What you need to know about NeoForm™

Your doctor or surgeon has recommended

that you have a surgical procedure in which NeoForm™, a Tutoplast® processed implant, will be used. This FAQ was designed to answer some common questions about Tutoplast® processed implants; however, your doctor is your best source of information about your specific procedure.

What is an Allograft?

Tissue transplanted from one location of the person’s body to another is called an autograft. An allograft, which may also be referred to as an implant, is bone or soft tissue that is transplanted from one person to another. In the U.S., an estimated 2 million allografts are transplanted each year. Transplanted bone, tendons, ligaments, and membranes are used in a variety of medical fields including orthopaedics, sports medicine, spinal, dental, urology/gynecology, maxillo-facial, and reconstructive surgery, as well as neurosurgery. Allografts are commonly used in procedures such as repair of fractures, bone loss, treatment of disc disease, ligament repair, bladder control/incontinence, treatment of periodontal disease, congenital ptosis in newborns and reconstruction of jaw and other facial defects.

Who Donates Allografts?

As you may be aware, many people choose to donate their organs and tissues. These otherwise healthy people often become donors as the result of an unexpected death, such as an accident or heart attack. Every donor is thoroughly screened and tested before tissue acceptance. This screening consists of a strict and comprehensive review of medical and social histories, including histories of high-risk behavior that automatically eliminate any possibility of donation. Individuals with a history of diseases such as AIDS, hepatitis or exposure to toxic substances are immediately rejected. Potential donors with histories of any condition that could affect the quality and performance of the tissue are also excluded. Moreover, a Medical Director and technical staff verify and approve each donation that is going to be Tutoplast® processed.

What is NeoForm™?

NeoForm™ consists of human dermal tissue that has been sterilized and preserved using the Tutoplast® Process.

What is the Tutoplast® Process?

The Tutoplast® Process is a proprietary process developed by Tutogen Medical, Inc. to sterilize and preserve human tissue for implantation. Not all allografts are alike. Your surgeon is recommending the use of a Tutoplast® processed implant because the Tutoplast® Process is recognized as one of the safest methods of sterilizing and preserving allografts for surgery. Tutoplast® processed implants are certified to have the same sterility assurance level as pharmaceutical products, while retaining the biomechanical and structural integrity of the tissue.

How Does NeoForm™ Heal in Your Body?

NeoForm™ will act as a support or bridge for normal tissue growth. Over time, your own living cells will begin to repopulate the implant. As your body undergoes its natural healing process, the implant gradually becomes a healthy part of your body.

How Safe is NeoForm™?

Tissue that undergoes the Tutoplast® Process is first cleaned by removing debris and organic matter. Then, the tissue is treated and bathed in a combination of solutions to eliminate bacteria and viruses. Tutoplast® processed implants receive a low dose of gamma-irradiation to achieve packaging sterilization. In addition, Tutoplast® processed implants have been tested for micro-biological contamination in accordance with United States Pharacopoeia (USP) guidelines to ensure compliance with regulatory requirements. Although there is some theoretical risk for disease transmission, the Tutoplast® Process significantly reduces those risks. All Neoform™
implants have undergone rigorous donor screening, serological testing, the Tutoplast® Process, and terminal sterilization.

Effectiveness against disease

NeoForm™ is refined using the proprietary Tutoplast® Process. This process removes unwanted cells and viruses and inactivates pathogens while preserving the strength of the collagen matrix and tissue integrity. The steps include treatment with various chemical solutions such as hydrogen peroxide, sodium hydroxide and saline, dehydration with acetone and terminal sterilization with low-dose gamma irradiation.

The FDA (Food and Drug Administration) has regulated this field very closely since 1993 to ensure the safety of allograft implants. Tutogen Medical, Inc. is registered with the FDA and accredited by the American Association of Tissue Banks (AATB). All required state licensures are maintained. Tutogen Medical, Inc. is also certified to ISO 13485-2003 and ISO 9001-2001.

As of 2007, Tutogen products have been used for over 35 years, and more than 1.5 million patients have received Tutoplast® processed implants, without a single reported case of disease transmission. Numerous published articles attest to the effectiveness and success of Tutoplast® processed implants in a variety of surgical procedures.

Your doctor or surgeon is your best source of information.

If you have other questions or concerns regarding your surgery, please direct them to your doctor or surgeon. You can help ensure the best outcome of your procedure by carefully following your doctor or surgeon's instructions.