FDA Safety Warnings and Investigations of IVC Filters
The FDA has been really involved in issuing information to the public about the dangers of retrievable IVC filters since they were made aware of adverse event reports from individuals who have them. First, in 2010, the FDA issued a safety communication stating that the FDA had received 921 notifications of IVC filter complications in the preceding five years.
In 2014, the FDA issued a safety communication update that certain retrievable IVC filters be removed as soon as the device is no longer needed, to protect against pulmonary embolism. In July of 2015 the FDA sent a warning letter to one of the major manufacturers directly, C.R. Bard, stating that Bard was marketing the device without FDA approval, their methods did not conform to FDA standards, and they did not have adequate procedures for reviewing the complaints related to their retrievable IVC filters. These FDA warnings and investigations are helpful and provide valuable information to IVC filter lawyers who bring cases against the manufacturers on behalf of injured parties.
IVC Filter Issues
There are multiple possible issues that can be caused by an IVC filter. One such issue is a filter fracture, which is when the device itself breaks apart. It is a metal, cage-like device and pieces of the device itself can fracture off and travel to the heart and become very problematic.
Device Migration
Device migration is where the entire device moves from its original location. It either travels from where it is supposed to be, or it moves out of place so it is not able to capture the blood clot.
Organ Perforation
Organ perforation would happen if the device or a piece of the device punctured the vena cava. If it punctured far enough it could damage the surrounding organs. This could have real, severe implications for anyone who may be affected.
Role of FDA Warnings and Investigations
The FDA is incredibly important and helpful in bringing to light issues that arise after a product has been approved and is already being used by the public. In the case of IVC filters, after they received 900 plus adverse event reports, they issued the safety communication, warning individuals and surgeons that there was an unusually high number of adverse events after the temporary IVC filter was used.
That is one way the FDA is really integral in sending out these messages to the public and to surgeons, because one common group is receiving and collecting all the data on injuries and incidents that are happening. That can really tell a tale on whether or not a device is effective or may be dangerous.
How an Attorney Can Help
What attorneys who are looking into IVC filter injury cases do is incredibly important, because if a company manufactures a medical device, gets it approved by the FDA, and that device begins hurting and in some instances killing people, the only way to hold that company accountable is through the civil justice system. Lawyers represent people and families who have been affected. Often times they are very severely affected by the migration or perforation of these retrievable IVC filters, and that is how society holds companies accountable for bad things that happen to innocent and unaware people.
