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CONTACT US

CONTACT US

For ordering and billing questions:
Customer Service: 1.800.367.5737 Customer Service: 1.800.367.5737 PRMOrder@allergan.com

For clinical/medical questions:
Medical Information

Resources to support you

Learn more about the AlloDerm™ Regenerative Tissue Matrix (RTM) Guarantee, access Regulatory Licensing Documentation, review our Allergan Aesthetics Plastic and Regenerative Medicine Return Goods Policy, and see our list of helpful materials and links.

AlloDermTM RTM Guarantee Program

The AlloDermTM RTM Guarantee Program offers facility customers a replacement of any piece of AlloDermTM RTM that is explanted, subject to the program terms and conditions.

To be eligible for the guarantee, facilities must comply with all terms and conditions. For more information, contact your local
Allergan Aesthetics representative today, or call Allergan Aesthetics Customer Service at 1.800.367.5737.

Terms and Conditions

The AlloDermTM RTM Guarantee Program applies to all pieces of AlloDermTM RTM that are explanted, provided that the product has been used:

  • As intended by appropriately qualified and licensed surgeons
  • In accordance with the current AlloDermTM RTM Instructions for Use, found at www.allergan.com/AlloDermIFU

All AlloDermTM RTM replacement requests are subject to the Allergan Aesthetics review process.

The AlloDermTM RTM Guarantee Program is available to all facility customers. No separate contract is required to take advantage of the program.

If a facility receives a replacement piece of AlloDermTM RTM at no charge from Allergan Aesthetics, the facility will not seek reimbursement for the product from the patient or any government or private healthcare plans.

Download to learn more about the
AlloDermTM RTM Guarantee.

Regulatory Licensing Documentation

The below are frequently requested documents pertaining to our certifications, registrations, and licensing.

AATB Certificate FDA Establishment Registration and Listing for Human Cells, Tissues, and Cellular- and Tissue-Based Products (HCT/Ps)

U.S. State Licenses

California Tissue Bank License
Delaware Tissue Bank Permit
Florida Tissue Bank Certificate
Illinois Renewal for Tissue Bank
Maryland Tissue Bank Permit
New York License for Tissue Bank Operation
Oregon Procurement Organizations/Tissue Bank Registry

Canada

CTO Registration Certificate From Health Canada

Allergan Aesthetics Plastic and Regenerative Medicine Return Goods Policy

Click for Return Goods Policy

Helpful materials and links

Our downloadable “Safety and Quality” brochure provides important information on our donor screening, proprietary processing, and quality testing measures, as well as the final tissue characteristics for each piece of AlloDermTM RTM. Download here.

Professional organizations are invaluable sources of information and tools to help you stay up-to-date on the latest advancements in the field of plastic and reconstructive surgery. Visit the links below to explore their offerings.

American Society of Plastic Surgeons
American Academy of Otolaryngology-Head and Neck Surgery
American Association of Oral and Maxillofacial Surgeons
ALLODERM SELECTTM Regenerative Tissue Matrix Indications and  Important Safety Information 

ALLODERM SELECTTM Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM available at www.allergan.com/AlloDermIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.433.8871.

References: 1. Wainwright DJ. Use of an acellular allograft dermal matrix (AlloDerm) in the management of full-thickness burns. Burns. 1995;21(4):243-248. 2. Data on file, Allergan, August 2020 Sales Tracker. 3. Data on file, Allergan. PubMed search performed in June 2020. 4. Data on file, Allergan. 2018. Sales Data. 5. Data on file, Allergan. 6. AlloDerm Regenerative Tissue Matrix (RTM) Instructions for Use, 2020. 7. Harper JR, McQuillan DJ. Extracellular wound matrices: a novel regenerative tissue matrix (RTM) technology for connective tissue reconstruction. Wounds. 2007;19(6):163-168. 8. Xu H, Wan H, Sandor M, et al. Host response to human acellular dermal matrix transplantation in a primate model abdominal wall repair. Tissue Eng Part A. 2008;14(2):2009-2019. 9. Sandor M, Xu H, Connor J, et al. Host response to implanted porcine-derived biologic materials in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2021-2031.
ALLODERM SELECTTM Regenerative Tissue Matrix Indications and  Important Safety Information 

ALLODERM SELECTTM Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM available at www.allergan.com/AlloDermIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.433.8871.