Zyderm and Zyplast ® Information and Background
Product Summary Zyderm® and Zyplast® implants, introduced in the early 1980's, remain the most widely used, safe, and effective choices for smoothing lines, wrinkles, scars, and for defining the lip border.
More than 1 million treatments in over 40 countries have been administered with Zyderm® and Zyplast® implants.
Although still popular, the use of this product in the U.K. has declined in recent years due to the introduction of newer fillers that do not require a patch test prior to treatment.
Generic name Bovine dermal collagen plus 0.3% lignocaine.
How is it made? From cow skins.
Is a skin test required before treatment? Yes. Four weeks prior to the procedure, Collagen Test Implant is administered intradermally into the volar forearm to determine if a patient has a sensitivity to the implants. Ninety-seven percent (97%) of men and women tested can be treated with Zyderm® and Zyplast® implants.
Is it temporary or permanent? Collagen is completely broken down within the skin over a period of months, eventually leaving no trace of the filler.
Licenced status Medical device.
Should be used by Trained members of the medical profession only.
Product range Zyderm® 1 implant Is used to treat fine lines, wrinkles, shallow scars and thin-skinned areas.
Zyderm® 2 implant Is used to treat moderate lines, wrinkles and scars. Both are administered by an injection with a fine-gauge needle just beneath the surface of the skin.
Zyplast® Is a form of injectable collagen that is cross-linked with the chemical glutaraldehyde to strengthen the collagen fibres. It is used to treat pronounced scars, lines, and furrows, as well as to define the lip border.
Not to be used in Patients who have a reaction to the required skin test, or previous allergic reaction to injectable collagen products or lidocaine, or patients who have a history of serious allergic (anaphylactic) reactions, Zyderm® or 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.
Individuals with a known hypersensitivity to lignocaine.
Pregnant or breastfeeding women.
Individuals with a history of autoimmune disease.
Patients who have a tendency to develop hypertrophic scars.
Duration of effect This depends upon the degree of correction required, your age and lifestyle as well as the correct placement of the product by a practitioner.
Reported side effects Transient erythema (redness), swelling, pain, itching, discoloration or tenderness at the implant site. 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.
With more than 1 million 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.)
Costs Again, this depends on area treated and how much is required, and the practitioner doing the treatment, but ranges are in the region of:
£100 - £400
Clinical results Rigorous clinical trials to determine the safety and efficacy of Zyderm® and Zyplast® collagen implants were conducted from 1976 to 1981. This data was submitted to the Food and Drug Administration (FDA) and Zyderm® and Zyplast® implants were cleared for marketing in 1981 and 1985 respectively. No other injectable collagen implants currently on the market have undergone such extensive study.
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