Collagen

The way your skin looks is directly related to the way your skin is supported.
Aging, disease, injury - these are some of the factors that can weaken the collagen fibers that give your skin its underlying strength.
Until the 1970s, it wasn't possible for doctors to replace damaged collagen. Now, both Zyderm® Collagen and Zyplast® Collagen Implants are available. Made of highly purified bovine collagen, these materials can be injected into your skin to supplement your body's own collagen and actually fill certain lines and facial furrows.
This booklet will not take the place of a consultation with your doctor, but it will answer some of the questions often asked about treatment with inject-able collagen. And it will help you and your doctor decide whether Zyderm or Zyplast Collagen treatments can help to smooth your skin.
What is collagen?
Collagen is a natural protein that provides structural support. It is found throughout the body in skin, muscle, tendon, and bone. Fibers of collagen are woven together like threads in fabric to form a framework into which new cells can grow. in the skin, collagen provides texture, resiliency, and shape.
The collagen in human skin is very similar to the collagen found in certain animals. As a result, animal collagen has had many medical applications: for example, animal collagen has been used in sutures for over a century. Heart valves used during surgery are also made of collagen. Inject-able Zyderm and Zyplast Collagen Implants are made of collagen from cow skin that has been highly purified
How was inject-able collagen developed?
In the early 1970's, a group of biochemists and physicians at Stanford University were researching alternatives to skin grafts. In the course of this work they developed the concept of purifying animal collagen so thoroughly that it could be used to replace lost skin tissue. Further research by Collagen Corporation led to the development of Zyderm and Zyplast Collagen Implants.
How long has inject-able collagen been used?
Inject-able collagen was first used to treat patients in 1976. Since then, over 500,000 people have been treated with either Zyderm or Zyplast Collagen Implants. The procedure is administered routinely by over 3.500 physicians nationally, and in more than 20 other countries.
How do Zyderm Collagen and Zyplast Collagen work?
Both Zyderm and Zyplast Collagen Implants lend additional support to the collagen network within the skin. When a physician injects small amounts of either material directly into areas where the body's own collagen has been weakened, depressions can be raised to the level of the surrounding skin. Thus, lines and scars can be minimized, texture is improved, and the skin has a softer and more even tone.
How does Zyderm Collagen differ from Zyplast Collagen?
Zyderm Collagen was formulated especially for people with small or superficial contour problems. It can be particularly effective in smoothing delicate frown and smile lines, as well as the fine creases that develop at the corners of the eyes and above and below the lips. It can also help correct certain kinds of shallow scars.
Zyp1ast Collagen was designed to treat depressions requiring a stronger material. It is used for more pronounced contour problems (such as deeper scars, lines. and furrows) and for areas upon which more force is being exerted (such as the corners of the mouth).
Zyderm and Zyplast Collagen Implants may be used alone or in conjunction with one another. Your physician will determine the potential benefits of each and an appropriate course of treatment.
Which skin depressions cannot be helped by either material?
Depressions with sharp edges and narrow 'ice pick" acne scars do not usually respond to these materials.
Should inject-able collagen take the place of surgical procedures such as face-lifts and dermabrasion?
No. Inject-able collagen treatments are not meant for people who have excess facial skin or for those who want a major resurfacing of the skin. However, doctors often use Zyderm or Zyplast Collagen implants in conjunction with surgery to fill in depressions not amenable to surgery. By using inject-able collagen following a face-lift or dermabrasion, surgical results can be enhanced.
How do collagen creams differ from inject-able collagen?
Regardless of the ingredients, moisturizers work only on the skin's surface as a temporary cap to help retain water. Zyderm and Zyplast Collagen Implants, however, are medical products that are injected below the skin's surface where contour problems begin and where collagen replacement can help.
Can anyone be treated with Zyderm Collagen or Zyplast Collagen Implants?
