New Laser Technique removes IVC Filters

Despite thereIVC Filter Graphic being no evidence blood clot filters help the overall population, or that they increase mortality for trauma patients, some 250,000 IVC filters are implanted in people yearly. Even more concerning, many of these devices are not removed as soon as they should be. Research has meanwhile shown that the longer IVC filters remain in the body, the more likely they are to cause problems.  Fortunately, help may be on the way.

New Technology could save Lives

New technology is showing some promise, paving the way for the possible safe removal of IVC filters. New technology and methods could potentially save thousands of lives.

FDA recommends Quick IVC Filter Removal
Studies estimate that only 8% of IVC filters are removed from patients within 3.8 years of their being implanted. The FDA, meanwhile, recommends IVC filters be removed 24 to 59 days after being implanted.

The problem is that IVC filters aren’t always easy to remove, even within the recommended window; and the longer they remain implanted, the more difficult they can be to remove. IVC filters like those made by C.R. Bard, Cook Medical, and Cordis Corporation, have been named in blood clot filter lawsuits which allege they are prone to perforating the inferior vena cava wall. They can also migrate throughout the body and fracture, causing their parts to embed into vital organs. One client at Matthews & Associates Law Firm, which represents people who have filed IVC filter lawsuits, has an IVC filter embedded in a kidney. The entire kidney will likely need to be removed to safeguard the person’s life.

When an IVC filter fails within a person’s body, it can be extremely difficult to remove the device. Besides the kidneys, pieces can lodge in the heart or lungs,  and devices that have perforated the vena cava wall often can’t be removed without causing further damage.

Serious, Life-threatening Complications

IVC filters left inside one’s body can cause serious, life-threatening complications, including internal bleeding or strokes. Patients left with the defective devices may live in constant fear that the wrong movement could jar a jagged piece loose and cause fatal damage. Into this fearful scenario comes this hopeful news.

Five-Year Study shows Promise for Filter Removal

A five-year study examined the safety and efficacy of using advanced laser technology to remove previously irretrievable IVC filters. Endovascular laser-assisted retrieval has been applied to successfully remove several different types of IVC filters. Researchers who worked in the study believe that nearly all defective IVC filters can be removed using this laser technology.

New Laser Technique removes IVC Filters

More clinical studies need to be performed using this procedure, which for now appears able to give many thousands of people hope for a better, healthier future unencumbered by IVC filter fears.



Morcellator Cancer Complaint Filed

A medical Morcellator-btndoctor has filed a formal legal complaint demanding full investigation and prosecution of corporations that have made and promoted morcellation devices. The doctor also calls for prosecution of doctors who have used morcellators on women with (undetected) cancer, as well as organizations that have promoted their use, such as ACOG – the American Congress of Obstetricians and Gynecologists.

Dr. Vikki G. Hufnagel, MD, is Director of the Institute for Ethics Law, Science and Medicine. She addresses her complaint to the FTC, SEC, FINRA, BBB, FBI, OIG, Calif. Attorney General, California Senators Boxer and Feinstein, the Calif. Dept. of Insurance, Calif. Dept. of Affairs, members of the US Congress, and The Hague.

Crime of Morcellation Worldwide

Dr. Hufnagel writes: “To The Hague: This crime of morcellation with a device that spreads disease and death is taking place around the globe. Poor women have been used as experimental animals without being educated or given informed consent. The WHO does many fine things. However WHO also promotes testing on women in underdeveloped nations who are taken advantage of. Money is given to WHO for the promotion of studies on these women for corporations’ research and development.”

The doctor says The Hague must lead the action to educate and protect women around the world from medical abuse, harm and battery, and to insure their health and welfare.

The Mayhem of Morcellation

The doctor also said she is available to debate any agent for the ACOG, AMA etc. She says she will not stop her “attack” until the truth is known worldwide.

The Politics of Medicine
Physicians in other parts of the world do not get all the information they need to learn about the politics of medicine in America, according to Dr. Hufnagel. She writes that organizations such as the WHO and others take on research projects using poor, uneducated women to benefit corporations. The doctor demands to know who has been harmed in the development of morcellation.

