BellaDerm®
Introduced in 2009, BellaDerm is the most up-to-date type of graft available for use in penile augmentation surgery. Dr. Alexander Krakovsky is among a select group of physicians who perform penile augmentation surgery using BellaDerm for penile girth augmentation and penile glanular augmentation.
Why BellaDerm? In the words of the manufacturer, “BellaDerm is the first tissue graft product made of natural dermal tissue and offered specifically for cosmetic surgery procedures.”
In the past, penile augmentation surgery used grafts of the patient’s own skin (dermal fat grafts, or DFGs) to add volume to the penis. More recently, Alloderm® provided an attractive alternative. Now, there is an even better product available. Today a patient can choose to have his penis enlarged with BellaDerm®.
BellaDerm grafts are pre-packaged and available for use at any time.
BellaDerm also means the surgeon does not have to obtain grafts from the patient’s skin. This makes augmentation surgery quicker, and avoids the potential complications, discomfort, healing process, and scars that would be involved if the grafts came from the patient’s skin.
Even if a patient has decided to use grafts of his own skin, BellaDerm can be used to supplement these grafts if there is not enough available skin.
BellaDerm is derived from tissue donated by living donors, which is preferable to those products, such as AlloDerm, that are derived from donated cadaver tissue. It is also superior to animal and synthetic products that have a higher risk of having the body reject them.
BellaDerm testing, processing, and sterilization processes are state-of-the-art and unique to MTF. As a result of its superior technology, testing of the source tissue for BellaDerm is more thorough, and the processing and sterilization methods do not over process and damage the matrix. The result is better tissue performance after surgery.
What is BellaDerm? BellaDerm is a graft that is made of a type of scaffolding or framework (matrix) that exists in all human skin. This framework is a place where cells and blood vessels can create new tissue.
To create BellaDerm, donated human skin, or tissue (allograft), is processed to remove human cells—especially the epidermal and dermal cells—through a patented method, while preserving and stabilizing the remaining biochemical components and structure (matrix) of the dermis.
The process of creating BellaDerm involves several steps. First, a skin graft is obtained from a live donor. Usually, the tissue is from a person with excess skin in the upper/lower abdominal area (“love handles”) following weight loss. The donor must agree that the donated tissue can be used for plastic surgery procedures.
Next, the graft is evaluated using MTF’s superior VanGuard Method™. If the tissue passes VanGuard testing, it is cleaned, processed, and sterilized, again using MTF’s superior technologies. During these procedures, the human cells are removed from the matrix or framework.
The resulting matrix is BellaDerm. In phalloplasty surgery, BellaDerm is used to enhance the girth and/or glans of the penis in the male cosmetic surgical procedures described on this website.
How safe is BellaDerm? BellaDerm is made by the Musculoskeletal Transplant Foundation (MTF), the country’s leading non-profit tissue bank, founded by surgeons in 1987. For over twenty years, MTF has provided high quality tissue to health care providers, including more than 3.5 million tissue grafts from more than 74,000 donors.
Today, MTF is made up of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. In the company’s own words, MTF “is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue.”
As described above, BellaDerm undergoes a strict and comprehensive series of procedures to assure its safety. In addition, BellaDerm is regulated by the FDA as a human tissue for transplantation, or as a banked human tissue. All procedures are performed in accordance with the standards and guidelines of the American Association of Tissue Banks (AATB); the Food and Drug Administration’s (FDA) applicable CFR (Center for Devices and Radiological Health) regulations and requirements for the procurement and processing of banked human tissue; and all applicable state requirements.
BellaDerm is an FDA-approved product that may be used by a licensed practitioner for uses other than those stated in the product label (off-label use). The use of BellaDerm in phalloplasty augmentation surgery is a legal off-label use of the product.
More information about BellaDerm and these procedures and technologies is available on the MTF Corporation website at http://www.mtf.org.
