Inferior Vena Cava (IVF) Filters are designed to be left in the body for a short period of time for the purpose of removing blood clots. Unfortunately, many surgeons fail to remove them in a timely fashion, or at all, causing irreparable harm to their patients. When the IVC filters fail, they can cause damage to the surrounding tissue.
Over 750 IVC filter lawsuits have been filed against the manufacturers of the devices. The lawsuits claim the implants tilt, break, migrate, or perforate the lungs or heart.
Intended to be Temporary
The Food and Drug Administration (FDA) has received hundreds of complaints about the devices. The IVC Filters catch blood clots in patients who cannot take blood thinning medications. The FDA has issued guidelines that the implants are to be removed within 54 days. However, many surgeons fail to ever remove the devices.
Manufactures like Cook Medical and Boston Scientific took a permanent device and weakened it. This was supposed to make it retrievable. But the weaker design increased the risk of complications like migrations to other parts of the body and perforations of the heart and lungs.
Furthermore, doctors implanted these “temporary” filters and never removed them. The filters were never designed for long-term use and the long-term effects of the devices in the body were never studied.
That led to cases like Olenda Holmes of Graves County, KY, who had a temporary IVC filter implanted which the surgeon never removed. The Cook Celect she had implanted began to tilt, causing chronic pain and severe blood clots in her legs.
Ms. Holmes is now part of an IVC Filter Lawsuit. She claims the defendants knew or should have known that the device “when used as expected and intended, had the possibility of shifting, breaking free from its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”
IVC Filters Should Be Removed After 29 to 54 Days
IVC filters are implanted in the veins of patients unable to take blood thinners. Once the immediate danger of blood clots has passed, they are supposed to be removed. The devices were approved for use in 2004. Between 2005 and 2010, the FDA received nearly 1000 complaints. In 2010, the FDA issued the first of several advisories about removing the implants in a timely fashion. The most recent advisory instructs doctors to use the IVC filters for a maximum of 29 to 54 days.
These warning signals came too late for some patients as the damage had already been done. For them, the only remedy was an IVC Lawsuit.
The Goldwater Law Firm – Nationwide Defective Medical Device Law Firm
Many of the IVC lawsuits allege that the manufacturing companies knew their devices had problems, but went ahead with the marketing and manufacturing of the implants anyway. For instance, Dr. John Lehmann was hired by Cook Medical to produce an independent report on the devices. His report showed safety problems, but Cook Medical did nothing to remedy the situation.
In 2002, Cook Medical brought on regulatory expert Kay Fuller to help them receive clearance. Fuller’s signature appears on the FDA application. However, Ms. Fuller says she never signed the application, leading some to speculate that the company forged her signature. If you’ve been injured as a result of an IVC filter, the Goldwater Law Firm can help. Contact us today for a free consultation about your case.