Dr. Hufnagel asks that all agencies of the government stop these abuses by physicians and corporations which have killed or injured women worldwide. The doctor says she redesigned the device herself in 1995, then demonstrated her redesign to the medical device committee of the FDA.

She said she is filing the complaint “as a gynecological surgical ethics specialist, a creator of a new surgical branch of gynecology called Female Reconstructive Surgery prior to 1985, a student of Kurt Semm (Germany) and Viktor Bonney (UK), as the first physician to write law to protect patients in the U.S., Calif., Texas, New York with informed consent for hysterectomy, as an internationally known women’s health care expert and whistle-blower.

The doctor also advertises her services to assist law firms in morcellator lawsuits against morcellation device makers, doctors, medical organizations that have injured women. She said she wants to work towards “actual jail time for these crimes,” not just a slap on the wrist and monetary damages.

“Our society must change and be leaders of ethics protecting the people,” she wrote.

Morcellator Cancer Complaint Filed

Dr. Hufnagel lists her contact information on her complaint.

Dr. V.G. Hufnagel MD
Director of the Institute for Ethics Law, Science and Medicine.
PST 323–210–3371 vm,
4244 Canoga Ave
Woodland Hills Ca 91364



IVC Filters Poor Choice for Trauma Victims

IVC filters are IVC Filter Graphica poor choice for trauma victims. Patients implanted with IVC filters were no more likely to survive more than 24 hours after injury than those who received no filter, according to a study published in JAMA September 28, 2016. The research examined 451 trauma patients given an IVC filter, against a control group of 1,343 not given a filter. The study also referenced several other points which give cause to question whether the benefits of IVC filters are worth their risks.

No Significant Difference

The research study concluded there was “no significant difference” in survival for trauma patients with or without an IVC filter, whether or not they had venous thrombosis.

Death Risks rise with IVC Filter Dwell Time

The authors’ conclusions called for a reexamination of the use of filters in the trauma population, especially given the fact that removal rates are low “and there is increased risk of morbidity in patients with filters that remain in place.”  The longer the filter remains in place, the more likely it is to cause problems.

Venous Thromboembolism (VTE)
VTE is a significant cause of morbidity and mortality in the U.S., with some 900,000 patients a year developing VTE or pulmonary embolism (PE). Blood thinners are typically used for VTE prophylaxis in hospitalized patients or for treatment of acute venous thromobosis. Blood clot filters are often implanted in patients for whom blood thinners are contraindicated, as they often are for trauma patients.

IVC Filter Use Increases despite Lack of Evidence

Study authors Shayna Sarosiek, MD; Denis Rybin, PhD; Janice Weinberg, ScD; and others point out that despite a “lack of high-quality evidence” to prove the safety and effectiveness of IVC filter placement, IVC filter use has increased in the trauma population. The authors set out to “delineate the long-term mortality risk associated with IVC filter placement in trauma patients with and without a VTE. They performed a retrospective cohort study of trauma patients at Boston Medical Center at Boston University School of Medicine.

IVC Filters –No Benefit

Once the trauma patients survived the initial injury for 24 hours, there was no significant difference in mortality between those who received an IVC filter and those who did not. The data the researchers saw showed no benefit or decrement in long-term mortality for trauma patients with IVC filter insertion, whether or not patients had DVT or PE. Most filters were placed in those without VTE, with 91.6% (413/451) not removed. That indicates long-term IVC filter placement did not increase survival through prevention of future PE or decrease survival because of IVC filter complications (embolism, ruptured viscera, filter fracture).

IVC Filters Need Removal
The authors also noted that most IVC filters are not retrieved in a timely fashion and no clear protocol has been set for a timetable to retrieve them. But the authors said that their study was designed to examine mortality only, “and any nonlethal morbidity attributed to filter insertion would not be evident in these data.

