What question is the study trying to answer? The researchers wanted to know if acellular (this means no cells are present) tissue matrix (brand name: AlloDerm) could be used to improve breast shape during reconstruction done immediately after mastectomy.

AlloDerm is made from donated human skin. It is handled in much the same way as other transplantable organs. The tissue is processed to remove cells that might cause your body to reject the foreign tissue or react negatively to it. What's left is the collagen structure (fiber-like proteins) and other proteins naturally found in skin. This structure acts as a frame for your tissue to grow into and around. AlloDerm also is used in cosmetic surgery to plump up lips and fill in facial wrinkles and creases.

About 75% of women who have mastectomies go on to have surgical reconstruction of one or both breasts. (The majority of women who are given the choice ask for immediate breast reconstruction.) Roughly half of women who have reconstruction decide on artificial implants. Most of the rest choose a surgery called the TRAM flap, which uses their own body tissue to rebuild the breast.

For most women who choose an implant, the skin and muscle that remains after mastectomy has to be stretched or expanded to make room. To stretch the skin, the surgeon inserts a balloon-type device called a tissue expander under the chest muscle. The expander has a port (a metal or plastic plug, valve, or coil). The port allows the surgeon to add increasing amounts of liquid over time (about six months), without extra surgery. When stretching is done and your other treatments (chemotherapy, radiation, or both) are completed, a second surgery is performed to replace the expander with a permanent breast implant.

In the study reported on here, the researcher wanted to know if AlloDerm could be used as a muscle graft during immediate reconstruction. By expanding the area of muscle with AlloDerm, the surgeon could immediately put in the implant, right after the mastectomy, and cover it with a combination of muscle and AlloDerm. If this can be done, expanders would not be needed—which might mean that a second surgery could be avoided.

Study design: Over four and a half years, 49 women had their breasts reconstructed after mastectomy using AlloDerm. The women were selected from all the women who were going to have reconstruction after mastectomy in Dr. Salzberg's practice. So this study is really just a look at what happened in one surgeon's practice. While the study is not a formal clinical trial, it does offer some early anecdotal information about how well AlloDerm might work. This information may contribute to the start of a clinical trial that investigates the role of immediate reconstruction with an implant, bypassing the expander step.

The women were good candidates for tissue expander surgery and decided to try reconstruction with AlloDerm. Women who chose to delay reconstruction or wanted reconstruction using their own tissue (a TRAM flap or latissimus dorsi flap) did not participate in the study.

After mastectomy, the surgeon created a pocket in the area where the breast was and inserted either a silicone or saline (salt water) implant, whichever the woman wanted. Typically the implant is placed under the chest muscle. But usually there's not enough muscle to cover the whole implant. So a piece of AlloDerm was used to bridge the gap and cover the implant. AlloDerm was attached to the muscles with stitches.

Study results: So far, the women are very satisfied with the size and symmetry of their breasts. No serious post-operative complications have been reported. None of the women have developed hard scar tissue capsules (these are tight and painful and can distort the breast). There have been no hematomas (an accumulation of blood in the wound) or seromas (a buildup of clear fluid in the wound).

Two women had secondary surgeries that were not related to their breast reconstruction. During these procedures, the surgeon removed a small sample of tissue from the area where AlloDerm was inserted. The women's skin had grown into and around AlloDerm, as expected.

Because so many women choose to have reconstruction and because so many of them would like to have it immediately after mastectomy, researchers are constantly looking for ways to improve and shorten the process.

Remember that immediate reconstruction is not for everyone. If you have been diagnosed with intermediate or advanced breast cancer, you'll probably need chemotherapy, radiation, or both after surgery. It may be necessary to delay reconstruction until after your treatment is completed. By that time, your needs, your shape, and any weight gain or loss during treatment will have settled in, and you can make a good decision about reconstruction.

For women who have been diagnosed with early-stage breast cancer, immediate reconstruction may be fine. For women who choose implants, using AlloDerm to enlarge the area of the implant covered by muscle may hold promise.

Still, this study is not a clinical trial. It is one surgeon's experience. These results are early results: most of the women have been followed only for about two years. We don't know what will happen as the skin and muscle around the implant begins to age and possibly sag.

More research, including a formal clinical trial, is needed to compare AlloDerm implant reconstruction with the more traditional reconstruction that uses an expander and then an implant.

This is cache, read story here