April 1996 Bulletin

Update on pedicle screws

On March 4, 1996, the Plaintiffs Legal Committee (PLC) in the pedicle screw lawsuit filed comments with the Food and Drug Administration (FDA) regarding that agency's proposed reclassification of the pedicle screw from Class III to Class II status. The PLC's filing attempts to demonstrate that the pedicle screw is a dangerous device and that there was a conspiracy on part of spinal implant manufacturers and others which should bring the value of the FDA-sponsored pedicle screw cohort study into question. It is anticipated that the PLC may initiate a negative publicity campaign regarding the pedicle screw in the near future. As the FDA nears a decision on whether to reclassify the pedicle screw as a Class II device, the media coverage is expected to increase.

The Academy has been named a defendant in more than 400 lawsuits by patients who have received pedicle screw implants and now are claiming personal injuries. The North American Spine Society (NASS), the Scoliosis Research Society (SRS), the Orthopaedic Trauma Association (OTA), the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS) and the Orthopaedic Research and Education Foundation, several university centers, as well as a number of spinal implant manufacturers also have been named defendants.

The PLC alleges that the pedicle screw is an unsafe device, and that the surgical societies named acted as "promotional centers" for the device and have unfairly conspired to harm patients for monetary gain. We have strongly disputed both allegations. The Academy's positions on these issues are:

Safety of pedicle screws

The use of the bone screw in the pedicle has proven to be a successful option for spine stabilization for specific types of conditions and has been a valuable tool for spine stabilization. When properly used, pedicle screws provide the same safety and efficacy as comparable internal fixation devices used to stabilize spinal fractures. More than 300,000 patients have been treated with pedicle screw implants. To date, 2,100 have participated in the related litigation, and the number of actual failures of the device, at most, is substantially less than 1 percent.

When properly performed by qualified surgeons on appropriately selected patients, implantation of a bone screw in the pedicle is the best treatment for some spinal conditions. The Academy and other surgical societies are deeply concerned that this litigation and the surrounding publicity has already begun to discourage surgeons from recommending this procedure, and could prevent a growing number of patients from receiving the appropriate and proven treatment they need.

Cohort study

The "Historical Cohort Study of the Pedicle Screw Fixation in Thoracic Lumbar and Sacral Fusions" was done at the FDA's request because there was little prospective data on the effectiveness of the pedicle screw. The agency viewed such a study as a means to determine whether there is sufficient clinical data regarding the use of bone screws in the pedicles of the spine to warrant FDA reclassification of the device to Class II. An independent Scientific Committee, made up of representatives of the Academy, NASS, SRS, AANS, CNS and the FDA, conducted the study. The cohort study, which was completed in 1994, reported on results from 314 surgeons who treated 3,498 patients. The study data supported expanded uses for the pedicle screw.

One of the cohort study's most compelling findings was that patients whose treatment for degenerative spondylolisthesis included pedicle screws achieved successful fusion at a rate of nearly 90 percent. That is a superior result compared to the 70 percent of patients in the control group who achieved fusion but did not receive implants. With regard to spinal fractures, pedicle screws were shown to offer comparable safety and efficacy compared to surgical treatments using other internal fixation devices.

FDA reclassification

The pedicle screw is currently designated as a Class III device by the FDA, but is expected to attain Class II status. As a Class II device, it would be clinically approved for use as an adjunct to fusion in the treatment of acute and chronic instabilities and deformities, including fractures and dislocations, spondylolisthesis, scoliosis, kyphosis, and spinal tumors.

The FDA's proposed reclassification of the pedicle screw simply provides timely regulatory clearance for a surgical method that has become the standard of care in treating selected patients with such disorders as spinal fractures and degenerative spondylolisthesis.

Academy's position

Information available from those who have experience in the use of pedicle screws for spinal fixation supports the conclusion that this treatment is superior to alternative procedures for properly selected patients. In fact, there is substantial literature documenting both the safety and efficacy of spinal fixation. Therefore, the Academy supports the recommendation of the FDA Advisory Panel that bone screws which are placed in the pedicles of the spine should be reclassified as Class II from Class III.

Release of names, records

Confidentiality is a key component of most research protocols and the participants in the cohort study were given that assurance of confidentiality as an inducement for their involvement. As part of the discovery process for the current litigation, the PLC has sought to obtain the names of the physician and patient participants in the FDA-sponsored cohort study.

The Academy, along with NASS, SRS and AANS, was very concerned about the potential chilling effect that the release of such information might have on future research. That is why, in December 1995, the Academy, NASS and AANS filed a successful motion to intervene with the United States District Court for the Eastern District of Pennsylvania to protect the confidentiality of this information.

The court denied the PLC's request for the release of names of physicians and individual health care providers from the Cohort Study's Master File. However, at the same time, the court did grant the PLC's request to use certain confidential data from the Cohort Study in order to make their own response to the FDA's request for public comment regarding the proposed reclassification of pedicle screw fixation devices.

'Promotional centers'

The Academy and the other surgical societies strongly deny they have acted as "promotional centers" for pedicle screws, as the PLC has alleged. As educational and research organizations, the Academy and the other named surgical societies provide forums in which orthopaedic surgeons may discuss research and practice-related issues. The use of the bone screw in the pedicle is just one of many such topics presented at the scientific programs of the Academy and other specialty organizations.

Manufacturers of the pedicle screws are among the many companies that advertise in Academy publications and exhibit at the Academy's Annual Meetings. The Academy does not endorse the products or services of any advertiser or exhibitor, nor has it entered into any relationships with these companies other than to facilitate understanding among orthopaedic surgeons of the products and services that are available to them.

A motion has been filed on behalf of the Academy, NASS, AANS and CNS to dismiss all allegations in the pedicle screw multi-district suit against them. The Scoliosis Research Society filed a similar motion.

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