Hernia Mesh Lawyer Connecticut - Hernia Mesh Lawsuit Connecticut
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 case review. Call Toll Free 1-866-777-2557 or use our online contact form below and a Lawyer will get back to you within 24 hours to discuss your possible case. Hernia Mesh Lawyer Connecticut. Time is limited, so please contact us today. Hernia Mesh Lawsuit Connecticut
We are investigating several hernia mesh systems including some manufactured by Atrium, Bard Davol, Ethicon (a division of Johnson and Johnson) and Covidien.
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The Food and Drug Administration is charged with the regulation of medical devices. These devices are classed based on the risks the products pose for humans. Class I devices are the least risky and least regulated. Examples of a Class I devices would be bandages or dental floss; 43% of the devices fall into this category. Class II devices pose an increased risk and require regulation to assure safety of consumers. Examples of Class II devices would be pregnancy tests or powered wheelchairs; 47% of the devices fall into this category. Class III devices are the highest risk as they “sustain or support” life. Examples of these devices would be pacemakers or heart valves; 10% of devices fall into this category. The different classifications require different levels of clearance by the FDA in order to gain market approval.
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Products that are entirely new to the market are required to submit a Premarket Approval application. This application has to show scientific proof gained through human clinical trials that demonstrate that the device is safe and effective for its intended use. This is the most rigorous level of examination that the FDA does in terms of product approval. By regulation, the process will take at least 180 days, but often longer. Once the decision has been made by the FDA either the product will proceed to market, or the owner of the product may ask for reconsideration of a denial. This process is required for all new Class III devices.
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Not all devices that are proposed are required to submit a Premarket Approval application. Products that are “substantially equivalent” to a device that has already been approved and is on the market do not have to submit at PMA. Instead of a PMA, under the 510(k) process, a Premarket Notification, or PMN is required for substantially equivalent devices. A device is substantially equivalent if it is at least as safe and effective as a prior-approved device. Substantially equivalent does not mean identical, but it must have the same intended use and technological features OR the same intended use and different features, but does not raise safety questions.
Hernia Mesh Lawyer Connecticut
The PMN process takes 90 days, in comparison to the 180+ day process for the PMA. Once approved, the manufacturer can market the product. If unapproved, the manufacture may reapply with new data, request a lower classification, or submit a PMA. The fast track process is often criticized as allowing products to market too quickly, without enough assurances of safety. However, there are processes in place to handle all aspects of device approval.
Hernia Mesh Lawsuit Connecticut
Hernia Mesh Lawsuit
Hernia Mesh Lawyers