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Laparoscopic Hernia Repair Surgery and Kugel® Patch

Bard Davol developed the Kugel Patch with the intention of facilitating minimally-invasive hernia mesh procedures. Unfortunately, a flaw in the design involved a faulty ring that had the potential to fracture and cause organ punctures. Subsequently, numerous recalls were initiated, and a multitude of lawsuits ensued. Ultimately, by the year 2018, Bard had ceased the marketing of the Kugel Hernia Patch within the United States.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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Detailed History of the Kugel Hernia Patch Development

According to a study published in the World Journal of Methodology in July 2021, the Composix Kugel hernia mesh patch, a groundbreaking innovation in hernia repair surgery, has a rich history that traces its evolution over the years [1].

Developed by Davol Inc., whose parent company is C.R. Bard, this Bard-Davol Kugel patch was designed to offer a minimally invasive solution for hernia repair surgery.

Robert Kugel placed a sutureless mesh in the PPS in 1999, and this mesh is known as the Kugel hernia patch, the researchers said. This patch was later modified to a so-called “direct Kugel patch” for placement of the mesh by means of a minimal incision in the IL. Double-sided polypropylene mesh (e.g., Prolene Hernia System; Ethicon, Inc.) and the direct Kugel patch have become widespread on a commercial basis.

However, the journey of the Kugel Patch wasn’t without challenges. Over time, reports emerged that the memory recoil ring of the Kugel patch had the potential to buckle or break, leading to complications. Despite these hurdles, the Composix Kugel hernia mesh patch remains a testament to medical innovation, reflecting the continuous quest for better surgical solutions.

Kugel Mesh Compared to Other Hernia Repair Products

The medical market offers various hernia mesh products, each with its unique features and benefits. The Composix Kugel hernia mesh patch stands out for its innovative “memory recoil ring” design, but how does the Kugel patch compare to others? For instance, the traditional gold standard Lichtenstein onlay mesh repair (LMR), another popular choice, boasts flexibility and elasticity.

According to ScienceDirect, a study presented at the 30th Annual Meeting of the Association for VA Surgeons in May 2006, compared Prolene Hernia System (PHS) mesh repair to the LMR for inguinal hernias [2]. The authors hypothesized that the recurrence rate of PHS mesh would be lower compared with the LMR with overall similar complication rates.

For the study, the researchers reviewed 622 charts during two distinct time periods, with 321 associated with PHS mesh and 302 with LMR. The median follow-up for this study extended to 17 months. No statistically significant differences were observed concerning age, race, gender, or comorbidities between the two groups.

Additionally, in the PHS mesh group, there was a trend toward decreased overall complication rates with significantly lower seroma/hematoma rates. Therefore, the PHS mesh repair may represent a superior alternative for the repair of inguinal hernias. Researchers stated.

On the whole, a noticeable trend toward reduced complications was evident in the PHS mesh group as opposed to the LMR group (PHS mesh = 17%, LMR = 23%, P = .07), particularly marked by a significant variance in hematoma/seroma rates (PHS mesh = 6.9%, LMR = 12.6%, P = .015), the authors said.

Lastly, a notable decrease in the recurrence rate was identified in the PHS mesh group when compared to the LMR group (PHS mesh = 0.6%, LMR = 2.7%, P = .04). Our study shows, during a median follow-up of 17 months, improved outcomes by using the PHS mesh compared with the gold standard Lichtenstein onlay mesh for inguinal hernias with significantly lower recurrence rates.

Kugel Hernia Patch Complications and Outcomes

A 2009 study by the Ulster Medical Journal compared the immediate and long-term postoperative outcomes of Lichtenstein and Kugel repair of inguinal hernia [3].

Between 1996 and 2006, a series of 219 consecutive individuals underwent inguinal hernia repair, with 92 undergoing a conventional Lichtenstein repair and 127 opting for a Kugel patch procedure.

An examination of patient characteristics, the duration of postoperative hospital stays, and complication rates was conducted through a retrospective analysis of medical records.

The evaluation of recurrence and persistent groin pain was carried out using postal questionnaires, with a subsequent telephone interview for those who did not respond. Individuals presenting symptoms or evident groin swelling underwent reevaluation by one of the authors.

The average monitoring duration encompassed 60 months (spanning from 9 to 132 months). Similar occurrences of immediate complications were noted in both groups.

There was no significant difference in the immediate complication rates between the two groups, the researchers concluded. Although recurrence and chronic groin pain rates are higher with Kugel repair, this was not statistically significant.

Regarding recurrence rates, Lichtenstein repair demonstrated a rate of 1.1%, while the Kugel patch group exhibited a higher rate at 6.3% (p = 0.09). Notably, none of the individuals in the Lichtenstein group reported severe chronic pain in the inguinal region, while 1.6% of patients in the Kugel patch group experienced such complaints.

Technical Aspects of the Kugel Mesh Patch

At its core, the Kugel mesh patch is a marvel of medical engineering. Comprising two layers of mesh surrounding a flexible “memory recoil ring”, the design of the Kugel patch allows for easy insertion through a small incision. Once inside, the memory recoil ring expands, positioning the kugel patch securely over the herniated area.

