Ryan Bradley Describes How Medical Devices Make it to You
"If you have a company with a new medical device there are two primary to bring your device to the American market by way of the FDA. One process is called “Premarket Notification,” often called the “510(k) process.” The other is called Premarket Approval and is known by its submission acronym “PMA.” There is however, a radical difference between the two approval processes."
Over at Recall Guide, a new consumer protection website focused on informing the public about dangerous drugs and devices, Partner Ryan Bradley describes how medical devices make it to market. Most residents of Central Illinois are aware of the wide variety of medical devices on the market but there is little understanding as to the process that companies such as Johnson & Johnson and Stryker must go through in order to bring a device to a patient. Even fewer people are aware of the 510(k) process and how fast a new implant, metal on metal hips for example, make it out of development and into the bodies of Champaign Urbana.
Read more at Recall Guide and stay tuned form more article from Koester & Bradley lawyers.
A Lessor Known Stryker Recall In Illinois: The Stryker Triathlon Knee Cutting Guide
In early 2013 comma as much of the medical device industry was focused on the epidemic of metal-on-metal hips, Stryker Orthopedics in conjunction with the FDA recalled its Shape Match cutting guide which was included in the installation of the Triathlon Knee System. This recall covered all lot numbers of the Cutting Guide produced between May of 2011 to November of 2012. It is important to keep in mind that the Stryker shape match recall was small in comparison to the more well-known Stryker metal-on-metal hip recall. While there were fewer incidences of failure, the shape match cutting guide cost serious injuries to patients including chronic pain, knee fracture, Knee instability, revision surgery, and permanent decreased mobility. Koester and Bradley has reason to believe that Stryker Triathlon knees using the Shape Match cutting guide were implanted in Central Illinois and across the Midwest. Individuals who received a Stryker knee implant between 2011 and early 2013, and are experiencing problems, are well advised their positions as well as an experienced who handles medical device.