IVC Filters are generally used when a patient cannot take blood thinners after back, knee, or hip surgery and the patient is at risk of developing a blood clot. IVC filters are used to catch blood clots which may develop and travel through the system potentially causing a deep vein thrombosis or a pulmonary embolism.
These devices are intended to be lifesaving and have been advertised to be so. Unfortunately, these products have caused thousands of injuries and wrongful deaths. If you or a loved one has been injured due to the use of an IVC filter, you should contact Abbott Law Group right away about an IVC Filter lawsuit.
Which Bard IVC Filters are part of the lawsuit?
Bard G2 IVC Filter – This is a filter device used to catch blood clots. The model RC-15 was never approved by the FDA for use, and has been on the market for a long time. The C.R. Bard company claimed that it is very similar to another model which has been approved. The FDA has issued a warning that these filters have been manufactured below quality guidelines.
Bard G2 IVC Express Filter – This filter was never approved by the FDA for use. There are also product quality concerns and an increased risk of migrating or fracture.
Bard Recovery IVC Filter – This device is used to retrieve the Bard IVC Filters. It has not been approved by the FDA for use, and C.R. Bard, the manufacturer have been sent a warning letter.
The FDA claims the manufacturer has sold these devices without approval and that the facilities that manufactured these devices failed to meet quality guidelines. The FDA also states that until C.R. Bard fixes the problems listed in the warning letters, they will not approve the recovery system filter for use.
What complications or adverse events are being reported due to the Bard IVC Filter?
Filter Perforations 70 events – This is when the device itself perforates or pierces through the vascular wall and embeds itself into other areas nearby. This could become extremely painful and be responsible for serious internal injuries or bleeding events which may require emergency treatment.
Filter Migration 328 events – This occurs when the device is no longer attached to the vascular wall or pieces of the device are no longer attached and the filter begins to travel through the blood system. The device could end up in a vital organ such as the heart, lungs, liver or kidneys and cause significant internal injuries which may require emergency surgery or treatment.
Device Fracturing 56 events – This may happen due to the filter’s inferior design or due to the quality problems at the manufacturing plant. Parts of the filter may break off and travel through the bloodstream ending up embedding themselves in a vital organ.
Embolization 146 events – if the device migrates to a place where the blood is trapped, the IVC filter may be responsible for creating a blood clot or an embolism. An embolism could be responsible for a number of catastrophic events including heart attack, stroke, and death.
What treatment may be necessary due to the Bard IVC Filters?
Device retrieval – In many instances, device retrieval was not necessary, but the people who had become injured due to the device, they needed to have the IVC filter removed due to the side effects or complications related to the IVC filters.
Emergency open heart surgery – when the IVC filter fractures or migrates to the heart, it may be necessary to perform emergency open heart surgery to retrieve the device. This may leave the patient with many months of recovery and permanent scar tissue which may affect how the heart functions in the future.
Emergency surgery – Surgery on other areas of the body may be performed to retrieve the device from other vital organs. It is possible the doctor may have to enter into the lungs, liver, kidney, or other organs the device could become lost or embedded in.
How long have the Bard IVC Filters been on the market?
Some of the early problems began for Bard in 2005 when the IVC filter was cited for fracturing and migration. Bard released the G2 which was supposed to be a better version of the IVC filter, but the FDA again in 2010 sent out a warning letter to the manufacturer due to the adverse events that were being reported.
Since then, the FDA inspectors were sent to a number of facilities that these IVC filters and retrieval systems are manufactured at and found a number of qualify safety concerns in the way the product is manufactured, packaged, and shipped.
In 2015, the FDA has sent a second letter to C.R. bard that they have not met the requirements to continue manufacturing the products for commercial use at the same facilities mentioned before in a previous 2010 letter.
What has been done about it?
The C.R. Bard company has acted inappropriately by selling medical device products before approval by the FDA. Many patients who have been injured by these devices have filed lawsuits against the manufacturer for failing to follow proper clearance to enter the market, and for manufacturing an inferior product which has a higher than a usual number of reported injuries.
Who to call about an IVC Filter lawsuit
The Abbott Law Group has a team of lawyers who are reviewing claims of patients who may have been injured due to the use of a Bard IVC Filter, G2 Filter, and IVC retrieval system.
If you or your loved ones are interested in joining the IVC Filter lawsuits against the manufacturers, you should contact us right away for a free consultation. Our lawyers have over 30 years of experience practicing personal injury and product liability law and will be able to quickly evaluate whether or not you may have a case.
We offer free consultations and if we believe you may have a potential case, we will conduct an investigation into the events which may have occurred to see if there is enough evidence to file. If we do file, we will fight for the maximum compensation you may be eligible to receive.
Bard IVC Filter Lawsuit Settlement Compensation may include:
Medical costs and bills,
pain and suffering through the injuries and the time it took to recover,
lost wages or income due to the IVC Filter,
and other items which may be included.
Call us today for a free IVC filter lawsuit consultation and see if we may be able to help you.