of adverse event reports dealing with complication caused by IVC filters and even sent a warning letter to IVC filter manufacturer C.R. Bard in 2015 in reference to inspections completed at two of the company’s facilities.

As of mid-January 2017, there were nearly 1,400 lawsuits consolidated for pretrial proceedings against Bard and almost another 1,400 lawsuits consolidated against Cook Medical—and the storm appears to be far from over.

The devices emerged as a seemingly safe alternative to prevent pulmonary embolism in cases where patients could not take an anticoagulant (blood thinning medication). However, IVC filters have the potential to dislodge and migrate throughout in the patient’s body, perforating veins and embedding themselves in the heart or lungs. Patients suffer severely, and in some cases, the migration of the device has caused death.

A study published in the January 2017 edition of JAMA Surgery found that the devices did not improve mortality rates in trauma patients, thus suggesting that not all who would receive the filters actually need them. In fact, the unnecessary implantation of the devices often leads to more issues rather than providing any meaningful benefits.

The study was conducted by the trauma center at Boston University School of Medicine and tracked patients who had received an IVC filter between the period of 2003 through 2013. Studying trauma patients provided researchers an opportunity to gauge the effectiveness of IVC filters in a population that was at a high risk of developing blood clots but who could not take blood thinners because of their severe situations.

Researchers compared 451 trauma patients who had received IVC filters to over 1,300 controls who did not have the devices. Astonishingly, the study found that in patients who survived longer than 24 hours, the use of an IVC filter did not improve mortality rates in comparison to those without one. Simply put, the use of IVC filter did not improve survival rates.

Researchers followed up at 6 months and 1-year post-discharge and found no difference between those with and without IVC filters.

Another troubling statistic that was identified during the study was the low retrieval rate of temporary IVC filters in trauma patients. Researchers found that only 8% of patients with IVC filters had them removed.

This is a major concern as medical professionals typically suggest that the IVC filters be removed two to three months after implantation. The FDA has an even shorter window of removal at between 29 to 54 days. Both assume the risk of a blood clot has passed.

Retrieval of the device is essential to the physical well-being of the patient. In May 2014, the FDA issued a Safety Communication that noted the increased chance of IVC filter complications when the devices were left unnecessarily longer that needed.

While the 8% retrieval rate was substantially lower than national numbers, studies show that overall retrieval rates stand at a terrible 30% for all patients (trauma and traditional).

While the devices are designed to improve survival rates from pulmonary embolism, the reality is that low retrieval rates place them at even greater risk of other serious health complications.

Adding to these issues is that trauma patients may not even realize that they have had an IVC filter implanted during surgery and follow-up appointments are hardly practiced or required by law. Furthermore, the doctors who recommend IVC filters may not even be the same who do the implantations, making it much more difficult for patients to understand who is responsible for the removal of the devices.

Dealing with pain and medical complications as a result of an IVC filter? Hotze Runkle will fight for you.

At Hotze Runkle, we are committed to helping those who have suffered harm at the hands of negligent and deceitful manufacturers. Your injury and pain deserve justice. Let our legal representatives serve your needs and provide you with the commitment of a team that can get the job done.

If you, or a loved one, has suffered physical, emotional, and financial injury, or even death, as a result of an IVC filter, contact us today at (877) 919-0830.


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