No. Your doctor will inquire about your medical history and administer a skin test to determine if you are an appropriate candidate for treatment. If you have a history of allergy to other bovine (cow) collagen products, severe allergies (indicated by a history of anaphylaxis [shock], or a history of presence of multiple severe allergies), if you are currentlyon cortisicosteroid or immunosuppressive therapy, e.g., prednisone, or are undergoing or planning to undergo desensitization injections to meat products, you cannot receive inject-able collagen. Also, people who are sensitive to lidocaine cannot receive collagen implants as a small amount of this anesthetic is contained in Zyderm and Zyplast Collagen Implants, and in the Collagen Test Implant. Furthermore, people who have had a previous allergic reaction to either Zyderm or Zyplast Collagen may not be re-treated. Neither Zyderm nor Zyplast Collagen Implant should be used for breast augmentation, and neither material should be injected into bone, tendon, ligament or muscle.
If you have a personal history of autoimmune disease which includes (but is not limited to) rheumatoid arthritis, psoriatic arthritis. scleroderma (including CREST syndrome), systemic or discoid lupus erythematosus, or polymyositis, a dietary allergy to beef. or if you have recentlybeen on corticosteroid or immunosuppressive therapy, your physician may want to administer additional skin tests before deciding if you should be treated.
If you have any questions about these medical conditions, be sure to discuss them with your doctor. You will also be skin tested prior to treatment. Anyone who exhibits sensitivity to the material, as demonstrated by the skin test, cannot proceed with treatment.
What is involved in inject-able collagen treatment?
There are three steps: a skin test, the treatment series, and periodic touch-ups.
How does the skin test work?
To determine if you are eligible for treatment with either Zyderm or Zyplast Collagen Implant, your doctor will inject a small amount of collagen into your forearm, just below the skin's surface. Both you and your doctor should watch the test site closely for four weeks for any signs of sensitivity to the material such as redness, swelling, or itching. Pay special attention to your test site during the first three clays since the majority of test reactions occur during this period. At the first sign of any of these problems, contact your doctor.
Only about three out of every 1OO tested patients show sensitivity to the test and cannot be treated with inject able collagen; 97 percent of all tested patients can be treated.
When does treatment start?
Treatment can begin after the four-week test observation period if you are not sensitive to the skin test. Treatment involves a series of office visits usually two weeks apart. Most patients see considerable improvement in one to three treatment sessions depending on the size, shape, and texture of the area undergoing treatment.
Do the injections hurt?
You may find that the injections are somewhat uncomfortable, particularly around the nose or lips. However, both Zyderm and Zyplast Collagen Implants contain a small amount of lidocaine that helps numb the area temporarily, and most people report that the injections are relatively painless.
How will my skin look and feel immediately after treatment?
Most patients feel comfortable in resuming their normal activities following treatment. Temporary puffiness of the treated areas, however, should be expected, especially with Zyderm Collagen Implant.
With both Zyderm and Zyplast Collagen Implants you may also notice temporary blushing, slight bruising, and tenderness around the treatment sites. Like the puffiness, these are normal occurrences and all should subside within a few days. Although the material is generally not visibly distinguishable from the surrounding skin, some patients have reported that they were initially able to feel the outline of the injected collagen.
However, as the new collagen is incorporated into your own skin, the treatment site takes on the natural look and feel of healthy skin. Any redness and/or visible swelling that persists for more than a few days may indicate a reaction to the material.
Be sure to report this or any other questionable symptoms to your doctor.
How common are treatment reactions?
With more than 500,000 people treated to date, only a small number of patients (approximately 1-2 percent) have developed an allergic reaction after one or more treatment injections. These reactions may consist of prolonged redness, swelling, itching and/or firmness at some or all injection sites. Most have lasted between three and four months, but in some cases have exceeded one year.
In less than 1 % of treated patients, formation of a scab and sloughing (shedding) of the tissue at the treatment site have been noted, which can result in a shallow scar. On rare occasions, abscess formation has occurred at implantation sites. These reactions develop weeks to months following injections, and may result in indurations and/or scar formation.
