Detailed History of the Kugel Hernia Patch Development
The Composix Kugel hernia mesh patch, a groundbreaking innovation in hernia repair surgery, has a rich history that traces its evolution over the years. 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.
Its unique "memory recoil ring" allowed surgeons to insert the Kugel patch through a small incision, which then expanded to cover the herniated area.
However, the journey of the Kugel Patch wasn't without challenges. Over time, reports emerged about 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.
Comparison with Other Hernia Mesh 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 Ethicon Physiomesh, another popular choice, boasts flexibility and elasticity.
However, each product has its pros and cons. While the Composix Kugel mesh patch offers a minimally invasive solution, it has faced challenges with its memory recoil ring.
On the other hand, products like the Ethicon Physiomesh have had their share of complications and recalls. A comprehensive comparison helps patients and medical professionals make informed decisions based on individual needs.
Kugel Hernia Patch Patient Testimonials and Experiences
Real-life experiences offer invaluable insights into the efficacy and safety of the Ethicon Physiomesh. Patients who underwent surgeries using the Kugel mesh patch have diverse stories to tell. Some laud the Kugel hernia patch for its minimally invasive approach and quick recovery times.
However, others highlight complications of the Kugel patch, ranging from mild discomfort to severe internal injuries. These Kugel patch testimonials underscore the importance of understanding potential risks and benefits. They also emphasize the need for continuous monitoring and post-surgery care to ensure patient safety and well-being of Kugel patch recipients.
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.
The choice of materials and the intricate design aim to provide a durable solution for hernias. However, the technical brilliance also brought challenges, especially with the ring's potential to buckle or break. Understanding these technical aspects is crucial for both medical professionals and patients to ensure optimal outcomes for patients implanted with the Kugel patch.
Kugel Patch Post-Surgery Care and Rehabilitation
According to the Food and Drug Administration, after undergoing hernia repair surgery using the Kugel mesh patch, post-operative care is paramount. Patients implanted with the Kugel patch are advised to monitor the surgical site for signs of infection, swelling, or unusual discomfort. Gentle exercises, under the guidance of a physiotherapist, can aid in faster recovery and strengthen the abdominal muscles.
It's also essential to avoid strenuous activities that might strain the surgical site of the Kugel mesh patch, according to the Food and Drug Administration. Regular check-ups and timely consultations can address potential Kugel patch complications early on. With proper care and rehabilitation, patients can expect a smooth recovery and return to their daily activities with confidence.
Laparoscopic Hernia Repair Surgery
Every year, close to 750,000 hernia repair surgeries are performed in the United States. 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 staple 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, then spring open to complete the repair.
In December of 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 a 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 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."
See all related medical device lawsuits our lawyers have taken on.
Do I Have a Kugel Mesh Patch Lawsuit?
The Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Kugel mesh patch lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you have problems following hernia surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.