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IVC Filter to Go Under Microscope, Lawsuits Continue to Settle

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Washington, DCIt isn’t quite the same as changing the oil filter on your car. But then again, perhaps there are some similarities: the IVC filter, or inferior vena cava filter, is a tiny device implanted by doctors to “catch” migrating blood clots that have broken away from an arterial wall. In so doing, the IVC filter prevents the blood clot from migrating to the lungs, an event that usually proves disastrous.

However, there are problems with the devices, and various lawsuits have been filed against the two primary manufacturers - Cook Group Inc. and C.R. Bard - alleging the devices are defective. A major post-market study aimed at evaluating the safety and efficacy of the devices launches this year.

The Cook Celect and Gunther Tulip IVC filters are fashioned from metal and are spider-like in appearance. While they have been found to perform well for the indication to which they have been designed, there have been allegations of other problems, including migration and perforation. A study published in 2012 in Cardiovascular Interventional Radiology found that 100 percent of the Cook filters perforated the study participant’s venal wall within 71 days of implantation.

The inferior vena cava filter in 40 percent of study participants was found to have tilted away from its original optimum position for capturing wayward blood clots from the leg.

IVC filters are also designed to be removed once their task is complete. In May of last year, the US Food and Drug Administration (FDA) issued a safety bulletin advocating that the ideal window for device retrieval is from 29 to 54 days after implantation. That said, the FDA was on record, as early as 2010, indicating that an IVC filter should be removed as soon as the danger of a pulmonary embolism had passed.

However, retrieving and removing the devices has also proven to be problematic and has fostered many an IVC filter lawsuit. A study published in JAMA Internal Medicine in March 2013 found that less than 10 percent of filters were successfully removed, with eight percent of IVC patients suffering a pulmonary embolism in spite of having an IVC in place.

In 2010, at the time the FDA issued its cautionary bulletin to doctors, more than 900 reports had flowed into the FDA’s Adverse Events Reporting System (AERS). Common amongst the complaints were the fracturing of devices, allowing small pieces to migrate through the bloodstream and risk potential injury or death.

Many health advocates would like to see an IVC filter recall or ban. But that hasn’t happened, and doesn’t appear to be on the horizon in the foreseeable future. To that end, the so-called PRESERVE Study (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) will commence this spring and last for five years. Once the multispecialty prospective clinical trial concludes, it will then take time to analyze, vet and publish the research data. The FDA would then study the data, perhaps convene expert panels and consider next steps. Those next steps - assuming the clinical trial extends to its planned completion - could take almost a decade to appear.

As for lawsuits involving the IVC filter, about 32 complaints involving the Cook Celect and Gunther Tulip filters have been filed in various federal courts across the US. Those lawsuits, by order of the US Judicial Panel on Multidistrict Litigation (JPML) are to be consolidated and centralized in the Southern District of Indiana for coordinated pretrial proceedings.

As for C.R. Bard, manufacturer of the Bard G2 IVC filter and the Recovery IVC filter, several hundred lawsuits have been reportedly filed. Allegations are that Bard knew for a period of some years that its IVC filters were prone to fracture, but failed to warn doctors and their patients, or so it is alleged.

The Bard lawsuits were never consolidated, according to reports. Other reports hold that Bard has been quietly settling lawsuits over its Bard G2 filter, although few details of specific lawsuits are available.

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READER COMMENTS

Posted by

on
I had a Greenfield implanted in 1999 during pregnancy. 5 months ago I had a CT scan for abdominal pain. It was discovered that all 6 legs had penetrated my vena cava; 3 in my liver and 1 is putting pressure on my renal vein. I am wondering why so many Greenfield filters are failing and why NO ONE is screaming about it. There has been a huge failure in patient information. Boston Scientific has to know that these things are failing, I'm just wondering at what rate. Even more terrifying is how many people are just sitting like ticking time bombs, not even realizing their abdominal or back pain, or their shortness of breath or chest pain might be related to a failing filter. To those of you who are searching for help, Dr. Desai at Northwestern and Dr. Kuo at Stanford have both spent hours talking with and guiding me. They are two of the leading physicians in this field. Good luck. I think it's time we start screaming, someone might listen.

