The same potential medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response.
INDICATIONS: Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
CONTRAINDICATIONS: 1. XenMatrix™ Surgical Graft should not be used on patients with known sensitivity to porcine products. 2. Not for reconstruction of cardiovascular defects. 3. Not for reconstruction of central nervous system or peripheral nervous system defects. 4. Use of this product in applications other than those indicated has the potential for serious complications.
WARNINGS: 1.This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user. 2. DO NOT RESTERILIZE. 3. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the package is damaged or open, or if the temperature indicator on the foil pouch is black. 4. If an infection develops, it should be treated aggressively. 5. An allergic reaction, which is unrelated to other therapy, is an indication to consider removal of XenMatrix™ Surgical Graft. 6. After use, any unused product and packaging should be treated as a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
PRECAUTIONS: 1. Please read all instructions prior to use. 2. Only physicians qualified in the appropriate surgical techniques should use this
surgical graft. 3. Strict aseptic technique should be followed. 4. Federal law restricts this device to sale by or on the order of a physician. 5. The surgeon should thoroughly understand the surgical procedure and the performance characteristics of the surgical graft. 6. Place device in maximum possible contact with healthy, well-vascularized tissue to promote cell in growth and tissue remodeling. 7. When unable to close skin over the XenMatrix™ Surgical Graft, ensure that the implant remains moist. Avoid drying of the implant through “continued suction devices” as this may negatively impact the performance of the implant.
ADVERSE REACTIONS: Potential complications with the use of any prosthesis may include, but are not limited to, allergy, seroma, infection, inflammation, adhesion, fistula formation, hematoma and recurrence of tissue defect.