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
- TREATMENT WITH ZYDERM COLLAGEN IMPLANT IS CONTRAINDICATED
IN ANY PATIENT EXHIBITING AN UNTOWARD TEST RESPONSE DURING THE FOUR-WEEK
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
(For those patients not exhibiting an untoward test
- 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
- 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.
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,
5. Barr RJ, King FD, McDonald RM, et al: Necrobiotic
granulomas associated with bovine collagen test site injections. J A m Acad Dermatol
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. 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,
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
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
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:
36. Rosenberg M and Reichlin M: Is there an association
between injectable collagen and polymyositis/dermatomyositis? Arth Rheum
A complete bibliography on Injectable Collagen Implant
may be requested from McGhan Medical Corporation.
McGhan Medical Corporation, 48490 Milmont Drive, Fremont,
CA 94538 - USA.