Kugel Patch Recall | Hernia Mesh Complications

The Bard Composix Kugel hernia mesh was removed from the market in December 2005. The Kugel patch recall was later expanded in January 2007 to include additional lot numbers. The hernia mesh recall was due to hernia mesh complications caused by the possibility of the mesh’s “memory recoil ring” breaking. If the ring breaks it can cause serious injuries including bowel perforations and chronic intestinal fistulae.

The recalled Kugel patch products were used for ventral or incisional hernia repair surgery. It is recommended that patients who have one of recalled Kugel patch mesh and are experiencing symptoms such as unexplained or persistent abdominal pain seek medical attention.

The following overview of hernias is from the National Institute of Health.

Description:
A hernia is a weakness or defect in the lining of the abdominal (belly) or pelvic (groin) wall. It can be present at birth or develop over the years.

Signs and Symptoms:
You may see or feel a lump under the skin or, in males, a bulge in the scrotum (this is usually intestine). This may present with straining while lifting heavy objects, during a bowel movement or urination. Coughing and sneezing may also produce a bulge. The lump may disappear when lying down or even with gentle pressure. A hernia can be present without an obvious lump. It can be painful or cause a burning sensation. Sometimes it may be present for years without any symptoms.

Treatment:
What should you do if you suspect that you have a hernia? There is no acceptable nonsurgical medical treatment for a hernia. The use of a truss (hernia belt) can help keep the hernia from bulging but eventually will fail. The truss also causes the formation of scar tissue around the hernia making the repair more difficult. Have your doctor perform an examination, because if the repair is delayed it can result in incarceration (intestine is stuck and cannot get back inside) or strangulation (intestine is stuck and develops gangrene). The latter is an emergency.

The hernia will not go away, it will only get bigger. The bigger the defect the bigger the operation required to fix it.

Under certain circumstances the hernia may be watched and followed closely by a physician. These situations are unique to those individuals who are high operative risks, i.e., severe heart or lung disease, or bleeding problems. Of course, even in the high risk person, if the symptoms become severe or if strangulation occurs then an operation must be performed.

Hernia Repair Surgical Options:

What type of operation is best for you?

There are two main options for hernia repair:

1) Open Repair: The traditional, open repair has been the gold standard for over 100 years. There are 5-10 different approaches and can be performed routinely with local and intravenous sedation. Open repair is generally painful with a relatively long recovery period.

2) Videoscopic (Laparoscopic) Repair: Videoscopic (laparoscopic) repair has been developed over the last 10 years. It is usually performed under general anesthesia but spinal anesthesia is an option. Local anesthesia can be used under special circumstances. Benefits of videoscopic (laparoscopic) repair compared to the open repair are: shorter operative time, less pain, and shorter recover period.

Videoscopic Hernia Surgery:
For videoscopic hernia surgery a telescope attached to a camera is placed through a small opening under the belly button. Two other small cuts are made (each no larger than the diameter of an eraser on the end of a pencil) in the lower abdomen. The defect is covered with a mesh (synthetic material made from the same material that stitches are made from) and secured in position with other stitches/staples/titanium tacks or tissue glue.

Risks to Videoscopic Hernia Surgery:
As with the open operation, bleeding and infection can occur. The risk of nerve injury appear to be less than in open repair, as does the potential for recurrences of the hernia.

After the Operation:
Usually you can be discharged home a few hours after the completion of the videoscopic hernia operation. Take it easy the first few days. Walking stairs is allowed, and walking outside (weather permitting) is encouraged. Taking a bath or shower 48 hours after the operation is permitted. Avoid driving for at least 3 days and any time while taking pain medication.

Remember to make a follow-up appointment with your surgeon 1-2 weeks following the operation. Seek medical attention sooner if you develop fever, bleeding, severe belly pain, excessive swelling or nausea and vomiting.

NIH Publication No. 02-4634
January 2002

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