Study Conclusion
The authors concluded that their data indicate IVC filters “should not be placed in trauma patients in an effort to decrease all-cause mortality.”  They also noted that “given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

IVC Filter Lawsuits

The failure of IVC filter manufacturers to inform implanting surgeons of the need to closely monitor IVC filter implantees, and to remove their filters as soon as anticoagulation resolves, is just one factor which leaves IVC filter makers vulnerable to IVC filter lawsuits.



Baby Powder Cancer Risks hidden, Jury told

A woman whoTalc Powder Lawsuit used Johnson & Johnson baby powder on her genitals and then developed ovarian cancer urged a Missouri jury on Oct. 4, 2016 to find J&J liable. In opening statement, her lawyer said J&J has known for years about a talc-based baby powder cancer link but failed to warn people about it. All talcum powder cancer lawsuits charge that J&J failed to warn of a talc-cancer link.

J&J prepared Defense Early

During opening arguments in St. Louis, Deborah Giannecchini’s attorney said J&J’s own inside documents showed the company anticipated the talc-cancer litigation to the point of writing out “a question and answer” to prepare for questions from plaintiffs’ attorneys who would sue J&J for women’s ovarian cancer cases. Another internal document feared the company would be compared to the cigarette industry if it failed to warn of the ovarian cancer link with talc powder. The attorney said J&J had been urged since at least 1982 to add warning labels to its talc-based baby powder.

Stage 4 Ovarian Cancer

Ms. Giannecchini has Stage 4 ovarian cancer, her lawyer told jurors, complications from her treatment, a greatly reduced life expectancy.

The attorney said the woman has had her spleen removed, along with part of her stomach and colon, and all of her ovaries and uterus.

Failure to Warn Key

A failure to warn is the legal terminology which sets the bar a plaintiff’s attorney must meet in order to make a case of this nature. The plaintiff’s attorney must not only prove a talc-cancer link, but also show that the company failed to warn of it. Her attorney argued: “[Ms. Giannecchini] said if there would have been a warning on the bottle to not use this on the genital area, she would not have done it and we might not be here.”

Defense Opening

J&J’s attorney argued in opening statement that there is no solid link between talc and ovarian cancer. He said the U.S. FDA and CDC were among “trusted medical institutions” that looked for a potential link but found none. “No one knows what causes ovarian cancer,” the attorney argued.

Imerys Talc America Inc., another defendant, which mines talc for J&J, repeated J&J’s contention that talc is not linked to cancer. Imerys’ attorney added that Imerys did not market the baby powder used by Mrs. Giannecchini, but simply provided the materials used to make it.

Plaintiffs 3-0 against J&J in Talc Cases

Ms. Giannecchini’s trial follows two huge verdicts against J&J in similar cases in 2016.

In February, a Missouri jury rendered a $72 million verdict to the family of Jacqueline Fox.  Ms. Fox died of ovarian cancer after using talc-based powder for decades. It was the first case in which J&J was ordered to pay damages over a talc-cancer link tied to its products.

The Fox family verdict involved $10 million in compensatory damages, $62 million in punitive damages, which are assessed by a jury when it is outraged and wants to send a message to a company it deems has done wrong.

In another J&J loss, in May 2016, a Missouri jury shocked the company with a $55 million verdict in a lawsuit brought by Gloria Ristesund.

J&J also lost a third jury trial, the first ovarian cancer-talc case to go to a jury, in 2013. In that one, a South Dakota jury ruled that J&J had failed to warn a woman about the link between talc-based powders and ovarian cancer. In that case, however, the woman’s cancer had been in remission for six years, though ovarian cancer is usually fatal. The fact that she was apparently recovered, according to legal experts, may have kept the jury from awarding damages despite its ruling that the company failed to warn of a talc-ovarian-cancer link. South Dakota, however, is a staunchly conservative state, which might give J&J pause in considering how long to fight talc cases before coming to the settlement table.

Baby Powder Cancer Risks hidden, Jury told

The case is Giannecchini v. Johnson & Johnson et al., case number 1422-CC09012-01, in the 22nd Judicial Circuit Court of the State of Missouri.



