FDA Warns of Problems with Blood Clot IVC Filters
By: Staff Writers | Published: August 10th, 2010
After receiving more than 900 reports of problems with IVC filters over the last five years, federal regulators are warning doctors to remove the filters, which are meant to prevent pulmonary embolisms, before they can break free inside the patient and do damage.
The FDA issued a safety alert this week for inferior vena cava (IVC) filters. The IVC filters are placed inside patients to prevent blood clots from breaking free and traveling to the lungs or heart and causing a pulmonary embolism. However, the FDA is telling doctors they should remove the filters once the danger of the clot has passed, or else the filters could break free and travel through the body of the patient.
The FDA warning notes that the agency has received 921 adverse event reports involving problems with IVC filters implanted. Of those, 328 involved the filter breaking free and migrating through the body, 146 involved components breaking loose, 70 involved the IVC being perforated and 56 reports were of the filters fracturing. While the agency did not detail the types of injuries resulting due to the side effects of IVC filter failure, it did note that some of the events led to “adverse clinical outcomes” for the patients.
The agency’s recommendations are that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning said that all physicians are encouraged to consider the benefits and health risks of IVC filter removal for each patient.
A pulmonary embolism can occur when blood clots travel through the blood stream and becomes lodged near the lung. This can cause a sudden blockage of the artery that brings blood into the lungs, causing serious and potentially fatal injuries.
In conjunction with the FDA warning, a clinical study was published online by the Archives of Internal Medicine that highlights the high failure rate of C.R. Bard’s Bard Recovery and Bard G2 IVC filters. An editorial accompanying the article says the problem with the Bard IVC filters highlights the failures of the FDA’s 510(k) premarket approval system, which has come under heavy fire in the last year.
Researchers found that the Bard IVC filter problems appear to be both commonplace and severe, with sometimes deadly results. The clinical trial involved 80 patients who received either the Bard Recovery or the Bard G2 filters. Of those, 13 of the patients had at least one strut that was part of the IVC filter fail.
The Bard Recovery, the older of the two filter designs, was the worst, with a failure rate of 25%. Of the seven out of 28 Bard Recovery filters that failed, five of them (71%) resulted in a piece of the filter traveling to the patient’s heart. Three patients experienced life-threatening complications, and one of them died as a result.
The Bard G2 filters had a failure rate of about 12%, with six of the 52 implants fracturing. In two cases, parts of the filters broke off and traveled through the patient’s body.
Researchers pointed out that addressing the problems of failed filters could require open-heart surgery. They also noted that the patients receiving the filters generally have a much higher mortality rate than the average population, making them even more vulnerable to IVC filter problems. They also said they suspect the failure rates would have been higher if the filters would have been left in longer.
The editorial, by Dr. Rita F. Redberg, an editor with the medical journal, points out that both of the Bard IVC filters involved in the study were approved using the expedited 510(k) approval process, which only requires that a medical device be substantially equivalent to a device already on the market for approval. The filters were categorized as Class II medical devices, the same classification as mercury thermometers, and were approved without any clinical data of safety and effectiveness.
The editorial comes as FDA officials and lawmakers are considering ways to strengthen the FDA’s control of medical devices and close some of the loopholes in the 510(k) premarket approval process.
Comment by Dennis on 13 August 2010:
I was diagnosed with a pretty bad PE condition last Aug and spent a week in the hospital. When I went in my O2 was at 78%. CT scan showed that I had about 30 to 40% of both lungs were affected. I have been on blood thinners and from recent blood tests and CT scans I am doing better. As part of the treatment they put one of these things in my lower aorta. I have had one of these for nearly a year. They still can’t figure out what caused the PE in the first place but it must have been going on for some time.
A couple of months ago I had sudden and severe chest pain to the left, base of my sternum. I went to the local ER and they told me that my BP was all over the place. But all indications was that my heart was fine. I told them that it felt like the filter had shifted and caused a burse or abrasion inside. They did a CT scan and said it was still there and working to block the clots.
After what I have read here I am pretty scared. I am working with a Hematology Doctor and am scheduled for another set of tests. At the end of the month. After what I have read I think I would like to risk taking it out.
Comment by Sam on 9 September 2011:
My daughter had one of these filters put in after a horrible car accident. They tried to get the filter out two months later. One of the legs of this filter had broken off and is now lodged in her vein and the doctor spent 4 hours trying to remove it with no success. Now what? Will that metal leg break clear from her vein in the future and migrate to the heart or lungs? She\’s having an ultrasound in two weeks to see if the leg has moved at all.
Comment by Alejandro on 14 November 2011:
I’ve suffered from blood clots, and at the present time I’m recovering from surgery for the removal of a blood clot (DVT). I’ve been told by my doctor that I need an IVC filter implant. This problem runs in my family.
My question is, is there a real reliable IVC filter that would not cause me any problems in the future?
