AlloDerm SELECTTM Regenerative Tissue Matrix (RTM)
Frequently Asked Questions (FAQ)

About AlloDermTM RTM

AlloDerm SELECTTM RTM is donated cadaveric human dermal tissue, processed using LifeCell Corporation’s proprietary technique to remove cells while preserving biologic components and the structure of the dermal matrix.1 The result is a sterile (with a Sterility Assurance Level (SAL) of 10-3) intact acellular dermal matrix of natural biological components that supports regeneration.2

  • The ability of AlloDerm SELECTTM RTM to support revascularization, white cell migration, and cellular repopulation with the patient's cells allows the implanted matrix to remodel into patient's own tissue.2,3
  • LifeCell Corporation developed freeze-dried AlloDermTM RTM in 1994.4 AlloDerm SELECTTM RTM, a sterile and ready-to-use product, which utilizes the same core processing, first became available in 2010.5
  • AlloDermTM RTM has been used in over 3 million grafts and implants.6
  • Yes, AlloDerm SELECTTM RTM is terminally sterilized to a Sterility Assurance Level (SAL) of 10-3 and is compliant with domestic standards to assure that sterility is maintained.1
  • Through extensive scientific research and tissue experience, the proprietary LifeCell Tissue Process was developed to create a sterile product while minimizing damage to the matrix structure.1

Using AlloDermTM RTM

  • AlloDerm SELECTTM RTM does not need to be rehydrated. However, AlloDerm SELECTTM RTM must be soaked in sterile saline or sterile lactated Ringer’s solution for a minimum of 2 minutes prior to use to rinse off the preservation solution and to facilitate handling.1
  • Please refer to the IFU for the blood drop test to determine the two distinct sides: The basement membrane and the dermal surface. The dermal side is shiny and absorbs blood. The basement membrane side is dull and repels blood.1
  • The dermal side should rest against the most vascular tissue.1 Tissue needs to conform to defect to have appropriate apposition to the vascular surface to revascularize. 7
  • AlloDerm SELECTTM RTM is to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.1
  • If you have any medically related product inquiries, please contact Medical Affairs.
  • AlloDerm SELECTTM RTM is contraindicated for use in any patient who is sensitive to any of the antibiotics listed on the package or Polysorbate 20.1
  • Polysorbate 20, a component of the phosphate buffered aqueous solution for AlloDerm SELECTTM RTM, is a detergent that is commonly used in a variety of medical and cosmetic products.8
  • Adverse outcomes potentially attributed to AlloDerm SELECTTM RTM must be reported promptly to your local sales representative or call LifeCell Corporation, an Allergan affiliate at 1.800.433.8871.1

Testing and Safety Measures

  • AlloDerm SELECTTM RTM is screened and tested according to FDA regulations, Standards for Tissue Banking of the American Association of Tissue Banks (AATB), and appropriate state regulations.1
  • These regulations and standards require extensive screening and testing of the tissue donor as well as the transplant grafts. Comprehensive medical and social history screening is performed on all tissue donors. Serological screening includes, but is not limited to, tests for evidence of hepatitis, AIDS and syphilis. LifeCell Medical Directors determine donor eligibility per FDA regulations, AATB standards, and LifeCell specifications.1
  • Additionally, LifeCellTM tissue undergoes a patented process that cleans and removes the cellular components and antigens while preserving and stabilizing the biochemical and biomechanical properties of the tissue.1
  • The validated sterilization process ensures that the product is terminally sterilized to a Sterility Assurance Level (SAL) of 10-3.1
  • No latex products are added to the product or contained in any of the packaging material. However, the product cannot be guaranteed to be latex-free. While latex gloves are not used in the processing, some individuals contacting the tissue during the procurement of the skin may have worn latex gloves. In addition, LifeCell cannot guarantee that all components from other manufacturers used during the process are latex-free.
  • LifeCell has not received any reports of latex reactions, allergy, or sensitivity related to the use of AlloDerm SELECTTM RTM or any LifeCellTM tissue products.9
  • AlloDerm SELECTTM RTM is contraindicated for use in any patient with sensitivity to specific antibiotics listed on the package. Although this is generally considered to be a non-issue unless the patient is hyper sensitive to any of the antibiotics listed on the package, trace amounts of these antibiotics may be present on the tissue, and it is the responsibility of the physician to make the decision for use.
  • Four antibiotics (Cefoxitin, Lincomycin, Polymyxin B and Vancomycin) are added only during the LifeCellTM tissue processing, and there are multiple subsequent rinses before the final product is released.
  • LifeCell has processed over 3 million grafts and implants to date.
  • AlloDerm SELECTTM RTM is derived from human dermal tissue which is processed using a proprietary technique to remove the cells that can lead to tissue rejection.1

