Integra NeuroSciences Gravity Compensating Accessory Recall Lawyer
The lawyers and attorneys at our firm are offering free case evaluations to patients injured by an Integra NeuroSciences Gravity Compensating Accessory. This device is used with a brain shunt system. Integra NeuroSciences recalled the Gravity Compensating Accessory in 2008 due to a manufacturing defect.
In patients who have brain shunt surgery, this defective device may have caused inflammation of brain, spinal cord, or abdominal membranes. It could also lead to pressure on the wound created by implantation of the device, or failure of the shunt system.
The Food & Drug Administration (FDA) recall notice said that the Gravity Compensating Accessory recall was a Class I recall. This is the agency’s most serious type of recall, and indicates that a device poses a reasonable probability of serious injury or death.
If you or someone you love was injured by this defective device, you may be entitled to compensation. Please contact our Integra NeuroSciences Gravity Compensating Accessory recall lawyers right away to discuss the legal remedies available to you.
The recall involves the Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, Prescription Use (Rx) only. The device was manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008 through June 1, 2008.
According to the company’s website, the Gravity Compensating Accessory consists of stainless steel balls that change flow resistance through a ball and cone mechanism. It comes in three ranges of pressure or flow resistance, low, medium and high.
According to the FDA, the Integra NeuroSciences Gravity Compensating Accessory is being recalled because it may leak cerebrospinal fluid. According to the recall notice, this may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
The Integra Neurosciences Gravity Compensating Accessory recall was initiated on October 9, 2008. At that time, Integra Neurosciences informed its customers of the recall via a letter. The firm also sent letters directly to doctors who may have implanted the recalled device.
The Integra NeuroSciences Gravity Compensating Accessory is used with a brain shunt system. A shunt is a tube that is placed in one of the fluid-filled chambers inside the brain. This tube usually sits outside the skull, but beneath the skin, somewhere behind the ear.
When infection or disease causes an excess of cerebrospinal fluid in the ventricles, the shunt is placed to drain the excess fluid to the abdomen. When working properly, the Gravity Compensating Accessory prevents fluid from being redirected from the brain while sitting or standing. If cerebrospinal fluid pressure is lowered too much, patients may have severe headaches, often with nausea and vomiting, whenever they sit up or stand.
Serious and long-term complications that can result from brain shunting include bleeding under the outermost covering of the brain (subdural hematoma), infection, stroke, and shunt failure. Infection at the shunt site may cause a loss of intelligence.
Complications of shunting occur in 30% of cases, but only 5% are serious. However, our Integra NeuroSciences Gravity Compensating Accessory recall lawyers believe that this faulty device put shunt patients at a much higher risk of complications than is typical.
Patients and practitioners seeking more information on the Integra Neurosciences Gravity Compensating Accessory recall may contact the company at 1-609-275-0500. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Legal Help for Victims of Integra NeuroSciences Gravity Compensating Accessory
If you or someone you know underwent brain shunt surgery, and suffered an injury related to the recalled Integra NeuroSciences Gravity Compensating Accessory, you may have valuable legal rights. Please fill out our online form, or call 1-800 YOURLAWYER (1-800 968-7529) right away to discuss your case with one of our Integra Neurosciences Gravity Compensating Accessory Recall Lawyers.