Comment by Kristin on 28 November 2011:
I had a Bard eclipse filter that migrated ,through the venacava into the bone and almast in the auorta when the doc tried to retrieve it he bent the leg and pushed it into the small intestines
Comment by Vatona on 3 May 2012:
I had an IVC filter put in about a week ago thru the groin.
Things were fine until a few days ago, when I take a step, it is painful
and feels like he hit my syatic nerve ,
I can also feel the IVC when I walk it is very painful, I have to hold
below whrere the IVC is just to walk.
I called the dr. that put it in, he said should be no problem but will check it before surgery on the 11th of May.
I think it has shifted!
Comment by robbin on 23 June 2012:
i am having severe swelling i have to take lassix ,i cant stand on my feet all day anymore to work .i have chest pains, i wish i never had this stupid thing put in,i hear other people at the clinic complain with same problem
Comment by Jim on 27 August 2012:
I had a blood clot (DVT) after a hip replacement 5 years ago it led to a pulminary embolism. Because I needed another hip replacement this past year my doctor recomended I have a Greenfield filter put in. Now 7 months later he recommends I have it taken out. Others doctors I have talked to say that it can be left in. I’m not sure what to do. Is there anyone that is going through this situation? I am 56 years old and have arthritic problems.I have heard about the filters failing and have heard about alternative blood thinners that are coming on the market that make the filter unnessary.
Comment by ressie on 27 August 2012:
how do i find out what type of mesh was inserted into my husbands leg?
Comment by Linda on 18 September 2012:
I had a filter put in and immediately started with back pain. My urine also had a horrible smell. The pain kept getting worse so they took the filter out and the pain went away. The doctor who took it out tried to tell me it was fine in the right place when he took it out. My family doctor thinks it punctured my urethra giving me the pain.
Comment by faith on 27 September 2012:
i was told i had a blood clot in the lung and i was pestered by dr until i gave in and let them put a filter in.i have problems understanding things cause i have mental condition but i let them put the ivc filter in and while they was doing i could feel the knife cutting me cause i wasnt out good enough,since then i have had pain all over my body esp leg and back pain,i have ask for it to be took out but the hospitial dr and ceo want even respond to phone calls.its painful.,in fact day it was put in i ran a fever that night.
Comment by Michael on 28 October 2012:
I have a Cook-Gunther-Tulip IVC filter.
Implanted 2007.
No follow-up by any medical staff that was involved.
I’m wondering if I’m at risk.
As there is a mass of information on the Internet about cases, I am at a loss to find any information that is useful.
Lawyers seen to jump at me from everywhere.
What to do ?
Comment by Jessica on 1 November 2012:
I had a gastric bypass June 7, 2011 and the doctor told I had to have a Grenbriar IVC filter placed. He would not do surgery without me having one. I had never had a blood clot or any other condition to warrant the need of a filter. He told me i would have the filter removed one year later after surgery.
Going in for my annual I find out that the radiolgy department placed a permanent fliter and it’s too late for met to get the filter out. I am concerned as too what the medical risks are and I have two kids and I am a single parent. My daughter is 10 and my son is 18.
I found out by going to the doctor that I have to go for an ultrasound on my heart due to some abnormal heart rhythems. Any suggestion as too what to do, the doctors are no help.
Comment by lekia on 29 December 2012:
I had blood clots on my lungs and leg in 2006 I had a filter placed every since I have had swelling in legs back problems unable to stand and pain in my growing area I’m at a lost because I’m only 28 years old now and dont know Who to call for help with this
Comment by faith on 2 February 2013:
im still in constant pain from ivc filter and ive just gave up.dr told me in august i had clot in the lung and then in oct her and another dr told me they was no proof of blood clot in the lung and the filter could be took out.they claimed they couldnt take it out,another dr said it shouldnt be in there to start with,the pain the filter has caused me is making my life very miserable,my leg stays swelled and leg pain is terrble and feel like needles in my back and i cant walk cause of internal bleeding,ive told fda but they dont seem to care .
Comment by Erica on 13 February 2013:
I am a 27 year old female, who had a severe automobile accident in April of 2008. I was in a coma for 2 months, numerous injuries and many surgeries. Roughly two weeks after I woke up not only did the doctor put my trachea but they found a blood clot in my lung or a PE. Before I knew it I went in for surgery, where they put filters in. I never knew this was done until a few months ago when my doctor said that the filters were never taken out. I have constant severe leg pain, can’t stand, walk, sleep, work I can’t do a thing without my legs killing me. I am wondering if anyone else has this issue? I can’t get a damn doctor to do anything about it, even to just look into it. Any information would help thanks!
Comment by beth on 5 April 2013:
back in 2007 i had a dvt. they put a greenfileld fitler in me. ever since that i been having pains. feels like it been moved. they even said it breaks up before moved to lungs it dont cause i had a meduim size clot in my lung. i heard about these filters i called a lawyer.
Comment by thomas on 19 April 2013:
Had bloodclots in my lungs they put a filter in my leg its causes terrible pain in my back and leg cant walk sometimes .can this be what’s happening to me.