Our regenerative medicines portfolio offers plastic and general surgery customers with high-quality dermal matrix products.
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For Consumers
Consumer Product Questions
Call 1 (800) 678-1605
Report a Side Effect or Adverse Event
Call 1 (800) 678-1605
For Providers
Provider Product Questions
Call 1 (800) 678-1605
See Indications, Important Safety Information, and Instructions for Use
IMPORTANT SAFETY INFORMATION AND INSTRUCTIONS FOR USE FOR
ALLODERM SELECT™ Regenerative Tissue Matrix and STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM).
ALLODERM SELECT™ Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is ALLODERM SELECT™ RTM? ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM) is a tissue product intended to be used for repair or replacement of damaged or inadequate skin or skin-like tissue or for other similar uses of human skin tissues. ALLODERM SELECT™ RTM is not indicated for use as a tissue substitute for covering the brain or spinal cord or intended for use in animals.
IMPORTANT SAFETY INFORMATION
Who should NOT use ALLODERM SELECT™ RTM?
ALLODERM SELECT™ RTM should not be used if you have a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.
What warnings should I be aware of?
ALLODERM SELECT™ RTM is not guaranteed to be free of all infection-causing agents. No long-term studies have been conducted to evaluate the potential of cancer or mutation or the reproductive impact of ALLODERM SELECT™ RTM.
What precautions should I be aware of?
Implantation of ALLODERM SELECT™ RTM should occur with caution if you have a poor general medical condition or any condition that would limit the blood supply and compromise healing. Your doctor may prescribe or apply local and/or general anti-infective medications whenever implantation occurs in an area that is contaminated or infected. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists).
What are possible side effects?
The most common side effects associated with the implant of a tissue include, but are not limited to the following: infections at the wound site; infections throughout the body; fluid collection at the surgical site; rupturing of the wound; overactive immune system response, allergic reaction or other inflammatory response; and shedding or failure of tissue implantation.
ALLODERM SELECT™ RTM is available by prescription only.
This information is not intended to replace discussion with your physician. It does not describe all the potential risks associated with the use of tissue product in surgical procedures. Every patient’s situation is different, so please consult with your physician to determine if the use of ALLODERM SELECT™ RTM is right for you.
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.
STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM)
INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is STRATTICE™ Reconstructive Tissue Matrix (STRATTICE™ RTM)?
STRATTICE™ RTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
IMPORTANT SAFETY INFORMATION
Who should NOT use STRATTICE™ RTM?
STRATTICE™ RTM should not be used by your physician if you have a known sensitivity to porcine material and/or Polysorbate 20.
What precautions should I be aware of?
Implantation of STRATTICE™ RTM should occur with caution if you have significant co-morbidities including, but not limited to, obesity, smoking, diabetes, compromised immune system, poor nutrition, difficulty breathing (eg, COPD), and pre- or post-operation radiation treatment. Your doctor may prescribe or apply local and/or general anti-infective medications whenever implantation occurs in an area that is contaminated or infected.
STRATTICE™ RTM is available by prescription only.
This information is not intended to replace discussion with your physician. It does not describe all the potential risks associated with the use of tissue product in surgical procedures. Every patient’s situation is different, so please consult with your physician to determine if the use of STRATTICE™ RTM is right for you.
For more information, please see the Instructions for Use (IFU) for STRATTICE™ RTM.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
ARTIA™ RECONSTRUCTIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
ARTIA™ Reconstructive Tissue Matrix (ARTIA™ RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single patient, one time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. ARTIA™ Tissue Matrix cannot be reused once it has been removed from the packaging and/or is in contact with a patient without increased risk of patient-to-patient contamination and subsequent infection. The user should be aware of high recurrence rates when using a surgical mesh for bridging repair in load-bearing applications (eg, hernia repair).
PRECAUTIONS
Use of the product in breast reconstruction has not been studied in a prospective clinical trial.
Discard product if handling has caused possible damage or contamination, or the product is past the expiration date. Ensure the surgical mesh is soaked in room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use. If a tissue punch-out piece is visible, remove using aseptic technique before implantation.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.
