Airline travelers have seen the magazine ad showing two topless women in bikini bottoms, their backs to the viewer. One of them wears a Band-Aid. “Who just had back surgery?” a caption asks.
The ad promotes the laser surgical procedures performed at the Laser Spine Institute LLC (LSI).
“Largest Spine Center in the World”
According to a May 2011 story written by David Armstrong of Bloomberg News, as many as 5, 000 procedures are performed annually at LSI surgical centers in Phoenix, Philadelphia, Oklahoma City and Tampa. The company bills itself as the “largest spine center in the world, ” with sales in 2010 of $109 million. That’s about $21, 800 per procedure according to our math.
While the overall spine surgery revenues have been under severe pressure, (Wall Street analysts estimate that spinal implant supplier revenues declined 0.4% in 2012 and the number of fusion procedures following diagnosis of degenerative disc disease has been declining steadily for the past three years) due to a much tougher reimbursement environment which is characterized by a rising tide of insurance coverage denials insurance carriers, LSI seems to be immune from the headwinds faced by every other spine care provider.
LSI’s sales and procedure volumes seem to be flying way above the rest of the spine care industry. Indeed, LSI booked a remarkably high 34.3% net profit margin from 2006 through 2009.
According to patient interviews conducted by Bloomberg’s Armstrong and copies of billing records he reviewed, LSI often charges $30, 000 for each procedure. That’s twice as much as Aetna Inc., the third largest U.S. health insurer, will pay for laser-less surgery. According to the corporate controller at Westchester, Illinois-based Regent Surgical health—which operates 15 outpatient centers—it’s more than twice the average reimbursement for spine procedures.
From 2006 through 2009, according to recently obtained court documents, LSI earned net income of $98.9 million on revenue of $288 million. Of that amount, $77 million, according to Armstrong, has gone to a small group of shareholders. James St. Louis, D.O., the company founder, purportedly received 25% of that. LSI disputes that figure. Other investors include a Dallas investment firm and two Outback Steakhouse founders.
In 2009 when the company considered an initial public offering, Goldman Sachs valued the LSI at around $428 million.
The Hulk Brings Scrutiny
Things appeared to be sailing along, until Terry Bollea, (aka Hulk Hogan) filed a $50 million lawsuit against LSI and, in the process, attracted the glare of the national spotlight on the privately held but, through their new ubiquitous ads, well known company. The complaint opened a window on this secretive company and the particular form of treatment for spine disease performed at LSI. Most ominous for LSI, the lawsuit examined promised patient outcomes against results—with Hulk Hogan acting as spokesperson for unhappy patients.
Ablation and Decompression
About 80% of Laser Spine’s patients get the same two-step procedure, according to Robert Gruber, a physician who directs spinal diagnostics at the LSI center in Tampa. First the surgeon burns off (ablates) sensitive nerve endings in the joints between vertebrae. Then, he removes herniated disc material or bone spurs that press on nerves and cause pain. In short, said Gruber, the LSI physicians decompress the nerves and perform a laminotomy.
The evidence that ablation—the laser-assisted process that gives the institute its name—helps patients is “pretty weak, ” Roger Chou, a physician at the Oregon Health & Science University in Portland who is the director of the American Pain Society’s clinical guidelines program, told Bloomberg News.
“Even in studies showing some benefit, the benefit is small and doesn’t last that long, ” Chou said. “Nerve endings can regenerate over time.”
Decompression is generally successful in treating 60 to 70% of patients with spinal stenosis says Jon Lurie, a spine doctor and researcher at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
“Spinal stenosis is our bread and butter, ” said LSI’s Gruber said in the Bloomberg article. Still, unaffiliated surgeons have treated former Laser Spine patients who didn’t need the procedure and shouldn’t have gotten it, said Choll W. Kim, a San Diego surgeon who founded the Society for Minimally Invasive Spine Surgery.
Kim said LSI’s marketing is so powerful but that he and many of his colleagues have seen patients that needed something different and got the laser spine surgery.
The Hulk’s Unstable Back
Bollea claims in his lawsuit that he went to three different spine surgeons in Tampa before going to LSI. He first saw a board certified orthopedic surgeon who recommended a laminectomy and fusion. A week later he went to the University of South Florida (USF) where he was told that he needed open lumbar fusion. A third surgeon told him he needed an anterior inter-body fusion with instrumentation.
He agreed to schedule and proceed with the surgery at USF.
Before the surgery, Bollea stopped in at LSI to consult with St. Louis. Bollea claims St. Louis told him he didn’t need a fusion, that he could fix him and that he would be back to normal wrestling activities “quickly” after LSI treatments. Bollea cancelled his scheduled surgery and agreed to get treatment at LSI.
Bollea now claims that St. Louis should have known that LSI procedures (ablations, rhizotomy, foraminotomy, laminotomy, facetectomy and percutaneous discectomy) would be ineffective for his diagnosed condition.
