What is OptiMesh? Pros and Cons for Spinal Surgery

The OptiMesh container is a hollow, expandable mesh balloon used for retention and containment of bone graft or bone graft substitutes.

The mesh material is woven polyester that is also used in other applications such as vascular grafts. The woven mesh restricts leakage of graft material outside of the cavity but theoretically allows passage of liquids, cells and proteins. OptiMesh takes advantage of creating conditions for delivery of morselized bone graft through a small access portal.

After the cavity is filled, further application of pressure can cause a granular material to change phase from a flowing liquid to a rigid solid. In its solid phase, the bone graft material is able to withstand physiological compression loads and not flow back through the access portal.

Instead of cement, this system uses de-mineralized bone packed within a sack that allows for bony in-growth and maintains structural support. This creates a vertebral body with a modulus of elasticity similar to bone (not cement), and thus in theory could reduce the risk of adjacent level fractures.

OptiMesh Pros: Supporters have hailed OptiMesh as a novel implantable and expandable device executed with a minimally invasive surgical approach to reduce and stabilize vertebrae compressed fractures by using biologically active allograft or autograft bone instead of bone cement.

OptiMesh Cons: Critics contend that the disadvantages of the system are that it used allograft bone material, which might cause rejection problems and that there were no long-term studies to determine how well the system holds up over time. Another critic said that OptiMesh was a more complex procedure and with more complexity comes more risk.

Have you or a loved one been harmed or paralyzed by OptiMesh? Find out what kind of lawsuit you or your family is eligible for. Contact Anapol Schwartz for your free legal consultation.

OptiMesh 1500 series: OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect such as a tumor that does not impact the stability of the vertebral body and does not include the vertebral endplates.

OptiMesh 1500 has not been FDA approved for fusion of the interbody space and should not be used for patients with collapsed vertebral bodies. OptiMesh does not provide structural support.

OptiMesh 500 series: OptiMesh is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500 device is not intended for any spinal indications. Effectiveness of the OptiMesh 500 device when implanted in the spine has not been established.

Nevertheless, both OptiMesh 500 and OptiMesh 1500 have been marketed and promoted for purposes that they were never approved for. And doctors still continue to use them for off label or untested purposes.