Originally developed by the LifeCell Corporation in 1994, AlloDerm Hernia Repair Patch is a surgical mesh used in hernia repair and breast reconstruction surgery. This patch is a human tissue patch which is made from natural tissues and is supposed to support tissue generation. It aids the healing process as it transforms into living tissues, often indistinguishable to the patient’s tissue.
Initially, AlloDerm Regenrative Tissue Matrix, commonly known as Alloderm, was used to replace the skin of burn victims. However, with the passage of time, more uses of this product were identified. Many reconstructive surgeries and similar medical procedures have been performed using these grafts and implants.
AlloDerm is mainly created from donated human tissues so the cells are able to regenerate and are less likely to be rejected by the body. Apart from breast reconstruction and hernia repair, AlloDerm repair patches have also been used to treat abdominal wall repair, dental implants, skin grafts for burns and other surgeries requiring skin or tissue grafts.
However increased risk of hernia recurrence or failure of the graft has been closely related with AlloDerm, which was mainly used in medical operations where the repair was bigger than originally anticipated. As this mesh is made from human tissues including skin, operative cases where the stretching of stomach too tightly had to be avoided, this mesh was used instead to bridge the gap. In most of the cases, the patients were informed after the surgery about the usage of this hernia mesh, although it had an extra cost attached to it, and possible complications as well. In scenarios where the mesh failed, additional surgeries to repair the hernia had to be performed.
AlloDerm is an expensive medical product, therefore in cases where additional surgeries had to be performed due to the failure of this mesh; it turned out to be an expensive affair for the patient who wasn’t even informed before the surgery that the mesh could be used.
LifeCell, the manufacturer of AlloDerm was fully aware of the side effects that the product could cause. It is believed that LifeCell bought tissues from Biomedical Tissue Services, which illegally harvested tissues from individuals who had not consented to be organ donors. Since these tissues were illegally harvested, they were neither tested nor approved, leaving many concerned whether AlloDerm skin graft made from these tissues would carry risks of serious illnesses like HIV, Hepatitis B, Hepatitis C or syphilis. Fortunately there were no deaths, however, reports of infections, abscess, pain/ soreness, inflammation or swelling were the common patient injuries and cases of ring breakage mesh tear, defective mesh, mesh perforation, adhesion issue and mesh erosion were the most frequent device problems reported from February 2007 to April 2009 by MedSun.
LifeCell has many lawsuits pending against it with regards to AlloDerm skin patches and it claims to defend itself against all lawsuits regarding the illegal tissue harvest. Four Biomedical Tissue Services employees were also indicted pertaining to this illegal tissue harvest.