Is Alloderm Not Sterile?

Question

I'm about to have surgery, where my doctor is going to use Alloderm. After reading that Alloderm is not sterile, how concerned should I be?

Richard Baxter, MD · Answer

Alloderm is a tissue matrix, a biological implant that becomes living tissue. Strictly speaking, although it is not associated with an increased risk of infection, it is not considred sterile because strerilization processes destroy the matrix. This would result in an infmammatory response instead of tissue integration. Other methods are used to remove bacteria and contaminants.

Jeffrey J. Roth, MD, FACS · Answer

AlloDerm is a good product that has been on the market for some time.  We used it in the burn units, and continue to use it in breast reconstruction.  Some have used it cosmetically as well. 

	It goes through a rigorous process so that there is no bacteria in the material.  This process leaves the structure intact, which is key to success.

Sam Jejurikar, MD · Answer

Hi,
There is some confusion about the sterility of alloderm.  Because it is a biologic mesh which supports tissue ingrowth, it can't be sterilized in a traditional manner.  Traditional methods of sterilization involve using high heat to kill bacteria - in the case of Alloderm, that would destroy the biologic matrix.
Alloderm does undergo rigorous processing, however, to ensure that all bacteria and cells are removed from the product.  And, because it's a biologic matrix which your body incorporates, it tends to be less prone to infection than other types of mesh utilized in surgery.
Hope this helps.  Best of luck.

Raj S. Ambay, MD · Answer

AlloDerm is essentially cadaver skin minus any living cells. It is used as a scaffold through which a persons living cells can grow into. It has many uses, but, in use his in breast reconstruction. AlloDerm does not help in mastectomy recovery. It does however help in breast reconstruction. In this application, AlloDerm was used to cover the lower portion of an implant that spans from the lower border of the pectoralis muscle to the breast fold. Because AlloDerm is a foreign substance in can always get infected and as such your doctor and you need to pay close attention to the signs and symptoms. AlloDerm has also been used in nipple augmentation as well as augmentation of other body parts. Its efficacy is really not known in these realms because it is not common. Some providers may use AlloDerm for these applications but please note that its most widespread use is particularly in breast reconstruction as well as repair for abdominal wall hernias. Please speak with a board certified plastic surgeon if you have any specific concerns regarding your care.

Glynn Bolitho, PhD, MD, FACS · Answer

Acellular dermal matrix (ADM) is derived from human tissue and has proved very useful in breast reconstruction, hernia repair and a variety of other applications. Donors to the tissue banks are very carefully screened and consented prior to use of tissue, with only 3% of donors accepted (MTF). The dermal allograft is then subject to a variety of techniques that clean or sterilize the tissue. Some of the processes that sterilize the tissue result in damage to the tissue quality, while others maintain the tissue quality while reducing the infective risk to a nationally accepted standard. Both types of products are available to surgeons and it is usually a question of surgical judgement as to which product is used.

Navin K. Singh, MD · Answer

AlloDerm is a tissue for transplantation, not a device.  It meets the FDA requirements for human tissue transplantation.  It is tested to be negative for infectious diseases.

Peter A. Aldea, MD · Answer

Mnjc,
I am not sure where you read that AlloDerm (or its close product Strattice) is not sterile. This cannot be farther than the truth.
Both products from Life Cell undergo a rigorous processing and ARE sterile. They have been used in various areas of surgery for years and have an established safety record.
If you really need the product, I would not worry about sterility.
Good Luck.

Lavinia K. Chong, MD · Answer

You should not be concerned about sterility issues with Alloderm. I have used the product since 1995 (initially in burn reconstruction and more recently, in breast reconstruction) and can attest that the manufacturer, LifeCell has extremely high quality control standards in production as well as in tracking any "complications", such as seroma, infection, delayed wound healing, transmissible viral particles. To my knowledge, there have never been any infections reported. The process by which it is prepared will ensure that the graft remains its ability to "grow" into and fuse with the patient's own tissues. Hope this helps. good luck.

D.J. Verret, MD · Answer

Greetings,
I am not sure what you are reading but Alloderm is sterile otherwise it could not get approval for implantation into the body. The product is safe and used in many different ways.

Karen Vaniver, MD (in memoriam) · Answer

AlloDerm is a regenerative tissue matrix made from donate human skin. It is prepared by an enzymatic process that removes cells without destroying the extracellular matrix, composed of the bridging components of skin and proteins that actually enhance the body's ability to heal. This type of processing is considered aseptic, rather than sterile. Because of this AlloDerm is recognized as a tissue, not just as an implant. Reports of infection from AlloDerm are nearly zero.The advantage to the patient is that growth factors maintained in AlloDerm actually allow the AlloDerm to be integrated into your body, rather than being rejected or destroyed by your body's immune system

Is Alloderm Not Sterile?

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