Stryker hip implants have been recalled due to serious defects causing injury to thousands of patients in the United States and throughout the world. The combination of chromium, cobalt and titanium in the neck area of the Stryker Rejuvenate Modular hip implant system has a tendency to corrode, and this corrosion causes serious medical conditions and pain in patients. The metal ions released from these metals are directly injected into the blood stream of patients, and this release of metal ions causes the serious medical condition of metallosis in patients.
The Stryker Rejuvenate Modular hip implants received approval to enter the market for medical equipment in 2008. The FDA provided this approval for the Stryker Rejuvenate Modular hip implant system, but it has subsequently revoked this approval in issuing a recall of the product. Many metal-on-metal hip implant manufacturers have had their products recalled in recent years, because an increasing number of patients are requiring revision surgeries due to the harmful effects of metal-on-metal hip implants. The FDA approval of Stryker hips has been in controversy, because it has now been acknowledged that there was a lack of regulatory oversight in the approval process. The FDA approval of Stryker hips was essentially very relaxed, and no research was conducted to assess the safety of Stryker hip implants.
Just three years after being released onto the market, the FDA issued a notice that there was a serious recall of all Stryker Rejuvenate and Stryker ABG II Modular Hip Implants. On July 6, 2012, Stryker voluntarily issued a recall of its own products, including the Rejuvenate and ABG II modular-neck stems. It is estimated that over 20,000 patients currently have Stryker hip implants that have been recalled by the FDA. These hip systems were surgically implanted into patients between 2008 and 2012.
Patients may now be concerned about how Stryker hip implants could be recalled so soon after receiving FDA approval. The reality is that the FDA never performed a clinical trial to assess the safety of Stryker Hip Implants in patients. Because no clinical trial was ever performed, the average patient was not aware of the potential negative side effects that could be associated with Stryker Hip Implants. The massive Stryker Hip Implant recall may be a wake-up call to the FDA that there needs to be a better premarket approval process in place to assess the safety of medical implants and devices. Due to the 510(k) submission obtained by Stryker, there has been essentially no regulatory oversight over the impact of Stryker Hip Implants on patients throughout the United States. Ultimately, the Government Accountability Office discovered that this lack of regulatory oversight is dangerous to the health of the public. It has been found that the 501(k) exemption from regulatory insight is an inherent flaw in the approval process of the FDA for new medical implants.
In April of 2012, Stryker finally recalled the defective Stryker hip implants. The voluntary recall notice acknowledged the corrosive nature of Stryker Hip Implants and just how dangerous this corrosive nature is to the health of patients with such implants. Some of the following harmful effects were the main reasoning behind the voluntary recall, and patients with these effects may wish to consider seeking assistance from Stryker personal injury lawyers:
Patients who have received a Stryker Hip Implant can consult with Stryker personal injury lawyers about filing a lawsuit. Call today to schedule an initial consultation with Stryker personal injury lawyers to see whether you have a claim that can be pursued against the manufacturer. While there is a third-party company handling claims for Stryker, it is important for patients to realize that this third-party may not provide enough compensation for the expenses and harm tha