Bill to make Drugmakers “Justify” Price Hikes

Democrat and epipensRepublican Senate and House representatives introduced a bill last week to make drugmakers “justify” price hikes greater than 10 percent. USA Today reported that the bill was proposed due to the firestorm surrounding Mylan’s recent EpiPen price hikes. The lawmakers were also careful to point out that this move was not “regulation,” per se, so as not to offend any  Reagananomics worshippers.

Related: How Deregulation Destroyed U.S. Dominance

Facing public outrage over recent exorbitant EpiPen price hikes, Mylan recently announced it was taking the unprecedented step of offering a generic version of EpiPen at roughly half the price of the brand item. Drugmakers typically milk the profits from a brand name of a drug as long as possible before federal drug pricing guidelines force them to introduce or allow generic versions to hit the market.

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act is co-sponsored by Sen. Tammy Baldwin (D-Wis.); Sen. John McCain (R-Ariz.); Rep. Jan Schakowsky (D-Ill.).

Drug Company Disclosure Demands

At least 30 days before raising the price of a particular drug by more than ten (10) percent, the bill would require a drugmaker to disclose to HHS – the U.S Department of Health and Human Services – the company’s spending on advertising, development, manufacturing, and research for the drug. The drugmaker would also need to report net profits from the sale of the drug.

Transparency Buzzword Sounds Good

Mr. McCain, with his heavy constituency of retirees using prescription drugs in his state of Arizona, said the bill “would bring much-needed transparency to prescription drug prices. Transparency leads to accountability, and it is past time that mantra applied to the skyrocketing cost of prescription medication.”

Ms. Schakowsky also echoed the transparency theme: “Prescription drug corporations should not be allowed to hide behind a curtain, refusing to disclose information on drug prices, and price gouging with impunity.”

Tammy Baldwin, (Rep. Wis.)
According to Ms. Baldwin, the bill is not likely to pass this year because it was introduced so late in the session. She said the main effort is “intended to create momentum” for 2017 when the lawmakers plan to reintroduce the measure.

Campaign for Sustainable Rx

Executive director for the Campaign for Sustainable Rx Pricing, John Rother, called the lawmakers’ effort a first step in repairing the “broken prescription drug market.” If it is a first step, it certainly seems to be a very small one.*

USPSTF Listing
Consumer advocates, as well as Mylan, seek to add EpiPen to USPSTF’s list of preventive medical services. Under the Affordable Care Act, insurers must cover services with that exclusive status at no cost to patients.

Mylan Profits Secure Either Way

The New York Times noted that while that designation could limit out-of-pocket costs for insured patients, it would also allow Mylan to raise prices further, because insured patients wouldn’t bear any of the treatment’s cost. Moreover, consumers could still be strapped with higher costs through higher premiums or copays for other drugs, if their insurers seek to mitigate the costs of covering the EpiPen at no cost.

Bill to make Drugmakers “Justify” Price Hikes

According to the Times, the USPSTF list does not include any other prescription drugs for diagnosed conditions, so it could be tough to get EpiPen listed. USPSTF has recommended at least one over-the-counter drug, aspirin. It usually lists treatments for patients only if there are “no signs or symptoms of the specific disease or condition” (O’Donnell, USA Today, 9/15; Flom, Roll Call, 9/15; Lipton/Abrams, New York Times, 9/16; Abrams, New York Times, 9/16).

Meanwhile, as more and more people are becoming aware of just how little power they have in deciding drug prices, more and more are turning to alternative healthcare, which is really a contradiction in terms. Whatever care one chooses is an “alternative.” The important thing is to choose yours wisely.

*As for the drug pricing flap, what difference could it make if companies had to disclose these things whenever they want to raise a price more than ten percent? They will likely be able to find a workaround even if only to save the “shame” of broadcasting their profits. Maybe just raising the prices by 9.9% over different periods of time will easily defeat the purpose of this bill, even if the bill ever reaches the point of being put into law in the distant future. This bill would appear to have no teeth to really control drug prices. Real action would require “regulation,” which most Washington D.C. politicians and most of the people of the U.S. have been brainwashed to believe would signal the death knell for Capitalism.



