Have you or someone you know experienced complications after a hernia repair surgery involving AlloDerm? Once thought to be a revolutionary medical breakthrough, AlloDerm skin grafts have recently been linked to a number of harmful side effects including mesh breakage and perforation, abscesses, and hernia relapse.
AlloDerm Lawsuit Update 1/17/13: This week, the number of lawsuits filed in New Jersey state court over LifeCell Corporation’s controversial AlloDerm product surpassed 300, with nearly 10% of the complaints entered in the last 45 days. Originally approved in the early 1990’s for use with burn victims and for select dental procedures, the AlloDerm Regenerative Tissue Matrix has since been aggressively marketed off-label for hernia surgery and abdominal repairs. Click here to learn more.
What’s the problem?
Manufactured and marketed by the bioengineering company LifeCell Corporation, AlloDerm is a unique skin grafting product that has been used in a wide variety of applications including hernia repairs, breast reconstruction following mastectomies, treatment for severe burns or lacerations, as well as head and neck plastic reconstruction and grafting. AlloDerm is made from cadaver dermis that undergoes a rigorous processing routine in which all of the cells are removed to decrease the likelihood that the recipient’s body will reject the tissue. These skin grafts are designed to provide rapid revascularization to minimize the risk of infection by using existing vascular channels to promote new blood vessel formation. This is supposed to resist adhesion formations in the bowel, and promote rapid repopulation of the patient’s cells.
AlloDerm was first approved by the U.S. Food & Drug Administration (FDA) in 1994, and was initially commended by the medical community for its ability to provide a safe alternative to traditional skin grafting. However, AlloDerm has recently been identified as presenting serious health risks to patients who are implanted with the products. In fact, some of these risks may be so severe that patients are required to undergo painful revision surgeries to correct the problems caused by AlloDerm.
Side Effects of AlloDerm
Regardless of the regulations dictating the qualifications for appropriate donors, as well as the methods for storing and implanting AlloDerm tissue, some patients have reported developing life-threatening complications. When AlloDerm skin graft products are used in hernia repair procedures, they have been linked to a number of extremely serious side effects including (but not limited to):
- Development of abscesses
- Infection, which can become life-threatening
- Graft explant
- Tearing of the mesh patch
- Defective patches
- Perforations in the product causing tissue weakness
- Injury to organs, blood vessels, and other tissues that are close to the patched area
- Adhesion failure
- Failure of proper healing of surgical incisions
- Mesh erosion
- Post-operative bulging
- Extreme discomfort
A 2008 study published in the journal Hernia found that the overall complication rate associated with AlloDerm hernia repairs was nearly 25 percent. Most of the complications investigated by the study involved hernia recurrence, with one rejection and two infections also being reported. According to another study, nearly 10 percent of AlloDerm patients required explant surgery, compared to less than two percent in control groups who were treated with other hernia repair products.
If you are preparing for hernia repair surgery
Before undergoing any serious medical procedure, be sure to enter into it with as much information as possible. If you are preparing to undergo hernia repair surgery, talk to your doctor about potential side effects and complications from AlloDerm corrective surgery. Important points you may wish to discuss with your doctor include:
- What are the risks and benefits of using AlloDerm in your particular case?
- Is there any patient information that comes with the AlloDerm product you will be treated with?
- What is your surgeon’s experience with AlloDerm?
- What can you expect to feel after the surgery is completed? How long will this last?