The DISCSEEL Procedure is the only treatment able to treat Leaky Disc Syndrome.
The DISCSEELĀ® Procedure – Frequently Asked Questions
The DISCSEELĀ® Procedure – Frequently Asked Questions
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The DISCSEEL Procedure is the only minimally invasive procedure demonstrating ability to regrow damaged spinal discs, therefore replacing the need to undergo most spine surgeries.Ā
The procedure is comprised of two steps:Ā
The first step utilizes live x-ray guidance to precisely identify all spinal disc tears and pathology unable to be seen by an MRI.
The second step introduces FDA-approved Fibrin to immediately bind to damaged disc tissue, sealing it, and more importantly, stimulating new disc tissue growth, healing discs to permanently relieve pain and weakness.Ā
Patients return home in 30 minutes and resume activities within days.
Patients are candidates if they have sciatica, pinched nerves, stenosis, slipped discs, disc bulges, disc herniations.
Patients are also excellent candidates if they had prior spine surgery, including fusion, laminectomy, or discectomy.
Research shows that those who failed prior surgery have excellent outcomes with the DISCSEEL Procedure.
Researchers now know that stem cells and PRP (platelet-rich plasma) fail because of several shortcomings that do not similarly hinder fibrin used in the DISCSEEL Procedure.
The first reason stem cells and PRP often fail is because they leak from discs into which theyāre injected. Their leakage was confirmed in many publications in which stem cells were labeled with tracers (radiolabeled) and injected into discs. Over 90% of stem cells leaked from discs within 24 hours of injection. In comparison, Fibrin does not leak because itās a natural bio-adhesive glue that immediately binds to annular tears, becoming part of discs, filling all tears and defects, and stimulating the growth and healing of new disc tissue. This is how Fibrin also works in nature to heal skin cuts and broken bones. Fibrin is the only substance ever confirmed to regrow disc tissue. Therefore, the DISCSEEL Procedure can be patented while no stem cell or PRP treatment qualifies for patent protection.
The second reason stem cells and PRP often fail is because Fibrin promotes disc tissue healing and growth after binding to damaged discs. Stem cells cannot bind or form this 3-D matrix necessary for all healing.
This year more physicians are stopping PRP (platelet-rich plasma) and stem cell spine treatments, and requesting to be trained to perform the DISCSEEL Proedure, more than all prior years combined.
Reasons physicians are switching to the DISCSEEL Procedure:
The DISCSEEL Procdure prevents the need for spinal surgery (fusion, discectomy, laminectomy) by introducing the FDA-approved biologic Fibrin to damaged spinal discs, stimulating new disc tissue growth, thus permanently repairing discs with normal disc tissue and not scar tissue. The DISCSEEL Procedure is the only procedure confirmed with the ability to regrow normal disc tissue.
Dr. Pauza performed the first DISCSEEL Procedures 17 years ago and collected outcome data since that time to assure safety and efficacy. More spinal discs have been treated by the DISCSEEL Procedure than stem cells and PRP treatment.
Optimal candidates include people with spinal stenosis (mild, moderate, or severe), sciatica (radiculopathy), pinched nerves, āslipped discs,ā and degenerative disc disease.
Optimal candidates also include those who underwent prior spine surgery, including fusion, laminectomy, and discectomy.Ā
Optimal candidates also include people who are frequently told they need spinal surgery, including fusion, discectomy, or laminectomy. However, they instead experience permanent relief from the DISCSEEL Procedure, as confirmed in published research.
The DISCSEEL Procedure costs less than the typical out-of-pocket copay for surgery with insurance. Spine surgery typically costs more than $100,000, with a patient copay of $20,000.
The DISCSEEL Procedure cost is $15,000-$20,000. Note: The IRS allows the deduction of the procedure. Some patients utilize financing plans to cover the cost.
The Veterans Administration and Department of Defense cover the DISCSEEL Procedure for all Veterans and military personnel because they recognize the higher costs, complications, and repeated surgeries associated with spinal surgery.
