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Joe Esposito talks with Dr David Bomback during a follow-up to his back surgery. Esposito recently had ground breaking back surgery, the first one done in the state, by Dr Bomback. Friday, July 9, 2021, Danbury, Conn.
Joe Esposito talks with Dr David Bomback in his office after a follow-up to his back surgery. Esposito recently had ground breaking back surgery, the first one done in the state, by Dr Bomback. Friday, July 9, 2021, Danbury, Conn. Bomback is showing a model of the device he implanted in Esposito's back.
A model of the device Dr David Bomback implanted in Joe Esposito's back during recent ground breaking back surgery, the first one done in the state. Friday, July 9, 2021, Danbury, Conn.
This past June, a Danbury doctor performed a groundbreaking new back surgery that had never been done in the state before.
The lower-back procedure uses a metal implant — commonly called a Barricaid device— to lower the chances of disk reherniation in patients who have already herniated a disk.
Dr. David Bomback, of CT Neck and Back Specialists, performed the surgery on fellow health care professional and Newtown resident Joe Esposito. Now two weeks out of surgery, Esposito is up and walking, reporting that everything has gone “really great” so far.
The small device from Massachusetts-based Intrinsic Therapeutics, Inc. only received U.S. Food and Drug Administration and premarket approval in March of 2020. And although it’s already been commercially available in Europe, Asia and Australia, it’s new to the U.S. market.
Here are a few things to know about the surgery and the new Barricaid device.
In order to understand why this surgery works, it’s essential to understand how herniation happens in the first place.
The spine is made up of a collection of bones called vertebrae that are stacked on top of each other. Between each bone is a round disk of padding that includes a tougher outer shell and a jelly-like substance on the inside. They act as little shock absorbers between bones. As such, these essential cushions, or disks, protect your spine as you go about your life.
Disk herniations occur more frequently in men and tend to occur between ages 35 to 55. Generally, they are caused by the gradual wearing down of tissue, weight gain or a physical injury. They are, unfortunately, quite common.
In a typical disk herniation, the inner jelly leaks out through the disk’s outer layer. Bomback said to picture an oozing jelly doughnut.
When this inner jelly leaks out, it can press on nerves surrounding the spine and cause radiating or chronic pain. Symptoms differ, depending on the severity and location of the herniation. Often, patients will get a lower-back surgery called a discectomy to remove that jelly from where it’s escaped from the disk casing.
Intrinsic estimates that there are about 350,000 to 480,000 discectomies performed every year in the United States.
While this surgery helps alleviate pain, it doesn’t solve the issue of the herniation itself. That’s where the new device comes in.
The Barricaid device is made a combination of titanium steel and mesh. When implanted, it looks a bit like an open car jack.
The mesh, or polyester flap as experts call it, helps to close the tear in the disk, while the jagged-looking anchor piece is inserted at a precise angle into the bone to hold the implant steady. The small teeth on the implant help keep the device from moving.
By anchoring into healthy bone near the tear in the disk, the device is able to stay rooted in the spine. The mesh arm then covers the tear in the disk, keeping the “jelly” inside and preventing any more from escaping and pressing on nerves.
For some patients with large tears, the chance of re-herniation of disks can be as high as 25 percent. And if a patient re-herniates, that can mean another surgery, and another possibility of re-herniation. It can become a painful cycle.
That’s where the device comes into play.
The new technology has been shown to reduce the chance of re-herniation to about 10 to 11 percent.
The device, according to Bomback, is expected to last the patient’s lifetime.
In order to be eligible to receive the implant, the lower disk herniation needs to be a certain size.
Larger tears are more likely to re-herniate than smaller tears, so the surgery can only be performed if the tear is between six to 10 millimeters wide (although the FDA website states 12 millimeters, the company has stated it is really 10) and four to six millimeters high.
While Esposito’s surgery marked the first completion of the surgery, Bomback had been prepared to implant the new device about six months ago during a surgery. However, once they got into surgery, that patient’s tear was too small to qualify for the implant.
Esposito’s happened to be the right size and the physical therapist was enthusiastic about the new procedure.
Barricaid has been training doctors to use the new device, and has also asked Bomback to help train surgeons now that he has successfully completed the procedure himself.
“It’s a bit of a learning curve,” he said.
