Hernia Mesh Lawsuit
Hernia Mesh Lawyers
Have you or a loved one suffered side effects after hernia mesh surgery? You may be entitled to financial compensation from the manufacturer. Call us today for a free consultation. Toll Free 1-866-777-2557 or use our online contact form below and a Oakland CA Hernia Mesh Lawyer will get back to you within 24 hours to answer your questions. Time is limited, so please contact us today. Hernia Mesh Lawsuit California
We are investigating several hernia mesh systems including some manufactured by Atrium, Bard Davol, Ethicon (a division of Johnson and Johnson) and Covidien.
How does the FDA handle products that are new to the market? Companies that wish to bring these products into the marketplace must submit a Premarket Approval application. A PA has to exhibit scientific confirmation gained through human clinical studies that illustrate that the device is effective and safe for its expected use, and this process usually takes at least 180 days. As soon as the decision has been made by the FDA either the product will go to market or a reconsideration request must be filed.
Hernia Mesh Lawyer Oakland California
How many different classes of devices are there? The FDA breaks these categories down into 3 different classes, according to their amount of risk. Class 3 are the riskiest and involve serious life and death products. Class 1 are for simple everyday things like bandages.
Hernia Mesh Lawyer Oakland CA
What is all of the news about regarding devices that are substantially equivalent. The FDA has a new carve out that allows companies to skip the premarket approval process. This is done under what is called a 510k process and it takes about 90 days. If approved, the company can immediately begin to market the product. Some say this fast track approach is a little dangerous.
Hernia Mesh Lawyer Oakland California
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