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1991.02.26 :  Survey -- Medical Device Implants

Contact: Sandra Smith (30l) 436-7135 Liz Greeley (30l) 436-7551
February 26, 1991

       The first nationwide survey of the use of medical device
implants shows that 11 million Americans, almost 5 percent, have
one or more implants, mostly screws and pins, intraocular lenses,
artificial joints, ear vent tubes, silicone implants and
pacemakers.
       The survey was conducted by the Centers for Disease
Control's National Center for Health Statistics and the Food and
Drug Administration's Center for Devices and Radiological Health
which has responsibility for the approval and regulation of
medical devices.  
       HHS Secretary Louis W. Sullivan, M.D., released the survey
today and said, "We are not the bionic women and 6-million-dollar
men of science fiction, but today many Americans are living more
secure and comfortable lives because of these devices.  We should
recognize, however, that there are sometimes problems with
medical device implants, as there are with drugs and various
medical procedures."
       The survey found:
     --  About 4.4 million people have screws, pins, nails,
plates or wires surgically placed in their bodies to hold a body
part in a fixed position.  These were the most frequently
reported implant.  Men were somewhat more likely to have these
fixation devices than women, probably due to a higher rate of
injuries among men.  
     --  About 2.5 million people, half of them 75 or older, had
intraocular lens implants.  Of all persons 65 years of age and
over, about 7 percent had a lens implant; among those 75 years of
age and over about 10 percent had a lens implant. Almost all were
implanted after cataract surgery.  
     --  An estimated 472,000 children 5 years or younger (2
percent of that age group) had ear vent tubes, primarily because
of infections.      
     --  There were about 620,000 silicone implants.  Some
544,000 of these were breast implants.
     --  About 460,000 persons had pacemakers.  Almost 85 percent
of those individuals were at least 65 years of age.    
       When multiple implants were counted, there were a total of
15 million implants in use in 1988.  The vast majority of the
multiple implants were of the same type, such as two ear vent
tubes or lens implants in both eyes.  Only 6 percent of the
implant population had two or more different kinds of devices.

       "The large number of Americans who use one or more medical
device implants and the increase in the use and types of implants
over the past few decades make the results of this research
especially significant," according to Dr. William Roper, CDC
director.  

       About 9 percent--1.3 million--of the implants were
replacement implants.  Ear tubes were most frequently replaced,
usually in association with the reoccurrence of a specific health
problem.  About 16 percent of pacemakers were replaced at least
one time.  Problems with the devices were usually the cause of
replacement for pacemakers as well as all other implants.

       Depending upon the type of implant, 20 to 50 percent of
all devices resulted in one or more problems.  Problems included
pain, healing problems, defects or failure, infection, bleeding
or blood clots.  Problems were reported in about one-third of all
ear vent tubes, fixation devices and artificial joints.  One out
of five artificial heart valves, one out of four pacemakers and
one out of two lens implants also had complications associated
with them.  

       For most types of implants, the most frequently reported
problem was pain.  With lens implants, clouding or blurred vision
was most often cited.  The most common problem for people with
pacemakers was an irregular heartbeat.   

       "As with drug therapies, vaccines and non-implant surgery,
it is inevitable that some devices will fail or produce side
effects, or that problems will result from the implant surgery," 
HHS Assistant Secretary for Health James O. Mason, M.D., said. 
Dr. Mason, who heads the U.S. Public Health Service, added,
however, that "the number of problems -- though many were easily
corrected and transient -- is surprising."  He said, "FDA is
analyzing the data and will be working with the manufacturers and
physicians to prevent problems and adverse effects whenever
possible."

       This information was collected by the NCHS' ongoing
National Health Interview Survey in household interviews with a
representative sample of the nation's civilian,
noninstitutionalized population.  Copies of the report "Use of
Selected Medical Device Implants in the United States, 1988" are
available from NCHS.

       CDC's National Center for Health Statistics and FDA's
Center for Devices and Radiological Health are parts of the U.S.
Public Health Service family of health agencies within HHS.

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