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The U.S. Food & Drug Administration (FDA) Premarket Approval (PMA) process provides for the FDA’s scientific and regulatory review of Class III medical devices to evaluate their safety and effectiveness. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
The full premarket approval (PMA) process for new medical devices (from concept to market) can take a better part of a decade and cost manufacturers millions of dollars in testing and clinical trials. Stryker hip implants are considered Class III medical devices.
However, the Stryker Rejuvenate Modular Hip System was approved by the FDA on June 3, 2008, less than two (2) months after Stryker submitted for the FDA’s expedited 510(k) clearance to get the hip implant approved and to the market quicker. The FDA’s 510(k) process only required Stryker to provide the FDA with product and performance information about the hip implant after its sale to the public with no testing or clinical trials beforehand. This was permitted by the FDA because the Rejuvenate hip implant was substantially similar to generally successful hip implants already on the market. Devices that go to market via the 510(k) process are not considered to be “approved” by the FDA, but can be marketed and sold in the United States regardless. Such devices are generally referred to as “cleared” or “510(k) cleared” devices.
Stryker Rejuvenate and ABG II hip implant necks were made of chromium and cobalt, and the stems were coated with titanium, a metal-on-metal effect was created which could lead to metallosis similarly caused by traditional metal-on-metal hip implants. As a result of Stryker’s 510(k) submission to the FDA, failures and problems associated with the Rejuvenate hip implant system were discovered by patients only after sale of the hip implants to the public without any warnings of danger.
Some in the medical and ethics communities have called for the end of expedited 510(k) device clearances despite the FDA’s original intention with 510(k) to bring beneficial products to market quicker. However, one of the original authors of the 510(k) process believes that the FDA should instead allocate more resources to stringently enforce existing federal laws requiring hospitals and device manufacturers to report adverse outcomes.
If you or a family member have a Stryker hip implant, or have had revision surgery to remove and replace a hip implant, you and/or your family member may be entitled to money damages.