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Guidelines of care for soft tissue augmentation: Collagen implants
This report reflects ~ e best data available at the time the report was prepared, but caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for soft tissue augmentation: Collagen implants Guidelines~Outcomes Committee: Lynn A. Drake, MD, Chairman, Scott M. Dinehart, MD, Evan R. Farmer, MD, Robert W. Goltz, MD, Gloria F. Graham, MD, Mafia K. Hordinsky, MD, Charles W. Lewis, MD, David M. Pafiser, MD, Duane C. Whitaker, MD, Barbara Butler, CPA-SDR Consultant, and Barbara J. Lowery, MPH Task Force: Harold J. Brody, MD, Chairman, Scott M. Dinehart, MD, Melvin L. Elson, MD, C. William Hanke, MD, June K. Robinson, MD, and John W. Skouge, M D I. Introduction The American Academy of Dermatotogy's Guidelines/Outcomes Committee is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration. II. Definition The most common type of collagen implant is bovine collagen and it is the subject of this document. Bovine collagen implants consist of sterile, purified, reconstituted fibrillar bovine collagen that is injected into the dermal layers of the skin for the purpose of soft tissue augmentation. Current Food and Drug Administration-approved products consist of preparations containing 35 mg/ml of collagen (Zyderm 1), 65 mg/ml of collagen (Zyderm 11"),or 35 mg/ml of cross-linked collagen (Zyplast). Cross-linking of collagen is accomplished by the addition of glutaraldehyde and is associated with a marked decrease in biologic degradation. All formulations are suspended in phosphate-buffered saReprintrequests:AmericanAcademyof Dermatology,P.O. Box 4014, Schaumburg, IL 60168-4014. (Providedfree of charge) J AM ACADDe~VtATOL1996;34:698-702. Copyright © 1996 by the American Academy of Dermatology, Inc. 0190-9622/96 $5.00 + 0 16/1/70952
698
line solution containing 0.3% lidocaine and are supplied in syringes that require refrigerated storage. III. Rationale A. Scope For centuries physicians have attempted to augment skin by injecting a variety of agents into the de/mis and subcutaneous fat. Bovine collagen implants have become increasingly popular for use in dermal augmentation of the skin since their introduction in the 1980s. After implantation, all current products undergo degradation by the body's own mechanisms. For this reason periodic maintenance injections are necessary to sustain correction. The following conditions are amenable to treatment with bovine collagen injections: 1. Painful corns or calluses 2. Depressed scars a. Postsurgical (e.g., after rhinoplasty or skin grafting) b. Trauma induced c. Resulting from acne or other disease 3. Wrinkles, creases, and lines caused by facial expression, aging, and other 4. Dermal atrophy from disease or from injection of corticosteroids 5. Angular cheilitis 6. Situations in which enhancement of facial contour is desirable (e.g., patient desires thicker lips) 7. Other The following conditions do not usually respond well to bovine collagen implants:
Journal of the American Academy of Dermatology Volume 34, Number 4
1. Ice pick scars 2. Viral pockmarks 3. Abdominal stretch marks 4. Conditions in which loss of soft tissue is primarily characterized by a loss of subcutaneous tissue 5. Other B. Issue Physician qualifications 1. General a. The physician should have completed residency training or be board certified in an appropriate specialty, such as dermatology. b. The physician should have knowledge of 1) The skin and subcutaneous tissues 2) Bovine collagen implants including their likelihood of improving various types of scars and depressions of the skin. 2. Specific The physician should have appropriate Iraining in bovine collagen implantation techniques during a. Residency, or b. Postgraduate training that includes hands-on experience IV. Diagnostic criteria A. Clinical Selection and evaluation of patients are critical in determining the feasibility of the procedure being considered. Patients undergoing bovine collagen implantation should have an appropriate history and physical examination. 1. History may include a. General medical history as appropriate b. Condition or area being treated 1) Duration 2) l.xJcation 3) Precipitating event(s) 4) Previous treatment(s) c. Patients' expectations, desires, and tolerance of side effects d. Conditions requiring caution in the use of collagen injections 1) History of autoimmune connective tissue disease 2) History of facial herpes simplex 3) History of atopy or allergic reaction to other substances 4) Current or long-term use of immunosuppressive therapy 5) History of a bleeding disorder or use of agents that affect coagulation,
