Spinal fusion surgery is often hailed as the ultimate solution for chronic back pain and spinal instability. However, behind the promises of relief lies a harsh reality that many patients are often unaware of - until it's too late.
In this eye-opening article, we'll delve into the devastating truth about spinal fusion surgery, shedding light on the risks, complications, and the often-overlooked phenomenon known as failed back surgery syndrome. We'll also explore the prevalence of this syndrome, recent lawsuits related to spinal fusion surgery, and the FDA's role in regulating this invasive procedure.
What Is Spinal Fusion Surgery
Spinal fusion surgery is a procedure that aims to stabilize the spine by fusing two or more vertebrae together using bone grafts, metal plates, screws, or rods. Spinal fusion surgery is commonly performed to treat conditions such as degenerative disc disease, spinal stenosis, and spinal fractures.
While the surgery can provide relief for some patients, it comes with significant risks and potential complications that patients should be aware of before undergoing the procedure.
Risks And Complications Of Spinal Fusion Surgery
Like any surgical procedure, spinal fusion surgery carries certain risks and complications that people should be aware of when considering whether to have the surgery or not.
Risks And Complications Of Spinal Fusion Surgery Include:
Infection at the surgical site
Blood clots
Nerve damage
Persistent pain
Failed fusion (pseudarthrosis)
Hardware failure
Loss of mobility
Chronic disability
Pseudoarthrosis
Pseudarthrosis, or non-union, occurs when the fusion doesn't heal properly and the bones fail to fuse together. This can result in persistent pain and may require revision surgery to address.
Pseudarthrosis is a common complication of lumbar spine surgery and it is vital that it is ruled out as a source of any pain that is present after the operation. Patients usually describe an improvement in their original symptoms after the surgery with the pain getting subsequently worse months afterward because of the continued movement in the spine.
Pseudoarthrosis doesn't always present as painful - sometimes it is totally asymptomatic. This makes is hard to estimate how common it is. Research shows that it can occur in anywhere from 10% of patients to as many as 30% of patients.
Failed Back Surgery Syndrome (FBSS)
Failed back surgery syndrome is a debilitating condition characterized by persistent or recurrent back or leg pain following spinal surgery. Despite undergoing spinal fusion surgery, patients with FBSS continue to experience their back pain symptoms after surgery and they are often even worse than the pain they were in before the operation.
The exact causes of FBSS are complicated. Some causes include:
Being a poor candidate for surgery
Incorrect procedure/ diagnosis
Surgeon error
Scar tissue formation
Recurrent disc herniation
Hardware failure/implant rejection
Prevalence of Failed Back Surgery Syndrome
Failed back surgery syndrome is more common than many people realize. Studies suggest that up to 40% of patients who undergo spinal fusion surgery may experience persistent or recurrent pain symptoms, leading to a diagnosis of FBSS.
The physical, emotional, and financial toll of FBSS can be devastating, leaving patients grappling with chronic pain, disability, and reduced quality of life.
Treating Failed Back Surgery Syndrome
Treating failed back surgery syndrome can be difficult for both the patient and the doctor. Generally, a multidisciplinary approach is what works best to help relieve symptoms. This can include treatments like physical therapy as well as collaborating with pain specialists, spine surgeons, and even psychiatrists.
Recent Lawsuits and Legal Issues For FBSS
In recent years, there has been a growing number of lawsuits filed against medical device manufacturers and healthcare providers related to spinal fusion surgery and its complications. These lawsuits allege negligence, defective medical devices, fraudulent marketing practices, and failure to disclose risks associated with the procedure.
Plaintiffs in these cases seek compensation for medical expenses, lost wages, pain and suffering, and other damages resulting from complications of spinal fusion surgery.
Infuse Bone Grafts - What You Need To Know
Medtronic has been a central figure in spinal fusion litigation, particularly concerning its Infuse Bone Grafts. Approved by the FDA in 2002, these grafts, formally known as "recombinant human bone morphogenetic proteins" or rhBMP-2, were initially intended for spinal fusions.
However, concerning data has emerged, indicating that up to half of patients treated with Infuse bone grafts experienced significant medical complications. This has led to legal action against Medtronic with almost 10,000 people suing the company and raised concerns about the safety and efficacy of Infuse in spinal fusion procedures.
FDA Regulation of Spinal Fusion Surgery
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating medical devices and surgical procedures, including spinal fusion surgery. The FDA reviews and approves medical devices used in spinal fusion procedures, ensuring they meet safety and efficacy standards before they can be marketed and used in patients.
However, critics argue that the FDA's regulatory process may not adequately assess the long-term safety and effectiveness of spinal fusion devices, leading to potential risks and complications for patients.
Conclusion
Spinal fusion surgery holds the promise of relief for those suffering from chronic back pain and spinal instability. However, the reality is far more complex, with significant risks, complications, and the potential for things like failed back surgery syndrome.
Patients considering spinal fusion surgery must be fully informed about the potential risks and benefits of the procedure and explore alternative treatment options before making a decision. Moreover, ongoing research, improved surgical techniques, and rigorous FDA regulation are essential for ensuring the safety and efficacy of spinal fusion surgery in the future.
If you are suffering from chronic low back pain you might want to try some less invasive therapies like physical therapy, digital physical therapy, or exercise before pursuing something like surgery that carries significant medical risks.