Consent forms > Collagen Injection

• The procedure
• Allergic reactions
• Infection risks
• Injection Risks
• Cancer risks
• Pregnancy risks
• Duration of beneficial effect
• No Warranty implied
• Other sources of information

The procedure

I, ________________________________, desire that James P. Thomas, MD and such assistants as may be assigned by him, to perform the elective procedure of micronized collagen (Cymetra) injection into the vocal folds.

Allergic reactions

Cymetra is produced from human allograft skin that has been decellularized to remove cells that cause graft rejection or immunological reactions. However, as with any allograft tissue composed of proteins and proteoglycans, the graft may cause an allergic reaction or sensitivity. No allergic or immunological reactions have been reported in clinical studies involving up to 200 patients thus far.

Infection

The risk of bacterial infection, though small, is always present with any injection that passes through the skin. In more than 8 years and in more than 100,000 AlloDerm grafts, there has not been a single reported case of viral transmission with this material according to the company producing the material.

Complications of injection

It is possible to experience a reaction to the process itself, such as bruising at the injection site. 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. 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.

Developing cancer

No long-term studies have been conducted to evaluate the potential of Cymetra to cause cancer. Potential risks to an embryo or fetus are unknown at this time and there may be other risks or side effects that are also unknown at this time.

Pregnancy

The safety of treatment during pregnancy or in infants or children has not been established.

Duration of effect

Several months would seem to be the normal duration. It is unlikely that the effects of the injection will be permanent. 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.

Beneficial effect

Since every patient's expectations and physical make-up are different and every physician's technique is unique, the desired result may be incompletely achieved.

More information

Additional information and opinions may be found, particularly on the internet. Life Cell has a web page on the material which is also in the packaging of the product. I maintain an informational page on injectable implants at http://old.voicedoctor.net/surgery/injection.html.

Date: ___ / ___ / 200__

_____________________________
Signature

_____________________________
Witness

_____________________________
James P. Thomas, MD