From February 2007 to April 2009, 29 adverse event reports associated with 30 hernia mesh patches in 30 patients were reported to the Food and Drug Administratin (FDA). In another study, out of 70 patients who had received AlloDerm following a hernia repair, one experienced rejection, two infections, and 14 had hernia recurrences. The overall complication rate was 24 percent. All of the complications associated with AlloDerm have the potential to require additional, painful surgeries. Most commonly, mesh explants (removal of the graft). Due to infected fluid collections following implantation of AlloDerm, explantation is often times necessary. According to one study, approximately 8 percent of AlloDerm patients require explant surgery, compared to 1.6 percent in control groups.
First introduced in 1994 to help physicians treat burn victims, AlloDerm is a human-derived tissue that is processed by LifeCell. It works by promoting tissue growth wherever it is placed. Although there are many complex ways to describe its formulation, AlloDerm is basically donor skin that is dried and chemically treated to remove all cells and cell markers (antigens) that a recipient patient's body could recognize as foreign material. According to the National Institutes of Health, an antigen is any substance that causes your immune system to produce antibodies against it. An antigen may be a foreign substance from the environment such as chemicals, bacteria, viruses, or pollen. An antigen may also be formed within the body, as with bacterial toxins or tissue cells.
AlloDerm is intended for use during facial reconstruction, breast reconstruction, and hernia repair. Although AlloDerm has had much success when used during facial reconstruction and breast repair, serious side effects and many instances of hernia recurrence have been experienced when AlloDerm has been used for hernia repair. A hernia occurs when the lining of a major organ tears, and therefore allows for a portion of the organ to surface. The two main types of hernia repair surgery are hernioplasty and herniorrhaphy. According to MedLine, conventional hernioplasty involves the administration of a single, long incision over the hernia. Depending on whether the hernia is bulging out or lying inward, it can either be pushed back or its sac tied off and removed. When the hernia is pushed back into place, a mesh patch made from synthetic material is sewn over the weakened area in the abdominal wall as reinforcement. The patch works to decrease strain placed on the abdominal wall as well as to reduce the risk of recurrence. Usually performed when the affected area is small, a herniorrhaphy simply sutures the defective tissue.
Side effects of AlloDerm include severe injury to nearby organs and blood vessels and the adherence of a patients intestines to the AlloDerm mesh. Other AlloDerm complications that occur with hernia repair include mesh erosion, ring breakage, mesh tear, adhesion issues, and mesh perforations. Mesh erosion simply refers to the breakdown of internal tissue due to irritation or infection caused by any type of foreign material. Ring breakage, one of the most common complications associated with AlloDerm, causes infection, inflammation and swelling, abscesses in the abdominal wall, and a high recurrence rate of hernia. Mesh tears and mesh perforations refer to the AlloDerm tearing or cracking once attached to the affected area, while adhesion issues cause the AlloDerm patches to come undone or adhere improperly. According to FDA reports, many doctors have reported a failure of adhesion and proper healing of surgical incisions with the use of AlloDerm.