AlloDerm Surgical Mesh in Hernia Repair May Lead to Recurrence

Questions continue to be raised over the safety of hernia repairs that utilize <"">AlloDerm Surgical Mesh. Reports about hernia recurrences in AlloDerm patients are not unusual, and some are beginning to ask if this product underwent enough testing to ensure that it was appropriate for hernia patients.

Manufactured by LifeCell, AlloDerm is made from donated cadaver skin that has had all of the cells removed in order to limit the chances of patients experiencing adverse reactions to the mesh. AlloDerm was originally manufactured for burn victims, but has since been used in other procedures including breast reconstruction and hernia repair.

Evidence is mounting that patients who undergo hernia repair with AlloDerm may experience hernia recurrence and other complications after their surgery. One 2008 study of 70 hernia surgery patient found that AlloDerm’s overall complication rate was 24 percent. Of the AlloDerm patients who experienced complications, there was one rejection, two infections, and 14 hernia recurrences.

Serious AlloDerm complications include injuries to nearby organs, nerves and blood vessels as well as adverse reactions to the mesh and adhesions (where the loops of a patient’s intestines adhere to the mesh or each other).

Between 2007 and 2009, the following hernia mesh complications were reported to the US Food & Drug Administration (FDA):

• 18 reports of additional surgical procedure required
• 5 reports of infection
• 4 reports of abscess
• 3 reports of pain/soreness
• 3 reports of inflammation/swelling

Such AlloDerm complications may require patients to undergo a potentially painful procedure called mesh explant, or the removal of the graft. According to one study, approximately 8 percent of AlloDerm patients require explant surgery, compared to 1.6 percent in control groups.

Unfortunately, it appears that few long term studies have followed people who received AlloDerm for hernia repair. It is becoming apparent that AlloDerm needs design improvement in order to prevent hernia recurrence.

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