Law Firm Filing IVC Filter Lawsuits

Matthews & Associates Law FirmIVC Filter is handling IVC filter lawsuits nationwide against all the major makers of IVC – Inferior Vena Cava – blood clot filters. The firm, with offices in Houston and New York, is engaged in litigation against Bard, Cook, Cordis, and Rex, the major IVC filter manufacturers.

IVC Filter Injury Research

Matthews & Associates attorneys have reviewed thousands of internal documents and dozens of published medical studies. They have also consulted with several leading experts in the field. These reviews and consultations have found, unfortunately, that mounting evidence indicates most IVC filters will eventually fail. In addition, many temporary filters are not being retrieved in a timely fashion, and many IVC filter implantees are unaware they have a filter implanted.

Several different injuries may constitute a potential IVC filter case. The firm is investigating cases in which one of the following IVC filter injuries obtain:

1) any part of the IVC filter fractured or broke off;
2) the IVC filter or a part of the IVC filter moved or migrated from its original location;
3) the filter perforated the inferior vena cava or other organ;
4) the filter is embedded or tilted;
5) a doctor tried to remove the filter without success;
6) a doctor recommended removal but felt the procedure was too risky;
7) a doctor diagnosed someone, AFTER the filter was implanted, with one of the following medical conditions, which could be associated with the IVC filter:
a. caval thrombosis;
b. pulmonary embolism;
c. DVT /post-thrombotic syndrome; or
d. thrombosis/embolism.

Filter Failure more likely over time

Virtually all of the medical evidence that our attorneys have reviewed indicates that the longer an IVC filter remains in the body, the more likely it is to fail. In addition, the medical literature we have reviewed indicates that damage caused by the filter tends to be progressive.

For these reasons, people with an IVC filter in place might be wise to get screened even if they have had a prior test which showed that the filter was intact and in place.

Statutes of Limitations Issues

If upon testing and screening by a doctor, someone is diagnosed with one of the seven conditions listed above, that person might may want to contact an attorney to consider an IVC filter lawsuit. Anyone who has had complications arising from the removal or attempted removal of an IVC filter, or has been diagnosed by a doctor with any of the conditions above, or who has experienced a failed attempted removal of the filter, could trigger a deadline to file a lawsuit in court. That person might be wise to contact an attorney if they do not already have legal representation. Lawsuits have strict time limits for filing, and IVC filter lawsuits are no different.



Epi Pen Scandal takes Generic Turn

Mylan has jacked epipensup the price of EpiPens – a lifesaving allergy treatment – 15 times since 2009. EpiPens now give a list price of $609 for a two pack, a 400% increase since 2009. The obscene price gouging has inflamed social media. To mollify the steaming public, Mylan has this week taken the almost unprecedented step of offering EpiPen in a generic turn years before the company would have been forced to do so by FDA and Congressional regulations.

Brand name drugs typically enjoy a long run at high prices – sometimes for as long as 20 years – before they must be offered in cheaper generic forms. (Sometimes brand names makers cheat a little bit, with pay-to-delay schemes, keeping generics off the market a little longer in order to make more profits, but that’s another story.)

Related Stories

Expensive at Half the Price

Mylan Pharmaceuticals and its now infamous CEO Heather Bresch knew they needed to respond to a relentless social media campaign that took umbrage at Mylan’s taking advantage of sick people. The company response was to announce the launching of a generic version of EpiPen, at 50% off its current price. The company also announced that it would work to make EpiPen treatment more affordable.

Congress Investigates EpiPen

Where social media goes, votes go, especially in an election year; so now Congress has announced that it is investigating Mylan. The House Oversight Committee sent a letter to Ms. Bresch Monday, August 29, 2016 to request a briefing as well as company documents regarding EpiPen.

Mylan has sought to pin the blame for its price gouging on a shadowy health care system and supply chain. Ms. Bresch has responded to criticism by calling the system “broken.” She has said it is in “crisis,” comparing it to the 2008 financial crisis. She took no blame (or credit, for that matter – depending on your viewpoint and stock portfolio) for her company’s wildly jacking up prices because they can.

