Dr. Robert D. Kugel is a general surgeon with an international reputation in the field of hernia repair. He invented the Kugel Method for Hernia Repair which employs a unique mesh patch that he also designed and patented, and he has authored numerous articles in medical books and journals describing his latest techniques. Surgeons around the world use his Kugel method and other experts in the field cite his work.
From his practice at the Hernia Treatment Center Northwest in Olympia, Washington, Dr. Kugel travels frequently to national and international medical conferences to deliver speeches and participate in panel discussions. He has been a member of the board of directors of the American Hernia Society, and has been active in the organization as a member of various committees and co-chairman of several panels.
Summary of Inventions
Dr. Kugel developed his unique method for repairing hernias in the early 1990’s and in 1994 filed a patent application for “a hernia mesh patch for use in repairing inguinal and other abdominal wall hernias for expansion into a preperitoneal space and direction into a pocket thereof of an abdominal lining, when directed by a surgeon using his or her finger…”
After a lengthy review, he was issued his first patent for what became known as the Kugel Mesh Hernia Patch in 1997. The patent was assigned to Surgical Sense, Inc., a Texas-based medical device supplier who manufactured, promoted and sold the product.
From 1996 to 1999, Dr. Kugel filed seven additional patent applications for a variety of technical improvements to the Kugel Patch, with the last of these patents issued in 2001. In between, he also received a design patent for the “ornamental design of a hernia patch.” He also obtained a patent for his “method of repair of an abdominal wall hernia” using the patch which became known as the Kugel Method.
On his last several patents, J. Douglas Inman and Keith D. Biggers – two officers of Surgical Sense, Inc. – are listed as co-inventors. We suspect that as the manufacturer, Surgical Sense personnel were involved in making improvements to the patch and thus shared credit for the new inventions. All of Dr. Kugel’s patents were assigned to Surgical Sense until that company was purchased by Bard ASDI, Inc. (a unit of C.R. Bard, Inc.) in 2000. Thereafter, all his patents were assigned to Bard.
Is Dr. Kugel at Fault?
After the Food and Drug Administration began recalling Kugel Mesh Patches because of reported patient injuries, the question had to be asked. Is Dr. Kugel at fault? The answer is “no.” It’s clear from the investigation conducted by the FDA that the failures of the Kugel Mesh Patch are not related to its design, but rather to its manufacture.
Problems with the patch did not begin to occur until Bard, the manufacturer at the time, began making larger versions of the patch for repairing typically larger incisional type hernias . The patch uses a very thin, flexible plastic rod bent into a loop to make the patch expand and flatten out once it’s placed inside the patient. In manufacturing, the ends of the plastic rod are “welded” together to create the loop. In the first versions of these larger patches, this weld could fail allowing the ends of the plastic rod to spring apart and become injurious to the patient.
Since discovering the source of the manufacturing defect, the manufacturing process now uses a less rigid rod and a substantially stronger weld, and quality control procedures have been improved under the FDA’s watchful eyes. This, of course, is of little solace to the patients who were implanted with the earlier faulty patches, and who have been or may yet be injured.