UNSAFE MEDICAL DEVICES - Medical devices require FDA approval, but the FDA allows devices that cause potentially irreversible harm to enter and remain on the market even though long-term studies into their safety have not yet been completed. Unsafe medical devices, whether approved years ago, or on the market and still awaiting the conclusion and analysis of post-approval studies, can cause injury, trauma or even death to millions of unsuspecting patients.

More than a million people each year suffer adverse events from medical devices. There were over 450,000 emergency room treatments for injuries directly linked to medical devices in 2006 alone, and over 55,000 of those injuries resulted in hospitalization or death. Technology has often outpaced long-term safety studies, and unsafe medical devices have flourished in a lax regulatory environment.

Many common devices are frequently found to be defective. They include, but are not limited to:

• Drug Coated and Drug Eluting Stents
• Defibrillators
• Pacemakers
• Infusion Pumps 
• Knee Implants
• Hip Replacements
• Syringes
• Tissue Transplants

Certain brand specific devices have had significant issues. Here are brief examples of some of the side effects, adverse events and regulatory actions of three potentially harmful medical devices.

• Medtronic Defibrillators – Defibrillator malfunction can cause shortness of breath, dizziness, a racing or a very slowed heartbeat, heart palpitations, confusion, loss of consciousness and death. Certain model Medtronic Sprint Fidelis defibrillator electrical leads, pacemakers and defibrillators were FDA recalled in 2007. 
• Baxter Pumps – The Baxter Healthcare Colleague Volumetric Infusion Pump used to deliver fluids and controlled medications has failed to alarm when warranted, triggered false alarms and failed to deliver the full patient-required infusion therapy, causing deadly risk to patients receiving life-sustaining medications via the pump. A recall was jointly announced by Baxter and the FDA in 2007.
• Guidant Defibrillators and Pacemakers – In 2005, Guidant began recalling multiple models of defective pacemakers that had resulted in patients’ deaths. They later admitted they knew of problems with the devices three years before any recall was initiated. In 2007 an FDA/Guidant recall was issued for implantable cardiac resynchronization defibrillators because of faulty capacitors that caused accelerated battery depletion.

Other brand specific medical devices with a documented history of potentially life-threatening adverse events include, but are not limited to:

• Panacryl Sutures
• ReliOn Insulin Syringes 
• Smith and Nephew Knee Implants
• Stryker Hip Implants
• Zimmer Durom Hip Cups 
• Johnson and Johnson Cipher Stents 
• Boston Scientific Express Stents
• Biomet Hip Replacements

Unsafe medical devices can cause irreparable harm, and unsafe medical device cases are quite complex. Guidance by a defective medical device attorney who is intimately familiar with each device and its history is crucial. If you or someone you know has sustained injury from any medical device, whether or not it is one of the products listed in this overview, use the form below to initiate a free evaluation from a qualified and experienced defective medical device lawyer and learn what recourse may be available. 

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