Drake et al. 699 such as aspirin and other platelet-inhibitory agents, and warfarin and other anticoagulants 6) History of keloids 7) Other e. Conditions that are absolute contraindications to collagen injection 1) Reaction to required skin test 2) Previous allergic reaction to injectable collagen products or lidocaine 3) History of serious anaphylactic reactions 4) Current or planned injections for desensitization to meat products f. Other 2. Physical examination may include a. General physical examination as appropriate b. Evaluation of the area(s) to be treated to assess likelihood of improvement with bovine collagen implants c. Inspection of the skin at and near the area(s) of planned injection for 1) Presence of active dermatologic disease (e.g., active ache lesions or herpes simplex) 2) Overall thickness and texture of the skin 3) Other d. Other 3. Other The patient should understand the procedure and its limitations so that expectations are realistic. B. Diagnostic tests Skin testing with Collagen Test Implant is required before augmentation. Single skin testing or double skin testing may be performed. Skin testing may be done in the following manner:. 1. The patient is tested on day 1 in one ann. The skin test is evaluated at 48 to 72 hours and at 4 weeks for erythema, induration, or pruritus. 2. If the test is negative at 4 weeks (absence of erythema or induration), the patient may undergo augmentation. If a second test is desired, the second test is placed in the skin of the volar aspect of the other forearm or other easily evaluated site. Both skin tests are read 2 weeks after the second skin test is placed. If both skin tests are negative, the patient may then undergo augmentation. 3. Equivocal tests may require a third test. 4. Patients are instructed to notify the physician of any untoward test response ob-
700 Drake et al. served during a period of up to 4 weeks after the last skin test. 5. Test site reaction '~ One percent to 5% of persons will have a hypersensitivity test site reaction characterized by erytherna, induration, and occasional pruritus or tenderness at the test site are~ Seventy percent of these reactions occur within the first 72 hours, an additional 10% within 7 days, and the remainder within 1 month of application of the test dose. Positive test site reactions are transient and last an average of 4 months. Ninety percent of patients with positive skin tests have circulating antibodies against bovine collagen. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical a. Preoperative 1) Obtain informed consent. 2) Remove all makeup before injection. 3) Cleanse the area with an antiseptic before injection. 4) Patients am often treated in a vertical or semireclining position to best judge the effects of gravity on the bovine collagen implant. b. Procedure Bovine collagen implants am supplied in a syringe and injected through a 30gauge needle. The needle should pierce the skin, usually at a 45-degree angle, and then be advanced once within the dermis to the proper level of implantation. 1) Non-cross-linked bovine collagen implants Non-cross-linked collagen implant is used for superficial dermal defects. The proper injection plane is the upper dermis, and often the needle can be seen through the epidermis. When the skin is injected with proper technique, a peau d'orange appearance and ballooning will oc-
Journal of the American Academy of Dermatology April 1996
cur. Multiple injections are made side by side when filling a linear area. Overcorrection of 150% to 200% is desirable with 35 mg/ml and somewhat less overcorrection is optimal for 65 mg/ml of non-crosslinked bovine collagen implant. 2) Cross-linked bovine collagen implant Cross-linked collagen implant is more useful for deeper dermal filling. When the skin is injected with proper technique, there is no ballooning or blanching, but the implant can be felt by palpation. If there is no resistance to injection, then the injection site is too low and is probably in the subcutaneous fat. If beading occurs, then the injection site is too high. The multiple injection t~hnique is commonly used. 3) Layering techniques In some circumstances, non-crosslinked collagen can be inserted in the upper dermis over the mid dermal implantation of cross-linked collagen to attain optimum correction of dermal defects. c. Postoperative care No special wound care is needed after treatment with bovine collagen implants. Cosmetics can be immediately applied. d. Postoperative findings 1) Usualand expected a) Fa3~ema b) Temporary overcorrection
