However, FDA has received reports of complications associated with the hernia mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels. Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence. Most of the complications reported so far have been associated with mesh products that have been recalled and are no longer on the market.

Which hernia mesh patches have been recalled?

The hernia mesh patches that have been recalled were manufactured by Davol, Inc., and released under the brand names Bard, Composix, and Kugel. In some cases, the ring in these hernia repair mesh patches has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas.

The first Kugel mesh recall was issued on December 22, 2005, when Davol, Inc. recalled its extra large hernia mesh patch. Davol notified U.S. customers of the initial recall by letter on December 27, 2005, which it sent via Federal Express.

In March 2006, the recall was expanded. Since the March 2006 recall expansion, Davol received four confirmed complaints of recoil ring breakage from one of their product codes manufactured between January 2004 and September 2005. Davol issued letters to hospitals and health care professionals on March 24, 2006, alerting them to the additional recalled products.

On January 10, 2007, Davol, Inc. issued another hernia mesh recall for patches that were manufactured before October 2005. Davol sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard, Composix, and Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

Hernia Mesh Lawsuit
If you or a family member has been affected by hernia mesh problems please contact us for a free no-obligation consultation to discuss your legal options and the latest hernia patch lawsuit news.

What manufacturer and what products are causing infections?
The hernia mesh patches that have been associated with infections were manufactured by Davol, Inc. They have been released under the brand names Bard, Composix, and Kugel. These mesh patches were approved by the FDA in 1996.

Are these products still on the market?
The hernia mesh patches that have caused most infections are no longer on the market. The first hernia mesh recall was issued on December 22, 2005, when Davol, Inc. recalled its extra large Kugel mesh patch. In March 2006, the recall was expanded. Since the March 2006 recall expansion, Davol received four confirmed complaints of recoil ring breakage from one of their product codes manufactured between January 2004 and September 2005. Davol issued letters to hospitals and health care professionals on March 24, 2006, alerting them to the additional recalled products.

On January 10, 2007, Davol, Inc. issued another hernia mesh recall for patches that were manufactured before October 2005. Davol sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard, Composix, and Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

What effects do hernia mesh infections cause?
In some cases, the ring in the Kugel mesh patch has broken. This has caused the hernia mesh infection, which has lead to severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Other complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nerves or blood vessels.

What should I talk to my doctor about before receiving a hernia mesh?
Before having a hernia operation, be sure to let the surgeon know if you’ve had a past reaction to materials used in surgical mesh or sutures, such as polypropylene. The FDA also recommends that you ask specific questions about hernia mesh complications, including the pros and cons of using a surgical mesh, and, if a surgical mesh will be used, what’s been the doctor’s experience with this particular product, and with treating potential hernia mesh complications?

What should I do if I have suffered an infection from a hernia mesh?
If you have experienced any hernia mesh infection, seek immediate medical treatment. Once you have stabilized, you should contact an experienced hernia mesh recall lawyer right away.

A hernia is an area of the body where a weakness in the wall allows an organ to bulge into or through that wall. While a hernia can develop in many parts of the body, it is most likely to develop in the abdominal area.

When an area of muscle or tissue in the abdomen wall is weak, a straining motion can create a hernia. Hernias can occur suddenly, or they can develop over time. Strong coughing, lifting heavy weights, or straining for a bowel movement can create enough pressure that an organ like the intestine can push through a weakened area of the abdominal wall. Other conditions like obesity or pregnancy can also create pressure on a weak area, making a hernia more likely.

Some hernias may not create any discomfort and may be unnoticeable. But when the hernia creates pain or noticeable lumps, they need to be seen by a doctor. The protrusion created by the hernia can sometimes be reduced, or pushed back into place. When it cannot be reduced, the intestine is caught in the wall opening, a situation known as an incarcerated hernia, which can create a bowel obstruction. Left untreated, the blood supply to the intestine can decrease, leading to serious conditions like gangrene.

Hernias are usually treated with surgery. Doctors reposition any protrusion and then insert a hernia mesh patch to strengthen the thin or weak abdomen wall area. In recent years, doctors have used the Kugel mesh patch, however this device has been recalled because of dangerous complications that can occur.

The Kugel hernia mesh patch is a device that has two mesh pads connected by an oval plastic ring. When the patch is placed on the wall area, the ring acts as a spring, keeping the device in place. Unfortunately, over 80 patients have had complications when the plastic ring broke. These Kugel mesh complications include bowel perforations and fistulas. Some patients even died as a result of these complications.

If you have had a hernia repair using a hernia patch, you may be at risk for complications. If you do not know whether or not you have a Kugel patch, we can assist you in determining if this device affects you. Doctors and the Kugel manufacturer suggest that patients who are symptom-free allow the patch to remain in place. Please contact us for a free case review and information regarding your legal options including filing a hernia mesh lawsuit.

Each year over 600,000 hernia repair surgeries are performed in the United States. Kugel mesh is used to repair inguinal, femoral, hiatal and umbilical hernias. The FDA along with the manufacturer issued a recall on Kugel mesh in 2005. This recall was announced after reports of hernia repair patients suffering from bowel perforations and chronic intestinal fistulae due to the memory recoil ring breaking following the surgery.

Kugel 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 mesh 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 hernia mesh 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 or fill out our short online contact form and a hernia mesh lawsuit attorney will contact you to answer any of your questions.