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Mike O'Fallon, Ph.D.
Professor of Biostatistics
Mayo Clinic
Title of
Talk
The breast cancer implant controversy: statisticians and epidemiologists
meet the media and the legal profession
Abstract
In 1992 the FDA announced a moratorium on the installations of breast implants
ending a 30 year period of increasing utilization of this technology. Women
with surgically removed or deformed breasts and women who desired breast
augmentation had access to such implants in the U.S. since about 1962 and
were by-and-large satisfied. However, some case reports of a variety of
connective tissue diseases occurring in women with implants and a small number
of court cases led by the FDA to use its newly obtained regulatory authority
to request safety data from the various manufacturers of implant materials.
When such data were not forthcoming and/or were deemed incomplete or unsatisfactory
the moratorium was declared. A firestorm of lawsuits ensued and pleas for
scientific information on the topic were issued. The Department of Health
Sciences Research at the Mayo Clinic provided the first response with a paper
published in the New England Journal of Medicine in 1994. This presentation
discusses our contacts with the media and primarily with the legal profession
following this publication. Some of our experiences were exhilarating but
most were nerve wracking, depressing, disillusioning, and even frightening.
However, we have survived.
Date and
Time
Friday, October 11, 2002
12:00 - 1:00 pm Lunch
1:00 pm - 2:00 pm Lecture
Location
Penn State Harrisburg
Educational Activities Building
Dr. O'Fallon (center) and Dr. Richards (right) with students
Frank Gadson (left), Derek Smith (center), and Julie Mann.
Dr. O'Fallon (center) and Dr. Richards (right) with Julie
Mann, Kelley Richwine, HBG-ASA President John Rhinehart (center), Jim Lehman
(front and left), Robert Dewar (left), and .