Critics say Mylan lacks Empathy

Ms. Bresch’s arguments don’t wash with many.

Wells Fargo analyst David Maris said Mylan doesn’t understand the “very emotional, very stressful situation” parents are going through when their children need this drug.

“No one’s expecting Mylan to give away their products,” said Mr. Maris. But empathy is the most human emotion. And when you raise prices year after year, by a lot, for a drug that’s lifesaving, it shows a complete lack of empathy.”

No one forced Mylan to dramatically raise EpiPen prices, Mr. Maris pointed out: “It’s outrageous. People shouldn’t be fooled by the idea that the system made them do it. Mylan is to blame for the high prices of EpiPen.”

Broken System or Opportunistic?

The most recent round of price hikes looks more opportunistic rather than a result of health care system problems. In November 2015, Mylan raised EpiPen prices by 15% (the 14th price raise since 2009), just one month after EpiGen’s main rival Auvi-Q was pulled from the market. Six months later, Mylan again raised prices, by another 15%.

Bernstein analysts wrote in a recent report that Mylan was in a position to raise prices because competitors were out of the market; so Mylan raised prices.

EpiPen CEO made $19 million last year

Ms. Bresch made a cool $19 million as Mylan CEO last year. Maybe the outrageous EpiPen price hikes were needed to help pay her outrageous salary. The daughter of a U.S. Senator (Joe Manchin), Ms. Bresch is nobody’s fool. She has shown that she knows how to fire back with a good sound bite as well as her daddy or any other Washington D.C. politician.

Do Good and Do Well?

Ms. Bresch said to the nation’s paper of record, The New York Times: “You can do good and do well, and I think we strike that balance around the globe.”

She did also add, perhaps for the benefit of her shareholders and the American way: “I am running a business. I am a for-profit business. I am not hiding from that.”

Some people, however, no doubt wish they could hide from her company’s prices.

$1,260 out of pocket expenses

A New York Post story of August 26, 2016 details the lives of Tom and Samantha Marino trying to keep up with their son’s EpiPen meds. While Ms. Bresch also told the Times that most of EpiPen’s costs for people are paid by insurance, that doesn’t appear to be the case with the Marinos.

Mrs. Marino told the Post that earlier this year, the couple paid $1,260 out of pocket for three EpiPens that will expire in February 2017. That was before the latest price increases.

The Marinos said they need three EpiPen Jr 2-Paks for their young son, who has a severe reaction to peanuts that can be life threatening They keep one at home, one in Mrs. Marino’s pocket, and one at school.

Epi Pen Scandal takes Generic Turn

This might be an easy story to ignore for those of us who don’t need EpiGen, but there for the grace of God go we. How many more drugs will Big Pharma be able to gouge people for before some sort of reasonable regulation is put into place to protect us from the unreasonable booty taken by a $19 million per year CEO and her rapacious company?

Perhaps her senator father will get the job done and protect us all from future gougings?  You think?




Merck sued by former Vaccine Employees

Two former Merck MMR Vaccinevaccine employees filed a lawsuit against Merck Pharmaceuticals. Virologists Stephen Krahling and Joan Wlochowski filed a lawsuit in 2010 against their former employer over what they say is the company’s falsely reporting the efficacy of the MMR vaccine. The lawsuit,  unsealed in June 2012, claims Merck defrauded the U.S. government and people for more than ten (10) years by overstating the effectiveness of the Merck MMR vaccine.

Merck Inflated Vaccine Efficacy

Merck needed to maintain a certain percentage of effectiveness with its MMR vaccine. When Merck found it could not do so, it simply fudged the numbers, according to the complaint, ratcheting them upward in order to keep their lucrative contract with the U.S. government.

The virologists’ petition claims that they “witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine’s efficacy findings.”

