STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick,
and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where
weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of
these products 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. STRATTICE™ RTM Laparoscopic is indicated for such uses in
open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time
IMPORTANT SAFETY INFORMATION
These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
- Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. 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.
- Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.
- For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.”
Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration
date. Ensure these products are placed in a sterile basin and covered with 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 these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth
and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh
is dry, do not use.
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. In large abdominal
wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques,
utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than
when used to reinforce fascial closure.
For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before
For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.
RTM Perforated, STRATTICE™
RTM Extra Thick, and STRATTICE™
RTM Laparoscopic are available by prescription only.
For more information, please see the
Instructions for Use (IFU) for all STRATTICE™
To report an adverse reaction, please call Allergan at