Questions Remain Over the Kugel Mesh Hernia Patch

Rockville, MDIt used to be that if a surgeon left something inside you, like a sponge, it was a huge issue. With the hernia patch, of course, the leaving of something inside is the whole idea—a patch that remains with you to properly treat and control the hernia. But the Kugel Mesh patch also came with a Kugel Mesh memory recoil ring, that didn't mesh well with the human body or with quality of workmanship, for that matter.

They are manufactured in another country.

Anyone familiar with the Kugel Mesh issue knows the back-story pretty well. The Kugel Mesh system for hernia repair is yet another device that takes advantage of the advent of laparoscopic surgery, where small incisions are made and surgery is performed with the aid of miniature television cameras and tools designed to be used through a catheter.

Laparoscopic surgery minimizes the invasiveness of traditional surgical procedures that once required massive incisions that took far longer to heal and incapacitated patients for longer periods. The move to laparoscopic for an increasing number of procedures allows patients to get back on their feet faster and out of the hospital more quickly. That frees up beds and relieves the pressure on the health care system.

The Bard Kugel Mesh system relied on a plastic 'memory recoil ring' that was inserted into the body in a collapsed position, then expanded at the right spot with the actual mesh to treat the hernia. The ring was also designed to hold the mesh patch in place.

On paper, the idea was sound. And one would assume that the memory recoil ring, which involved hinges and welds that facilitated the expansion of the devices, would have been rigorously tested to ensure in no way, shape or form would this thing break or come apart inside the human body. Pity the poor patient were that to happen. One could just imagine the physiological chaos that could result.

Sadly, there are many who have not needed to imagine it happening, and the Kugel Mesh patch was recalled three times—in 2005, 2006 and again in 2007. Patients were experiencing debilitating pain and upon investigation it was found that in many cases the memory recoil ring had come apart at one of the welds, leaving sharp edges that could perforate bowels and cause other serious injuries.

It was also determined that the ring has the potential to migrate inside the human body, leaving the potential for lesions and tearing of the intestines and other digestive organs.

The human body is anything but an inert object, after all. It moves. It works. It runs, and skis, and dances.

It has been reported that at one time Davol affixed the blame with surgeons for not handling, and installing the Kugel Mesh memory recoil rings correctly. However, it was soon determined that the fault lay with faulty welds that were prone to failure, especially in an environment where there was so much potential for movement. With little fanfare, the manufacturer strengthened the welds in the product.

But questions remain. How thoroughly were the welds tested prior to approval by the US Food and Drug Administration (FDA)? How thorough was the field-testing in actual patients—and for how long? Were patients with varying lifestyles selected for testing? After all, some people are more active than others. Some people are also heavier than others. Did weight play a factor, as a patient tossed and turned in bed, perhaps?

As for the Class I recall which was first announced in December 2005 and later expanded to include a total of six types of Kugel Mesh patch, why did the FDA wait three years to trigger the recall in tandem with the manufacturer? It has been reported that problems with the Kugel Mesh patch had been reported as far back as 2002.

And what of the Kugel Mesh patients who still have the original mesh, and memory ring? Not all of the memory rings fail. They could fail, but not all do. What does that do to the psychological wellbeing of the patient? You know that you have a medical device inside you that could fail, and has failed for some. So you're always waiting for the other shoe to drop.

Does the sudden onset of persistent abdominal pain, fever, and/or sensitivity or tenderness in the surgical area mean that the ring has finally failed? Or is it something else? Any abdominal pain will trigger your worst fears. And yet, what surgeon would consent to replacing a hernia patch if the one you have is working fine? Sure, it could break. But it hasn't yet. And until you have a problem, why would you change it?

Like a ticking time bomb, it fills your head and haunts your every waking moment. Little wonder that patients are contacting their lawyers and seeking compensation with respect to their Kugel Mesh patch, even if the hernia patch has not failed. The psychological trauma that comes with knowing you have a recalled device in your gut can be devastating.

It also doesn't help knowing that the devices were manufactured in Puerto Rico, and that C.R. Bard has been taken to task by the FDA for concerns over good manufacturing practices there. Thousands of lawsuits have ensued over the Kugel Mesh patch. Yours may be next…