Silicone gel breast implant rupture rates: research issues.
Documenting the rate of rupture of silicone breast implants appears to be deceptively easy. Largely because of the phenomenon of "silent rupture," it isn't. The authors explore the various technical biases (selection, misclassification, and confounding) and methodological problems that have plagued much of the research conducted to date. By means of a series of illustrations, they argue that explantation has limited utility. Noninvasive techniques have to be used to gather the proper type of data on the timing and frequency of these events. Only with the proper incidence data will researchers be able to identify better the different mechanisms underlying implant rupture and the relative importance of each. The authors recommend that better and standardized definitions of implant rupture be developed, that greater recognition be given to the technical biases and a greater effort be made to eliminate them from investigations of implant rupture, and that more research be conducted by multidisciplinary teams. Because of the growing awareness of the complexity of this issue, the authors also recommend that properly constituted advisory teams be used to provide comprehensive oversight of future research projects from beginning to end.
Cook
Ralph R
RR
RRC Consulting and LLC, Midland, MI, Dow Corning Corporation, Midland, MI, USA.
Bowlin
Steven J
SJ
Curtis
James M
JM
Hoshaw
Susan J
SJ
Klein
Patti J
PJ
Perkins
Laura L
LL
Austad
Eric D
ED
D015982:Bias; D018427:Breast Implants / Q000706:statistics & numerical data*; D015986:Confounding Factors, Epidemiologic; D020878:Device Removal; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D015994:Incidence; D011475:Prosthesis Failure; D015983:Selection Bias; D020034:Silicone Gels
D020034:Silicone Gels