Posted by

on
I am a 37 yr old male that has a blood clotting disorder. I was implanted with the Bard G2. I hated seeing the commercials for all the problems thinking it was just lawyers doing what they do and would change the channel. A few weeks later my life changed. Yes it tilted. Yes it penetrated my Vena cava and UNC tried for 5 hours to remove it unsuccessfully after being in me for 6 yrs. Their next plan was going to gut me up the middle to take it out because if not I was going to die. I found this article, read a Ladys post (see above) and asked for my records to be sent across the country to Stanford in California to Dr. Kuo. With in days they called me and said they could in fact remove it non-invasively so today I had it removed shortly over an hr under. Im back at my Hotel and grateful to the Stanford Medical staff, Dr. Kuo and the lady who posted the exact same thing she did. I owe my life to them, this woman, most certainly the Lord and was just overwhelmed with joy when I saw that mid evil looking device in a jar instead of me. I just wept. I do not think I had much more time. I have retained legal counsel and encourage anyone that is in my shoes that heres it can't be done to look into Stanford Medicine in California. Dont worry about insurance, just get it out of you...now! God bless everyone and thanks to all who SAVED MY LIFE and are helping me seek justice for so much unnecessary pain and tremendous suffering!

Posted by

on
I have a Greenfield filter it was done in 2005 after history of deep vein thrombosis. I been on warfin since the age of 19 I am 52 now. This stuff about these filters are really bothersome. I am not sure what could be done I just took the advice of the doctor and went with it because he said without it I could die. So what do you do??? Its dangerous to remove so do we suffer the anticipation of worrying about tomorrow??? Worrying about it moving or breaking off etc leaving the possibility of loved ones to worry about if it was the filter!!! This is crazy that we're dealing with possibilities!!! Do we need legal help do we wait can we sue before it gets worse? I feel we should be compensated for being misled!!!!

Posted by

on
I had a bard filter placed in 2004 because of a dvt and pe at same time i still have it i take warfrin 10mg everyday ...since then i have had a total of 15 clots in my legs arms and lungs ...im 43 yrs old have 3 grandkids and all i can do is hope im here to see tommarrow. For my filter could kill me to remove but i am at risk if they leave it ...i have a Laywer and trying to get justice. . we will see soon ... Good luck all and god bless u..

Posted by

on
I have a Gunther Tulip that the doctor was not able to retrieve even though I went back shortly after having it inserted. He's telling me it's fin but I have concerns, if someone can recommend a lawyer in New Jersey that would be great. Thanks

Posted by

on
I Had A Bard G2 Filter Placed In 9/18/2007 Before My Colon Cancer Surgery. My Vascular Dr Said It's A Risk Taking It Out Because They Have To Go Down The Jugular Vein, And I Could Have A Stroke, And He Said It's Probably Embedded In The Vein By Now.
My Toes Are Numb, Pain In My Feet, And Legs, And Bad Leg Cramps That Are So Painful. Legs Swell Up, And Turning Color. Somedays My Lower Back Is Very Painful. Just Had A Stomach Xray, And Dr Says Everything Looks OK. I'm Wondering If I Should Have A Catscan, Something Just Isn't Right. I'm Scared Just Like The Rest Of You, Please Reply!

Posted by

on
I have a IVC filter put in on 12/17/2013 and my legs have been swollen and weeping water ever since and I'm short on breath. My doctor knows about everything and now I just received a registered letter from the radeology department at the hospital where it was installed and they said at the time it seemed like a good idea but upon further investigation we feel it needs to be looked at because of possible problems today is my appointment for a consolation to see what my options are. I feel like a walking time bomb if they remove it I could have another DVT if they leave it in it could do any number of things and kill me it's a catch 22 either way seems like a death sentence. I've got several lawyers wanting to represent me but I've not retained one yet not much point till I know what the damage is. I wish everyone on here all the luck in the world and if I was ever awarded a seven figure settlement I would throw a big party for everyone in our situation maybe that one day might just take our minds off of all the bad things were going through.

Posted by

on
I had a filter implanted in 2005 before a surgery. In 2010 I had a PE.
After experiencing severe back pain a Cat Scan has revealed 2 struts in my lung and one in my vertebrae.

The back pain is horrible. My doctors have all said that the filter can't be removed.

Any referrals to a surgeon who removes these is welcomed.

Posted by

on
For all of you looking for a savior with any filter removal problem--- old or other, contact Dr. Kuo of Stanford University. He is head of Interventional Radiology. He is the founder of the removal procedure and specific tools. Does most as outpatient. Best of the best doctors, hospital, whole experience.......... Flew in, test and intro to Dr. Kuo next day, surgery next morning, out that pm. Back to hotel for dinner. Stayed in area for a couple of days before flying home. Unbelievable after every other vascular surgeon and hemotologist told me my old (2003) filter could not be removed......

