Risk assessment of polymyositis/dermatomyositis after treatment with injectable bovine collagen implants.
BACKGROUND
Questions have been raised about a possible relation between injectable collagen and polymyositis and dermatomyositis (PM/DM). Predictions of the prevalence of PM/DM have been based on anecdotal estimates of the duration of follow-up for the collagen-treated population.


OBJECTIVE
Our purpose was to study the duration of follow-up for a large sample of collagen-treated patients.


METHODS
Physicians in North America who purchased collagen implants during fiscal year 1988 were categorized according to collagen practice size; one third were randomly invited to participate in the study.


RESULTS
Review of 2622 patient records yielded an average duration of follow-up of 4 years.


CONCLUSIONS
Five-year incidence rates were used to estimate the expected number of cases of PM/DM in the collagen-treated population. Through June 1993 the expected number was 30.2. The number of confirmed cases after treatment was seven, less than one fourth of the number of cases expected for a model of the collagen-treated population, matched for age, sex, and race.
Hanke
C W
CW
Department of Dermatology, Indiana University, Indianapolis, USA.
Thomas
J A
JA
Lee
W T
WT
Jolivette
D M
DM
Rosenberg
M J
MJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002170:Canada / Q000453:epidemiology; D016022:Case-Control Studies; D002417:Cattle; D003094:Collagen / Q000009:adverse effects*; D003882:Dermatomyositis / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D005544:Forecasting; D006801:Humans; D015994:Incidence; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D017285:Polymyositis / Q000453:epidemiology*; D015995:Prevalence; D011364:Professional Practice / Q000706:statistics & numerical data; D019736:Prostheses and Implants / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment; D014481:United States / Q000453:epidemiology
D003094:Collagen