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This article was originally published in The Gray Sheet

Executive Summary

COLLAGEN IMPLANT RISK/BENEFIT RATIO REASSESSMENT NEEDED due to concerns about a link between the use of collagen dermal implants and a dermatomyositis or polymyositis-like syndrome, Jean Cukier, MD, Baylor College of Medicine, et al. conclude in a study published in the June 15 Annals of Internal Medicine. The authors state that "our data suggest that patients receiving collagen dermal implants are at increased risk for developing a dermatomyositis or a polymyositis-like syndrome. It would seem prudent to reassess the cosmetic use of injectable bovine collagen in a context of risk versus benefit." The historical cohort study covers an eight-year period in the U.S. (July 1980-June 1988) during which approximately 345,000 patients received collagen implants for cosmetic purposes, the authors estimate. The study found nine patients with a dermatomyositis or polymyositis-like illness among the patients in the study population. There were a combined total of 15 treatment visits among seven of the patients; the other two patients had positive skin test reactions and did not receive implants. "Seven patients met criteria...for definite dermatomyositis, one patient for probable dermatomyositis, and one patient for probable polymyositis," the study reports. For the nine patients, "the interval from the mean of collagen exposures to diagnosis...averaged 6.4 months (range, 0.7 to 24.9 months)." The authors maintain that "compared to the general population, the incidence of dermatomyositis or polymyositis among collagen- treated patients was statistically increased (standardized incidence ratio, 5.05; 95% CI, 2.31 to 9.59; P < 0.0001)." However, in an editorial in the same issue of the Annals of Internal Medicine, Marc Hochberg, MD, MPH, University of Maryland at Baltimore, questions the methods used by Cukier et al. "Some of the assumptions underlying the statistical analysis may not be valid," Hochberg says, adding that "the expected number of [collagen] cases may have been underestimated." He notes that the number of patients estimated to have been exposed to bovine collagen during the study period did not include persons who were exposed to test doses only. "Inclusion of those persons is essential because two of the nine patients received only test doses of collagen," Hochberg says. "Thus, the number of persons exposed to bovine collagen implants was probably higher than estimated by the authors, and the expected incidence of inflammatory myositis was probably lower than reported by the authors." Hochberg also maintains that the incidence rates used in the authors' calculations probably contributed to the underestimation of expected cases. Hochberg argues that "underestimation of the expected number of patients would increase the likelihood of finding an association where one does not exist (type 1 error); the robustness of the author's statistical model cannot be judged without appropriate consideration of these and other potential concerns about the validity of their assumptions." He adds: "Even if future studies show that an association exists, the interpretation of that association will not be clear without evidence supporting the biologic plausibility of a causal role of bovine collagen implants in inflammatory myositis. Animal studies...have failed to show evidence of the development of inflammatory myositis..., and patients with myositis have not been shown to produce autoantibodies against native collagen despite the presence of antibodies to myosin." Collagen Corp., the manufacturer of Zyderm and Zyplast implants, issued a statement on June 14 emphasizing Hochberg's criticisms. The company also said that the contents of the Cukier article were presented at an October 1991 meeting of an advisory panel convened by FDA. The panel, of which Hochberg was a member, concluded that there was a lack of statistical and biological evidence to support a link between collagen injections and polymyositis/dermatomyositis. Collagen also noted that FDA already has reassessed Collagen's premarket approval application for Zyderm and concluded that the approval was appropriate.

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