Kugel Patch Hernia Mesh: Complications, Recalls and FDA Safety Alerts

The Kugel Patch was a unique mesh device used to help fix hernias, which occur when part of an organ pushes through a weak spot in the abdominal wall.

Bard designed this unique patch to expand and fit comfortably once placed inside the body. One side of the patch consisted of two layers of polypropylene mesh, which encouraged tissue growth. The other side — consisting of a Teflon-like material — helped prevent the intestines, bowel or colon from sticking to the patch.

It also had a “memory recoil ring” embedded between the mesh layers to allow the patch to spring open and maintain its position in the hernia opening. However, this ring was prone to breaking, leading to recalls and hernia mesh lawsuits starting in 2005.

In December 2005, Bard initiated recalls for six types of large Kugel Patches after receiving reports of serious injuries linked to the product. This recall affected over 130,000 patches.

The company informed the U.S. Food and Drug Administration (FDA) that the recoil ring on the device could break, leading to severe health issues such as damage to the intestines and bowel.

Bard contacted U.S. customers with a letter on December 27, 2005, and later expanded the recall twice in early 2006. The company only recalled the large patches — the smaller sizes were not affected.

The recalls raised significant safety issues, leading hospitals and surgeons to stop using the patches. At that time, Bard and the FDA informed doctors that they shouldn’t remove the patches unless patients experienced serious problems.

The novel memory recoil ring caused multiple injuries and led to the recalls. While this feature could lead to bowel perforations and intestinal injury, the Kugel Patch could also cause other complications common to all hernia meshes.

Hernia mesh is often used during surgeries to help repair weak or damaged muscles in the abdomen. While using mesh can offer better support than stitches, it can also come with risks.

Surgeons commonly use hernia mesh because it can help prevent the hernia from returning after treatment. However, there are some risks involved with its use. Before surgery using hernia mesh, talk with your doctors about possible complications.

The FDA and Kugel Patch lawsuits played key roles in addressing Kugel Patch safety concerns. After reports of injuries, the FDA investigated Bard Davol’s handling of complaints in 2006, uncovering failures in how Bard monitored and reported complaints about the Kugel Patch.

Meanwhile, injured patients filed lawsuits, claiming the device caused severe complications. These legal and regulatory actions led to recalls and hernia mesh settlements.

What Did the FDA Do and Say About the Kugel Patch?

The FDA questioned Bard Davol’s safety monitoring of the Kugel Patch after reports of device failure and serious injuries emerged. A 2007 New York Times article discovered that despite initial concerns, the company delayed recalling the patch, citing a low number of complaints that seemed too random to indicate a pattern.

However, growing evidence of harm eventually led to increased scrutiny from the FDA.

The FDA continued to monitor Bard’s compliance, while the company claimed to have addressed the identified issues.

Kugel Patch Lawsuits & Settlements

The recalls and injuries triggered hundreds of Kugel Patch lawsuits claiming the devices injured or killed people. In June 2007, a federal panel ordered 13 Kugel Patch lawsuits to be consolidated into a multidistrict litigation (MDL) in a Rhode Island federal court. MDLs allow the Judicial Panel on Multidistrict Litigation to combine similar lawsuits into a single litigation to make the legal process more efficient.

The lawsuits targeted Kugel Patches manufactured by Bard and its then-subsidiary Davol. They claimed the memory recoil rings broke, causing various complications.

In June 2011, Bard offered $184 million to settle more than 2,700 Kugel lawsuits. District Judge William E. Smith closed the Kugel Patch MDL in 2017. Becton, Dickinson and Company (BD) acquired Bard Davol later that year.

If you’ve had hernia surgery with a Kugel Patch, it’s important to watch for signs that it may be failing. A failing mesh can cause serious health problems, including pain, infections or even a recurring hernia.

While some issues stem from recalled patches, even non-recalled mesh can lead to hernia mesh complications. Knowing the warning signs can help prevent further damage and may reduce the need for revision surgery.

How to Know if Your Kugel Patch Is Failing

Regardless of the brand, the warning signs of hernia mesh failure tend to be similar. A hernia mesh failure happens when the mesh used in surgery causes problems, such as pain or infections, which may require more surgery.

Some issues arise from recalled products, such as the Kugel Patches from 2006 and earlier, but even relatively safe mesh can cause complications.

If the mesh from hernia surgery fails, you may need another surgery to remove or replace it. This can be more complicated due to scar tissue. You might also need medication for hernia mesh infections. If you notice any unusual symptoms, contact your doctor immediately.

Can Doctors Remove Kugel Patches?

Hernia mesh removal procedures exist, but they’re typically a last resort. Mesh manufacturers and the FDA usually recommend against removing mesh or any medical device unless you experience complications.

Doctors often try conservative treatments before removing hernia mesh to help manage pain and complications. These treatments aim to reduce infections, relieve pressure and promote healing while keeping the mesh in place.

Antibiotics can treat early infections, while doctors can drain fluid buildup using guided imaging techniques. Special wound therapy can also help speed healing.

If these methods don’t work, mesh removal surgery may be necessary. Though surgery carries risks like scar tissue or numbness, it can relieve pain and improve patients’ quality of life.