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IVC Filter Manufacturer C.R. Bard Knew of Problems with Their G2 Filter Early On and Did Nothing, New Report Says

Posted on - Wednesday, February 3, 2016 under Dangerous Drugs & Products

A major manufacturer of inferior vena cava (IVC) filters knew almost from the time their device was approved by the FDA that there were serious concerns about its safety, according to a recent report by NBC News.

According to the report:

“Records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration.”

The Parian Law Firm, a west Georgia personal injury and defective medical device law firm serving clients across the country, is currently investigating and pursuing claims for damages on behalf of individuals who may have been harmed by IVC filters manufactured by Bard and other companies.

Defective Bard IVC filters have been associated with a range of serious health problems, including:

• Chronic chest pain
• Pulmonary embolisms
• Respiratory problems
• Hemorrhaging
• Organ and tissue damage
• Death

At least 12 people have died and hundreds of health problems have been linked to the G2 series filters alone, according to Bard and FDA records.

IVC Filters Break and Leave Pieces That Can Damage Vital Organs

Usually implanted in patients dealing with deep vein thrombosis in their legs, IVC filters are designed to prevent blood clots from migrating up from the legs to the heart, lungs, or brain, where they could be fatal.

Some IVC filters are permanent implants while others are removable if and when the risk of blood clots goes away.

The problem with both devices is that they have been shown to be particularly vulnerable to breaking down and fracturing inside the body. When an IVC filter fractures, parts of the device – including sharp metal shards – can migrate to other parts of the body where they can cause severe damage to vital organs including the heart and lungs, where they can cause severe bleeding and other potentially fatal problems.

When a broken IVC filter is discovered inside a patient, they will typically require surgery to have the defective device, along with any parts that may have broken off from the device, removed.

All of these problems were present not only in Bard’s Recovery IVC filters, but in the replacement G2 filters as well, and Bard knew it. According to the NBC News report:

• “A confidential memo written in December 2005 by a Bard vice president soon after the G2 was cleared by the FDA shows his concern about “problems with…migration,” “tilting” and “perforation.”
• “Another document written later that includes data through 2010 showed the G2 series filters had more fractures, migrations and reported problems than any of its competitors.”

Thousands of reports and complaints have been filed with the Food and Drug Administration since the filters were introduced in 2005, and lawsuits are being filed by patients who have suffered from broken IVC filters that have left broken pieces in their bodies and caused numerous health complications and even death.

Parian Law Firm: Experienced Georgia Defective Medical Device Lawyers

At the Parian Law Firm, we have extensive experience representing individuals who have been harmed by defective medical devices. We are committed to holding the manufacturers of defective devices such as IVC filters responsible for the damage they cause, and are passionate about obtaining compensation and justice for our clients.

If you or a loved one have questions or concerns about IVC filters, please give us a call at (770) 727-5550 or chat live online with a member of our staff today. We can discuss your situation, evaluate your potential claim, and advise you of your options. We look forward to assisting you.