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Cryolife Products 100 Times more dangerous than products like Baycol, Propulsid, Rezulin, Duract, Lotronex, Posicor, Raxar and Rotashield, all pulled from the market by the FDA.

Cryolife: The Smoking Guns

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Adverse Incidence Rate

Cryolife claims an orthopedic allograft associated infection rate of 0.2%, that is 2 out of every 1000 people receiving tissue from Cryolife will suffer an infection associated with the tissue. Cryolife also states that the general incidence of infection associated with orthopedic surgery is between 0.6% and 2.2%. There are several points to consider in reference to theses claims.

First, because there is no mandatory reporting of adverse incidents involving tissue, there are no reliable statistics on the incidence of allograft tissue associated infections. The problem is compounded by the fact that anaerobic bacteria are delivered into the recipient of the allograft via spores in the tissue, which will not be killed by Cryolife’s antibiotic cocktail. These spores may not germinate and produce serious bacterial infection for a significant period of time. In one of the cases noted in the CDC study, there was an 85 day period between the operation and the growth of the infection. Thus, events may seem isolated from the procedure and the connection is not made with the tissue as the source of the infection.

Second, the comparison between orthopedic allograft tissue surgery and general orthopedic surgery is not valid because of the differing circumstances between the procedures. General orthopedic surgery, because of the incidence of recent severe trauma to the patient requiring immediate surgical attention, is many times unavoidably undertaken under less than ideal conditions. The surgical site may already have debris or other contaminants associated with the trauma introduced into the site. Thus, it is to be expected that general orthopedic surgery has a relatively high incidence of infection.

Orthopedic tissue allografts are designed to enhance the patient’s quality of life. They are elective procedures. Accepting at face value the Cryolife claim of an allograft associated infection rate of 2 per 1000 patients for the purposes of comparison, the chart below compares that adverse incidence rate with the rate of adverse incidents with 8 of the 12 drugs which the Food and Drug Administration has removed from the market place since 1997 as posing an unreasonable risk of harm. The comparison figures for these drugs represent the adverse incidents which had been reported to the FDA at the time the decision was made to pull the drug off the market.

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Cryolife: The Smoking Guns

Adverse Incidence Rate