The Stryker hip recalls have raised many questions and concerns from the general public. Perhaps you were one of the thousands of Stryker hip patients to receive a hip implant and wonder, “Isn’t this device FDA-approved? How could a defective hip implant be used for so many patients like myself?” If you are asking yourself these questions, then you are not alone. It is important to understand the FDA approval process as well as the history of Stryker hip implants so that you can now stand up for your legal rights.
The Lack of Clinical Trials For Stryker Hips
The lack of Stryker clinical trials is one of the main reasons that thousands of patients received these hip implants. By foregoing clinical trials, Stryker Orthopaedics was able to release thousands of hip implants without the typical scrutiny of the FDA. Stryker Orthopaedics utilized the Premarket Approval process so that it would be able to release its hip implants onto the market as quickly as possible.
The Work-Around of the 501(k) Premarketing Submission Process
The 501(k) Premarketing Approval process only requires an application by the medical device manufacturer informing the FDA that the products it intends to release onto the market are similar and have a positive track record. Stryker Orthopaedics essentially informed the FDA that its Rejuvenate and ABG II Modular-Neck systems were similar to former products released by the manufacturer. The main crux that a manufacturer must prove is that the new product is “substantially equivalent” to another product produced and distributed by the manufacturer. Legal issues arise with the 501(k) Premarketing Approval process allows products to be released onto the market that actually have different characteristics from former products.
In the case of the Rejuvenate and ABG II hip systems, it is clear that these two products have deviated from the norm of former Stryker hip implants. The metal-on-metal construction of the Rejuvenate and ABG II hip systems have been shown to be correlated to the development of swelling, metallosis, infection and other serious side effects in patients. Medical research studies have also tracked the numerous patients who have required revision hip surgeries as a result of having an implant that featured the Rejuvenate or ABG II hip systems.
The Need for Heightened Levels of FDA Scrutiny
Even though Congress has explicitly issued orders for the FDA to use more specific standards for its classification process, the FDA has yet to implement these more rigorous standards. The use of the “substantially equivalent” alternative under the 501(k) Preapproval Process was originally only intended for short-term use. After this process was initiated decades ago, Congress made it clear that the FDA needed to create more stringent classification levels for products.
Despite the urgings of Congress that the FDA create these classification levels, they remain yet to be seen. The result has been that companies like Stryker Orthopaedics are using a loophole in the legal process for their own benefit. The marketplace for medical devices is less secure with this type of approval process in place. Patients are the ones who suffer from these laxed standards that seem to work in favor of corporate medical manufacturing plants.
Further Findings of a Flawed 501(k) Process
The federal government has repeatedly found that the 501(k) Preapproval Process is inherently flawed. In 2009, the Government Accountability Office conducted a study on the FDA’s current approval processes for medical devices. The Government Accountability Office released a report on its findings in regards to the medical devices. In its report, the Government Accountability Office found that the current approval processes are flawed in foundation.
In the future, it is important that the FDA respond to research reports released by the Government Accountability Office and other entities. Until the FDA actually changes its preapproval process, suffering patients will need to simply pursue legal claims against Stryker Orthopaedics.
Pursuing Claims Against Stryker Orthopaedics For Failed Hip Prosthetics
It is unclear how many thousands of people have suffered as a result of the Stryker Rejuvenate and ABG II hip implant systems. What is clear is that patients who have suffered have legal remedies available to them. While it may not be possible to completely reform the 501(k) Premarket Approval process right now, suffering patients with Stryker hip implants can pursue legal claims to stand up for their rights. Stryker patients may be able to receive compensation if they become part of a class-action lawsuit, multi-district litigation proceedings or through the pursuit of individual claims against Stryker Orthopaedics.
This may be the best recourse for patients who have already expended thousands of dollars in fixing the adverse effects of Stryker hip implants. For patients who have required a revision hip surgery, their best means of finding resolution may be to meet with a lawyer who has experience in handling Stryker hip implant claims. Revision hip surgeries often cost thousands of dollars, and the suffering that a patient experiences after such surgery can last for many more months. It is important that these patients receive the compensation that they deserve for suffering in this manner.
The Voluntary Recall of Rejuvenate and ABG II Devices
In 2012, Stryker finally issued a voluntary recall of Rejuvenate and ABG II devices after numerous patient complaints were filed with the FDA. Prior to the voluntary recall, Stryker had issued an “Urgent Safety Alert” that informed doctors of the negative side effects associated with the Rejuvenate system. Doctors should have informed patients about the adverse risks associated with Stryker hip implants. If you were a patient and not informed about the negative effects associated with Stryker hip implants, then you may want to meet with a lawyer to discuss your legal rights. A lawyer experienced in handling Stryker hip implant claims will alert you as to the warnings that have been released in regards to Stryker hip implants.
Side Effects Associated with Stryker Hip Implant
There are numerous negative side effects that have been associated with the Stryker Rejuvenate and ABG II hip implant systems. If you have a Stryker Rejuvenate or ABG II hip implant, then you should pay attention to your legal rights if you are suffering from any of the following effects:
- Tissue inflammation
- Internal bleeding
- Hip or groin pain
- Change in mobility
- Need for revision surgeries