c) Whealing d) Edema e) Bruising (resolution of bruising may be accompanied by pigmentary changes) 2) Occasional a) Collagen visiblein the skin (may produce ridging or beaded appearance to the skin) b) Treatment site reaction One percent to 3% of persons having a negative single skin test reaction will have a hypersensitivity treatment site reaction after their first treatment with non-cross-linked bovine collagen implant. The reaction is identical to those of a test site
Journal of the American Academy of Dermatology Volume 34, Number 4
hypersensitivity reaction (see section IV.B.5.). Fewer reactions can be expected with cross-linked collagen. Double skin testing will eliminate most persons who would experience this reaction. Treatment of the reaction with antihistamines and intralesional corticosteroids may provide symptomatic relief. c) Reactivation of latent herpes simplex infection 3) Rare a) Recurrent, intermittent swelling at the treatment site This type of swelling is accompanied by erythema and induration in approximately half of the cases and may last up to 3 years. Occasionally the swelling can be initiated by exercise, ingestion of alcohol, or other causes of vasodilation. b) Local necrosis Local necrosis occurs in 0.09% of treated patients and is most common with the use of crosslinked collagen, particularly when used in the glabellar region (56%). Interruption of the vascular supply to the involved area is the presumed mechanism. The vessel may be injured, obstructed with collagen, or compressed. Healing may be accompanied by scarring and pigmentary change. Local necrosis begins soon after injection and can be heralded by an initial blanch or cyanotic appearance of the skin. Shortly thereafter the skin turns dark and an eschar develops. Resolution is often accompanied by scar formation. Suspected early necrosis can be treated by massage. Ice and nitroglycerin ointment have been suggested as reasonable treatments, but their efficacy is unproved. c) Abscess.formation Abscesses develop at treatment injection sites (0.01% for noncross-linked and 0,07% for
Drake et al.
701
cross-linked collagen) in 0.04% of patients. Abscess formation most often occurs 8 to 12 weeks after treatment and varies from a small fluctuant or draining papule or nodule at the site of injection to severe fluctuance with significant swelling, erythema, and induration of the surrounding tissue. Sometimes an abscess will develop in only one injection site. Scarring may result. Abscess formation is thought to be a severe hypersensitivity reaction. Eighty-six percent of patients with this reaction have elevated collagen antibody titers. Treatment of the abscess consists of drainage and intralesional injection of corticosteroids. Oral corticosteroids given over short durations of time have also proved useful. Abscess formation can occur as long as 2 years after injection. d) Visual loss In one instance an embolus of collagen entered the ophthalmic artery after an attempted correction of g!abella frown lines. Partial loss of vision resulted from the arterial occlusion. B. Miscellaneous The issue of whether injection of collagen is associated with an increased risk of significant systemic connective tissue disease is controversial. VI. Supporting evidence See Bibliography (Appendix) VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Further, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
702
Journal of the American Academy of Dermatology April 1996
D r a k e e t al.
Appendix. Bibliography Clark DP, Hanke CW, Swanson NA. Dermal implants: safety of products injected for soft tissue augmentation. J AM ACAD DERMATOL 1989;21:992-8. Cooperman LS, Mackinnon V, Bechler G, et al. Injectable collagen: a six-year clinical investigation. Aesthet Plast Surg 1985;9:145-5 I. Cucin RL, Barek D. Complications of injectable collagen implants. Plast Reconstr Surg 1983;71:731. DeLustro F, Dasch J, Keefe J, et al. Immune response to allogeneic and xenogeneic implants of collagen and collagen derivatives. Clin Orthop 1990;260:263-79. Elson NIL. Clinical assessment of Zyplast Implant: a year of experience for soft tissue contour correction. J AM ACAD DERMATOL1988;18:707-13. Elson ML. Correction of dermal contour defects with injectable collagens: choosing and using these materials. Semin Dermatol 1987;6:77-82. Elson ML. The role of skin testing in the use of collagen injectable materials. J Dermatol Surg Oncol 1989;15:301-3.
