Healthcare Professional Official Site ─ AlloDerm SELECT™ Regenerative Tissue Matrix

Surgeons have utilized AlloDerm Regenerative Tissue Matrix (RTM) products for over 20 years1

ALLODERM SELECT RTM IS AN ACELLULAR DERMAL MATRIX (ADM) FOR REPAIR OR REPLACEMENT OF DAMAGED OR INADEQUATE TISSUE OR FOR OTHER HOMOLOGOUS USES2

  • Offers a soft tissue support in single- or two-stage breast reconstruction3
  • Helps reinforce weak or thin tissue in breast reconstruction and revision surgeries2

Reimbursement
support hotline

Mon-Fri 8:00 am-6:30 pm ET
(Closed on major observed holidays)
Phone: 888.543.3656
Fax: 877.499.2986
LifeCell@ReimbursementAccess.com

REGULATORY LICENSING DOCUMENTATION

Allergan provides this regulatory licensing documentation page to allow interested parties with regulatory responsibilities and/or the general community to access and review frequently requested documents pertaining to Allergan certification, registrations, and licensing.

Canadian

US State Licences

INDICATIONS

ALLODERM SELECT Regenerative Tissue Matrix (ALLODERM SELECT RTM) 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 SELECT RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECT 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 SELECT 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 SELECT RTM.

DO NOT re-sterilize ALLODERM SELECT RTM. Discard all open and unused portions of the product. 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 pouch is opened or damaged. DO NOT use product after expiration date noted on the label. Transfer ALLODERM SELECT 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 SELECT™ 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 SELECT™ 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 SELECT™ RTM should be hydrated and moist when the package is opened. If product is dry, DO NOT use. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists).

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 SELECT RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT RTM.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

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. AlloDerm™ Select Regenerative Tissue Matrix Instructions for Use, 2016.
  3. Sigalove S, Maxwell GP, Sigalove NM, et al. Prepectoral implant-based breast reconstruction: rationale, indications, and preliminary results. Plast Reconstr Surg. 2017;139(2):287-294.
ALLODERM SELECT Regenerative Tissue Matrix (RTM) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. Click here for Indications and Important Safety Information.

INDICATIONS

ALLODERM SELECT Regenerative Tissue Matrix (ALLODERM SELECT RTM) 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 SELECT RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECT 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 SELECT 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 SELECT RTM.

  • DO NOT re-sterilize ALLODERM SELECT RTM. Discard all open and unused portions of the product. 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 pouch is opened or damaged. DO NOT use product after expiration date noted on the label. Transfer ALLODERM SELECT 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 SELECT™ 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 SELECT™ 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 SELECT™ RTM should be hydrated and moist when the package is opened. If product is dry, DO NOT use.
  • Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists).

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 SELECT RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT RTM.

To report an adverse reaction, please call Allergan at 800.367.5737.