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Sensitization reactions to injectable collagen implants have occurred in 1-2% of treated patients. Most reactions have been of a hypersensitivity nature and have consisted of erythema, swelling, induration and/or urticaria at implantation sites.
Often these reactions have occurred following an unrecognized or unreported positive collagen skin test. Most of the remaining responses occurred in patients who became sensitized to ZYDERM collagen implant at some point during their course of treatment. Approximately 80% of these reactions occur within four weeks following the sensitizing dose.
Typically, allergic reactions persist between one and nine months, with an average duration of four months. These reactions may be intermittent or continuous in nature. In rare instances, reactions have resolved in one or two weeks or have persisted for more than one year. Although several forms of therapy (antihistamines; oral, topical and intralesional steroids) have been tried, they usually resulted in only temporary improvement. In most cases, time has proved to be the determining factor in the resolution of these reactions. In rare instances, patients have been left with residual firmness at the site of a resolved adverse reaction.
On rare occasions, the hypersensitivity response has progressed to a cystic reaction which may drain purulent material. The incidence and severity of this type of hypersensitivity response reported to date has been greater with ZYPLAST collagen implant than with ZYDERM collagen implant. These reactions develop weeks to months following injection and may result in scar formation, rarely requiring medical revision to correct. This type of reaction can occur as multiple and/or recurrent sterile abscesses which tend to be persistent and resistant to drug therapy; careful incision and drainage has been a useful treatment.
Infections at implantation sites have occurred in fewer than one per thousand treated patients, and herpes simplex eruptions at sites which had been previously affected with herpes simplex have been reported in fewer than one per ten thousand patients. These responses resolved quickly and without sequelae.
Systemic complaints have been reported by fewer than 0.5% of collagen implant patients. During clinical testing and subsequent monitoring of patient complaints following exposure to ZYDERM collagen implant, a variety of systemic complaints have been reported. These reports have included flu-like symptoms (fever, myalgia, neuralgia, headache, nausea, malaise, or dizziness); pruritis; rash; transient visual disturbances including blurred vision; tingling and numbness; transient polyarthralgia; and various systemic diseases including immune-mediated diseases. Rare anaphylactoid responses have been reported with ZYDERM collagen implant, including acute episodes of hypotension, difficulty in breathing, tightness in chest, and/or shortness of breath.
As with any injection into the head or neck, the injected material may be inadvertently implanted in a blood vessel. Localized necrosis and/or sloughing, which may result in a scar, has occurred following interruption of blood flow through blood vessel laceration or occlusion, or through tissue overdistention which compromised vascularity. The extent of necrosis has varied and has been reported more frequently in the glabellar region of the face than in other areas; nevertheless, the incidence is less than 1% of treated patients. Scar formation may also occur in conjunction with either infection and/or hypersensitivity responses. If implantation is followed by prolonged blanching or significant ecchymosis at the treatment site, gentle massage and close follow-up are recommended.
In addition, forceful injection into superficial dermal arterial branches of the face and scalp could cause retrograde movement of the implant material into retinal arteries, resulting in vascular occlusion. Such a complication has been reported with the use of ZYDERM collagen implant in one patient and resulted in the sudden and permanent loss of vision in one eye. Similar complications have been associated with other injectable preparations including corticosteroids, local anesthetics, and angiographic agents. These findings emphasize the importance of superficial dermal implantation to avoid dermal blood vessels during implantation of ZYDERM collagen implant.
To report an adverse reaction, phone the Medical Monitoring Department, McGhan Medical Corporation, toll-free: (800) 722-2007.
Read the Zyderm (highly purified bovine dermal collagen implant) Side Effects Center for a complete guide to possible side effects
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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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