Geronemus RG, Hanke CW, eds. Fundamentals of dermatologic surgery for the dermatologist. Schaumburg, m: Association of Academic Dermatologic Surgeons, 1992:57-9. Hanke CW, Higley HR, Jolivette DM, et al. Abscess formation and local necrosis after treatment with Zyderm or Zyplast Collagen Implant. J AM ACADDERMATOL1991;25:319-26. Kdein AW. Indications and implantation techniques for the various formulations of injectable collagen. J Dermatol Surg Oncol 1988;14:27-30. McPherson JM, Ledger PW, Sawamura S, et al. The preparation and physicochemical characterization of an injectable form of reconstituted, glutaraldehyde cross-linked, bovine corium collagen. J Biomed Mater Res 1986;20:79-92. Monheit GD. Soft tissue augmentation. In: Wheeland RG, ed. Cosmetic surgical procedures. Philadelphia: WB Saunders, 1994:446-52. U.S. Food and Drug Administration. Approval letter to Collagen Corporation, July 22, 1981. Zyderm/Zyplast physician package insert. Collagen Biomedical, Palo Alto, Califomia, 1992.
1-800-55-MOSBY This number links you to the full text of articles published in over 20,000 journals, including Mosby journals. M O S B Y D o c u m e n t E x p r e s s ®, a rapid response information retrieval service, provides quick turnaround, 24-hour availability, and speedy delivery methods. For inquiries and pricing information, call our toil-free, 24-hour order line: 1-800-55-MOSBY; outside the United States: 415-259-5046; fax: 415-259-5019; E-mail: [email protected]. MOSBYDocumentErpress~ is offeredin cooperationwithDynamicInfommtionCorp.
Guidelines of care for soft tissue augmentation: Collagen implants Guidelines~Outcomes Committee: Lynn A. Drake, MD, Chairman, Scott M. Dinehart, MD, Evan R. Farmer, MD, Robert W. Goltz, MD, Gloria F. Graham, MD, Mafia K. Hordinsky, MD, Charles W. Lewis, MD, David M. Pafiser, MD, Duane C. Whitaker, MD, Barbara Butler, CPA-SDR Consultant, and Barbara J. Lowery, MPH Task Force: Harold J. Brody, MD, Chairman, Scott M. Dinehart, MD, Melvin L. Elson, MD, C. William Hanke, MD, June K. Robinson, MD, and John W. Skouge, M D I. Introduction The American Academy of Dermatotogy's Guidelines/Outcomes Committee is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration. II. Definition The most common type of collagen implant is bovine collagen and it is the subject of this document. Bovine collagen implants consist of sterile, purified, reconstituted fibrillar bovine collagen that is injected into the dermal layers of the skin for the purpose of soft tissue augmentation. Current Food and Drug Administration-approved products consist of preparations containing 35 mg/ml of collagen (Zyderm 1), 65 mg/ml of collagen (Zyderm 11"),or 35 mg/ml of cross-linked collagen (Zyplast). Cross-linking of collagen is accomplished by the addition of glutaraldehyde and is associated with a marked decrease in biologic degradation. All formulations are suspended in phosphate-buffered saReprintrequests:AmericanAcademyof Dermatology,P.O. Box 4014, Schaumburg, IL 60168-4014. (Providedfree of charge) J AM ACADDe~VtATOL1996;34:698-702. Copyright © 1996 by the American Academy of Dermatology, Inc. 0190-9622/96 $5.00 + 0 16/1/70952
698
line solution containing 0.3% lidocaine and are supplied in syringes that require refrigerated storage. III. Rationale A. Scope For centuries physicians have attempted to augment skin by injecting a variety of agents into the de/mis and subcutaneous fat. Bovine collagen implants have become increasingly popular for use in dermal augmentation of the skin since their introduction in the 1980s. After implantation, all current products undergo degradation by the body's own mechanisms. For this reason periodic maintenance injections are necessary to sustain correction. The following conditions are amenable to treatment with bovine collagen injections: 1. Painful corns or calluses 2. Depressed scars a. Postsurgical (e.g., after rhinoplasty or skin grafting) b. Trauma induced c. Resulting from acne or other disease 3. Wrinkles, creases, and lines caused by facial expression, aging, and other 4. Dermal atrophy from disease or from injection of corticosteroids 5. Angular cheilitis 6. Situations in which enhancement of facial contour is desirable (e.g., patient desires thicker lips) 7. Other The following conditions do not usually respond well to bovine collagen implants:
Journal of the American Academy of Dermatology Volume 34, Number 4
1. Ice pick scars 2. Viral pockmarks 3. Abdominal stretch marks 4. Conditions in which loss of soft tissue is primarily characterized by a loss of subcutaneous tissue 5. Other B. Issue Physician qualifications 1. General a. The physician should have completed residency training or be board certified in an appropriate specialty, such as dermatology. b. The physician should have knowledge of 1) The skin and subcutaneous tissues 2) Bovine collagen implants including their likelihood of improving various types of scars and depressions of the skin. 2. Specific The physician should have appropriate Iraining in bovine collagen implantation techniques during a. Residency, or b. Postgraduate training that includes hands-on experience IV. Diagnostic criteria A. Clinical Selection and evaluation of patients are critical in determining the feasibility of the procedure being considered. Patients undergoing bovine collagen implantation should have an appropriate history and physical examination. 1. History may include a. General medical history as appropriate b. Condition or area being treated 1) Duration 2) l.xJcation 3) Precipitating event(s) 4) Previous treatment(s) c. Patients' expectations, desires, and tolerance of side effects d. Conditions requiring caution in the use of collagen injections 1) History of autoimmune connective tissue disease 2) History of facial herpes simplex 3) History of atopy or allergic reaction to other substances 4) Current or long-term use of immunosuppressive therapy 5) History of a bleeding disorder or use of agents that affect coagulation,
Drake et al. 699 such as aspirin and other platelet-inhibitory agents, and warfarin and other anticoagulants 6) History of keloids 7) Other e. Conditions that are absolute contraindications to collagen injection 1) Reaction to required skin test 2) Previous allergic reaction to injectable collagen products or lidocaine 3) History of serious anaphylactic reactions 4) Current or planned injections for desensitization to meat products f. Other 2. Physical examination may include a. General physical examination as appropriate b. Evaluation of the area(s) to be treated to assess likelihood of improvement with bovine collagen implants c. Inspection of the skin at and near the area(s) of planned injection for 1) Presence of active dermatologic disease (e.g., active ache lesions or herpes simplex) 2) Overall thickness and texture of the skin 3) Other d. Other 3. Other The patient should understand the procedure and its limitations so that expectations are realistic. B. Diagnostic tests Skin testing with Collagen Test Implant is required before augmentation. Single skin testing or double skin testing may be performed. Skin testing may be done in the following manner:. 1. The patient is tested on day 1 in one ann. The skin test is evaluated at 48 to 72 hours and at 4 weeks for erythema, induration, or pruritus. 2. If the test is negative at 4 weeks (absence of erythema or induration), the patient may undergo augmentation. If a second test is desired, the second test is placed in the skin of the volar aspect of the other forearm or other easily evaluated site. Both skin tests are read 2 weeks after the second skin test is placed. If both skin tests are negative, the patient may then undergo augmentation. 3. Equivocal tests may require a third test. 4. Patients are instructed to notify the physician of any untoward test response ob-
