Solved crisis by developing new product
Tekst: Anne-Lise Aakervik
Foto: Synlig.no v/Erik Børseth
When the manufacturer suddenly pulled from the market a critical medical mesh used to keep parastomal hernias under control, the doctors were forced to take matters into their own hands.
From right: surgeons Brynjulf Ystgaard and Tor Eivind Bernstein, with Tonje S. Steigedal from TTO. Surgeon Tommy Bernhard Johnsen also worked on this invention, but he was not present when this photograph was taken.
This was one of only a few types of mesh on the market that were fit for the purpose. Gastric surgeons at St. Olavs Hospital were not lost, however. They literally picked up a needle and solved the crisis by developing a new type of mesh. They are currently in the process of patenting their solution, hoping to distribute the mesh worldwide.
“The situation was actually quite critical for us,” says Dr. Tor Eivind Bernstein, a surgeon and one of the three inventors. In addition to practising medicine at St. Olavs Hospital, he is also affiliated with the Department of Clinical and Molecular Medicine at NTNU.
“We had several surgeries scheduled when this mesh was suddenly pulled from the market. It was discovered that the seams on the mesh were weak. They could quite literally unravel, and the product was therefore pulled from the market worldwide.”
Now, surgeons and patients were left with a different type of mesh made from porcine connective tissue, but this is not as durable as the other type, and few surgeons would use it as a permanent solution.
The surgeons asked around to find out what other hospitals were doing, but they didn’t get any solutions. “That’s when we decided to just go for it ourselves, and our solution proved to work quite well. So well, in fact, that we’re hoping to find someone who would like to licence our product.”
Sat down with needle and thread: When a surgical mesh used in ostomy surgeries was pulled from the market, the surgeons were forced to find their own solution. The result was “Bakermesh”, an improved and specialized mesh.
The patients who need this type of mesh are patients who have had surgery to create an artificial opening in the abdomen to drain urine and/or faeces. These openings are called stomas. There are around 15 million ostomy patients worldwide, and approx. half of these will develop a hernia after the surgery where the artificial opening in their abdomen was created. A hernia occurs when tissue from the abdominal cavity pushes through a weakness in the abdominal wall. This often causes the ostomy bag to detach, and new surgery is needed to repair the hernia. That is what the mesh is for—it reinforces the abdominal wall.
So, when it was held back in October of last year the surgeons had to find their own way.
Crisis drives creativity
The gastric surgeons already knew their way around a sewing needle, even when human tissue is not involved. “The cost of these types of mesh is extremely high, so we couldn’t use the same material during the design phase, but as soon as we had a mesh we knew would work, we had it made in the right material, and we have been testing it in surgeries since October 2018.”
“We follow up on this patient group very closely. The patients who are eligible to try this mesh have permanent stomas,” Bernstein explains. “The results have been good. We have documented that the mesh works well both during and after surgery, as well as in the long term. We have not had any irregularities since the patients were fitted wit our solution. And now, we’ve followed our first patients for more than six months—we’re scheduling their one-year check-up.”
Along with Tonje S. Steigedal from TTO, they have been working on a patent application and presenting their invention to potential industrial partners. They are hoping that the product they developed can be licensed to a manufacturer, so they don’t have to make them themselves when they need them.
“It’s not like we’ve revolutionized anything here, that would be hard, but we’ve made key adjustments.”
If nobody wants to manufacture these, the surgeons have to make the mesh themselves when they need them. They would spend around 10–15 additional minutes during every surgery to make the mesh, as they cannot be pre-produced. Of course, they would prefer a ready-made mesh, where they can simply open a package.
“We know there is a need in connection with this type of surgery, and that’s why we believe the chances are good to find an industrial partner who can assist in the regulatory certification process and the commercialization of this new type of mesh. Industrial stakeholders are expressing an interest in the product and follow the results from our clinical testing closely,” says Tonje S. Steigedal.
With funding from NTNU Discovery, the team has completed their patent application and prepared a marketing package.
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