November 17th, 2007

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Hernia Patch Recall Information

Hernia Patch Recall-Bard Composix Kugel Mesh Patch Injury

Hernia Mesh PatchThe hernia patch is a device intended to repair ventral hernias.

The Bard Composix Kugel Mesh patch is placed behind the hernia during surgery and is held open by a memory recoil ring. Unfortunately, the memory recoil ring had a tendency to break, which can lead to bowel perforations and/or chronic intestinal fistulae. This was the defective part of the hernia patch that caused it to be recalled.

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Herniarrhaphy – Hernia Repair

Herniorrhaphy (Hernioplasty, Hernia repair) is a surgical procedure for correcting hernia. A hernia is a bulging of internal organs or tissues, which protrude through an abnormal opening in the muscle wall. Hernias can occur in the abdomen, groin, and at the site of a previous surgery.

Herniorraphy, or hernioplasty, is now often performed as an ambulatory, or “day surgery,” procedure. Almost 700,000 are performed each year in the United States. A workable technique of repairing hernia was first described by Bassini in the 1800s; the Bassini technique was a “tension” repair, in which the edges of the defect are sewn back together without any reinforcement or prosthesis. In the Bassini technique, the conjoint tendon (formed by the distal ends of the transversus abdominis muscle and the internal oblique muscle) is approximated to the inguinal canal and closed. Although tension repairs are no longer the standard of care due to the high rate of recurrence of the hernia, long recovery period, and post-operative pain, a few tension repairs are still in use today; these include the Shouldice and the Cooper’s Ligament/McVay repair. The Shouldice techniques is a complicated four layer reconstruction, however, it has very low reported recurrence rates (1%). An operation in which the hernia sac is removed in addition to tension repair is described as a ‘herniotomy’.

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What Is An Inguinal Hernia?

Inguinal HerniasInguinal hernias (IPA: /ɪnˈgwinəl ˈhɝniəz/) are protrusions of abdominal cavity contents through the inguinal canal. They are very common and their repair is one of the most frequently performed surgical operations.

There are two types of inguinal hernia, direct and indirect. Direct inguinal hernias occur when abdominal contents herniate through a weak point in the fascia of the abdominal wall and into the inguinal canal. Indirect inguinal hernias occur when abdominal contents protrude through the deep inguinal ring; this is ultimately caused by failure of embryonic closure of the internal inguinal ring.

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Average Asking Price of a Hernia Surgery Tops $10,000 and Some Health Plans Won’t Cover It

The average hospital’s asking price of an inguinal or femoral hernia surgery is $10,600 for an adult male in the United States in 2006.  For a patient with viable insurance, the majority of hernia surgery costs will be covered. Unfortunately, more than 40 million Americans don’t have insurance.In addition, some health plans qualify some forms of hernia surgery as “elective.”

A 1999 study in American Family Physician warned about the consequences of not covering hernia surgery because of cost concerns. “In the managed-care environment, elective herniorrhaphy is under increasing pressure. Some state health plans do not reimburse for elective hernia repairs. The long-term impact of complications secondary to untreated herniation is not fully known. A decrease in surgical repair may lead to an increase in hospitalizations related to incarceration or strangulation.” (Source: T. Bax, B Sheppard, R. Crass. Surgical Options in the Management of Groin Hernias. American Family Physician. January 1999.)

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