Knee Replacement Device Used Without FDA Approval

When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them.
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Pain Pumps Can Necessitate Further Surgeries

Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury.
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New da Vinci Surgical Robot to Hit Market in 2015

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
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Invasive Procedure Equipment Causes Big Problems When Contaminated

With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term.  A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition.
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Dangers of FDA 501(k) Classification

When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.
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Improper Medical Product Instructions & Defective Labeling

Products liability covers a large range of products and can include intangible property such as pets, gas leaks, and real estate. Defective medical products are one of the most damaging types of products liability. Examples of defective medical products include those that were not fully vetted for compatibility with the body, those with side effects more severe than the disease they are supposed to alleviate, and those that cause unexpected additional issues for the patient.
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HeartMate II Pocket Controller Responsible for Four Deaths

Sometimes the medical devices meant to keep you alive are more dangerous than the condition they are meant to alleviate. When Thoratec introduced its HeartMate II monitor with pocket control, patients across the U.S. lauded the introduction as an easier way to deal with a debilitating condition.
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Nonprofit Group Calls for Body Part Warranties

Consumers are likely familiar with warranties offered any time a purchase is made for a new appliance or electronic. But what about surgeries for replacement body parts? Although one million individuals receive hip or knee implants every year, only one manufacturer offers a warranty, and this warranty is only on a partial knee implant.
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Filter Designed to Catch Patient Blood Clots Focus of Nationwide Recall

Doctors doing surgery at a hospital in Maine made a discovery regarding the Cordis Opt-ease Vena Cava Filter that have led to investigation and defective device recalls for the item. The filter is supposed to catch clotted blood traveling through the Vena Cava to hold it there so that the clot doesn’t travel farther into the heart or lungs. Doctors struggled to remove the filter from a patient who no longer required it, finding that the instructions for insertion and removal were not accurate.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL