HUDSON, Fla. – The Food and Drug Administration (FDA) has approved yet another spinal fusion implant device that will exacerbate the pain and suffering that comes along with spinal fusion surgeries, Alfred Bonati, M.D. says.
On Aug. 8, the FDA cleared the SPIRA-A interior lumbar spacer for use on patients.
The product is 3D printed, and intended to be used as a supplemental hardware for those who have already had hardware implanted in attempts to heal back pain through spinal fusion procedures.
The product can be used on patients who have had spinal fusions, but are still afflicted with a wide array of spinal conditions.
Those conditions include degenerative disc disease, disc herniation, spondylolisthesis, deformity, spinal stenosis and failed previous fusions.
Dr. Bonati does not implant hardware to treat any of the conditions listed above, and his patented, minimally invasive surgical technique has a 98.75 percent patient-reported satisfaction rate.
“Spinal fusions are incredibly painful procedures to begin with,” said Dr. Bonati. “They include large incisions in the back, the use of general anesthesia, heavy narcotics to deal with post-surgical pain, long recovery times, expensive and painful physical therapy and the risk of failure at any time. Adding another piece of hardware to fix the failure of previous hardware implants is just ridiculous.”
Dr. Bonati says that spinal fusions are unnecessary to begin with, and that the FDA continues to approve hardware products to boost profits for the companies that make them.
“I can have a patient who is diagnosed with spinal stenosis, for example, in and out of my institute with their back pain treated in a matter of hours, without any hardware at all,” he said. “My patients don’t need general anesthesia, and remain communicative during their procedures. That way, they can tell me whether their pain is relieved on the spot, instead of waiting weeks and weeks to know whether a spinal fusion was successful. Manufacturers might need more hardware products to make more money, but I can assure you that patients do not.”
Dr. Bonati has completed about 80,000 minimally-invasive spinal procedures without the use of hardware in nearly 40 years of heading the Bonati Spine Institute, which he founded in 1984.
He often treats patients who have had unsuccessful spinal fusions in the past.
About The Bonati Spine Institute:
Since 1984, The Bonati Spine Institute, led by Dr. Alfred O. Bonati, has provided world class surgical treatment to patients suffering from spine pain. Dr. Bonati and his team of highly trained specialists have successfully performed nearly 80,000 patented procedures, helping patients with spine pathologies. While the Bonati Spine Institute is located in the Tampa Bay area, patients from all over the world have sought Dr. Bonati’s care, often after other doctors tried and failed to relieve their pain. Of those patients seen, 65 percent have had a history of failed back surgery prior to coming to the Bonati Spine Institute. The Bonati Spine Institute has received a patient-reported satisfaction rate of higher than 98 percent.