Indications
The Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.
Contraindications
- Because Phasix™ ST Umbilical Hernia Patch is fully resorbable, it should not be used in repairs where permanent wound or organ support from the patch is required.
- Do not use this patch for the reconstruction of cardiovascular defects.
Warnings
- Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.
- The use of any synthetic patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the patch.
- If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the patch. An unresolved infection may require the removal of the patch.
- If the unused patch has been in contact with instruments or supplies used on a patient or contaminated with bodily fluids, discard with care to prevent the risk of transmission of viral infections.
- To prevent recurrences when repairing hernias, the patch should be sized with appropriate overlap for the size and location of the defect, taking into consideration any additional clinical factors applicable to the patient. Careful attention to patch fixation placement and spacing will help prevent excessive tension or gap formation between the patch and fascial tissue.
- Phasix™ ST Umbilical Hernia Patch should not be used in pregnant or breastfeeding women.
- The safety and effectiveness of Phasix™ ST Umbilical Hernia Patch in the following applications has not been evaluated or established: a. Pediatric use b. Neural tissue.
- The safety and effectiveness of Phasix™ ST Umbilical Hernia Patch has not been evaluated for trocar use or for closing trocar sites.
- The safety and effectiveness of Phasix™ ST Umbilical Hernia Patch in bridging repairs has not been evaluated or established.
- This patch is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use.
- This patch has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging may compromise the structural integrity and/or essential material and design characteristics that is critical to the overall performance of the patch. This may lead to patch failure which may result in injury to the patient. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the patch 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.
- This patch should be used once the exterior foil pouch has been opened. Do not store for later use. Unused portions of the patch should be discarded.
- Ensure proper orientation; the coated side of the patch should be oriented against the bowel or sensitive organs. Do not place the uncoated patch side against the bowel. There may be a possibility for adhesion formation when the patch is placed in direct contact with the bowel or viscera. (Reference Surface Orientation section.)
- Do not cut or reshape any portion of the Phasix™ ST Umbilical Hernia Patch, except for the positioning strap, as this could impact its effectiveness. Care should be taken not to cut or nick the SorbaFlex™ Memory Technology. If the SorbaFlex™ Memory Technology is cut or damaged during insertion or fixation, additional complications may include but are not limited to, bowel or skin perforation and infection.
- Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may potentially compromise the SorbaFlex™ Memory Technology.
- To ensure a strong repair, the patch should be secured with tacks or sutures through the patch straps or positioning pocket.
- Excess positioning strap material must be cut off below the blue delineation marker to prevent permanent PP material from remaining in the body.
- Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black.
- This patch is not for the use of repair of pelvic organ prolapse via transvaginal approach.
- This patch is not for the use of treatment of stress urinary incontinence.
Precautions
- Please read all instructions prior to use.
- Only physicians qualified in the appropriate open surgical techniques should use this patch. Users should be familiar with strength and patch size requirements. Improper selection, placement, positioning and fixation of the patch can cause subsequent undesirable results.
- Care should be taken not to cut or nick the SorbaFlex™ Memory Technology during fixation.
- The safety and effectiveness of Phasix™ ST Umbilical Hernia Patch in the proximity of existing or excised cancer has not been established.
Adverse Reactions
In preclinical testing, Phasix™ ST Umbilical Hernia Patch elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the patch was resorbed.
Possible complications may include, but are not limited to, seroma, adhesions, hematomas, pain, infection, inflammation, hemorrhage, extrusion, erosion, migration, fistula formation, allergic reaction, and recurrence of the hernia or soft tissue defect.
If the SorbaFlex™ Memory Technology is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult package insert for more detailed safety information and instructions for use.
