Kugel Mesh Patch: "Someone Should Be Held Accountable"

Cranston, RISome patients who have had the Kugel Mesh Patch implanted to repair their hernias have experienced very painful complications, ranging from tenderness in their abdominal area to the development of life threatening fistulas. Lawsuits are now being filed against Davol Inc., maker of the Kugel Mesh Patch, alleging the company knew or should have known about the severity of the complications associated with the hernia repair patch.

"One person who reported problems with the Kugel Mesh Patch, as found at the FDA's website, experienced severe abdominal pain, bleeding, and numbness of the arms a month after having a Kugel Mesh Patch implanted. The same person noted that in 2005 doctors had to perform surgery to repair the patient's organs and bowels twice because mesh adhered to them. After the Kugel Mesh Patch was replaced with a different patch, the person writes that the symptoms went away. The complainant asks the FDA to investigate the Kugel Mesh Patch because other people have also had the same problems. The note on the website closes by saying, "Someone should be responsible and be held accountable for this."

In a different adverse event report regarding the Kugel Mesh Patch, a health professional noted that a laparoscopy done on a patient in 2005 found that the patch had shriveled. The patch was replaced with a larger Kugel Mesh Patch, but another laparoscopy found fistula formation in the patient. Doctors later determined that "the large composix Kugel mesh rings had broken."

Other adverse event reports at the FDA website show a variety of problems including ventral hernia/infected mesh after six months after the Kugel Mesh Patch was implanted, fluid build-up, low grade fever, nausea, diarrhea, discoloration, stabbing feelings in the abdomen, infection, inflammation, and pain in the leg on the side of the mesh.

One patient, as noted in an adverse event report, developed abdominal pain, fluid build-up and an infection at the site of the Kugel Mesh Patch. The patient was hospitalized two times for seven days each time. The mesh was eventually removed because the patient's condition was believed to be life threatening. Another patient required surgery when exploratory surgery should his mesh patch had "collapsed and migrated, connecting the colon and the bladder."

Not all patients have survived problems with their Kugel Mesh Patches. One adverse event report records a patient who died after emergency surgery to remove a mesh that caused a fistula when the mesh failed to maintain its original form.

As time passes, more and more adverse event reports are filed detailing patient problems associated with the Kugel Mesh Patch. Some patients may have experienced complications from the hernia patch for a while but not realized what was causing their pain. In fact, many patients believe their pain is a normal side effect of hernia repair surgery.

If you had hernia repair surgery and are not sure what device was implanted, contact your doctor to find out for sure. Some patients have reported that doctors are not forthcoming with information about which patch was used in hernia repair surgery. Patients have the right to know which devices they have had implanted. If you believe your doctor used a Kugel Mesh Patch to repair a hernia, contact him or her to find out.