Phasix™ Plug and Patch, Extra Large, 1.4 in x 2.0 in (3.8 cm x 5.1 cm)

1. Millikan KW., Doolas A. “A Long-Term Evaluation of the Modified Mesh-Plug Hernioplasty in Over 2,000 Patients.” Hernia. 2008 Jun; 12(3): 257-260.

2. Phasix™ Plug and Patch Instructions for Use

3. Martin DP, Williams SF. “Medical Applications of Poly-4-Hydroxybutyrate: A Strong Flexible Absorbable Biomaterial.” Biochemical Engineering Journal. 2003 (16): 97-105.

4. Benchtop test data on file at C. R. Bard, Inc. Results may not correlate to performance in humans.

5. Preclinical data on file at C. R. Bard, Inc. Results may not correlate to performance in humans.

6. Nienhuijs S et. al.“Chronic pain after mesh repair of inguinal hernia: a systematic review”. Am J Surg. 2007;194(3):394-400.

7. Demierer S, et. al. “The Effect of Polypropylene Mesh on Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia.” Journal of Surgical Research 2006 (131): 175-181.

Indications for Use

Phasix™ Plug and Patch is indicated for reinforcement of soft tissue where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Contraindications

Since Phasix™ Plug and Patch is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Placement of Phasix™ Plug and Patch in direct contact with bowel or viscera is not recommended. The safety and effectiveness of Phasix™ Plug and Patch in neural tissue and cardiovascular tissue has not been evaluated or established.³ Device manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. The use of this device in susceptible patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided. The safety and effectiveness of Phasix™ Plug and Patch in pediatric use has not been established. If an infection develops, treat the infection aggressively. Consideration should be given regarding the removal of the mesh. An unresolved infection may require removal of the device. This device is for single use only. Do not resterilize or reuse any portion of the Phasix™ Plug and Patch.⁷ To avoid injury, attention is required if fixating the mesh in the presence of nerves or vessels.⁸ 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.⁹ If unused device has been in contact with instruments or supplies used on a patient or contaminated with body fluids, handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. 

Precautions

1. The safety and effectiveness of the Phasix™ Plug and Patch device in infants, children or pregnant women has not been evaluated. 2. Please read all instructions prior to use. 3. Only physicians qualified in the appropriate surgical techniques should use this device. 4. Long term absorbable monofilament sutures are recommended to properly secure the Phasix™ Plug and Patch. 5. When two or more plugs are used for large direct or pantaloon hernias, they should be joined together with sutures where the plugs abut. 6. The safety and effectiveness of Phasix™ Plug and Patch in the proximity of existing or excised cancer has not been established. 

Adverse Reactions

In preclinical testing, Phasix™ Plug and Patch elicited a minimal foreign body response. The tissue reaction resolved as the mesh was resorbed. Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.