Synthes Company Background
Synthes is a leading medical device company specializing in development of innovative implants and biomaterials. Created in 1975, Synthes has grown into a multi-national organization spanning the globe. With research facilities and manufacturing plants located on all five continents, Synthes provides surgeons with an array of surgical technologies and implants used to repair human skeleton and soft tissues.
Synthes Company consists of five main business units: Trauma, Spine, Cranio-Maxillofacial, Biomaterials, and Power Tools. A large part of Synthes business is concentrated in the traumatology (accident surgery) department. The company provides an array of surgical plates and screws, as well as systems of external bone fixation. The company's cranio-maxillofacial surgery unit develops and distributes implants for facial bones and upper and lower jaws. Synthes also provides hospitals with advanced surgical power tools and biomaterials, such as bone graft substitutes and antibiotic implant coatings.
Spinal Surgery and Synthes Vertebral Body Replacement
Synthes ranks among the top three companies worldwide for spinal devices. The company gained a significant U.S. market share when it began distributing the novel Ti Synex II Central Body Replacement in June 2007. This product was designed to replace spinal vertebrae damaged due to tumors or trauma. By replacing damaged vertebrae with titanium Synthes vertebral body replacements, surgeons were often able to improve patients' spinal function and alleviate pain. However, in 2009 several patient reports revealed that Synthes vertebral body replacement was prone to reduction in height and collapse.
After the FDA learned about the defects in Synthes vertebral body replacement devices, it issued a Class I Synex recall on November 12, 2009. The FDA warned surgeons to stop using Synthes vertebral replacement products and to carefully monitor patients implanted with the Ti Synex II Central Body Replacement. Synex spine surgery complications can range from serious problems, including severe back pain, neural injury, and abnormal spinal curve, to spinal compression fracture. Patients with malfunctioning vertebral replacements might require surgery to remove the defective devices.
Illegal Clinical Trials
Alarmingly, Synthes vertebral body replacement is not the only product the company has had trouble with. In June 2009, Synthes was indicted on charges of the illegal testing of two bone cement products, Norian XR and Norian SRS. The 52-count indictment alleges that Synthes conspired to have its products used during spinal surgery. From May 2002 to September 2004, Synthes bone cement was used in 200 patients, three of whom died during surgery.
Synthes used the bone cement despite FDA warnings that such use was highly dangerous. According to the indictment, preliminary studies had shown that Synthes bone cement could react with human blood, causing blood clots. Later studies of the bone cement in a pig caused blood clots that became lodged in the lungs. However, Synthes apparently disregarded this knowledge and performed unauthorized clinical trials on human patients. It also appears that after several patients died, Synthes attempted to cover up its illegal actions by misleading the FDA. The Company also failed to recall the clearly troublesome bone cement products, Norian XR and Norian SRS.
Experienced Synthes Lawyers
If you suspect that you or your loved one has become victim of a defective Synthes vertebral body replacement, you might be entitled to compensation. Please contact the dedicated Synex attorneys. They will carefully evaluate your claim in order to recommend the most appropriate plan of action.