ASSOCIATION BETWEEN BOVINE COLLAGEN DERMAL IMPLANTS AND A DERMATOMYOSITIS OR A POLYMYOSITIS-LIKE SYNDROME

Objective: To determine whether an excess incidence of dermatomyositis or polymyositis or both exist in patients treated with injectable bov ine collagen implants and to characterize the clinical picture. Design : Historical cohort study (July 1980 through June 1988). Patients: Pat ients were identified from personal experience or adverse reaction rep orts received by the manufacturer. Setting: An 8-year period in the Un ited States during which approximately 345 000 patients received impla nts. Results: Eight patients with dermatomyositis and an additional pa tient with polymyositis were identified from approximately 345 000 pat ients receiving injectable bovine collagen implants from July 1980 thr ough June 1988. The nine patients with dermatomyositis or polymyositis were diagnosed an average of 6.4 months (range, 0.7 to 24.9 months) a fter collagen implant or skin test exposure or both. Eight of the nine patients had a delayed-type hypersensitivity response at the test or treatment sites or both, and five of six patients tested were found to have increased serum antibodies to collagen. Compared with the genera l population, the incidence of dermatomyositis or polymyositis among c ollagen-treated patients was statistically increased (standardized inc idence ratio, 5.05; 95% CI, 2.31 to 9.59; P < 0.0001). A similar analy sis of the eight dermatomyositis case patients produced a standardized incidence ratio of 18.8 (CI, 8.1 to 37.0; P < 0.0001). Using a Monte Carlo simulation, an interval of 6.4 months or less from exposure to o nset of disease was found to be an extremely rare event, occurring les s than 72 times per one million simulation trials (CI, 57 to 91). Conc lusions: Because these data suggest that an immunologic response to bo vine type I or type III collagen or both caused this dermatomyositis o r polymyositis-like syndrome, the risks versus benefits for the cosmet ic use of collagen implants should be reassessed.