Storage and Shipping

  • AlloDerm SELECTTM RTM is packaged hydrated, terminally sterilized, and provided to customers ready to use after a minimum two-minute rinse in sterile saline or Ringer’s lactate.1
  • AlloDerm SELECTTM RTM is supplied sealed in an inner plastic holder, which is enclosed within an outer film/foil pouch.1
  • The inner plastic holder is sterile and may be placed directly into the sterile field.1
  • AlloDerm SELECTTM RTM should be stored at room temperature in its original packaging.1
  • AlloDerm SELECTTM RTM must be stored between -8ºC to 30ºC (18ºF to 86ºF). This temperature range includes the typical room temperature range of 20ºC to 25ºC (68ºF to 77ºF).1
  • AlloDerm SELECTTM RTM does not need to be refrigerated.1
  • AlloDerm SELECTTM RTM is packaged with a TagAlert visible from the outside of the carton. If the alert indicates that the temperature range has been breached, please contact Customer Solutions at 800-367-5737.10
  • AlloDerm SELECTTM RTM’s expiration date is indicated on the package label and expires on the last day of the month indicated.1
  • Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue.1

LifeCell and Tissue Processing

  • LifeCell Corporation, an AbbVie company, is the manufacturer of AlloDerm SELECTTM RTM, which is located in Branchburg, New Jersey.1
  • Yes. LifeCell is a fully accredited institutional member of the AATB and has been since 1997.1,11 LifeCell regulatory licenses, certificates and registrations can be obtained here.
  • LifeCell provides the Tissue Transplant Return Record (TTRR) for completion and return. It does not contain patient information. LifeCell Customer Solutions can aid facilities in obtaining the tissue matrix lot number, surgeon, procedure, and date of surgery if the TTRR has been returned.1
  • LifeCell is required to track AlloDerm SELECTTM RTM to the consignee. Tissue recipient records must be maintained by the consignee in order for tracing tissue post-transplantation.
  • Click here to download a Tissue Transplant Return Record.
  • AlloDerm SELECTTM RTM Use is regulated by the US FDA as human tissue for transplantation.1
  • AlloDerm SELECTTM RTM is processed and marketed in accordance with the FDA’s requirements for banked human tissue (21 CFR Part 1270 and Part 1271), AATB’s Standards for Tissue Banking, state guidelines (such as California, Florida, New York, Maryland, Illinois, etc), and LifeCell Corporation’s specifications.1 Click here for tissue licenses.
  • If you have any medically related product inquiries, please contact Medical Affairs.

Resources and Support

  • AlloDermTM RTM has extensive commercial insurance coverage.12
  • AlloDermTM RTM has a product-specific HCPCS code, Q4116.13
  • AlloDermTM RTM may also qualify for incremental reimbursement to the facility for outpatient cases.
  • For questions about reimbursement, contact our reimbursement hotline at AllerganPRM@thepinnaclehealthgroup.com or call 1.888.543.3656.
  • Specific literature or a bibliography can be requested from our Medical Affairs team by contacting 1.800.678.1605, or visit https://www.abbviemedinfo.com/
  • A full bibliography can be found on PubMed.
  • A patient brochure can be downloaded here for discussion with your patients.
References: 1. AlloDerm™ Regenerative Tissue Matrix (RTM) Instructions for Use, February 2020. 2. Harper JR, McQuillan DJ. Extracellular wound matrices: a novel regenerative tissue matrix (RTM) technology for connective tissue reconstruction. Wounds. 2007;19(6):163-168. 3. Holton LH, Chung T, Silverman RP, Haerian H, Goldberg NH, Burrows WM, Gobin A, Butler CE. Comparison of acellular dermal matrix and synthetic mesh for lateral chest wall reconstruction in a rabbit model. Plast Reconstr Surg. 2007;119:1238-1246 4. LifeCell Corporation reports second quarter results. News release. LifeCell Corporation; August 3, 1994. 5. Data on file, Allergan Aesthetics, June 28, 2022; RE: AlloDerm FAQs - references. 6. Data on file, Allergan Aesthetics, AlloDerm Global Product Sales 2023. 7. Khansa I, Janis JE. Modern reconstructive techniques for abdominal wall defects after oncologic resection. J Surg Oncol. 2015;111(5):587-98. 8. National Center for Biotechnology Information. PubChem Compound Summary for CID 443314, Tween 20. https://pubchem.ncbi.nlm.nih.gov/compound/Tween-20. Accessed Aug. 22, 2022. 9. Data on file, Allergan Aesthetics, July 6, 2022; RE: AlloDerm FAQs - references. 10. Data on file, Allergan Aesthetics, 2019; AlloDerm SELECT™ Regenerative Tissue Matrix packaging. 11. Data on file, Allergan Aesthetics, November 10, 1997; American Association of Tissue Banks. 12. Data on file, Allergan Aesthetics, October 2022; Payor covered lives. 13. US Federal Register. December 14, 2017; Vol 82(239). CMS-1678-FC; 42 CFR parts 414, 416, and 419. Office of the Federal Register, National Archives and Records Administration. Washington, DC.
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. ALLODERM SELECTTM RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. 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

Potential adverse events which may result from surgical procedures 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.

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

References: 1. LifeCell Corporation reports second quarter results. News release. LifeCell Corporation; August 3, 1994. 2. Data on file, Allergan Aesthetics; March 2021. Plastic Surgery Aesthetic Monthly Tracker. 3. Data on file, Allergan Aesthetics, LIS Publication Search performed March 2024. 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. ALLODERM SELECTTM RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. 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

Potential adverse events which may result from surgical procedures 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.

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