Posted by

on
I had a bard g2 put in 10 yrs ago after a PE. Recently I got a call with a labeled critical ct scan ny filter migrated and was told they were going to have to do this huge open surgery with grafts to get it out. They said they couldn't take it out the normal way because it had been in so long and too risky. I was not a good candidate for such a big surg with my other medical problems and feared the surgery they wanted me to have. After a bit of research I emailed & sent my copy scans to a dr in Hershey PA Dr Frank Lynch who looked like he was known for getting the more complex ones out that other Dr's failed to be able get out percutaneously. He gave a much higher chance of retrieving it without a big surgery. Traveled to PA and it was so worth the trip. I had so many Dr's tell me it couldn't be taken out and he was able to get it out in a quick outpatient procedure and was back home resuming normal activities a few days later. That dr was awesome, and very impressive hospital too. I'm so glad I found him. The nurses told me ppl travel from all over to go to him after their local Dr's fail. They said he has a very high success rate and had taken out many deemed irretrievable. Misperceptions by many of my doctors was that it had been in too long to be able to get out ...mine was 10 yrs in, and he had said he had taken out some even longer. I had leg pain and swelling since it was put in that all my Dr's said couldn't be related...severe pain that mysteroiously disappeared after it was out. I wish I had found him sooner for yrs I begged them to take it out to see if related....it took it tilting and migrating with strut perforating caval wall 10 yrs later to finally get it out. So glad I didn't let them do that big graft surgery found him and sent that email.

Posted by

on
I was rewarded 1.5 million but every case is different depends on weighing factors good luck to all of you

Posted by

on
I had a Greenfield IVC Filter placed in May of 2010.A month later I was having severe chest pain.My cousin took me to the nearest hospital.After completing a CT Scan of my chest the doctor told me that I have Pulmonary Embolism.Over the next 6 years,I've had 5 more cases of blood clots traveling to my lungs.I asked my doctor a couple of years ago that what's the purpose of having the filter in the first place.When further study was done to see if they can remove the filter successfully,the doctor said that it would be impossible to remove it now because the filter is embedded in the vein.

Posted by

on
My husband went to Mercy Hospital in Des Moines Iowa on October 2nd with an obstructed bowel and October 25th of 2011 passed away from a pulmonary embolism that I believe was because of a IVC filter placed in his growing

Posted by

on
I was in a severe MVA in 6/06 I was ran off road & brake pedal went thru back of thigh & impaled me to front seat of my expedition which was on top of back seat,shattered face, compound humerous, & much more, anyway, a filter was put in to prevent clots.Since I was unable to even use crutch or wheelchair this was preventative measure.
4 yrs goes by,I learn to walk again, learn to use arm, can throw baseball with my sons,Walk and even run it was blessing by God if ever I saw one,a massive miracle, but very soon my feet swell when up & on my feet 4 few hrs, then legs discolord dark purple/greenish from 3" below knees down to feet., -First it's thought 2 be Edema,but one day walking my boys to bus stop, I collapse in foyer, UNABLE to get up, at 6'8 330lbs No-one can get me up, I thought it was my back, had problems prior etc,so 2 daysI laid there thinking it was a spasm or pinched nerve,finally was taken to ER,& Come to discover the severe pain,Discoloration legs, massive swelling was blood clots.
Had them in both legs had 4 surgeries thru back of knee in R leg D 5 in Left, put on Coumadin, 6 mons later unable to walk again, this time used a new procedure putting an ultrasound machine to shoot waves up my arteries to break up clots, it heated my blood up so much they had to surgically implant inlets/outlets on top & bottom of calf to "COOL' heated blood, VERY PAINFUL had that in leg 2days,7 more surgeries but one day I was mid-operation and a younger man 29 very healthy looking no clot history was rushed in OR next to me w/ clot in his lung, he died right there in front of me, I got so freaked out I signed a DNR and demanded to be put under everytime after that I was so terrified and this past spring it happened yet again,I finally got an at home test kit for Coumadin which is much better than hospital once a week.Anyway I was unable to use only right leg this time they found a majority in both femural Arteries from groin getting more space as they went down leg. FINALLY they admitted that the filter itself is causing the clots, like a lawnmower gas filter when that is in your artery as blood passes thru the blood even thinned coagulates around the rim of implant creating strings of small clots like beaded necklace and then they drop off into lower extremities and when I get up to be active to try and move enough blood to break them up etc My legs look like tree trunks so I have to lay with my feet above chest and sleep that way for near 10 yrs now. They can't remove it, it is embedded in my Vena Cava and if something goes wrong I die, I have good possibility of losing lower legs, I have loss of feeling in feet, they are gross and now I even have HUGE vericose type viens growing to find a way to get blood from heart to feet since blocked and it's routing thru tiny capillaries and making them huge ugly surface eyesores.What are to do, the very thing put in as a preventative measure has turned my 2nd chance at life into a shit-storm, I can't be active with my now teen boys 17/13, gained weight, a lot of water weight because clots don't allow blood to flow enough to kidneys to excrete the fluids no longer needed,my blood pressure is up and this has put my heart under huge stress pumping hard trying to push blood past these road blocks.
I pray this isn't taken lightly and something can be done to those of us who have tremendously suffered and worst yet, my children by my absence, I can the anything but my boys, I won't stand for it. PLEASE LORD HELP US.-SW

