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ZYDERM collagen implant is indicated for the correction of contour deformities of the dermis in non-weight bearing areas. The etiology and distensibility of the lesion, tissue stress at the implant site, and the tissue plane of placement of the implant will affect the degree and duration of contour restoration. ZYDERM collagen implant should be injected into the superficial papillary dermis (see Directions for Use for complete instructions).
ZYDERM 1 and ZYDERM 2 collagen implant 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; rhinoplasty, skin graft or other surgically-induced irregularities; 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 proven 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. Deposits of even small amounts of ZYDERM collagen implant within a scar, however, often soften the tissue and allow for subsequent distension and correction.
Transient or minimal swelling, mild redness and discomfort will probably occur at the implant site immediately following implantation. Increasing discomfort or swelling, or spreading redness should be brought immediately to the physician's attention.
To decrease the total number of treatment visits required, it is recommended that the contour deficiency be overcorrected to compensate for the loss of saline in the suspension. Overcorrection to 1.5-2.0 times the initial depth of the lesion is recommended for ZYDERM 1 collagen implant. A lesser degree of overcorrection is required to achieve a given level of correction with ZYDERM 2 collagen implant. To date, no permanent overcorrection has been reported as a result of this technique.
Syneresis of the implant and the resulting absorption of the exuded saline result in a rapid (less than 24 hour) reduction of overcorrection, which is followed by a further, but more gradual (two or more weeks) reduction as the implant stabilizes. Approximately 25-30% of the ZYDERM 1 collagen implant and a higher percent of the ZYDERM 2 collagen implant volume remains, although this volume varies among individual patients. Therefore, two or more implant sessions at intervals of at least two weeks usually are required to achieve the desired effect.
Long-term follow-up data indicate that “touch-up” implantations at 6- 18 month intervals are usually required to maintain maximum correction. The interval at which touch-up implantations are needed depends on the stresses that may exist at corrected sites. For example, ongoing mechanical stresses (such as smiling or frowning) will eventually cause these defects to recur. However, correction tends to persist longer in areas in which disease processes (such as acne) have been quiescent. Nevertheless, if a stable level of correction is desired, all patients should be counselled to anticipate supplemental implantations.
DOSAGE AND ADMINISTRATION
Directions For Use
NOTE: ZYDERM collagen implant should be stored at standard refrigerator temperatures. DO NOT FREEZE.
Prior to test implantation with ZYDERM collagen implant, the patient should be provided with a copy of the Patient Brochure. The patient should be fully apprised of the indications, contraindications, warnings, precautions, treatment-associated reactions, adverse reactions, and method of administration of ZYDERM collagen implant. Patients also should be advised that supplemental “touch-up” implantations may be required to maintain maximum correction.
- At the time of the initial evaluation, a complete medical history should be obtained to determine conditions that might influence the successful use of ZYDERM collagen implant.
- After verifying that contraindications do not exist, a ZYDERM collagen implant test implantation is administered to ensure that the patient is not sensitive to ZYDERM collagen implant. After cleansing the site, 0.1cc of material from a ZYDERM collagen implant test syringe should be implanted intradermally into a volar forearm surface.
- The results of the test implantation must be carefully evaluated for a four-week period prior to the initiation of treatment. Patients should be instructed to notify their physicians of any untoward test response observed within the four-week period. A positive test site response is defined as: erythema of any degree, induration, tenderness, or swelling at the test site, with or without pruritus, which persists for more than six hours or appears more than 24 hours following implantation. Patients with such responses are ineligible for treatment with ZYDERM collagen implant. In addition, the onset of rash, arthralgia or myalgia should be brought immediately to the attention of the treating physician in order that he might evaluate its possible relationship to the test dose. To date, approximately 3.0% of the patients tested have had one or more of the above-described reactions to the test implantation.
- TREATMENT WITH ZYDERM COLLAGEN IMPLANT IS CONTRAINDICATED IN ANY PATIENT EXHIBITING AN UNTOWARD TEST RESPONSE DURING THE FOUR-WEEK EVALUATION PERIOD.
Occasionally, a normal skin test will exhibit a palpable bead of collagen in the absence of inflammation, swelling or pruritus. If the test implantation response is equivocal, it is recommended that a second test implantation be administered in the opposite arm and evaluated prior to the initiation of treatment. The majority of retest responses will occur within 72 hours; however, the repeat test also should be observed for the full 4 weeks.
Clinical experience has shown that the screening of the test implant cannot be overemphasized. However, a negative skin test does not preclude the possibility of the patient subsequently developing a delayed hypersensitivity response to the implant material following additional exposures.
(For those patients not exhibiting an untoward test response):
- 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.
- 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.
- ZYDERM collagen implant is implanted intradermally through a finegauge needle into the plane(s) of apparent deformity. The needle should be placed as superficially as possible in the papillary dermis and the lesion should be deliberately overcorrected. When using ZYDERM 1 collagen implant, it is recommended that the lesion be overcorrected to 1.5-2.0 times the initial depth of deformity. A lesser degree of overcorrection is required to achieve a comparable level of correction when using the more concentrated ZYDERM 2 collagen implant. If blanching is not achieved, withdraw the needle immediately as it has probably been placed too deeply in the dermis. The rate and degree of subsidence of the implanted area is variable, but utilization of this technique has not resulted in any instances of permanent overcorrection. However, 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. Thus, these areas should be treated cautiously and small amounts of ZYDERM collagen implant should be implanted over several treatment sessions without overcorrection. Severely indurated lesions which initially resist distention often require several treatment sessions before desired correction is obtained. In such lesions it is preferable to implant within the scar rather than beneath it. Needles may become occluded or dull during a treatment session and replacement may be necessary.
- Additional implantations at intervals of two or more weeks are usually necessary to achieve the desired level of correction.
- 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 ZYDERM collagen implant use should also be promptly brought to the attention of the physician.
- Discard any unused material and the syringe after a single treatment visit.
ZYDERM collagen implant is supplied as ZYDERM 1 collagen implant and ZYDERM 2 collagen implant. Test and treatment syringes are packaged sterile with fine-gauge needles, ready for implantation.
ZYDERM Test syringes are appropriate for testing prior to treatment with either ZYDERM collagen implant or ZYPLAST collagen implant.
To place an order, phone toll-free: (800) 624-4261.
ZYDERM collagen implant should be stored at standard refrigerator temperatures. DO NOT FREEZE.
ZYDERM collagen implant has a whitish, opaque or semi-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.
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A complete bibliography on Injectable Collagen Implant may be requested from McGhan Medical Corporation.
McGhan Medical Corporation, 48490 Milmont Drive, Fremont, CA 94538 - USA.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/5/2013
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