ZYDERM® and ZYPLAST® Collagen Implants
Approved by the U.S. Food and Drug Administration in 1981 and 1985 respectively, ZYDERM® and ZYPLAST® injectable collagen implants are still widely used as safe and effective choices for smoothing lines, wrinkles and scars, and for defining the lip border. ZYDERM® and ZYPLAST® supplement the skin's natural collagen to treat fine lines, wrinkles, shallow scars and thin-skinned areas.
ZYDERM® and ZYPLAST® implants are indicated for the correction of contour deformities of the dermis in non-weight bearing areas. These implants have been employed successfully in many areas of the body to correct distensible acne scars, glabellar frown lines, nasolabial folds, and other soft tissue defects.
Important Safety Information
All medical procedures are subject to certain risks. Although thousands of men and women have found ZYDERM® and ZYPLAST® Collagen treatments to be a safe, non-surgical option for many skin contour problems, you should be aware of the safety issues and restrictions associated with their use. Although you should review these points at the time of your consultation with a physician trained in the use of collagen, we have summarized them for you as follows:
If you have a reaction to the required skin test, or previous allergic reaction to Injectable collagen products or lidocaine, or have a history of serious allergic (anaphylactic) reaction, ZYDERM® and ZYPLAST® Collagen must not be used. Also, if you are undergoing or planning to undergo desensitization injections to meat products, you cannot receive Injectable collagen. The onset of connective tissue diseases has been reported after treatment with collagen injections in patients with no previous history of these disorders. Conflicting studies have been published in scientific journals regarding the association between polymyositis (PM) and dermatomyositis (DM) and Injectable collagen. A casual relationship between collagen injections and the onset of PM/DM or other connective tissue diseases has not been established. Also, patients with connective tissue disease may have an increased susceptibility to hypersensitivity responses and/or accelerated clearance of their implants. Therefore, Injectable collagen should be used with caution in such patients with consideration given to multiple skin tests. Since studies have shown that injected collagen may stimulate the deposition of your own collagen at injection sites, there is a possibility that part or all of the correction may last two years or more. Use of ZYDERM® I Collagen Implant in an individual patient should be limited to 30 cc over a one-year period. Use of ZYDERM® II 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® 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.
The risk of infection is always present with any injection, and it is possible to experience a reaction to the process itself, such as mild bruising or a slight blush at the injection site. This does not mean it is necessary to discontinue treatment. Previous facial herpes simplex at the site of injection may recur if provoked by the injection. Though unlikely, it is possible for the needle to be accidentally placed through a blood vessel during injection, which could result in temporary discoloration of the treated area, or in tissue death leading to a scab and/or scar formation. Injectable collagen, like other substances that are injected (particularly local anesthetics and steroids injected into the head or neck area or the extremities), could be accidentally injected into a blood vessel. Although this possibility is remote, it could result in a blockage of the blood flow and loss of circulation to nearby sites. Blood flow blockage resulting in permanent loss of vision in one eye has been reported once since product introduction in 1981. Occasionally, injected collagen has been reported as visible in the skin, in the form of a small raised or white area at the treatment site, which may persist from a few weeks to several months. Some areas (such as compressed scars) resist precise placement of the material, resulting in a slight elevation beside the defect. People with histories of atopic or allergic reactions to other substances require extra care when treated with Injectable bovine products. Cautious use of ZYDERM® and ZYPLAST® Collagen is recommended in such cases. In addition, caution is advised with people who are receiving immunosuppressive therapy. (Patients on long-term prednisone or other steroid therapy should consult their doctor before beginning Collagen Replacement Therapy.)
More than one skin test is recommended prior to injectable bovine collagen treatment if you have a history of dietary beef allergy. It is possible that the collagen component of the beef may be causing the allergy. If you are using drugs that reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs, you may, as with any injection, experience increased bruising or bleeding at injection sites. Active inflammatory skin conditions (eruptions such as cysts, pimples, rashes or hives) or infections require that treatment be postponed, until the condition has been controlled. The safety of treatment during pregnancy or in infants or children has not been established. With more than 500,000 people treated since 1976, Injectable collagen has proven to be safe. However, a small number (one to two percent) have developed an allergic reaction after one or more injections, which has consisted of prolonged redness, swelling, itching and/or firmness at some or all of the sites. On rare occasions, these reactions can proceed to a cyst-like reaction that can drain, and may form a scar. Between one and nine months is the usual duration, but a few cases have involved intermittent flare-ups which have exceeded 24 months. Importantly, many people who developed an allergic reaction after treatment did not report or recognize a response to the skin test. (With proper monitoring of the skin test, many of these later reactions could have been prevented.) Systemic complaints have been reported in fewer than five per one thousand people treated and included flu-like symptoms (nausea, dizziness, headache, join aches), rash, visual disturbances, anaphylactic reactions (severe allergic reaction) involving difficulty in breathing, and various systemic diseases including immune-mediated diseases. Since every patient's experiences and physical make-up are different and every physician's technique is unique, there have been cases reported where collagen injections have not achieved the desired result.