Reporter Volume 25, No.17 February 17, 1994

By ELLEN GOLDBAUM
News Bureau Staff
Are breast and jaw implants "ticking time bombs?" 
How can the performance of these implants in different patients be
better documented? 
What can bioengineers, manufacturers and clinicians do to make
implants safer and more effective?
On April 10-11, "Management Requirements for a National Implant Data
System," the first conference to address systematically these and
other urgent problems relating to implants, will be held in the Tara
Hyannis Resort in Hyannis, Mass.
Sponsored by the Society for Biomaterials and the Food and Drug
Administration, the conference is being held with additional support
from the National Institute of Standards and Technology and the
National Institutes of Health.
Robert E. Baier, professor of biomaterials at UB and conference chair,
said the goal of the meeting is to begin laying the groundwork for a
national data system on implants. 
"There had been a presumption that these devices were safe and
effective when they came on the market prior to 1976, but then when
the failures began, and there were calls for the data on them, the
data turned out to be insufficient," he added.
Baier is immediate past president of the Society for Biomaterials and
a member of its board of directors.
"After being played out on the front pages of The Wall Street Journal
and other publications, this is the first time these issues are going
to be addressed by the professionals, the bioengineers, doctors,
insurers, manufacturers, attorneys, regulators and patient groups they
affect," said Baier.
"The Society for Biomaterials has been the voice of reason in the
background of this debate, but we've been too quiet," he said. "This
conference is the first opportunity for the many disparate groups to
sit down together and begin addressing the hard questions." 
He noted that problems with biomedical implants have been
well-publicized, although there is an alarming paucity of scientific
information available on how these devices function in patients. 
Conference attendees will discuss the proposed IDr3 system (Implant
Data Record/Report/Review), a national database on all aspects of
implants, including some method of patient identification,
documentation of procedures and clinical outcomes, and scientific
information on implants that have been removed or "harvested" from
patients.
The conference will provide those with a vested interest in the
improvement of implants with an opportunity to contribute to the
formation of the IDr. 
"We are issuing an invitation to anyone whose work involves implants,"
said Baier. "We are saying, 'Come to our meeting and let's address
these problems in a uniform way so that we can safeguard the public
good.'"
Major participants will include representatives of Dow Corning,
Johnson & Johnson, the Food and Drug Administration, the Cleveland
Clinic Foundation, the American Hospital Association, Lund University,
Case Western Reserve University, the University at Buffalo, the
Hospital for Joint Diseases and other institutions and associations.