Fibrin is an FDA-approved biologic glue made by Baxter and Johnson & Johnson. It is the natural molecule that heals skin cuts by regrowing skin. Fibrin also causes disc tissue to heal and regrow. Fibrin is the only drug or biologic proven to regrow human discs. People cannot be allergic to Fibrin because Fibrin is naturally found in every human. This would be analogous to being allergic to water or calcium; a person cannot be allergic to water or calcium because water and calcium are in every human, just like Fibrin.
Like many drugs, fibrin is obtained from human blood plasma. Fibrin has been used for several decades, on tens of thousands of people with zero incidence of transmitting pathogens because it is a highly purified molecule.
Fibrin binds to damaged discs because it is a strong bio adhesive glue sealant, and this property allows Fibrin to remain in discs and heal them while stem cells or PRP fail because they leak and cannot bind to damaged disc tissue.
Yes, Fibrin is an FDA-approved drug. The FDA allows the use of fibrin in spinal discs. The first indication approved for Fibrin by the FDA was to use in the spinal canal to seal dura tears and cuts caused by spinal surgeons.
Fibrin heals spinal discs the same way Fibrin naturally heals skin cuts and other injured tissue. In comparison, stem cells and PRP cannot heal discs, because they lack fibrinās properties.
Fasten your seatbeltsā¦although you will recognize the healing process is simple.
When a personās skin is cut or damaged, it exposes amino acid chains. Next, the two natural molecules always flowing in the bloodstream recognize the damaged skinās exposed amino acid chains and bind to them at the injury site to seal and heal the damage.Ā When these two molecules come together at the injury site, they form Fibrin, a strong adhesive sealant. This Fibrin sealant is a 3-dimensional matrix that serves as a foundation causing new skin growth.
During the following weeks, Fibrin branches intentionally break away and are replaced with normal skin tissue molecules. In the disc, they are replaced with normal disc tissue molecules in the same manner. This is the natural āhealing process.ā In comparison, after surgery, discs donāt heal with normal tissue, so discs continuously re-tear, causing recurrent disc herniations.Ā Whereas the DISCSEEL Procedure causes strong, normal disc tissue growth.
“For Geeks:”
The healing process:
The two natural molecules mentioned above flow in everyoneās bloodstream and are called āprothrombinā and āfibrinogen.ā When they sense exposed amino acid chains of injured tissue and come together, the āprothrombin moleculeā causes āfibrinogenā to become Fibrin, a natural adhesive sealant. Fibrin is a āpolymerā comprised of small branches (called monomers) which break away, to be replaced with normal skin tissue. In the disc, they are replaced with normal disc tissue.
Annular tears are the true underlying cause of all disc problems, including disc herniation, bulge, degeneration, protrusion, pinched nerve, and prolapsed discā¦ all result from annular tears.
Ironically, annular tears are rarely mentioned because, before the DISCSEEL Procedure, no treatment existed to repair annular tears.Ā
Annular tears are tears of the annulus fibrosus. The annulus fibrosus is the 17 layers that encircle the center nucleus pulposus gel and contains pain nerves within its layers. When annular tears allow the gel to leak outwards, the gel is perceived as a foreign substance by the human body and causes inflammation of the annular layers, which is the true cause of low back pain or neck pain. If there are many annular tears, they allow the gel to leak entirely outwards onto spinal nerves adjacent to discs, causing inflammation of spinal nerves. Spinal nerve inflammation is called āradiculopathyā (aka sciatica) so radiculopathy is caused by spinal nerve inflammation and not by āpinched nervesā as was once thought. This explains why epidural steroids occasionally only provide temporary relief. However, if discs continue leaking through annular tears, they need the DISCSEEL Procedure to repair annular tears.
Congress granted special patent protection to the DISCSEEL Procedure because it deemed it worthy of protection, while no other biologic procedure was deemed worthy of protection.
