OptiMesh Problems: Consumer Fraud, Failed Surgery, Medical Malpractice

The Food & Drug Administration discovered after reviewing their records that Spineology Inc. did not obtain marketing clearance prior to offering OptiMesh® for kyphoplasty, vertebroplasty, or spineoplasty, or medical procedures requiring structural support or for surgical treatment of vertebral compression fractures.

According to a letter sent to Spineology by the FDA in 2007, OptiMesh was approved for use in maintaining the relative position of autograft or allograft bone graft material within a vertebral body tumor that does not impact the stability of the relative position and does not include the vertebral endplates.

OptiMesh was required to bear a contraindication not to use the device in patients with instability and to state that the device does not provide structural support. The device was also required to have a black box warning that the safety and effectiveness of the device for use in fusion of the inter body space has not been established.

Prior to FDA approval, portions of Spineology’s website and a promotion DVD were distributed at the North American Spine Society annual meeting in Seattle in September 2006. Both the website and the DVD promote a device that needs the FDA 510(k) pre-market approval for its intended usage.

Spineology was requested to make the FDA’s prescribed recommendations. The FDA’s Office of Compliance requested Spineology to immediately cease the dissemination of promotional materials for OptiMesh that include the intended uses described above and to explain how Spineology was going to carry out this directive.

While Spineology rectified the marketing materials—the ultimate problems with OptiMesh are…

1. Because of unethical promotions/consumer fraud of OptiMesh, patients are facing spinal surgery which involves the removal of the OptiMesh and spinal reconstruction.

2. Patients’ spines have collapsed when the OptiMesh was used erroneously as it had not yet been approved for structural purposes.

As of May 2008, the safety and effectiveness of this device (Optimesh) used for fusion of the interbody space has not been established.

3. Also some doctors are recklessly opting to continue to use OptiMesh for “off-label” purposes such kyphoplasty. This act of “off label” procedures would be deemed medical malpractice.

Have you or a loved one suffered from spinal reconstruction and spinal surgery due to your doctor using OptiMesh that was unethically marketed or where your doctor continued to use OptiMesh off label? You and your family may be eligible for a lawsuit against the Spineology, the hospital or spinal outpatient clinic, and your doctor for medical malpractice. Please contact Anapol Schwartz for your free OptiMesh legal consultation. Find out how what your legal options are.