700 Drake et al. served during a period of up to 4 weeks after the last skin test. 5. Test site reaction '~ One percent to 5% of persons will have a hypersensitivity test site reaction characterized by erytherna, induration, and occasional pruritus or tenderness at the test site are~ Seventy percent of these reactions occur within the first 72 hours, an additional 10% within 7 days, and the remainder within 1 month of application of the test dose. Positive test site reactions are transient and last an average of 4 months. Ninety percent of patients with positive skin tests have circulating antibodies against bovine collagen. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical a. Preoperative 1) Obtain informed consent. 2) Remove all makeup before injection. 3) Cleanse the area with an antiseptic before injection. 4) Patients am often treated in a vertical or semireclining position to best judge the effects of gravity on the bovine collagen implant. b. Procedure Bovine collagen implants am supplied in a syringe and injected through a 30gauge needle. The needle should pierce the skin, usually at a 45-degree angle, and then be advanced once within the dermis to the proper level of implantation. 1) Non-cross-linked bovine collagen implants Non-cross-linked collagen implant is used for superficial dermal defects. The proper injection plane is the upper dermis, and often the needle can be seen through the epidermis. When the skin is injected with proper technique, a peau d'orange appearance and ballooning will oc-
Journal of the American Academy of Dermatology April 1996
cur. Multiple injections are made side by side when filling a linear area. Overcorrection of 150% to 200% is desirable with 35 mg/ml and somewhat less overcorrection is optimal for 65 mg/ml of non-crosslinked bovine collagen implant. 2) Cross-linked bovine collagen implant Cross-linked collagen implant is more useful for deeper dermal filling. When the skin is injected with proper technique, there is no ballooning or blanching, but the implant can be felt by palpation. If there is no resistance to injection, then the injection site is too low and is probably in the subcutaneous fat. If beading occurs, then the injection site is too high. The multiple injection t~hnique is commonly used. 3) Layering techniques In some circumstances, non-crosslinked collagen can be inserted in the upper dermis over the mid dermal implantation of cross-linked collagen to attain optimum correction of dermal defects. c. Postoperative care No special wound care is needed after treatment with bovine collagen implants. Cosmetics can be immediately applied. d. Postoperative findings 1) Usualand expected a) Fa3~ema b) Temporary overcorrection
c) Whealing d) Edema e) Bruising (resolution of bruising may be accompanied by pigmentary changes) 2) Occasional a) Collagen visiblein the skin (may produce ridging or beaded appearance to the skin) b) Treatment site reaction One percent to 3% of persons having a negative single skin test reaction will have a hypersensitivity treatment site reaction after their first treatment with non-cross-linked bovine collagen implant. The reaction is identical to those of a test site
Journal of the American Academy of Dermatology Volume 34, Number 4
hypersensitivity reaction (see section IV.B.5.). Fewer reactions can be expected with cross-linked collagen. Double skin testing will eliminate most persons who would experience this reaction. Treatment of the reaction with antihistamines and intralesional corticosteroids may provide symptomatic relief. c) Reactivation of latent herpes simplex infection 3) Rare a) Recurrent, intermittent swelling at the treatment site This type of swelling is accompanied by erythema and induration in approximately half of the cases and may last up to 3 years. Occasionally the swelling can be initiated by exercise, ingestion of alcohol, or other causes of vasodilation. b) Local necrosis Local necrosis occurs in 0.09% of treated patients and is most common with the use of crosslinked collagen, particularly when used in the glabellar region (56%). Interruption of the vascular supply to the involved area is the presumed mechanism. The vessel may be injured, obstructed with collagen, or compressed. Healing may be accompanied by scarring and pigmentary change. Local necrosis begins soon after injection and can be heralded by an initial blanch or cyanotic appearance of the skin. Shortly thereafter the skin turns dark and an eschar develops. Resolution is often accompanied by scar formation. Suspected early necrosis can be treated by massage. Ice and nitroglycerin ointment have been suggested as reasonable treatments, but their efficacy is unproved. c) Abscess.formation Abscesses develop at treatment injection sites (0.01% for noncross-linked and 0,07% for
Drake et al.