Also, in fewer than 5 per 1000 treated patients, the following have been reported: systemic complaints such as flu-like symptoms (nausea, fever, dizziness, headache, malaise, and joint aches), rash, blurred vision, tingling. numbness or difficulty in breathing.
Of the patients who have developed an allergic reaction after treatment, one-half had an unreported or unrecognized response to the skin test. With proper monitoring of the skin test, many of these reactions could have been prevented. The remaining one half of this group developed allergic reactions despite a response-free skin test.
An additional one percent of individuals experience symptoms similar to those of an allergic reaction that may, however. Occur periodically. Recent research has shown that some of these patients are allergic to bovine collagen.
If you observe any symptoms such as redness and/or swelling, please inform your physician. He or she will determine if you should discontinue treatment; no further inject-able collagen can be administered to anyone who has experienced an allergic reaction to the material.
Are there any other types of reactions I should be aware of?
Yes. There is a possibility that you could experience a reaction related to the injection process itself. However, this does not mean it is necessary to discontinue treatment. For instance, mild bruising or a slight blush could occur at the injection site. If you have previously had facial herpes simplex at the site of injection. there is a chance that the injection process itself could provoke another herpes simplex eruption. If you are using aspirin or non-steroidal anti-inflammatory drugs that reduce coagulation, you may experience increased bruising or bleeding at injection sites. In addition, any injection carries a small risk of infection.
Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus. dermatomyositis (DM), and polymyositis (PM) subsequent to collagen injections, in patients with no previous history of these disorders. Statistical analysis comparing the number of collagen treated patients who were diagnosed with two rare connective tissue diseases (PM)/(DM) with the expected number of these diseases, suggests that the rate of occurrence of these two rare diseases appears to be higher than expected in the collagen treated population. However, a causal (cause and effect) relationship between collagen injection and the onset of autoimmune disease or systemic connective tissue disease 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). Patients with these diseases may thus have an increased susceptibility to an allergic response and/or accelerated clearance of their implants when injected with bovine dermal collagen preparations. If you have any of these diseases, you should discuss this specifically with your doctor.
It is possible that, during the process of administering inject-able collagen, the needle could be accidentally placed into or through a blood vessel. This has been reported to have occurred in less than I % of patients treated. However, if it should happen, it could result in temporary discoloration of the treated area and/or formation of a scab, and sloughing (shedding) of this tissue at the treatment site can result in a shallow scar. Also, as with other substances that are injected (particularly local anesthetics and steroids injected into the head and neck area or the extremities), there is a remote possibility of accidental injection of the material into a blood vessel. This could result in blockage of the blood flow and loss of circulation to nearby sites, which in one case resulted in permanent loss of vision in one eye.
There have been infrequent reports of the injected collagen being 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. Also, some areas (such as compressed scars) resist precise placement of the material, resulting in a slight elevation beside the defect.
An understanding of the safety of inject-able collagen is based on clinical data from 1978 to the present. Ongoing research will continue to provide more information.
Does the correction last forever?
No. Touch-up injections are usually needed to maintain maximum correction. Because both Zyderm and Zyplast Collagen Implants are similar to your own skin, they will be altered by the same ongoing mechanical forces such as smiling or other muscle activity and biochemical processes such as aging and active acne that caused the original skin depressions. It has been reported that the body may deposit its own collagen at the site of collagen implantation. You should therefore be aware that part or all of the correction may last for 2 years or longer.
How often will I need a "touch-up" injection?
Most patients who choose to receive touch-ups for lines or furrows do so within 3 to 12 months of the on original treatment series. For scars, and perhaps those depressions treated with Zyplast Collagen. the time between touch-ups may be longer. But keep in mind that the amount of collagen used to restore full correction will he considerably less than that used in the initial treatment series.
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.
Without touch-up injections, how will my skin look?
Correction may subside gradually until your skin looks like it did before treatment.
Touch-up injections will help you maintain your correction and can provide a long-term solution to skin contour problems.