Investigation and potential action against Spineology Inc. relating to the marketing practices and general effeciveness of its OptiMesh brand set of medical products.
The investigation includes:
(1) alleged unethical promotions/consumer fraud of OptiMesh by patients a facing second 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) Some doctors are recklessly opting to continue to use OptiMesh for "off-label" purposes such as kyphoplasty.
The Food & Drug Administration claims 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.
In the United States, almost 800,000 people suffer from vertebral compression fractures (VCF) every year. Most of these fractures are caused by osteoporosis, in post menopausal women with low bone mineral density. Men of any age suffer too especially from taking steroids or other drugs over the long term.
Both kyphoplasty and vertebroplasty have gained in popularity for being minimally invasive and as an alternative to regular surgery. Most patients marvel at feeling better with greater pain relief and regaining mobility. Vertebroplasty is an image-guided interventional procedure where surgeons stabilize the collapsed vertebrae by injecting medical-grade bone cement into the spine. The cement fills the spongy bone cavity and any cracks and crevices rapidly harden. The goal of vertebroplasty is to reduce pain, stabilize the fracture, improve patient function, and restore mobility. Kyphoplasty, developed not long after vertebroplasty, is similar except that the surgeon inserts an inflatable balloon to create a cavity where the cement is injected. Kyphoplasty has a bonus?restores the height of the vertebrae. Kyphoplasty requires in-patient stay. Kyphosis is the condition known as a hunchback appearance. In prospective studies, kyphoplasty has resulted in decreased pain in 89% to 97% of subjects.
The OptiMesh system is similar to kyphoplasty, but instead of a balloon and bone cement, the surgeon prepares a cavity in the vertebrae and uses a flexible mesh container (OptiMesh) with a biologic fill material, which is delivered under pressure to fill the cavity and support the vertebrae.
Spineoplasty is a minimally invasive procedure typically performed by specialists including interventional radiologists and spine surgeons. The best candidates for spineoplasty are those who have moderate to severe back pain and have a vertebral compression fracture that is clinically stable.
According to the Spineology marketing materials, the OptiMesh system has several advantages over vertebroplasty or kyphoplasty, the most significant is using the biologic material, which allows bone to re-grow and the vertebrae to heal over time. However, some skeptical radiologists disagree because using larger size instruments make it a more invasive procedure and don't see much improvement over the success or safety of vertebroplasty or kyphoplasty. 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.
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. 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.
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