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When was your surgery to repair hernia?

Hernia Mesh Lawyer Fresno CA - Hernia Mesh Lawsuit California

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 Fresno 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.

Hernia Mesh Lawyer Fresno California

Everyone knows that the FDA is tasked with the important job of regulating medical products and systems in the United States. These products are classified and sorted depending upon the dangers they can potentially create. Class I devices are the least dangerous and therefore least regulated. Examples of a Class I devices would be something as simple as a band aid, or dental floss for your teeth; 43% of the devices fall into this classification. Class II devices pose a heightened risk and obviously require a little more regulation to assure the safety of people.

Hernia Mesh Lawyer Fresno CA

Examples of Class II devices could be pregnancy tests or powered wheelchairs; 47% of the devices fall into this category. Class III devices generally contain the maximum risk as they sustain or support life. Examples of these devices would be pacemakers or heart valves; 10% of devices fall under this classification. The many classes need distinct degrees of clearance by the FDA in order to gain market authorization.

Hernia Mesh Lawyer Fresno California

Products that are entirely new to industry have to submit what is called a Premarket Approval Application. This application has to demonstrate scientific evidence acquired through human clinical studies that exhibit that the device is effective and safe for its expected application. This is the most rigorous degree of examination that the FDA will do concerning product approval. Through regulation, this process can take at least 180 days, but frequently longer. After the decision has been given by the FDA either the product will proceed to market, or the owner of the product could ask for reconsideration of the denial. This process is necessary for all new Class III devices.

Hernia Mesh Lawyer Fresno CA

Does everyone need a PMA? No. Items that are considered substantially equivalent to a device that has previously been accepted and is on the market aren't required to turn in at PMA. Instead they follow the 510(k) process, Premarket Notification, or PMN is needed for substantially equivalent devices. A device is substantially equivalent if it is at least as safe and effective as a prior-approved system. Substantially equivalent does not mean the exact same, nevertheless it must have a similar designated use and technological functions OR the same intended use and different capabilities, however does not raise safety issues. The PMN approach usually takes 90 days, as opposed to 180+ day process for the PMA. Once approved, the maker might market the product. If unapproved, the manufacturer can reapply together with new data, obtain a lower classification, or attempt a PMA. The fast track method is usually belittled as allowing products to marketplace prematurely, without enough assurances of safety. Nonetheless, you will find processes in place to address all aspects of device approval.

Hernia Mesh Lawyer Fresno California

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Hernia Mesh Lawsuit

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