Posted by

on
I suffered bilateral tib-fib fractures in 2001 got a staph infection while un nursing home had my r leg amputated in 2002 i dont remember anyone explaining that i had an ivc filter placed found out in 2005 that it was there had pulmonary embolism last year have been told i will have to take xaralto for the rest of my life i dont feel well most days still cant walk having surgery next week in my limb for neuroma which is horribly painful why put the thing in ir leave it in if i will still get pe's can anyone advise me
Is it to late to remove it

Posted by

on
In 2011, my father had the Greenfield filter put in place to "catch" blood clots. He has spent the last 2 weeks in pain. He was told at our local ER that there was nothing wrong, and no blood clots because he had a filter. Today, I'm sitting with him as he is doubled over in pain for day 3 in the hospital. After tests were conducted, we've learned he has 3 clots in his lungs and one in his right leg. This morning, we were told he now has pneumonia. I've never seen him in some much pain! What good is having a filter? If anyone has information or help to offer, please help my Dad!!!

Posted by

on
this is tragic . Has ANYONE yet been compensated
monetarily for the stress, anxiety and gross negligence in many of these cases I've read about? We're walking around with the very real danger of large needle-like projectiles that just may shoot into your heart and kill you. I think we need to get together regarding this topic and the many related cardiovascular dangers that are accompanying this risk. I don't know how people can have their lives altered because of a potential bomb inside us.

Posted by

on
I HAD SURGERY IN 2006 AND THREE DAY after I RETURNED HOME HAD PAIN IN MY LEFT LEG. CALLED MY DOCTOR TOLD HER I THINK I HAVE A BLOOD CLOT IN MY LEG. SHE TOLD ME IMPOSSIBLE, TAKE A PAIN PILL AND CALL HER IF IT GETS WORSE. NEXT MORNING MY LEG WAS PURPLE. BLOOD CLOG THAT FILLED THE WHOLE VEIN OF MY LEG. I have a Greenfield filter and I have lived in chronic pain since. Thousands of dollars spent on test and can't find nothing wrong. I want this taken out, but told impossible. Now I live in fear that this will break and kill me.

Posted by

on
I had a filter placed in 1999 when I was 25 due to 30 mobile clots in both legs. They discovered in 2004 that it had migrated and placed a 2nd filter which is now perforated through iliac outside my right kidney, they have been unsuccessful in locating 1st filter. I suffer from chronic fatigue and slow blood loss. I have had several blood transfusions, black outs, dehydration and a stroke since 2nd filter decided to take a stroll! I'm extremely tired, miserable and quite frankly terrified

Posted by

on
Major problems with the IVC that's been in my groin for 8yrs. Doctors won't take it out at the required 71 days then and now they say it is grown into the vein.

Posted by

on
I had a Greenfield filter put in 2012 when I had lower back surgery. I had two huge clots on my lungs and two in my leg. They trellised the leg clots and out in a stent. I never had the filter taken out. I had to get a Spinal Cord Stimulator put in in 2014 and I have massive upper back pain and my legs and ankles are swelled like elephant legs.. I am on Xarelto for blood thinners. My pain in my upper back and my ribs hurt all the time.. short of breath.. What should I do?

Posted by

on
Had Bard filter placed in June 2014 2 days before gastric sleeve surgery. Its November 2015 and Im just finding out about this. Never a word from my former surgeon. Im trying to see if vascular surgeon will remove but may not be possible since its been in for over a year. I have back pain nausea vomiting daily which may be from this and not bariatric surgery.

