Zyderm

Warnings
Precautions

WARNINGS

A test implantation must be administered and evaluated prior to soft tissue deficiency correction with ZYDERM collagen implant (see Directions for Use for further details). If the test implantation response is positive, the patient must not be treated with ZYDERM collagen implant. 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.

Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus , polymyositis (PM), and dermatomyositis (DM) subsequent to collagen injections in patients with no previous history of these disorders. Conflicting studies have been published (35, 36) in peer reviewed journals regarding the association between PM/DM and injectable collagen. A causal relationship between collagen injections and the onset of PM/DM, or the other connective tissue diseases listed, has not been established.

Also, an increased incidence of cell-mediated and humoral immunity to various collagens have been found in systemic connective tissue diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). 29-34 Patients with these diseases may thus have an increased susceptibility to hypersensitivity responses and/or accelerated clearance of their implants when injected with bovine dermal collagen preparations. Therefore, caution should be used when treating these patients including consideration for multiple skin testing (see Skin Test Package Insert).

Patients with a history of dietary beef allergy should be carefully evaluated before injectable bovine collagen therapy, since it is possible that the collagen component of the beef may be causing the allergy. More than one skin test is highly recommended prior to treating these patients.

ZYDERM collagen implant must not be implanted into blood vessels. Collagen can initiate platelet aggregation, and implantation of ZYDERM collagen implant into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena.

PRECAUTIONS

Use of ZYDERM 1 collagen implant in an individual patient should be limited to 30 cc over a one-year period. Use of ZYDERM 2 collagen implant in an individual patient should be limited to 15 cc over a one-year period. The combination of these products or of ZYDERM in conjunction with Zyplast® collagen implant in an individual patient should be limited to 30 cc over a one-year period. The safety of injecting greater amounts on an annual basis has not been established.

Injectable bovine collagen should be used with caution in patients who are atopic or have a history of allergies. This class of patient has a greater potential of ultimately exhibiting an allergic reaction to bovine collagen than do other patients.

The implantation of ZYDERM collagen implant carries an inherent, yet minimal, risk of infection, as does any transcutaneous procedure.

Use of ZYDERM collagen implant at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.

The safety of ZYDERM collagen implant for use during pregnancy or in infants and children has not been established.

ZYDERM collagen implant should be used with caution in patients on immunosuppressive therapy.

Patients who are using substances which reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.

Overcorrection of lesions in the periorbital area, as well as around the vermilion border of the lip, has been slow to resolve due to minimal tissue stresses at these sites. Therefore, caution is advised when treating these areas. Special caution should be used when implanting ZYDERM 2 collagen implant in these sites, as the more concentrated material may lead to persistent overcorrection.

Clinical experience with injectable collagen implant was not available prior to 1976; the safety of this product for a longer duration is not known.

Since it has been reported that host collagen may be deposited at the site of collagen implantation, the patient should be informed that part or all of the correction may last for 2 years or more.

Treatment Responses

Fewer than 1% of patients receiving ZYDERM collagen implant have at some time reported an intermittent swelling response, involving moderate induration at the implant site and edema within the surrounding tissues. At times this has been accompanied by mild pruritus or minimal transient erythema. These reactions may last only a few hours and are usually associated with causes of peripheral vasodilatation, such as consumption of alcohol, prolonged exposure to sun and/or heat, exercise, and flare-ups of hay fever and other causes of nasal and sinus congestion. To date, these reactions have been self-limiting and have not been shown to affect adversely the long-term success of ZYDERM collagen implant corrections, although they may persist throughout the life of the implant.

On occasion, transient painless bruising or discoloration has been noted to develop at one or more of the implantation sites. Resolution has always been spontaneous.

Approximately 20% of patients treated with ZYDERM 2 collagen implant have reported temporary palpable lumpiness or visible white patches at injection sites. Both of these types of treatment-associated responses resolved spontaneously without sequelae, and are believed to reflect the fact that with ZYDERM 2 collagen implant, a higher concentration of collagen can be injected in a single treatment session.

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

Warnings
Precautions
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