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March 16, 2004 — An avid swimmer, bicyclist and weightlifter, Bruce Baughman strives for strength and flexibility. As he recovers from hernia surgery, he’s grateful that a new medical device is designed to offer both benefits.
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Baughman, of Sarasota, Fla., was among the first people in the United States to receive TiMESH, a nano-enhanced mesh device for hernia surgery developed in Germany. The “Ti” stands for titanium, which forms a 30-nanometer thick coating on a standard plastic mesh implanted to repair damaged tissue.
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The composite material remains as flexible as the plastic, but the high-strength titanium atoms are chemically bound to the plastic so they cannot be detached. One of the strongest selling points for surgeons and their patients is that titanium is compatible with the body, which reduces the scar tissue formed by the plastic mesh and the post-operative pain that often comes with it.
“Now that I’ve got a bionic crotch, I’m the latest and greatest,” joked Baughman, 46, owner of a Web site graphic design business who underwent surgery in January.
“I feel like I have a strength advantage. I have a little more intellectual comfort. This is something less likely to allow (recurrence). As anyone who has gone through it will tell you, you don’t want to go through it again.”
Nashville-based GP Surgical recently launched a sales and marketing push for TiMESH, which received approval in September from the U.S. Food and Drug Administration. GP secured the rights to sell the product in the United States and Canada from Germany’s GfE-Medizintechnik. Since 2002, TiMESH has been implanted in more than 70,000 European patients.
The Bavarian Research Association for Biomaterials in 1996 launched a project to develop biocompatible implant materials. The industrial partner was GfE-Medizintechnik’s parent company, GfE Gesellschaft fur Elektromatallurgie mbH, a nearly century-old developer of ultrathin coatings and specialty materials.
GfE-Medizintechnik expects TiMESH will be available for other surgical uses, and it has applied its technology to developing other plastic-based products. They include a titanized silicone shell for breast implants and a suture material.
Although there are other composite meshes for hernia repair, the company said it’s the first to combine titanium with the plastic known as polypropylene. Titanium, valued for its strength and biocompatibility, long has been used in orthopedic implants. But its rigidity and stiffness has limited its use in other implantable devices. In GfE’s process, the plastic molecules and titanium atoms form a covalent bond — and a new compound material that combines the attributes of both.
Dr. Jonathan Yunis, Baughman’s surgeon and the first U.S. doctor to use TiMESH, said the technology also creates the lightest mesh on the market. That makes it easier to pass through smaller holes, which is less invasive and more conducive to faster recovery.
“Basically I see a big difference in the response after surgery to pain,” said Yunis, who first saw TiMESH at meeting last year in London and has used it in about 50 surgeries since late November. “The scar formation is much less, and that’s how it’s translating (for me) clinically.”
Larry Griffith, a principal of GP Surgical, was equally impressed when he first heard about in 2002 while exhibiting at the American College of Surgeons meeting in San Francisco. A German surgeon was interested in a device Griffith was selling, and Griffith sought distribution in Germany. The surgeon returned the next day with GfE medical unit’s president, who showed a company presentation on his laptop.
Griffith said he was initially intrigued by something else made by GfE, but in the middle of the presentation, up popped the hernia mesh. GP Surgical worked diligently to seal a deal that would allow it to be the exclusive North American distributors of TiMESH.
“We said, ‘This is too good to be true,'” Griffith said. “And we fit their needs very well.”
Part of the reason GP fit GfE’s needs was practical. The German firm decided they wanted to grow a new medical products division, and a U.S. distribution deal would help get them there. GfE even turned down a deal with a major medical device maker, he said.
Sales began after the FDA’s approval in September, but Griffith said the rollout was delayed due some processing steps related to resterilization that had to be modified for the U.S. market. GP has since built up its inventories and is ready for broad sales.
The TiMESH, like other implantable meshes, typically is covered by health insurance companies, Griffith said. He did not give an exact price for the TiMESH, but said it’s priced “at the lower end of composite meshes,” which can be as low as $30.
Dr. Robert Zollinger Jr., immediate past president of the American Hernia Society and Cleveland-based surgeon, said the TiMESH shows how far technology has advanced during his nearly 50-year career.
Until about 20 years ago, when the mesh was introduced, surgeons would sew muscles and tendons together and rely on the scar to seal the area and hold it. Such techniques had failure rates among general surgeons of between 5 and 10 percent. The mesh brought those rates down to between 1 and 2 percent, according to Zollinger.
“It allows us to become more sophisticated in looking at pain — issues such as return to work and a thing called discomfort,” he said.
Zollinger said TiMESH is “a promising avenue” to modifying the mesh, which acts like steel bars in a sidewalk by distributing the pressures and tensions over a wider zone. The scar tissue serves as the cement that grows in between the steel bars. Sometimes, the scar tissue can be too active and the TiMESH might offer a way to reduce it — but he cautioned against any approach that removes too much of the scar tissue.
“The unknown is how much scar tissue to you need to get a good repair? It’s a two-edged sword: Sometimes it’s too much; sometimes it’s just right. It’s one of those things that time and numbers will tell.”
He said it’s nice to be able to debate the merits of such refined, advanced approaches. He’s preparing to give a retirement speech in a few months, and will remind young colleagues of what it was like when he started. “If we had an old man … who had multiple failures of his hernia repair, we’d often recommend taking a testicle off. That was a serious consideration 50 years ago.”