LSI Procedures
Over the next 19 months, LSI performed the following procedures on Bollea:
- Feb 28, 2009 – “Destruction By Thermal Ablation Bilateral Sacroiliac Joint Nerves and Paravertebral Facet Joint Nerves Bilateral L2/3, Bilateral L3/4, Right L4/5, and Bilateral L5/S1.” Also performed was a “Lumbar Laminotomy (Hemilamniectomy) with Foraminotomy, Including Partial Facetectomy With Decompression of the Nerve Roots Left L4/5.”After two to three weeks, the pain returned.
- May 21, 2009 – “Destruction By Thermal Ablation Paravertebral Facet Joint Nerves Left L2/3” and a “Lumbar Laminotomy (Hemilamniectomy) with Foraminotomy, Including Partial Facetectomy With Decompression of the Nerve Roots Left L3/4 with Percutaneous Lysis of Adhesion.”More temporary relief and returning pain.
- October 12, 2009 – “Endoscopic Surgical Rhizotomies of the Facet Joints with Posterior Capsalectomy and Facet Joint Arthroplasty at Right L4/5 and Bilateral L5/S1.No relief.
- May 27, 2010 – “Percutaneous Discectomy, L3/4″No relief
- June 30, 2010 – “Percutaneous Discectomy, L4/5”
- August 12, 2010 –”Percutaneous Discectomy, L2/3″
Fusion, Posterior Instrumentation and Scoliosis Correction
On December 20, 2010, Bollea went back to USF and had an anterior lumbar inter-body fusion (L2-L3, L3-L4, and L4-L5) with posterior instrumentation and scoliosis correction. He claims he got significant relief and was able to return to his professional activities in about three months.
Bollea claims his eventual recovery was delayed and that cost him $50 million dollars of income he could otherwise have earned.
Informed Consent
Did LSI properly inform Bollea and receive informed consent?
We asked Tony Yeung, M.D. about the procedures used on Bollea. Dr. Yeung did not review Bollea’s medical records and did not speak to any physicians at LSI. He has seen patients who had previous experience with the LSI center in Phoenix.
In Defense of Laser Procedures
Yeung told us laser procedures can relieve facet mediated back pain with facet denervation. Symptoms from mild central stenosis and medial facet stenosis can be relieved by laminotomy/laminectomy and removal of the ligamentum flavum. The result can be as good as open fusions without “burning bridges” for a fusion procedure later if the initial relief worsens due to the progression of the degenerative process, usually years later. “Most patients, if fully informed, understand that returning pain can be the result from an aging spine, ” said Yeung
“Most patients can tolerate a partial deterioration of the initial good result. It’s a matter of informed consent based on past experience, honestly explained, ” continued Yeung.
Bollea claims LSI purports to provide long lasting and permanent remedies for scoliosis, spondylolisthesis and decreased disc space. For severe conditions, Yeung recommends either non-surgical treatment of decompression and fusion with traditional techniques.
Yeung says he doesn’t disagree with the surgeons who advise traditional fusion for these conditions, but has had many patients who reject fusion and get good results with MIS decompression (foraminal decompression) and dorsal ramus (or its branches) visualized ablation for axial back pai
“I also have patients who rejected their spine surgeon’s recommendations, and elect to try an alternative to fusion with good results. About two-thirds of those patients receive good results that allow enough pain relief over two to five years that they are able to avoid fusion. These painful degenerative conditions can be relieved to the patient’s satisfaction with MIS decompression and dorsal ramus ablation, but this is with foraminal decompression that does not destabilize the spine.” He emphasizes that his technique is not the same as that performed by LSI.
Yeung recommends transforaminal epiduralgrams and therapeutic injections to be performed first, and only those patients with good results from the diagnostic and therapeutic injections would be considered for foraminal decompression and dorsal ramus ablation.
“I would not have repeated the rhizotomies more than once as the second time is not as effective and I have never done it three times, ” says Yeung.
“If Bollea’s allegations are true then there may have been a lack of proper informed consent, ” added Yeung.
Throwing the Laser Baby Out With the Bathwater
As a pioneer in the field of minimally invasive spine surgery, Yeung is aware that not every physician is expert at the procedures he has helped develop and not everyone gets the same results he gets. He wants to be careful that we don’t throw the baby (MIS) out with the bathwater if ineffective or badly executed procedures are performed on patients.
Bollea is also suing LSI for using his image without his permission. We found the North American Spine Society (NASS) logo on LSI’s website. Apparently they used that image without permission because the logo was removed after we asked NASS about it. A NASS spokesperson said LSI did not have permission to use the logo. The Becker’s Orthopedic & Spine logo is also on their site. We asked Becker’s if they have a relationship with LSI. We did not hear back from them.
The Hulkster’s lawsuit is bringing the bright light of scrutiny on privately held LSI’s financial success. A jury will decide on the financial damages. Public opinion and payers will decide on the veracity of LSI’s claims and decide if the baby gets thrown out with the bathwater.
