Spinal Cement Associated with Serious Injuries, Surgeries May Not be Effective

The use of spinal cement to repair cracks in the vertebrae during surgery to treat back pain has been linked to patient deaths and serious injuries. Meanwhile, new medical research suggests the surgeries may not be any more effective at relieving back pain than doing nothing.

Each year, up to 80,000 people undergo a form of spinal surgery, such as vertebroplasty, using surgical cement to strengthen cracks in the spine. Spinal cement holds the fracture in place until the bone can heal and regenerate on its own.

But an August 2009 report in the New England Journal of Medicine found that vertebroplasty was no more effective at reducing back pain than sham operations in which no actual repairs were made. Patients in two separate clinical studies of the products could not tell the difference between actual spinal cement surgery and a fake surgery in which surgeons only pressed on the spine and acted as if they were performing a real procedure.

The surgeries can cost up to $3,000 and the number of vertebroplasties done in the United States each year has doubled in the last six years. As a result, thousands of patients may have paid thousands of dollars for surgeries that were no more effective than sham procedures while being exposed to the risk of death and severe injuries.

Heart and Lung Damage, More Fractures May Result

The use of spinal cements also has been linked to life-threatening heart and lung damage in patients. If the cement leaks into the blood stream and blood vessels, it can reach the heart and cause fatal complications. Also, there is some concern in the medical community that using spinal cement to strengthen one vertebra in the spine can put increased pressure and stress on others, causing more breaks.

Spinal Cement Makers Accused of Illegal Promotion

Earlier this year, officials from two companies that make spinal cement products were accused of breaking the law by promoting the use of the products in surgical procedures that were not approved by the Food and Drug Administration.

Synthes Inc. and Norian Corp. allegedly conducted unauthorized clinical trials of two products, called SRS and CRS, between 2002 and 2004. At least 200 patients at Veterans Affairs facilities and other hospitals were included in the illegal trials, and three of them died as a result of injuries linked to spinal cement.

The patients died after suffering steep and sudden drops in blood pressure and officials said the deaths may have been a direct result of the use of the unapproved spinal cement products.

Company officials were accused of pushing the use of the products in surgeries for which they were not approved even though they knew that patients might die or suffer significant injuries.

Federal prosecutors filed a 96-count criminal indictment against the companies and four high-ranking executives in the illegal promotion scandal. The companies and executives face millions of dollars in fines and long prison terms if convicted.

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