New insight into the PL lumbar cage recall may answer your back pain questions!
Recent studies looking into the Stryker lumbar cage recall raise even more suspicions about Stryker’s product quality and business tactics.
Stryker Corporation’s Howmedica Osteonics subsidiary issued a Class 2 recall November 2018 in regards to its 3D-printed Tritanium PL lumbar cage. To many’s surprise, the recall did NOT remove the lumbar cage from the market but only updated the Instructions For Use (IFU). The updated IFU resulted from reports of Tritanium PL cages crumbling and fracturing apart during and after implantation, causing the suffering of possibly hundreds of unsuspecting patients.
The new instructions provide numerous details and techniques for implantation that were not included in the original IFU. However, what really raised the public’s suspicion about the quality of the Pl lumbar cage is that numerous new additions to the IFU make suggestions that go against typical procedures during a cage insertion surgery. For example, many surgeons state that twisting and rotating the cage into its final position is normal for such a procedure. But the updated IFU states “Do not twist, cantilever or rotate to achieve final position. This may result in damage to the implant.” The original IFU did not include a warning that problems could arise by twisting, rotating, or cantilevering the implant during insertion.
Additionally, the directions for distraction of the implant space were distinctly changed. The instructions altered from stating “minimal distraction may be required to insert the interbody implant” to “effective distraction aids in removal of the superior articular process, decompression of the neuroforamen, preparation of the disc space and insertion of the Tritanium PL Cage.”
Multiple FDA Manufacterer and User Facility Device Experience (MAUDE) reports indicated that surgeons who experienced breakages when implanting the PL lumbar cage think that the problem was not the surgical insertion technique, but the product itself. Stryker’s deceptive marketing of the product presents the product as a necessary, quality product fro surgeons to use to relieve patients’ pain from degenerative disc disorder (DDD) or scoliosis. So, if issues do arise with the product, the company places any blame on issues with the cage solely on the surgeons, not themselves. However, the constantly shifting instructions for how to insert the cage and questionable recommendations who should not receive the cage calls into question not just underhanded marketing techniques, but the safeness and quality of the cage implant itself.
Researchers noted that finding the recommendations for who should actually use the lumbar cage is very hard to find on Stryker’s website, buried in the middle of the “Surgical Technique” document. Stryker’s recent update warns against implanting the Tritanium PL lumbar cage in obese patients or patients who frequently or vigorously exercise. However, since a significant percentage of the US population is obese and many people get spinal surgery to return to exercising, surgeons question who Stryker wants to market the Tritanium PL lumbar cage to if not the people who typically need this lumbar cage.
With a case full of Stryker’s long-winded guarantees about concern for patients and caregivers’ safety, constantly shifting instructions and dubious product recommendations raise questions about whether or not Stryker actually values the safety of their customers, or whether making easy money is what they really value.