Synex FDA Recall – Vertebral Body Replacement Side Effects – Synthes

On November 12, 2009, the FDA issued a recall of Synex II vertebral body replacement device. The Synthes FDA product recall was prompted by reports indicating that Synex vertebral replacement had collapsed inside the patients’ spinal cords only months after the implant surgery. In some patients, Synex vertebral replacement had decreased in height, leading to spinal instability and severe back pain. According to the FDA, if not detected and treated promptly, a defective Synex vertebral body replacement can cause serious nerve damage, abnormal spinal curve, and decreased range of motion. In some cases, additional spinal surgery is necessary to repair the malfunctioning vertebral replacement or replace it with a different surgical technology.

Synthes Recalls

As several reports demonstrate, the manufacturer of Synex vertebral replacement, Synthes, knew about the defects at least several months before the Synthes FDA recall. After receiving several alarming reports, the company mailed a warning letter to surgeons and sales representatives, explaining the potential Synthes side effects and asking them not to distribute and use the Synthes vertebrae body replacement device. However, the company did not initiate a formal recall of its products.

Sadly, the questionable behavior of Synthes has several precedents. In 2009, the company settled several lawsuits involving unethical business practices. Furthermore, in June 2009, Synthes was indicted on charges of performing illegal clinical testing of its bone cement products. According to the indictment, Synthes had been warned by the FDA not to use the bone cement in clinical trials due to the risk of causing blood clots. However, the company disregarded the FDA advice and used the bone cement in 200 spinal surgeries. Three of the patients died on the operating table.

Vertebral Replacement Surgery

Vertebral replacement devices are manufactured by several companies, the largest of which are Synthes, Medtronic and Stryker. Dominating the U.S. market, these companies offer sophisticated surgical technologies that promise to repair serious spinal damage while reducing pain and enhancing patients’ overall quality of life. While the devices marketed by each company are slightly different, all of them are based on the same anatomical principles.

Vertebral body replacement products do what the name suggests, replace damaged natural vertebrae. During vertebral replacement surgery, a perforated metal cylinder is inserted in the place of the damaged vertebral. The implant is integrated into the spinal cord, improving spinal strength and stability. The implant becomes part of the patient’s spine and functions similarly to a natural vertebral. Because of the improved alignment and strength of the spine, back pain often disappears within several months of vertebral replacement surgery.

Synex Lawsuits

If you have undergone spine surgery with Synex II vertebral body replacement technology and experience painful vertebral replacement side effects, you might be entitled to compensation. You should consult with an experienced Synex attorney in order to learn about your legal rights and evaluate your options. In some cases, filing a Synthes lawsuit is the recommended course of action as adjudication might compel the company to settle claims in order to avoid a costly trial. Compensation Synthes victims might be able to obtain through a settlement can include medical expenses, physical pain and emotional suffering, time off work and reduction in future earnings.