Zyderm

Indications
Dosage
How Supplied

INDICATIONS

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.

Test Implantation

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Corrective Implantation

(For those patients not exhibiting an untoward test response):

  1. 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.
  2. 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.
  3. 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.
  4. Additional implantations at intervals of two or more weeks are usually necessary to achieve the desired level of correction.
  5. 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.
  6. Discard any unused material and the syringe after a single treatment visit.

HOW SUPPLIED

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.

Storage Directions

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.

REFERENCES

1. Knapp TR, Luck E, Daniels JR: Behavior of solubilized collagen as a bioimplant. J Surg Res 23:96-105, 1977.

2. Knapp TR, Kaplan EN, Daniels JR: Injectable collagen for soft tissue augmentation. Plast Reconstr Surg 60:398-405, 1977.

3. Stegman SJ, Tromovitch TA: Implantation of collagen for depressed scars. J Dermatol Surg Oncol 6:450-453, 1980.

4. Brooks N: A foreign body granuloma produced by an injectable collagen implant at a test site. J Dermatol Surg Oncol 8:111- 114, 1982.

5. Barr RJ, King FD, McDonald RM, et al: Necrobiotic granulomas associated with bovine collagen test site injections. J A m Acad Dermatol 6:867-869, 1982.

6. Courtiss EH: Cosmetic defects and collagen injection. J A M A 247:3360, 1982.

7. Bailin PL, Bailin MD: Correction of depressed scars following Mohs' surgery: The role of collagen implantation. J Dermatol Surg Oncol 8:845-849, 1982.

8. Jarrett MP, Roguska-Kyts J: Collagen-induced arthritis in a human. Arthritis Rheum 25:1024-1025, 1982.

9. Stegman SJ, Tromovitch TA: Cosmetic dermatologic surgery. Arch Dermatol 118:1013-1016, 1982.

10. Knapp TR: Development of an injectable collagen for soft tissue restoration. in Rubin, LR (ed.): Biomaterials in Reconstructive Surgery St. Louis, CV Mosby, 1983, pp. 882- 910.

11. Cucin RL, Barek D: Complications of injectable collagen implants. Plast Reconstr Surg 71:731, 1983.

12. Pharriss BB, Cooperman LS: Role of collagen in polyarthrtis questioned (letter). Arthritis Rheum 26:694-695, 1983.

13. Watson W, Kaye RL, Klein A, et al: Injectable collagen: A clinical overview. Cutis 31:543-546, 1983.

14. Swanson NA, Stoner JR, Siegle RJ, et al: Treatment site reactions to ZYDERM Collagen implantation. J Dermatol Surg Oncol 9:377-380, 1983.

15. Hanke CW, Robinson JK: Injectable collagen implants. A r c h Dermatol 119:533-534, 1983.

16. Kaplan EN, Falces E, Tolleth H: Clinical utilization of injectable collagen. Ann Plast Surg 10:437-451, 1983.

17. Klein AW: Implantation techniques for injectable collagen: Two-andone- half years of personal clinical experience. J A m A c a d Dermatol 9:224-228, 1983.

18. Castrow FF II, Krull EA: Injectable collagen implant — update. J A m Acad Dermatol 9:889-893, 1983.

19. Stegman SJ: Current Status of Zyderm Collagen implants, in Callen JP et al. (ed.): Current Issues in Dermatology Boston, GK Hall, 1983, pp. 255-268.

20. Kamer FM, Churukian MM: The clinical use of injectable collagen: A three-year retrospective study. Arch Otolaryngol 110:93-98, 1984.

21. Tromovitch TA, Stegman SJ, Glogau RG: Zyderm collagen: Implantation techniques. J Am Acad Dermatol 10:273-278, 1984.

22. Siegle RJ, McCoy JP, Schade W, et al: Intradermal implantation of bovine collagen: Humoral responses assciated with clinical reactions. Arch Dermatol 120:183-187, 1984.

23. Kaplan EN: Clinical variations in the utilization of Zyderm I and II. Plast Reconstr Surg 73:329, 1984.

24. Glogau RG, Stegman SJ: Zyderm Collagen for implantation: Problems for consideration. In Controversies in Dermatology Philadelphia, Saunders, 1984, pp. 294-297.

25. Cooperman LS, Michaeli D: The immunogenicity of injectable collagen: I. A one-year prospective study. J A m A c a d Dermatol 10:638-646, 1984.

26. Cooperman LS, Michaeli D: The immunogenicity of injectable collagen: II. A retrospective review of seventy-two tested and treated patients. J Am Acad Dermatol 10:647-651, 1984.

27. Barr RJ, Stegman SJ: Delayed skin test reaction to injectable collagen implant (ZYDERM). J Am Acad Dermatol 10:652-658, 1984.

28. Klein AW, Rish DC: Injectable Collagen Update. J Dermatol Surg Oncol 10:519-522, 1984.

29. Stuart JM, Huffstutter EH, Townes AS, Kang AH: Incidence and specificity of antibodies to types I, II, III, IV, and V collagen in rheumatoid arthritis and in other rheumatic diseases as measured by 125 I-radioimmunoassay. Arthritis Rheum 26:832-840, 1983.

30. Stuart JM, Postlethwaite AE, Huffstutter EH, Townes AS, Kang AH: Cell-mediated immunity to collagen and collagen alpha-chains in rheumatoid arthritis and other rheumatic diseases. Am J Med 69:13-18, 1980.

31. Claque RB, Shaw MJ, Lennox Holt PJ: Incidence of serum antibodies to native type I and type II collagens in patients with inflammatory arthritis. Ann Rheum Dis 39:201-206, 1980.

32. Rosenberg AM, Hunt DWC, Petty RE: Antibodies to native collagen in childhood rheumatic diseases. J Rheumatol 11:421-424, 1984.

33. Stuart JM, Postlethwaite AE, Kang AH: Evidence of cellmediated immunity to collagen in patients with progressive systemic sclerosis. J Lab Clin Med 88:601-607, 1976.

34. Mackel AM, DeLustro F, Harper FE, LeRoy EC: Antibodies to collagen in scleroderma. Arthritis Rheum 25:522-531, 1982.

35. Cukier J, Beauchamp R, Spindler J, Spindler S, Lorenzo C and Trentham D: Association between bovine collagen dermal implants and a dermatomyositis or a polymyositis-like syndrome. Ann Internal Med 118: 920-928, 1993.

36. Rosenberg M and Reichlin M: Is there an association between injectable collagen and polymyositis/dermatomyositis? Arth Rheum 37:747-753, 1994.

A complete bibliography on Injectable Collagen Implant may be requested from McGhan Medical Corporation.

McGhan Medical Corporation, 48490 Milmont Drive, Fremont, CA 94538 - USA.

Last reviewed on RxList: 7/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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