PART THREE. BUSINESS AND SOCIETY
Ino a fow rge cass-acton suits so that their pooked legal
resouroes would he mor than a match fo the manufactrers.
Meanie, Kessler nstucte the FDA's advisory panel 1
re-stuy the breast implant question, Presonad wih a series
cof anecdotal rports about diseases that are not rare, the
panel complained about the lack of hard scletfic data From
the sient pinto ew, the pablom was hawt distinguish
coincidence from causation, For example, f connective tise
disease strkas 1 percent of ll women and 1 milion vemen
have implants, then statistical one should expect that 10,000,
women vl ave bath Implants and connoctve-tssue disease
Sofa woman develgs the disease, can it corecty be said
‘hat it was caused by her breast implants? Moreover, not only
does sloane appear ta be chemically net, but sllenne from a
ruptured breast implant wil remain trapped inside a fous
capsule of scar tissue. Neverteless, onthe basis ofthe panel's
eeommendation, the FDA ruled tat scone may be used nly
for econstructon and that cosmetic breast augmentation must
be dane ony wih saline packs
‘that point he gut between science, on the ane hand,
and the FDA and public opinion, onthe other, began to widen
‘uta Mayo Gnc study published inthe prestigious New
England Journal of Medora in June 1994 showed that there
was no difference between worven with breast implants and
‘ter women with respect to incidence of conective-issve
«seas; by the summer of 1995 two larger studles ad oon
fied the Mayo Gris repr. On top ofthat, the FL and other
Investigators exposed several labs that wore song to lawyers
and victims fraudulent test results purporting to show the pes
‘oe of silcone inthe blond af women with breast implants.
Lauyers and other advocates forthe women wth implants
repuilate those stutis, contending tat the women have a
new disease, To tis contention scientist respond that the
scription of tho sympoms of his supposed disease keeps
changing. Some say 1 looks tke fromyalia, which is
included in ther studies. Many feminist actiist groups cis
trust lence; they below that we should pay less attention
to statistics and medical stules and greater attention to the
‘women who have suffered, These women know what their
bodies have been through, an they are convinced that heir
Implants are response
This reasoning, and the skepticism toward science a
statistes that It represents, has swayed jurors, After Do
Corning Ted bankrupty in 1995, which brought to halt the
lavsuits against it, na avsuits were fled against ts paren
‘company, Daw Chemical. The fist ofthese rested in =
{$14.4 milion verdict against the company, despite the l
ct scenic evidence. Distearding the New England Jour
(of Medicine sty, te jurors were convinoed that his
ticular pain’ suffering somehow stemmed from her Dov
‘manufactured breast implant. few years lat, the women
who said te slcone breast implants made them ill agreed
to sete their claims against Daw Coming for $3.2 bition
‘The setlement is pat of ls bankruptcy reorganization pan
and is similar to a settlement entered into earor by 3M,
Bristol-Myers Squib, and other manufacturers of breast
Implants.
Update
8 now, more tan tent repuebe scene stutles have
been conducted on implant safety. Thre European gore
ments have convened scene panels. The Anercan College
«of Rheumatology, the American Academy of Neurology, the
Insite of Medicine, and the American Metical Assocation
have all published reves of the evidence, 2 has an inde
pendent scenic panel appoied by 2 feral cout. Te
conclusion is unaimous ard unequiocak Ther is no ei
dence that breast implants cause disease of ay kn
Ing ofthese fnngs and ihe recommendations of
federal edvsory pana, In 2006 the FDA gave condtonsl
anproval to Mente Corporation's aplication to prod si
cane beast moans, ths efetely ending atiteen year
tenon the wseo lone or casmet reas enhancers
JON QUESTIO!
What oes the reas implant controversy revel about
viet’ atiudes tard product safety, abou the legal
Fai of manufacturers, and about the rol of ecatory
agencies ike the FDA in potetng consumes? our
society oo catous about product safety or not caus
onougi?
cosmetic pl
‘stheegonoy
Iepay greater
india
fect esses
Implanis?
land nothing more
bya spilled cup of
through window of
her $160,000 in
$2.7 milion ng
the punitive dam
tied out of cour
‘Unlike the ou
vere eoeted
Yo many ordinal