ZYPLAST 6 x 1,0ml

ZYPLAST® COLLAGEN IMPLANT PHYSICIAN PACKAGE INSERT DESCRIPTION

Zyplast® collagen implant is a sterile device composed of highly purified bovine dermal collagen that is lightly crosslinked with glutaraldehyde and dispersed in a phosphate-buffered physiological saline containing 0.3% lidocaine.  Zyplast: A form of injectable collagen that is cross-linked with the chemical glutaraldehyde to strengthen the collagen fibers. It is used to treat pronounced scars, lines, and furrows, as well as to define the lip border.

MODE OF ACTION
ZYPLAST collagen implant is introduced into mid to deep dermal tissues for correction of contour deficiencies. After injection, the suspended collagen forms a soft cohesive network of fibers, which is responsible for restoring contour. Over a period of months the implant is colonized by host connective tissue cells; once established, the implant takes on the texture and appearance of normal host tissue and is subject to the same stresses and aging processes.

INDICATIONS AND USAGE
ZYPLAST collagen implant is indicated for the correction of contour deficiencies of soft tissue. The etiology and distensibility of the defect, tissue stress at the implant site, and plane of placement of the implant will affect the degree and duration of contour restoration. Results of in-vitro and in vivo studies suggest that ZYPLAST collagen implant, because it is crosslinked, may persist in tissue to a greater extent than non-crosslinked Zyderm® collagen implant; therefore, it is recommended that during treatment, correction should be limited to no more than
100% of the defect. Two or more implant sessions at intervals of at least two weeks may be required to achieve the desired effect.  Collagen implants have been employed successfully in many areas of the body to correct distensible acne scars, atrophy from disease or trauma, glabellar frown lines, nasolabial folds, or defects secondary to rhinoplasty, skin graft or other surgery, and other soft tissue defects. Severely indurated, sharply marginated and very superficial lesions (e.g., ice-pick acne scars, viral pockmarks, and superficial rhytides such as some perioral lines) have proved difficult to distend and, therefore, are difficult to correct. If a defect cannot be distended because of extensive scarring or nonelastic tissue, the course of correction will be prolonged, if correction is achievable.

Touch-up implantations at 6-18 month intervals will be required to maintain maximum correction. The interval at which touch-up implantations are needed depends on the nature of the lesion, the amount of implant introduced, the plane of placement and the stresses that may exist at corrected sites. For example, ongoing mechanical stresses eventually cause these defects to recur. Correction tends to persist longer in areas in which disease processes have become quiescent. Nevertheless, if a stable level of correction is desired, all patients
should be counselled to anticipate supplemental implantations.

CONTRAINDICATIONS

ZYPLAST collagen implant therapy must not be initiated if the patient has a positive response to the required Collagen Test Implant. Refer to Collagen Test Implant Physician Package Insert for complete instructions for administration and evaluation of the test implant.
ZYPLAST collagen implant must not be used in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
ZYPLAST collagen implant contains lidocaine and must not be used in patients with known lidocaine hypersensitivity.
ZYPLAST collagen implant must not be used in patients with a history of allergies to any bovine collagen products, including but not limited to collagen injectables, collagen implants, hemostatic sponges and collagen-based sutures, because these patients are likely to have hypersensitivity to ZYPLAST collagen implant.
ZYPLAST collagen implant must not be used in patients undergoing or planning to undergo desensitization injections to meat products, as these injections can contain bovine collagen.
ZYPLAST collagen implant is contraindicated for use in breast augmentation, and for implantation into bone, tendon, ligament, or muscle.

ADVERSE REACTIONS
Patients treated intradermally with ZYPLAST collagen implant have reported temporary palpable lumpiness or visible material (milia-like yellow or white papules) at injection sites. Both of these types of treatment responses resolved spontaneously without sequelae, and are believed to reflect reduced shrinkage of crosslinked implants due to water resorption, compared with non-crosslinked collagen implants. Sensitization reactions to injectable collagen implants have occurred in 1-2% of treated patients. Most reactions have been of a hypersensitivity nature and have consisted of erythema, swelling, induration and/or urticaria at implantation sites. Often these reactions have occurred following an unrecognized or unreported positive collagen skin test.
Typically, allergic reactions persist between one and nine months, with an average duration of four months. These reactions may be intermittent or continuous in nature. In rare instances, reactions have resolved in one or two weeks, or have persisted for more than one year. Although several forms of therapy (antihistamines, NSAIDS, oral, topical and intralesional steroids) have been tried, usually they resulted in only temporary improvement. In most cases, time has proved to be the determining factor in the resolution of these reactions. In rare instances,
patients have been left with residual firmness at the site of a resolved adverse reaction.

