AlloDerm skin grafts have recently been linked to a number of extremely serious injuries in hernia repair patients. In fact, some of the risks posed by AlloDerm can be so severe that patients may be forced to undergo painful revision surgeries to correct the problems caused by these products.
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?
Originally developed in 1994 by a company called LifeCell, AlloDerm – also known as acellular human dermis (AHD) – is a type of skin graft typically used in treating burn patients, hernia and dental repairs, as well as in breast reconstruction following mastectomies. AlloDerm products are made from an acellular cadaveric dermal matrix, which means that skin cells are harvested from cadavers, processed, and used as skin grafts.
Donated skin is intensively processed to remove the epidermis and other cells that can lead to tissue rejection and graft failure. The end result is a matrix of biological components that are intended to promote rapid revascularization, white blood cell migration, and cell repopulation. This unique design is intended to increase the safety of AlloDerm, and the product was initially welcomed by the medical community as a safe alternative to traditional skin grafts. However, AlloDerm has subsequently been found to carry a large number of dangers and risks.
AlloDerm Side Effects
Unfortunately, recent studies show an extremely high rate of hernia recurrence in patients whose abdominal hernias were repaired with AlloDerm skin grafts. In fact, studies of patients who had AHD implanted to repair an abdominal hernia have the shortest follow-up period and the highest overall failure rate compared to patients repaired with other products. Many believe that longer-term results are needed as AlloDerm graft stretching may occur over the long-term.
Additionally, the Medical Product Safety Network (MedSun) received numerous reports of other problems associated with surgical mesh products 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
Between 2007 and 2009, at least 29 adverse event reports involving AlloDerm hernia patches were reported to the FDA. In a study involving 70 test subjects who had received an AlloDerm patch for hernia repair, there was one report of rejection, two infections, and 14 hernia recurrences. All of these complications have the potential to require painful revision surgery to remove the graft. According to one study, almost 10 percent of AlloDerm recipients required additional revision surgery to remove the defective grafts.
Why was AlloDerm Approved by the FDA?
During the pre-approval development of a medical device, numerous tests are conducted to determine whether the product has dangerous side effects. Even if certain side effects are found to exist, the FDA may still approve the device if the benefits are thought to outweigh the risks. Once a product is released on to the market, it is sometimes discovered that the prevalence of side effects is greater than that estimated by the FDA during the approval process. FDA approval does not in and of itself ensure that any particular device is safe.
In September 2005, the FDA announced that LifeCell had issued a recall of certain AlloDerm, Repliform, and GraftJacket products from the U.S. marketplace. The recall was initiated when internal quality processes raised questions about the donor documentation received from a tissue recovery organization called Biomedical Tissue Services (BTS). According to reports, there had been allegations that BTS was harvesting tissue from cadavers without first obtaining the proper documentation. Before tissue can be legally harvested, permission must be obtained by the donor while he or she is still alive or from the immediate family after death.
BTS’s failure to obtain the required documentation not only caused distress for the surviving family members, but it also endangered the patients who had been treated with the recalled AlloDerm skin grafts. Many of these individuals were forced to undergo additional revision surgeries to remove and replace the recalled products.
To make matters worse, a surgery recipient may not even be aware that an AlloDerm device was used until after the procedure. As well, AlloDerm products are expensive, which makes it financially difficult for many patients to have additional surgeries.