According to a May 2020 study published in the ANZ Journal of Surgery, here’s a general overview of how the Kugel Mesh Patchworks [4]:

  1. Placement:
    • During hernia repair surgery, the Kugel Mesh Patch is positioned over the hernia defect, which is the weakened or damaged area in the abdominal wall.
  2. Material:
    • The patch is typically made of a synthetic material, often polypropylene, which is a durable and commonly used material in hernia mesh devices.
  3. Design:
    • The Kugel Mesh Patch is named for its innovative design, which includes a flexible, spring-like ring that allows the mesh to be folded for insertion through a smaller incision. Once in place, the ring springs open, securing the mesh over the hernia defect.
  4. Reinforcement:
    • The mesh serves as a physical barrier, reinforcing the weakened abdominal wall and preventing the protrusion of tissues through the hernia opening.
  5. Tissue Integration:
    • Over time, the patient’s tissues are expected to grow into and around the mesh, creating a more stable and integrated repair. This process is known as tissue ingrowth.
  6. Healing and Recovery:
    • As the tissues heal and the mesh provides support, the patient is expected to experience reduced symptoms and a lower risk of hernia recurrence.

Kugel Patch Post-Surgery Care and Rehabilitation

According to the Food and Drug Administration (FDA) notice from 2023 [5], postoperative care and rehabilitation guidelines for Kugel mesh patch recipients include:

  1. Activity Restrictions:
    • Patients may be advised to avoid strenuous physical activities, heavy lifting, and certain movements for a specified period to allow for proper healing.
  2. Pain Management:
    • Pain management strategies, including prescribed medications and/or non-pharmacological approaches, may be recommended to help manage postoperative discomfort.
  3. Follow-Up Appointments:
    • Regular follow-up appointments with the surgeon are crucial to monitor the healing process, address any concerns, and assess the need for further interventions.
  4. Dietary Guidelines:
    • Patients may receive dietary guidelines to promote healthy digestion and minimize strain on the abdominal area during the initial recovery phase.
  5. Monitoring for Complications:
    • Patients are advised to monitor for signs of potential complications, such as infection, swelling, or unusual pain, and seek prompt medical attention if any concerns arise.

If mesh is used, consider obtaining information on the manufacturer, brand name, Unique Device Identifier (UDI) and material from your doctor’s office or from the hospital or facility where your surgery was performed, the FDA said. It is helpful to have this information available if you have any post-surgical problems.

Laparoscopic Hernia Repair Surgery

As claimed by Surgical Treatment, every year, close to 750,000 hernia repair surgeries are performed in the United States [6]. Traditionally, these surgeries were performed as “open” surgeries, requiring a large incision to be cut into the lower abdomen to allow surgeons the access and room for maneuverability that they required for the repair.

Today, a minimally invasive procedure named laparoscopic hernia repair surgery is gaining popularity, due to the rapid healing and reduction of pain associated with this type of surgery. Patient are able to return to their normal activities much faster than with traditional “open” surgeries.

Most hernias can be repaired laparoscopically. First, general anesthesia is given and a tiny incision is created in or just below the navel. The abdomen is inflated using air to give the surgeon a better view of the internal organs, and a small, lighted scope, called a laparoscope is inserted in the incision.

Instruments to repair the hernia are inserted through other pencil-width incisions in the abdomen. The intestines or organs protruding into the herniated area are put back into their original places and a patch is placed on the weakened area of the abdominal wall.

Placing the patch on the inside of the abdomen takes advantage of the natural, outward pressure of the abdomen, securing the repair in place and reducing the chance that the hernia will reoccur.

Laparoscopic hernia repair surgery does have some risks associated with it, the same as any other surgery. Major risks associated with laparoscopic hernia repair surgery include:

  • Fluid or blood in the abdominal muscles, scrotum, or inguinal canal
  • Inability to urinate
  • Pain in the spermatic cord, the testicles, or the thighs
  • Infection of the stitches or mesh
  • Formation of scar tissue
  • Testicular atrophy, a rare occurrence

Recurrence of the hernia occurs in a small percentage of patients undergoing laparoscopic hernia repair surgery, usually related to the Kugel mesh patch not being stapled well enough or the patch being too small to cover the entire herniated area. Laparoscopic surgery is also more expensive due to the increased cost of technology and slightly longer operating room time.

One of the most popular hernia repair patches for laparoscopic hernia repair surgery is the Kugel Mesh Hernia Patch manufactured by Davol, Inc., a division of C.R. Bard. These patches have a “memory recoil ring” that allows the patches to be folded for insertion into the abdomen, and then spring open to complete the repair.

In December 2005, a link was found between the larger versions of the patches and serious side effects, leading to a recall of the devices by the manufacturer.

The recall was issued because the “memory recoil ring” can break under the stress of placement in the abdomen, causing bowel obstructions, bowel perforations, and chronic intestinal fistulae, which are abnormal passageways between the intestines and other organs.

To date, the US Food and Drug Administration (FDA) has received close to 100 reports of serious injuries and deaths associated with the implantation of the larger versions of the Kugel Mesh Hernia Patch. The recall is classified as a Class I Recall by the U.S. Food and Drug Administration (FDA), a class limited to devices that could predictably cause serious health problems or death.

Individuals who have had the memory recoil ring implanted are urged to seek emergency medical attention if breakage of the Kugel Mesh Hernia Patch is suspected, according to the U.S. Food and Drug Administration.

Kugel Hernia Patch Lawsuit Update:

On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.”

As early as August 2001, the U.S. Food and Drug Administration began receiving reports of complications and failures of the Kugel mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from the implantation of Composix® Kugel Mesh Patch.

The Food and Drug Administration reports also contain descriptions of problems other then memory recoil ring breakage including, “buckled mesh,” “patch shriveling” and “edges curled up,” as well as descriptions of the mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated” and “folded.”

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