On rare occasions, abscess formation has occurred at implantation sites. In some cases this reaction has been associated with elevated titers of anti-bovine collagen antibodies, and can be multiple or recurrent. These reactions develop weeks to months following injections and may result in induration and/or scar formation. Most of the remaining responses occurred in patients who became sensitized to collagen implants at some point during their course of treatment. The antigenic specificity of ZYPLAST collagen implant has been determined to be identical to that of ZYDERM collagen implant. During clinical trials and post-marketing surveillance, the incidence of hypersensitivity responses to ZYPLAST collagen implant has been significantly lower
than to ZYDERM collagen implant; however, because of the potential for prolonged local availability of antigen, it is possible that the longterm rate of response to ZYPLAST collagen implant may exceed the low rate experienced to date.

Systemic complaints have been reported by fewer than 0.5% of collagen implant patients. During clinical testing and subsequent monitoring of patient complaints following exposure to ZYPLAST collagen implant, a variety of systemic complaints have been reported. These reports have included flu-like symptoms (fever, headache, myalgia, neuralgia, nausea, malaise, or dizziness); pruritis; rash; transient visual disturbances including blurred vision; tingling and numbness; transient polyarthralgia; and various systemic diseases including immune-mediated
diseases. Rare anaphylactoid responses have been reported, including acute episodes of hypotension, difficulty in breathing, tightness in chest, and/or shortness of breath. Localized necrosis and/or sloughing, resulting in a scab and/or a scar, has occurred following interruption of blood flow such as through blood vessel laceration or occlusion. The extent of necrosis has varied and is in the pattern of the tissue served by the vessel involved. This phenomenon has been reported more frequently in the glabellar region of the face than in other areas; nevertheless, the incidence of this scab or scar formation is less than 1%, and may occur in conjunction with either infection and/or hypersensitivity response. In these patients, implantation can be followed by prolonged blanching or development of ecchymosis at the treatment site. It is possible that overdistention of tissue in areas of compromised vascularity may lead to similar complications, caused by interruption of blood supply to an injection site.

To report an adverse reaction, phone the Medical Monitoring Department, McGhan Medical Corporation, toll-free: (800) 722-2007.

DIRECTIONS FOR USE

NOTE: ZYPLAST collagen implant should be stored at standard refrigerator temperatures. DO NOT FREEZE.

1. Prior to a Collagen Test Implant, the patient should be provided with a copy of the Patient Brochure.

2. Prior to treatment with ZYPLAST collagen implant, the results of the test implantation must be carefully evaluated; the patient must not have a response to the required Collagen Test Implant. For a complete discussion of the Collagen Test Implant, refer to the Collagen Test Implant Physician Package Insert supplied with test syringes.

3. Prior to treatment with ZYPLAST collagen implant, the patient should be fully apprised of the indications, contraindications, warnings, precautions, treatment responses, adverse reactions, and method of administration. Patients also should be advised that supplemental touch-up implantations will be required to maintain maximum correction.

4. A complete medical history should be obtained to determine whether the patient is an appropriate candidate for treatment with ZYPLAST collagen implant.

5. The patient’s soft tissue deficiencies should be characterized with regard to etiology, distensibility, stress at the site, and depth of lesion. Pretreatment photographs are recommended.

6. After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be swabbed with alcohol or other antiseptic.

7. ZYPLAST collagen implant is implanted through a fine-gauge needle. The needle should be placed into the plane(s) of apparent deformity and the defect should not be overcorrected. Best results with ZYPLAST collagen implant are achieved in defects requiring mid to deep dermal implant placement. The rate and degree of subsidence of correction in the implanted area varies with patient, treatment site, and plane of implant placement. Correction should be conservative during initial treatment. Clinical experience has shown that overcorrection has been slow to resolve in the periorbital area and in treatment sites around the vermilion border of the lip. Therefore, caution is advised for ZYPLAST collagen implant use in these areas. Severely indurated defects such as scars, which initially resist distention, may require several treatment sessions before desired correction is obtained. Needles may become occluded or dull during a treatment session, and replacement may be necessary.

8. Vigorous massage of the treated areas is recommended following implantation.

9. Successive implantations at intervals of two or more weeks may be necessary to achieve the desired level of correction.

10. The physician should instruct the patient to report to her/him any evidence of adverse texture change in the surrounding implantation site. Other problems possibly associated with the use of ZYPLAST collagen implant should be promptly brought to the attention of the physician.

11. The syringe and any unused material should be discarded after a single treatment visit.

STORAGE DIRECTIONS
ZYPLAST collagen implant should be stored at standard refrigerator temperatures. DO NOT FREEZE.
ZYPLAST collagen implant has an off-white opaque appearance. In the event that a syringe contains material that is clear (like water), do not use the syringe and notify McGhan Medical Corporation immediately at (800) 624-4261.

CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION, OR USE BY, OR ON THE LAWFUL ORDER OF A LICENSED PHYSICIAN OR AN ORAL AND MAXILLOFACIAL SURGEON.

HOW SUPPLIED
ZYPLAST collagen implant is sterile and supplied in individual treatment syringes packaged with fine-gauge needles, ready for use.

To place an order, phone toll-free: (800) 516.2406
Spanish speaking operators; if English just ask for English operater.