Merck sued by former Vaccine Employees

This is not the first time quality control issues have surfaced over Merck vaccines. National Vaccine Information Center (NVIC) President and Co-Founder, Barbara Fisher, noted in an interview with Dr. Mercola that in 2010 Merck’s RotaTeq® vaccine was contaminated with a virus lethal to baby pigs.  Merck is the biggest player in the international vaccine game, taking in some  $20 billion annually in global vaccine sales. The company also makes the controversial shingles vaccine which causes shingles, as well as the ill-fated gardasil vaccine.

Vaccine Safety Compromised by Cozy Relationships

Ms. Fisher discusses the dangerously cozy relationship and conflicts of interest between federal agencies charged with vaccine safety oversight and vaccine makers. NVIC has long called for investigation into federal agency conflicts of interest and the creation of an independent agency to oversee vaccine safety.

Merck Vaccine Safety Questionable

Merck is also maker of the ill-fated Gardasil vaccine and the troubled Shingles Vaccine, which can give someone shingles and also cause eye damage.



Gunther Tulip IVC Filters Troubling Studies

IVC blood clot IVC Filter Graphicfilters have a troubled history when one looks closely at their safety and efficacy studies. The general safety profile of IVC filters makes them difficult to justify using for the general population.

Gunther Tulip IVC Filter Tilt 91%

Several researchers – including Alan Sag, BS; Joseph M. Stavas, MD; Charles T. Burke, MD; and several others – analyzed a retrospective review of 175 patients with the Gunther Tulip IVC filter implanted from 2003-2007. They reviewed each patient’s medical records and cavagrams, and published their conclusions in the Journal of Vascular and Interventional Radiology in 2008. Ninety-one percent (91%), 159/175 patients had tilt in their filters upon the first retrieval attempt. They found that the tilt “resulted in decreased clot-trapping abilities, increased complications, thrombosis, and difficulty in removing.”

IVC Filters increase DVTs

An American Heart Association study published in March 2005 by the PREPIC Study Group concluded that, at eight years, vena cava filters reduced the risk of PE, but increased the risk of DVT’s, and had no effect on patient survival. The authors’ conclusion was that although IVC filter use “may be beneficial in patients at high risk for pulmonary embolism, systematic use in the general population with venous thrombotic embolism (DVT and PE) is not recommended.” (emphasis ours)

IVC Filter Role Unproven

A clinical investigation by the International Society of Endovascular Specialists in 2007 looked at the retrievability of Cook’s Gunther Tulip Vena Cava Filter after dwell times longer than 180 days for multiple trauma patients. Thirty three (33) of 115 filters could not be retrieved. The investigation concluded that the role of IVC filters is unproven, and that retrieval should be done as soon as clinically indicated.

IVC Filters Difficult Removal

A Journal of Medical Imaging and Radiation Oncology article published in 2008 looked at the retrievable Gunther Tulip inferior vena cava filter in 317 patients. The authors reported that reported retrieval periods for the Gunther Tulip filter have continued to lengthen despite recommendations to remove them at 14 days, which later became at the doctor’s discretion.

The authors concluded: “Our data suggest (that) the extended filter dwell times may compromise successful retrieval.”

IVC Filters Not Retrieved

A Journal of Vascular and Interventional Radiology article published in 2008 examined 188 patients with attempted filter removal, with a mean dwell time of 63 days. Even at just two months, 12% were retrieval failures. The authors concluded that 90 percent of filters not retrieved perforated the IVC, the connection between perforation and inability to remove. Just as disconcerting, they concluded that increased dwell time was a significant factor in determining retrieval success.

Gunther Tulip worsens over time

Another Journal of Vascular and Interventional Radiology article, this one published in 2013, found the Gunther Tulip Filter troubling when left in a person over time. The authors concluded: “Although the Gunther Tulip and Option filters exhibit caval penetration on CT imaging, only the GTF (Cook) exhibits progressive penetration over time.

Gunther Tulip IVC Filters Troubling Studies

A 2007 study published in The Journal of Trauma and Acute Care Surgery found that despite IVC filters being generally accepted to reduce the risk of fatal PE, “this has not been proven, particularly when used for prophylactic indications.”

