Kugel Hernia Mesh Patch Recall News | Lawsuit Updates

Davol announced a hernia mesh patch recall in 2005 which was later expanded after it was discovered that the memory recoil ring which opens the patch after it is implanted can break due to a failure in the hard plastic ring.

Hernia Repair Mesh

A hernia is a condition in which part of the intestine bulges through a weak area in muscles in the abdomen. An inguinal hernia occurs in the groin (the area between the abdomen and thigh). It is called “inguinal” because the intestines push through a weak spot in the inguinal canal, which is a triangle-shaped opening between layers of abdominal muscle near the groin. Obesity, pregnancy, heavy lifting, and straining to pass stool can cause the intestine to push against the inguinal canal.

Symptoms of inguinal hernia may include a lump in the groin near the thigh; pain in the groin; and, in severe cases, partial or complete blockage of the intestine. The doctor diagnoses hernia by doing a physical exam and by taking x rays and blood tests to check for blockage in the intestine.

The main treatment for inguinal hernia is surgery to repair the opening in the muscle wall. This surgery is called herniorrhaphy. Sometimes the weak area is reinforced with steel mesh or wire including products like the Kugel mesh patch. This operation is called hernioplasty. If the protruding intestine becomes twisted or traps stool, part of the intestine might need to be removed. This surgery is called bowel resection. (Bowel is another word for intestine.)

We represent all hernia mesh patch recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a hernia patch lawsuit attorney will contact you to answer any of your questions.

Kugel Mesh Patch News | Hernia Repair Recovery Information

The Bard Kugel mesh patch was recalled in 2005 due to reports of serious injuries after a plastic ring in the patch had broken causing serious injuries including bowel perforation and infections. The hernia mesh recall was later expanded to include additional product codes.

Hernia Repair Surgery

Hernia repair is surgery to correct a hernia. A hernia is an abnormal bulging of internal organs, often the intestine, through a weakness in a muscular wall.

Before surgery, you will be given a sedative to make you drowsy. A local or spinal numbing medicine (anesthesia) will be used so you do not feel pain during the procedure. In some cases, the procedure is done while you are under general anesthesia (unconscious and pain-free).

The surgeon makes a cut over the area of the hernia. The bulging tissue or organ is placed back inside the muscle wall, the muscle tissue is repaired, and the skin is closed. In many inguinal hernia repairs, a small piece of plastic mesh is used to repair the defect in the muscle tissue. An example of this mesh is the Kugel mesh patch which was used to repair hernias. The manufacturer recalled certain lots of the hernia repair mesh in 2005 following reports of patients suffering life-threatening complications.

Laparoscopic hernia repair is becoming more popular. This approach uses a minimally invasive technique.

Why the Procedure is Performed

Hernia repair may be recommended when a hernia is painful or symptoms interfere with daily activities. It may also be done when there are large bulges through a small hole, which interferes with blood flow or causes a blocked intestine.

Most hernias should be repaired to prevent the possible complications of restricted blood flow or blocked intestine.

Hernia Repair Risks

Risks for any anesthesia include:
• Reactions to medications
• Problems breathing

Risks for any surgery include:
• Bleeding
• Infection

Additional risks of hernia repair include:
• Injury to nearby structures
• Hernia returns

Outlook (Prognosis)

Most hernias can be repaired with a simple operation with minimal risks to the patient.

We represent all Kugel mesh patch recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Kugel mesh attorney will contact you to answer any of your questions.

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

Kugel Lawsuit

We represent all Kugel patch recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Kugel lawsuit attorney will contact you to answer any of your questions.

Kugel Hernia Patch Recall

Kugel Mesh Repair

The Kugel hernia mesh patch is used during hernia surgery for several types of repair procedures including:

• Inguinal
• Ventral
• Laparoscopic

The most common type of hernia repair is the ventral where the folded mesh patch is placed behind the hernia through a small incision. After the patch is properly inserted it springs open through a memory coil ring and then lays flat. A Kugel hernia patch recall was announced following increasing reports that the memory recoil ring was breaking and causing serious injuries.

C.R. Bard (Davol), the manufacturer of the Kugel hernia mesh patches, first notified consumers of the recall in December 2005. At the time of the initial Kugel recall approximately 32,000 mesh patches had been sold worldwide. The recall was later expanded to include additional lots of the Large Oval and Large Circle products. The expanded recall of the Kugel mesh patch came after Davol became aware of patients suffering from life-threatening complications such as bowel perforations and chronic enteric fistulas.

Davol initially placed blame on the surgeons doing the hernia repair surgeries stating that they were performing the procedures incorrectly. However, further testing later showed that the Kugel hernia patch consistently failed at the area where it was welded during manufacturing.

Kugel Mesh Lawsuit

We represent all Kugel hernia patch recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Kugel mesh lawsuit attorney will contact you to answer any of your questions.

Recall On Hernia Mesh Patch | Kugel Mesh Lawyer

In December 2005 the manufacturer of the Kugel mesh patch and the FDA announced a recall of certain lot numbers of the Kugel patch. The recall was later expanded to include additional products and lot numbers. The Bard announcement is reprinted below.

Bard Announces Recall of Composix® Kugel® Mesh X-Large Patch

MURRAY HILL, NJ — (January 13, 2006) — C. R. Bard, Inc. (NYSE-BCR) today announced that it is voluntarily recalling its Bard Composix Kugel Mesh X-Large Patch intended for ventral hernia repair. This recall does not affect any of the company’s other hernia repair products.

The company is initiating this recall due to reports that the device’s plastic coil ring, designed to aid in its deployment, may not withstand the increased stress associated with certain surgical placement techniques. The company has received 24 reports of broken rings out of approximately 32,000 units sold since 2002, a rate of approximately 0.08%.

The products affected by this recall were distributed to customers worldwide. Bard has notified affected customers and the appropriate regulatory agencies, including the U.S. Food and Drug Administration.

The three product codes involved generated sales of approximately $11 million in 2005, before the effect of the recall.

The company expects to record a sales reduction and related charges associated with the recall in the 2005 fourth quarter and these adjustments will cause the company’s results to be below previously stated guidance for the quarter. The company remains comfortable with its previously stated guidance for 2006 of constant currency net sales growth of between 9 percent and 10 percent and diluted earnings per share equivalent to a minimum of $3.42, excluding the effect of FAS123R.

C. R. Bard, Inc. (http://www.crbard.com/), headquartered in Murray Hill, N.J., is a leading multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.

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