Specifically, for the good of Mankind, the United States Congress proclaimed: āNo medical procedure may be patented because medical procedures are for the good of Mankind.ā Thus, although Congress allows drugs or medical devices to be patented, (to incentivize their research) it does not allow procedures to be patented.Ā
However, it was acknowledged that biologic treatments have the potential to provide the greatest advancements in healthcare, so Congress passed a Congressional Act stating that a procedure may be patented only if it can cause the regrowth of new tissue and healing.Ā
Only the DISCSEEL Procedure meets this strict criterion by healing spinal discs, and so only the DISCSEEL Procedure is patented. No other biologic procedure meets these criteria and so no other procedure (including PRP and stem cells) can be patented.
A herniated disc is sometimes wrongly referred to as a āslipped discā or āruptured disc.āĀ Herniation occurs after the outer portion of a disc, the annulus fibrosus, tears, causing the inner gel contained in the nucleus pulposus to leak outwards. When the gel flows through the disc and contacts the spinal nerve, the spinal nerve becomes inflamed. The inflamed disc and spinal nerve cause low back pain and sciatica leg pain, numbness, and weakness (radiculopathy). Symptoms often increase and decrease, proving that it is liquid inflammation and not a pinched nerve, as was once wrongly believed.
āLeaky disc syndromeā describes the symptoms caused by leaky spinal discs. Discs leak when they are degenerated, bulged, herniated, or torn in any manner. The outer annulus fibrosus tears cause the inner gel to intermittently leak. Itās acknowledged that this gel is perceived as a foreign substance by the human body (akin to battery acid) when gel leaks from the center of a disc. The foreign body reaction results in two things: the immune response and the inflammatory response. The inflammatory response causes alternating pain, numbness, weakness, muscle spasms, and other symptoms.
Historically, surgeons once believed that symptoms were solely caused by pinched nerves and stenosis. However, now itās acknowledged by scientists that the gel of āLeaky Disc Syndromeā causes symptoms more than pinching. This explains why research confirms that MRI appearance doesnāt correlate with symptoms and explains why many spinal surgeries fail.
Your spine has discs that act like cushions between the bones. The disc has a soft center (nucleus pulposus) and a tough outer ring (annulus fibrosus).
According to the leaky disc theory, tears in the outer ring (annulus) can allow the soft center (nucleus) to leak out. This leaked gel is seen as a foreign object by the body, triggering inflammation and pain.
MRIs can show abnormalities in the discs, but many people without back pain have abnormal MRIs on scans. The leaky disc theory suggests that the pain comes from the chemical response to the leaked gel, not necessarily the physical structure seen on MRI.
The leaky disc theory suggests that the amount of leaked gel and the resulting irritation of nerves can fluctuate, causing your pain to wax and wane.
Yes, leaky discs cause all symptoms, pain, numbness, tingling, and weakness without pinched nerves. Symptoms occur because the āliquid gelā (nucleus pulposus) leaks outwards from the discās center onto spinal nerves causing inflammation of spinal nerves and all adjacent tissue. This explains why MRIs often donāt show the cause. Leaky gel also explains why symptoms come and go, changing in location and severity, based on activities or rest.Ā
The only treatment to repair Leaky Disc Syndrome is Fibrin of the DISCSEEL Procedure. Surgery cannot repair Leaky Discs. Epidurals cannot repair Leaky Discs.
Itās not a mental health problem, but instead, itās Leaky Disc Syndrome. Fluctuating pain and other symptoms (left, right, or both sides) are common with leaky discs. Many doctors mistakenly believe patients are depressed or ācrazyā when they describe varying symptoms. However, we expect patients to have varying symptoms because it’s Leaky Disc Syndrome.
Unknowing doctors mistakenly prescribe antidepressants or refer patients to psychologists or psychiatrists. This is wrong because it’s Leaky Disc Syndrome, so we are educating doctors around the world about Leaky Disc Syndrome.
The DISCSEEL Procedure is the only treatment able to treat Leaky Disc Syndrome.