Posted by

on
I AM 51, HAD A IVC FILTER PLACED WHICH ENDED UP IN MY RENAL VEIN. I ALSO HAD ANOTHER FILTER PLACED WHICH IS IN MY VENA CAVA. THE FILTER THAT WAS MISTAKENLY PUT IN THE RENAL VEIN IS NOT RETRIEVABLE. WOULD YOU SAY THAT IS A LAWSUIT AGAINST THE DR THAT DID THAT? WHY WOULD SONEOME PlACE A PERMANENT FILTER IN A 51 YR OLD , WITH NO PREVIOUS PROBLEMS. IS THAT A LAWSUIT?

Posted by

on
i was in a motorcycle accident about 5 years ago. broke my hip and my pelvis towards the right side. almost got cut in half in that area. i was in a drug induced coma for three days. they had my right leg strapped up. i was told i was not to move it. it was like that for 14 days. they put one of these filters in my leg and left it there. i still have it inside me. i still have very active lifestyle. i am worried if i eat it that it will do damage. what should i do. i am a single father with an little boy that has Asperger. i have no insurance. what happens if it dislodges and i get hurt. what are my alternatives. i really could use some advice. thanks!

Posted by

on
I had a bard ivc filter placed 2010 prior to a bariatric surgery.Had my surgery.Physician said it could stay after procedure. Had car accident whipblash. The IVC filter migrated, embedded horizontally on the vena cava and perforated the renal vein,artery and also lodge 1 cm inside L3 vertebra.Afer 4 removal trials including a thoracic surgeon in which I had to travel from the carribean to Florida to get it done,I developed a Pulmonary Emboli during the last procedure.Lucky for me the surgeon was able to remove the emboli.I currently remain anticuagulated with chronic back pain.

Posted by

on
I have a Vic filter put in Dec. 21 2005
After a bad car accident I was 25 I was in a drug induced coma for almost a month and non ambulatory for almost 2 months. I still have the filter in. I'm in good health really have no problems (knock on wood). Really have not seen this law suit till about a week or two ago listing to Pandora radio. Not sure what I should do.

Posted by

on
Request a CT scan from your vascular surgeons! This will show the migration. An X-ray did NOT show it had migrated too far out of place for me. My cook filter had the legs go into the kidney vein but it "looked normal and upright" on an X-ray. Only a CT will show any perforations ect.

Posted by

on
For all of you in pain get them out! I had a cook celect that migrated into my kidney vein! I was blacking out. Couldn't breathe. Back hurt. And radiated into hip! Get it out!!!!

Posted by

on
When I saw the 2 part report on NBC I was really pissed off.
I had a BARD IVC Filter procedure done in 2013. It is still in me. But not for long. I am getting rid of that asap.
Bard should be prosecuted to the fullest extent of the law. But there big money so they will get off with paying a few suits brought against them. That's just the way it works.

Posted by

on
I have had my ivc filter placed in 2013 an its been 10 years since my doctor seen me an he ain't got me on no type of anticougulants is that posed to be normal

Posted by

on
I had a greenfield filter put in in 2010 prior to knee surgery bc I have history of PE's. A few weeks later I had absolutely excruciating pain in the area where they inserted the filter and I had to go to the ER. I thought I was going to literally die. They could find nothing wrong and send me home. Pain meds helped and it went away after 3 days or so. Came back a month later and lasted for 2 days. My pain mgt dr did a nerve block that seemed to work. (iliac nerve?) and then a year or so later pain was coming back and he did another block. I get pain still on and off and am terrified it will worsen again. I had no idea Greenfield filters were a problem.

Posted by

on
I had a Greenfield filter put in 2 weeks ago because of a bood clot in both legs..Dr said I was not a candidate for blood thinners although I was on them before. I have had nothing but excruciating pain that has sent me to emergency room several times they keep saying nothing is wrong with the filter..I can not stand the pain . I can't functions at all at times I want to die...I asked to hav it removed and was asked did I want to die from the clots going to my heart???what do I do?? please help me

Posted by

on
I have had an IVC filter in my body since 2003. I had lower back surgery and it was put in at that time. When I Went back to have it removed but the doctors couldn't retrieve it. I can only say that I am appalled at this because I have been suffering all kinds of ailments since then. I was only 35 yeas old then, I am now battling gastritis which is severe at times along with anxiety and depression since the procedure was done. I want this out of my body it has taken too many years from my life. I don't want to lose anymore.

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