Currently, the procedure has been performed on roughly 250 Americans in more than 30 states, but it could be hard to find a surgeon trained on the procedure since it’s relatively new to the market.
Intrinsic provides an online form to help locate a doctor in the event a patient is interested in the procedure.
The surgery starts like a regular microdiscectomy.
After the excess material from the disk is removed during the microdiscectomy, the surgeon will identify whether you are a candidate based on the size of your disk herniation. This assessment can only be done during the surgery, as the surgeon cannot know how big the tear is until they are able to see it.
If the patient is a good candidate, the surgeon will then use a guided X-ray to take one or two photos of how the device is lined up. It has to be lined up properly at the right angle before being implanted to prevent bone fracturing.
Then, using a small mallet, the surgeon will tap the device’s anchor into place in such a way that the sharp “teeth” are able to secure into the bone.
After the device has been put in, the surgeon checks the placement again and the patient is sewn back up as normal.
If you are a qualified candidate (and have pre-approved the use of the implant in the event you are eligible) the surgeon should be able to implant the device in about 15 to 20 minutes.
Bomback said the microdiscectomy surgery generally takes about 35 minutes, and that in Esposito’s case, inserting the device only added about 15 minutes. He hopes that with more time and practice, that could be cut down to about 10 minutes.
The initial follow-up care for this procedure is the same as it would be for any microdiscectomy, according to Bomback.
That includes six weeks of limited movement — no heavy lifting, bending or twisting.
But while the immediate time frame contains the same restrictions as a regular discectomy, Bomback said the device allows you to get back to “normal” faster after those six weeks.
“I might be a little more liberal in allowing them to resume normal activities a bit faster than I would if they didn't have a device,” he said.
Studies have shown that there are risks related to the implant such as “device-related issues” and “development of voids” in your vertebrae, according to Barricaid’s website.
“There’s always concern about a foreign body potentially displacing or moving,” said Bomback, noting that Intrinsic did not see this in their studies.
Displacement is a possibility any time a foreign body is put into a patient, but in this circumstance, Bomback said it would be “exceedingly rare,” and in numerical terms, “significantly less than 1 percent.”
A void occurs when a bone does not heal itself, leaving a cavity space that can lead to a bone graft or use of a bone void filler. The implant can double your risk of developing voids in your vertebrae, the Barricaid website states.
Despite the risk of bone voids, Intrinsic said it has found that one in five people already have these voids before surgery. Bomback said he wouldn’t typically see bone voids created by this type of device. That is more likely with the insertion of larger devices where the surgeon has to remove bone to implant it.
No bone is removed during this procedure.
So far, over 8,000 implants have been placed worldwide, with roughly 250 in the U.S., according to Maddox Kay, a senior marketing associate at Intrinsic.
The product was officially approved by the FDA just 72 hours before elective surgeries closed in the U.S. during the coronavirus pandemic in March of 2020, so the company has said initial rollout was slower than expected, he said.
To date, Intrinsic has virtually trained more than 100 surgeons and estimates the device has been used in more than 30 states.
Intrinsic founder Greg Lambrecht was inspired to design the device after watching his own mom struggle with disk herniations and surgery, Kay said.
Lambrecht wanted to find a way to help her and others experiencing degeneration with their spinal disks.
After founding Intrinsic in 1999, the Barricaid device went through different iterations and designs before the incorporation of the bone anchor implant element during 2008 and 2009.
Following some tweaks and changes to their product, the Barricaid device became commercially available in places like Europe, Asia and Australia.
Bomback said he has been looking for a solution to the problem of disk re-herniation for years and has been following this specific product for the past two to three years, reading the randomized control studies and talking to another colleague who performed the surgery in Louisiana.
The five-year studies done on patients who received the implant in Europe were “really well done,” he said.
“I’m always cautious with new technology, I always try to stay one or two fads behind,” Bomback said. “Although I did adopt it early, I still waited to see 8,000 patients done internationally before I hopped on the bandwagon.”
“I just wanted to stay on the sidelines and make sure that there were not any long term device-related complications.”
Currie Engel covers health issues and the towns of New Milford and Brookfield for the News-Times. A graduate of Princeton University and Columbia Journalism School, she has worked for publications like The Houston Chronicle, Harper's Magazine, and TIME. When she's not reporting, Currie is usually reading, running, and singing, but usually not at the same time.