ARTIA™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ARTIA™ RTM.
For product complaints and potential adverse events, please contact your local Sales Representative, or 1.800.433.8871.
See Indications, Important Safety Information, and Instructions for Use
IMPORTANT SAFETY INFORMATION AND INSTRUCTIONS FOR USE FOR
ALLODERM SELECT™ Regenerative Tissue Matrix and STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM).
ALLODERM SELECT™ Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is ALLODERM SELECT™ RTM? ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM) is a tissue product intended to be used for repair or replacement of damaged or inadequate skin or skin-like tissue or for other similar uses of human skin tissues. ALLODERM SELECT™ RTM is not indicated for use as a tissue substitute for covering the brain or spinal cord or intended for use in animals.
IMPORTANT SAFETY INFORMATION
Who should NOT use ALLODERM SELECT™ RTM?
ALLODERM SELECT™ RTM should not be used if you have a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.
What warnings should I be aware of?
ALLODERM SELECT™ RTM is not guaranteed to be free of all infection-causing agents. No long-term studies have been conducted to evaluate the potential of cancer or mutation or the reproductive impact of ALLODERM SELECT™ RTM.
What precautions should I be aware of?
Implantation of ALLODERM SELECT™ RTM should occur with caution if you have a poor general medical condition or any condition that would limit the blood supply and compromise healing. Your doctor may prescribe or apply local and/or general anti-infective medications whenever implantation occurs in an area that is contaminated or infected. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists).
What are possible side effects?
The most common side effects associated with the implant of a tissue include, but are not limited to the following: infections at the wound site; infections throughout the body; fluid collection at the surgical site; rupturing of the wound; overactive immune system response, allergic reaction or other inflammatory response; and shedding or failure of tissue implantation.
ALLODERM SELECT™ RTM is available by prescription only.
This information is not intended to replace discussion with your physician. It does not describe all the potential risks associated with the use of tissue product in surgical procedures. Every patient’s situation is different, so please consult with your physician to determine if the use of ALLODERM SELECT™ RTM is right for you.
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.
STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM)
INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is STRATTICE™ Reconstructive Tissue Matrix (STRATTICE™ RTM)?
STRATTICE™ RTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
IMPORTANT SAFETY INFORMATION
Who should NOT use STRATTICE™ RTM?
STRATTICE™ RTM should not be used by your physician if you have a known sensitivity to porcine material and/or Polysorbate 20.
What precautions should I be aware of?
Implantation of STRATTICE™ RTM should occur with caution if you have significant co-morbidities including, but not limited to, obesity, smoking, diabetes, compromised immune system, poor nutrition, difficulty breathing (eg, COPD), and pre- or post-operation radiation treatment. Your doctor may prescribe or apply local and/or general anti-infective medications whenever implantation occurs in an area that is contaminated or infected.
STRATTICE™ RTM is available by prescription only.
This information is not intended to replace discussion with your physician. It does not describe all the potential risks associated with the use of tissue product in surgical procedures. Every patient’s situation is different, so please consult with your physician to determine if the use of STRATTICE™ RTM is right for you.
For more information, please see the Instructions for Use (IFU) for STRATTICE™ RTM.
To report an adverse reaction, please call Allergan at 1.800.367.5737.
ARTIA™ RECONSTRUCTIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
ARTIA™ Reconstructive Tissue Matrix (ARTIA™ RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single patient, one time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. ARTIA™ Tissue Matrix cannot be reused once it has been removed from the packaging and/or is in contact with a patient without increased risk of patient-to-patient contamination and subsequent infection. The user should be aware of high recurrence rates when using a surgical mesh for bridging repair in load-bearing applications (eg, hernia repair).
PRECAUTIONS
Use of the product in breast reconstruction has not been studied in a prospective clinical trial.
Discard product if handling has caused possible damage or contamination, or the product is past the expiration date. Ensure the surgical mesh is soaked in room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use. If a tissue punch-out piece is visible, remove using aseptic technique before implantation.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.
ARTIA™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ARTIA™ RTM.
For product complaints and potential adverse events, please contact your local Sales Representative, or 1.800.433.8871.