Collagen Injections
November 11, 2011    
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Collagen, the single most abundant protein in the animal kingdom, is the major insoluble fibrous protein in the
extracellular matrix and in connective tissue. There are different types of collagens and they are made by numerical
epithelial cells. Types I, II, and III are popularly existing in our body. These collagen molecules pack together to form long
thin fibrils while type IV collagen forms a two-dimensional reticulum; these collagens together with other types collagens
and other matrix components are linked together. The various collagens and the structures they form all serve the same
purpose, to help tissues withstand stretching. Collagens differ in their ability to form fibers and to organize the fibers into
networks. For example, type II is the key collagen in cartilage. In many connective tissues, type VI collagen is bound to
the sides of type I fibrils and may bind them together to form thicker collagen fibers. [National Center for Biotechnology
Information, U.S. National Library of Medicine; November 10, 2011]
Collagen Injections
Most injectable wrinkle fillers have a temporary effect, because over time they are absorbed by the body. FDA has
approved only one product made from a material that remains in the body and is not absorbed. Some wrinkle fillers
contain lidocaine, which is intended to decrease pain or discomfort related to the injection. Collagen is a type of protein
that is a major part of skin and other tissues in the body. Sources of purified collagen used in wrinkle fillers can be from
cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting
of injectable filler materials. There are some other applications of collagen injections.

ArteFill® PMA Applicant: Artes Medical, Inc. Approval Date: October 27, 2006
ArteFill® is a filler that is injected into the nasolabial folds around the mouth to smooth these wrinkles. The device
contains small polymethylmethacrylate beads, collagen and lidocaine. ArteFill® will help smooth nasolabial folds
around the mouth. In a clinical study most patients needed more than one injection to achieve optimal wrinkle
smoothing. The average number of treatment sessions was 2.28. General side effects of ArteFill® include: lumpiness
at injection area more than one month after injection, persistent swelling or redness, increased sensitivity and rash,
itching more than 48 hours after injection. [ArteFill® - P020012, November 11, 2011]

CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-
Based Collagen - P800022/S050 Manufacturer: INAMED Corporation Approval Date: March 11, 2003
CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile injectable liquids made of highly purified
human collagen, a natural protein that supports the skin. They’re injected into the skin to correct soft tissue defects
such as wrinkles and acne scars. These products also contain lidocaine, which numbs the skin at the site of injection.
CosmoDerm is used for minor skin defects. CosmoPlast is used for more serious defects. Previous studies with
injections of collagen derived from cows showed that collagen injections can fill soft tissue contour defects. Clinical
studies of injections with human collagen showed that the frequency of adverse immune responses (rejection by the
body) with the use of CosmoDerm™ 1 Human-Based Collagen is less than 1.3%. Because of the low percent of
adverse responses, each of these two products may be injected without a skin test prior to treatment. [Consumer
Information, FDA website, November 11, 2011]

There are adverse side effects associated with human collagen implants, such as cold symptoms, flu-like symptoms,
urinary tract infection, bronchitis, strep throat, sinus infection, acid dyspepsia or reflux, back pain, pain and spasm.
Side effects further include ear infection, fever, high blood pressure, insomnia and sore throat. There are also reports
of allergic or sensitization reactions. In a clinical study, one subject reported redness and pain (moderate severity) at
one week after the first injection. This was confirmed by the investigator as redness, tenderness, in duration and
swelling at the injection site.Sensitization reactions to injectable bovine collagen implants have occurred in 1-2% of
treated patients, and have consisted of erythema, swelling, induration and/or urticaria at implantation sites. But, the
percentage frequency of most of these side effects is low. [CosmoDermTM Human-Based Collagen Implant, Inamed,
FDA website November 11, 2011]

ZYDERM COLLAGEN (INJECTION)  MAUDE Adverse Event Report Event Date 04/03/1996
Event Type  Injury   Patient Outcome  Life Threatening; Disability Other
Collagen problems rptr is having include damage to "my immune system as told to me by some of my drs. " rptr has
been and continues to see many specialists and takes many prescribed medications, with limited relief. Unfortunately,
symptoms continue to plague her. Rptr has been diagnosed by two rheumatologists as having symptoms of rheumatoid
arthritis, lupus and also fibromyalgia as a result of the collagen injections. Originally rptr had been diagnosed with
ankylossing spondylitis, this was a misdiagnosis. However, blood tests have revealed that rptr is hla-b27 positive. Rptr
was diagnosed a short time after the collagen injections in 1996 with interstitial cystitis. Rptr has also been diagnosed
with hypothyroidism. The thyroid blood levels now have been ok since the last lab test. However, rptr does have an
enlarged thyroid since collagen. "i am plagued by fatigue and chills. In addition, i have an elevated temp of two
degrees above what has been normal for me my entire life. " after the collagen injections, rptr had many skin problems,
mouth ulcers and hyperpigmentation, all lasting twenty months from the time of the collagen injections. "the above is a
short update, and by no means complete. On my medical status/condition which i believe to be necessary for your
records. I have been on the fda website, mdr search details, center for devices and radiological health. There appears
to be numerous reports where individuals have had problems, diseases, and or conditions that appear to be of an
autoimmune type or related, and they too have had collagen injections, implants, etc. Over the last two years i have
acquired a lot of medical literature and copies of studies on bovine collagen. Had i been made aware of the potential
risks of bovine collagen, i never, never would have had the collagen injections. Unfortunately, my dr told me none of
the risks involved. " about two weeks or so after the collagen injections, rptr got a large swollen lymph node in the left
side of her neck. In a week or pehrhaps a few weeks to follow, rptr developed forty or more swollen lymph nodes in her
groin which lasted many, many months. At the same time rptr had developed, almost total, body rashes. These rashes
would come and go for many weeks. These symptoms came along at about the same time as the mouth ulcers, skin
hyperpigmentation and also hard nodules on her thighs and chest. However, the mouth ulcers lasted close to twenty
months. The hyperpigmentation has faded somewhat. The hard nodules have gotten a lot smaller and have faded
considerably. The red, swolen test site appeared a day after the test injection and the swollen lips began a day after
the lip injections, both lasting twenty months also. "since my dr did not alert me to any possible side effects including flu-
like symptoms, i can not give you specifics. I know i would have ignored these symptoms thinking it was the flu or some
other virus. I do vaguely remember having not felt well on many different occasions possibly after the collagen test and
definitely after the collagen lip injections. I remember taking my temp many times, and i continue to do so, and it
routinely would be elevated to 99. 6 degrees. Temp remains elevated about two degrees since the collagen injections.
My normal temp generally is 97. 4 to 97. 6 degrees. My gynecologist has told me that an elevated body temp indicates
immune system damage. ". [
FDA Website, November 11, 2011]