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Several lots of the Kugel mesh patch are subject to recalls because of injuries caused by the Kugel products. A hernia mesh is a surgical patch that is sometimes used to repair hernias. Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

What does the Kugel hernia patch do?

Kugel mesh was introduced to the market by Davol Inc. This hernia mesh patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. The FDA approved the patch in 1996. In 2002, problems began to be reported by patients.

What mesh recalls have been announced?

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

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

Davol notified U.S. customers of the initial recall by letter on December 27, 2005, which it sent via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information.

On January 10, 2007, Davol, Inc. issued another Kugel hernia patch recall for mesh that was 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 Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

It should be noted that Davol also made the decision to withdraw from the market specific lots of mesh patches that were manufactured from October 2005 to October 2006. A market withdrawal is a company’s removal or correction of a distributed product that would not be subject to legal action by the FDA.

Why was the Kugel mesh recalled?

In some cases, the plastic ring in the Kugel mesh patch has broken. This has caused seerious injuries to patients’ internal organs including bowel obstructions, bowel perforations, and enteric fistulas. Davol initially blamed the surgeons who implanted the Kugel mesh patch for the broken rings. Davol claimed that the doctors made mistakes during the surgical procedure which caused the breaks in the rings.

When should you seek medical attention?

The FDA recommends that patients who have been implanted with one of the recalled devices seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.