Question 13 Tab 2 Pg 16 7378.010 Question: 1. Do consumers know how to report any concerns or problems to their local FDA district office or to BMD's Problem Reporting Program (PRP)? (Please refer to the PRP article in the April 1982 issue of the "Consumer Update.") Part II, Page 3 Refer to the General Medical Device Education Program, 7378,010, for the general audiences to approach for this program. Specific Audiences to Approach Target Audiences: Junior high school students, high school students, college students, adults (especially women). Multiplier Groups: Teachers of health, physical education, family living, and consumer education; women's organizations; magazine and newspaper editors; broadcast program directors; health clinics; health professionals; and consumer and health groups. Refer to General Medical Device Education Program, 7378.010, for additional field responsibilities which apply to this attachment. Headquarters' Responsibilities Refer to General Medical Device Education Program, 7378.010, for headquarters responsibilities which apply to this attachment. • FDA Consumer article, "The Collagen Connection" Background Information: "20/20 Story on Collagen", CDRH • FDA Talk Paper, Response to ABC's "20/20" on Collagen It is the chief constituent of skin and It is body connective tissue. It is the living component of bone. It gets its name from the Greek words kolla (glue) and gennan (to produce). It is collagen-according to Dr. Christopher Lovell of St. John's Hospital in London, "the most important structural protein in the entire animal kingdom." Collagen makes up 25 percent of all protein in the human body. Its primary function is to act as a connecting structure and give mechanical stability to the entire body. Collagen is essential for maintaining both durability and flexibility. It performs this role by arranging itself in various patterns according to function. For example, in the tendons, which connect bone to muscle, the collagen fibers are arranged in parallel bundles to permit a twisting, turning and stretching effect. In the skin-that protective blanket that envelopes the body -the fibers form a flat crisscross pattern that provides strength and flexibility in all directions. Collagen has other useful features, and probably the most important is its ability to slow and halt bleeding in body tissues. It does this by providing a fibrous mesh in which blood platelets can coagulate and form a clot. According to Lovell, there was little medical interest in collagen until well into this century, although its commercial uses have long been understood. Leather, for example, has been manufactured for centuries by removing the gluey collagen from animal skins and then soaking the hide in a tanning solution. The leftover collagen can be processed into glue or, if further treated and purified, can become medical collagen, food gelatin, and numerous other products. Collagen molecules originate in the various body cells, then move out through the cell membrane to help form the bones, tendons and other structural body parts. The supply of collagen is continuously being replenished to meet the needs of healing. growth and replacement. 34/ June 1985/FDA Consumer Several disorders, generally inherited and all quite rare, can hinder or prevent the proper formation of collagen, One of these is Marfan's syndrome, characterized by long, thin arms, legs, fingers and toes, excessive height, overly flexible joints, and subtle eye and blood vessel changes. Lovell speculates that Abraham Lincoln may have had this condition and might. have died of one of the associated blood vessel problems-an aortic aneurysm ballooning out of a weakened wall of the aorta-had he not been assassinated. Lovell notes that the painter El Greco seems to have Marfan-like subjects in his works. He also notes that some persons with a similar disorder (Ehlers-Danlos syndrome) have such extreme elasticity of their bodies and such mobility of their joints that they become contortionists. Brittle-bone disease (osteogenesis imperfecta) is another inherited collagen disorder, which is marked by soft-skin changes, easy bruising, and abnormal fragility of bone. Persons with this condition also suffer from dwarfism and often have deformed limbs where broken bones have not healed properly. Lovell places the painter Toulouse-Lautrec in this group. (Continued on page 36) |