When patients learn about Stryker’s implant failures, their first question is often: “I thought this was FDA approved?” They wonder how something so defective could have gotten past the FDA’s scrutiny.
The truth is, the FDA never examined the Stryker Rejuvenate implant. No clinical trials were performed to ensure that the implant didn’t cause side effects.
How Stryker Bypassed Clinical Trials
If an orthopedics company wants to put a new kind of device into circulation, it needs to first pass the FDA’s Premarket Approval process. This is a highly stringent approval process that requires extensive clinical studies. In the Medical Device Amendments of 1976, the FDA split regulatory classes for medical devices into three different categories, called Class I, Class II and Class III.
Hip replacement implants are classified as Class III, meaning they have the highest impact on human life and should therefore have the highest level of regulation and oversight.
According to the FDA, a Class III device is one that “… supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury.”
Unfortunately, there is a way around the FDA’s testing requirements.
Instead of going through the Premarket Approval process, Stryker was able to get their device approved by submitting a 510(k) “premarketing submission.” This essentially tells the FDA that the device is similar enough to other devices on the market that it shouldn’t need to go through the approval process again. The device is able to get approved on the basis that other similar products are on the market and have a good track record.
Using a 510(k) submission, Stryker is able to bring their implants to market with only post-market surveillance. In other words, they don’t need clinical trials, but they do need to keep tabs on how their implants affect patients. The downside with this approach is that problems can only be spotted once they show up in real patients. That’s exactly what happened here.
Institute of Medicine: 501(k) is “Flawed”
In 2009, the Government Accountability Office commissioned the Institute of Medicine (IOM) to conduct a study into the FDA’s approval processes for medical devices. The IOM’s report found the FDA’s processes to be “flawed based on its legislative foundation.”
The report pointed out that 501(k) processes can’t ensure a patient’s safety. A 501(k)’s premise is basically that one device on the market is already safe, which makes the new device safe. Yet the reality was that many of the devices already on the market hadn’t been scrutinized for public safety either.
The Stryker Failure Timeline
- April 14, 2008 – Stryker submits the Stryker Rejuvenate Modular Hip System’s 501(k) to the FDA.
- June 3, 2008 – The FDA approves the application, based on a determination that the Stryker Rejuvenate was substantially similar to an existing product.
- August 21, 2009 – Stryker submits the Stryker ABG II Modular-Neck Stem’s 501(k) to the FDA.
- October 20, 2009 – The FDA approves the application, based on a determination that the Stryker ABG II was substantially similar to an existing product.
- February 2010 – Stryker begins marketing the Rejuvenate Modular Primary Hip System to doctors and medical facilities.
- April 2012 – Stryker issues an “Urgent Safety Alert” informing doctors of the potential side effects of using the Rejuvenate system.
- July 6, 2012 – Stryker issues a voluntary recall of all Rejuvenate and ABG II devices sold in the United States. A voluntary recall means it was issued by the manufacturer, though most recalls are also done with the help and cooperation of the FDA.
The Stryker Hip Recall
If you or a loved one had a Stryker Rejuvenate or ABG II implant, you’re encouraged to contact your surgeon for a checkup. If you’re unsure whether or not you had a Stryker implant, contact your surgeon to find out.
Though Stryker has a claims process for compensating patients, patients are most likely to get the highest compensation and the best deal by contacting a law firm experienced in representing people with defective Stryker hips. Rosenfeld Injury Lawyers is one such law firm.