In the past couple of months, we can hear a lot about the ongoing case against IVC Filters. Many people who have had these filters implanted in them have received compensation and many others are filing their cases against the company. Before we can get into the specifics of the case let us learn a little bit about IVC filters.
What is an IVC Filter?
An inferior vena cava (IVC) filter is a small cone-shaped device implanted in the inferior vena cava vein that is one of the largest veins in the body. It helps in carrying deoxygenated blood from the lower parts of the body into the heart’s right atrium and then to the lung to be oxygenated. This filter is implanted just below the kidney and is designed to catch an embolism or blood clot which may have broken loose from one of the veins and makes its way to the heart or lungs. Without this the embolism will make its way into the heart and cause a blockage in the pulmonary artery and can result in various health problems such as chest pain, difficulty in breathing and also in some instances death. The FDA approved this device in 1979 and by 2012 there were 259,000 filters implanted. The FDA realized that these filters were being overused and hence sent out safety communications in 2010 and 2014. They recommended that the retrievable filters be removed as soon as the threat of blood clots was over which is between the 29th and 54th day after the filter is implanted.
How does the filter work?
The doctor uses a catheter tube which is inserted into the body through a small cut in the neck or the groin. Once the filter is inserted in the right place it expands and goes to its original shape that is a sort of mesh in the vein and is able to catch the embolisms before they can go to the heart or the lungs.
Types of IVC filters
There are two main types of IVC filters depending on how long the filter will remain in the body, mainly the permanent IVC filters and retrievable IVC filters.
Permanent IVC filters
- Simon Nitinol Filter
- Vena Tech LGM vena cava filter
- Vena Tech LP vena cava filter
- Stainless steel Greenfield filter (SGF)
- Titanium Greenfield filter (TGF)
- Percutaneous stainless steel Greenfield filter (12F SGF)
- Gianturco-Roehm Bird’s Nest filter (BNF)
- TrapEase permanent vena cava filter
- Safeflo vena cava filter
Retrievable/Optional vena cava filters
- ALN optional vena cava filter
- Recovery vena cava filter
- G2 vena cava filter
- G2 X vena cava filter
- Eclipse vena cava filter
- Günther Tulip vena cava filter
- Celect vena cava filter
- OptEase retrievable vena cava filter
- Option retrievable vena cava filter
When do doctors recommend an IVC filter?
The doctor will suggest that you get an IVC filter implanted if you continue developing deep vein thrombosis (DVT) or pulmonary embolisms even after the use of anticoagulants. In case you are not able to take anticoagulants due to a previous condition that makes you susceptible to bleeding. If you developed bleeding complications caused due to the consumption of anticoagulants. If you already suffer from large clots present in the inferior vena cava or iliac veins. Other cases in which the doctor will most likely suggest the use of an IVC filter is for persons involved in a car crash, in cases of voluntary or emergency surgeries, for gunshot and stab victims, dialysis patients, women who have recently had babies, patients with spinal cord injuries, people who are immobile, cancer patients, or those who have had serious falls.
Risks involved in getting an IVC filter
There are various risks that are involved with the implantation of an IVC filter and they can be classified into three main situations
These are the risks that are caused during the implantation procedure of an IVC filter. They include severe bleeding or bruising of the site through which the filter was inserted into the body, accidental puncture of a blood vessel, the filter can be placed in the wrong location and finally the filter can be wrongly deployed inside the body.
The risks that are involved with the retrieval of the IVC filter are perforation of a blood vessel, the presence of large clots in the filter, difficulty in locating the filter that will cause a longer surgery time and finally scarring of the veins that can cause difficulty in removal of the filter.
These include the migration of the IVC filter from the inferior vena cava to other parts of the body such as the heart or other organs; blood clots in the legs (Deep vein thrombosis); breakage or a fracture in the device; organ perforations; infection caused due to the device; detachment of the components of the device; and blockages that can cause the swelling of the legs.
Symptoms of an IVC complication
It is very important for individuals that have an IVC filter implanted to be able to recognise when there is something wrong. The symptoms that are involved with a fractured or migrated IVC filter are most commonly confused with those of a heart attack. These patients may experience shortness of breath.
In the years between 2005 and 2010, FDA received a number of reports about the adverse effects of the device. These reports amounted to 921, 328 about device migration, 146 were embolizations, 70 were perforations of the inferior vena cava and 56 were fractured devices. The first warning to IVC filters was sent in August 2010 which was mainly issued to keep the medical professionals updated about the potential complications and risks that are involved with the extended use of an IVC filter. The FDA further went on to advise the medical professionals to remove the filter as soon as the risk of pulmonary embolism has passed. The FDA required more clinical data about the IVC filters that were being produced and marketed in the US. These studies brought forth more questions about safety and remained unanswered.
Second FDA warning
In May 2014, the FDA issued the second warning in regards to the IVC filters. This was an update to their initial warning and stated that after analysis and studies it was found that there were severe complications associated with the extended use of IVC filters and they should be removed between 29 and 54 days after the filters were implanted in the patient.
Recalling of the IVC filters
The FDA announced the Class 2 device recall of the IVC filters manufactured by Boston Scientific in 2005. These devices lacked a taper on the braided sheath of the delivery system. This lack of taper at the ends could cause damage to the blood vessels by it catching on the end of a vein and tearing it. The manufacturer of the filter then issues an urgent recall notice to all their customers and ensured that the use of these filters were discontinued. This recall ended in 2006.
A class 2 recall is used in cases where the product may cause temporary or medically reversible health problems in the patient or if the possibility of major adverse effects is remote.
In 2013, the FDA recalled the retrievable IVC filters manufactured by Cordis Corporation for a labeling correction. 33,000 devices that were distributed between May 6, 2010, and April 2, 2013, were recalled and the label was corrected to “provide clarification and additional information to minimize likelihood of implanting the filter backwards”
Warning letter to C.R. Brad
The FDA sent a warning letter to C. R. Brad Inc. in 2015 to notify them that violations were found in their facilities in New York and Arizona. The agency then conducted the inspection of the NY facilities between Oct. 6, 2014, and Nov. 25, 2014, and the facility located in Arizona between Nov. 18, 2014, and Jan. 05, 2015. According to the warning letter, C.R. Brad was manufacturing a Recovery Cone Removal System without any clearance or approval.
There were 300 reports received by the FDA that were related to the recovery filters.