In July 2007, John Doe entered the hospital for a routine umbilical hernia surgery. Other than the hernia issue, he was a healthy male who had been told to expect a routine, quick procedure from which he would recover quickly. Little did he know that his entire life would be turned upside down that day.
His surgeon opted to use a large Ventralex patch for the repair. He had considered a non-mesh, or primary repair, but elected to use the Ventralex because there was undue tension and he could not do a primary repair.
When he opened up John Doe he did not find an entrapped hernia but found purulent (pus) material and that a loop of the small bowel was densely adherent to the overlying mesh and an erosion of the bowel was evident into an abscess cavity involving a portion of the mesh, which had turned to expose the polypropylene to the bowel at some point, causing an area of adherence.
The surgeon excised the infected Ventralex from Doe's abdominal wall and resected the bowel, removing nine centimeters of his small intestine. The surgeon described the explanted Ventralex as “distorted,” “firm,” “not pliable,” and in a “buckling” shape. A few days after the initial surgery, the patient returned to the hospital for emergency surgery because he had a high-grade post-operative small bowel obstruction. This obstruction was caused by adhesions in the right lower quadrant. The surgeon successfully removed the adhesions.
After the emergency surgery, it was discovered that John Doe at least two areas of herniation extending laterally from the umbilicus in each direction. Further surgery was recommended.
The nightmare wasn't over for the unsuspecting patient. He had had no idea or expectation that what had been described as a routine procedure would alter his life so dramatically. What John Doe could not have know is that the Ventralex hernia mesh inserted into his adbominal cavity to repair a hernia would cause irrepairable damage to other organs. What he couldn't have known was that the polypropylene resin from the mesh oxidatively degrades in vivo. He couldn't have known that the ePTFE layer of the mesh contracts more than the polypropylene, which in combination with the too-weak memory coil ring causes the device to fold or buckle or potato chip. The buckling leads to the Ventralex patch pulling away from the abdominal wall and curving in toward the bowel, causing the bare polypropylene side of the Ventralex to adhere to the bowel.
Finally he couldn't have known that the ePTFE layer was prone to infection because of the ePTFE layer’s small pore size, which is big enough for bacteria to grow in but too small for white blood cells to enter to intercept the bacteria.
All of this suffering because of a medical device that causes more problems than it resolves. All of this because a medical device company was allowed to bypass strict testing in order to push it to market in order to increase profits. This is what happens when companies put profits over people. People suffer because they put their trust in medical devices and technology that should not have been on the market in the first place.