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Safety Issues

What you should know about collagen Replacement Therapy

In the light of the media attention on "mad cow disease", medically known as bovine spongiform encephalopathy ("BSE"), you may have questions about the safety of your Zyderm and Zyplast collagen implants/injections.

Zyderm and Zyplast Collagen Replacement therapy has been proven safe and effective for over 15 years.  Zyderm and Zyplast collagen implants have been used in over 1.5 million treatments worldwide.  They are the only injectable collagen products for use in facial aesthetics to undergo rigorous studies in 5,000 patients and the only injectable collagen products to be subjected to the strict device approval process of the Food and Drug Administration.  The McGhan Medical Corporation is proud to be the world leader in providing a variety of lifestyle products used to impact two extremely important facets of everyday life:  confidence and self-esteem.  As such your questions about safety, and trust in these products are our greatest priority.

Where does bovine collagen come from?

Zyderm and Zyplast collagen implants are composed of highly purified bovine dermal tissue.  this material is obtained from the hides of steers with in a closed herd.

What is a closed herd?

A closed herd is defined as one in which:
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there has been no case of BSE;
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there has been no feeding of mammalian-derived protein (animal by-products);
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there is fully documented breeding history;
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there has been fully documented veterinary monitoring;
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each animal is monitored and traceable, and
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genetic material has been introduced only from herds with the same BSE-free status.

Have there been any reported cases of BSE in the U.S.?

No.  The United States Department of Agriculture (USDA) certifies that BSE has not been detected in the U.S. cattle.  BSE is not known to exist in the United States.

Has there been a case of BSE in the closed herd which Zyderm and Zyplast are sourced?

There has been no case of BSE of any other herd-threatening disease in the closed cattle herd used to source Zyderm and Zyplast.

How do we know McGhan Medicals bovine based collagen facial injections are safe and free of contamination?

McGhan Medical manufactures a highly purified form of Bovine collagen, derived from the USDA-certified and carefully monitored closed herd of cattle in California.

Where can I get more information on BSE?

The following list of website resources may help you find more information regarding BSE:

United States Food & Drug Administration
United States Department of Health and Human Services
United States Department of Agriculture
Center for Disease Control and Prevention

 


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 Erel Laufer, MD, FACS l Jay H. Ross, MD, FACS l Jennifer Buck, MD, FACS
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