701
cross-linked collagen) in 0.04% of patients. Abscess formation most often occurs 8 to 12 weeks after treatment and varies from a small fluctuant or draining papule or nodule at the site of injection to severe fluctuance with significant swelling, erythema, and induration of the surrounding tissue. Sometimes an abscess will develop in only one injection site. Scarring may result. Abscess formation is thought to be a severe hypersensitivity reaction. Eighty-six percent of patients with this reaction have elevated collagen antibody titers. Treatment of the abscess consists of drainage and intralesional injection of corticosteroids. Oral corticosteroids given over short durations of time have also proved useful. Abscess formation can occur as long as 2 years after injection. d) Visual loss In one instance an embolus of collagen entered the ophthalmic artery after an attempted correction of g!abella frown lines. Partial loss of vision resulted from the arterial occlusion. B. Miscellaneous The issue of whether injection of collagen is associated with an increased risk of significant systemic connective tissue disease is controversial. VI. Supporting evidence See Bibliography (Appendix) VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Further, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
702
Journal of the American Academy of Dermatology April 1996
D r a k e e t al.
Appendix. Bibliography Clark DP, Hanke CW, Swanson NA. Dermal implants: safety of products injected for soft tissue augmentation. J AM ACAD DERMATOL 1989;21:992-8. Cooperman LS, Mackinnon V, Bechler G, et al. Injectable collagen: a six-year clinical investigation. Aesthet Plast Surg 1985;9:145-5 I. Cucin RL, Barek D. Complications of injectable collagen implants. Plast Reconstr Surg 1983;71:731. DeLustro F, Dasch J, Keefe J, et al. Immune response to allogeneic and xenogeneic implants of collagen and collagen derivatives. Clin Orthop 1990;260:263-79. Elson NIL. Clinical assessment of Zyplast Implant: a year of experience for soft tissue contour correction. J AM ACAD DERMATOL1988;18:707-13. Elson ML. Correction of dermal contour defects with injectable collagens: choosing and using these materials. Semin Dermatol 1987;6:77-82. Elson ML. The role of skin testing in the use of collagen injectable materials. J Dermatol Surg Oncol 1989;15:301-3.
Geronemus RG, Hanke CW, eds. Fundamentals of dermatologic surgery for the dermatologist. Schaumburg, m: Association of Academic Dermatologic Surgeons, 1992:57-9. Hanke CW, Higley HR, Jolivette DM, et al. Abscess formation and local necrosis after treatment with Zyderm or Zyplast Collagen Implant. J AM ACADDERMATOL1991;25:319-26. Kdein AW. Indications and implantation techniques for the various formulations of injectable collagen. J Dermatol Surg Oncol 1988;14:27-30. McPherson JM, Ledger PW, Sawamura S, et al. The preparation and physicochemical characterization of an injectable form of reconstituted, glutaraldehyde cross-linked, bovine corium collagen. J Biomed Mater Res 1986;20:79-92. Monheit GD. Soft tissue augmentation. In: Wheeland RG, ed. Cosmetic surgical procedures. Philadelphia: WB Saunders, 1994:446-52. U.S. Food and Drug Administration. Approval letter to Collagen Corporation, July 22, 1981. Zyderm/Zyplast physician package insert. Collagen Biomedical, Palo Alto, Califomia, 1992.
1-800-55-MOSBY This number links you to the full text of articles published in over 20,000 journals, including Mosby journals. M O S B Y D o c u m e n t E x p r e s s ®, a rapid response information retrieval service, provides quick turnaround, 24-hour availability, and speedy delivery methods. For inquiries and pricing information, call our toil-free, 24-hour order line: 1-800-55-MOSBY; outside the United States: 415-259-5046; fax: 415-259-5019; E-mail: [email protected]. MOSBYDocumentErpress~ is offeredin cooperationwithDynamicInfommtionCorp.