Further troubling, the study found that most IVC filters are not retrieved when placed for trauma patients. That information comes in addition to the fact that IVC filters have not been proven to increase trauma patients mortality.



IVC Filters Risk Serious Complications – Health Canada

IVC filters riskHealtha Canada serious complications, said Health Canada this week. Serious IVC filter complications, including death, have been reported in patients implanted with an IVC filter.  IVC filters can result in caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, and/or cardiac tamponade. Many of these serious complications occurred with long-term filter implantation – greater than 30 days. Health Canada said these complications have also been reported internationally.

Dear Doctor Letter for IVC Filter Use

On July 25, 2016, Health Canada sent a “Dear Healthcare Professional Letter” (a ‘Dear Doctor letter’ in American parlance) to warn doctors and other medical professionals about the dangers of IVC filters. The IVC Filters named in the letter include those made by Bard, Cook Medical, B. Braun and Cordis.

The letter said its intended audience was physicians who request or implant Inferior Vena Cava (IVC) filters and clinicians responsible for follow-up care:  radiologists, cardiologists, vascular surgeons, thrombosis specialists, internists, emergency physicians, bariatric surgeons, orthopaedic surgeons, primary care physicians.

It also asked these professionals to distribute the letter to “relevant departments and appropriate personnel who use IVC filters.”

Limited Indications for IVC Filters

Healthcare professionals were cautioned in the letter that they should carefully consider the indications for IVC filters. Health Canada said the IVC filter should be considered only for patients with acute proximal deep vein thrombosis (DVT) of the leg, and those with acute pulmonary embolism (PE) IF those patients also have a contraindication to anticoagulation (blood thinner medication such as cumadin).

Retrievable IVC Filters short-term only

The letter further cautioned that retrievable IVC filters are intended only for short-term placement. When possible, they should be removed when anticoagulation therapy can be started or if a patient’s PE risk subsides.

Health Canada encourages each hospital to identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.
Health Canada said it had received 121 reports of serious complications associated with IVC filters as of June 6, 2016. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation. These complications have also been reported internationally.

Health Canada named six IVC filter manufacturers and twelve (12) different IVC blood clot filter products in the letter:

Filter & Maker:


•  ALN Vena Cava Filter   (Retrievable)


•  Denali Vena Cava Filter (Retrievable)

•  G2 Filter System            (Retrievable)

•  Simon Nitinol Vena Cava Filter  (Permanent)

B. Braun Medical:

•  VenaTech LP Vena Cava Filter (Permanent)

Cordis Cashel:

•  Optease Vena Cava Filter       (Retrievable)

•  Trapease Permanent Vena Cava Filter

William Cook, Europe APS And Cook, Inc.:

•  Cook Celect Platinum Vena Cava Filter (Retrievable)

•  Cook Celect Vena Cava Filter (Retrievable)

•  Gianturco-Roehm Birds Nest Vena Cava Filter (Permanent)

•  Gunther Tulip Vena Cava MREye Filter Set (Retrievable)

 REX Medical, LP

•  Option Retrievable Vena Cava Filter System  (Retrievable)

Randomized Control Trials show IVC Filters fail efficacy

Randomized control trials are the gold standard for testing medical device safety. Health Canada said there have been several clinical studies of IVC filters, but only two randomized controlled trials (RCTs). Results from those two RCTs fail to support IVC filter use in patients who can be treated with anticoagulation. In addition, those RCTs failed to show reductions in VTE and mortality.

IVC Filters Risk Serious Complications – Health Canada

Health Canada also noted that it is working with IVC filter makers to monitor post-market safety and effectiveness of IVC filters in Canada and worldwide. Health Canada has required IVC filter makers to put post-market evaluations in place that could include Canadian registries. The agency said it wants to “further understand appropriate patient populations that should be treated with IVC filters.” Health Canada said it is also sharing this important IVC filter safety information with healthcare professionals via fax, in addition to publication on Healthy Canadians Web site, as well as MedEffect.