CHAPTERSIX CONSUMERS 229
CASE 6.1
‘THE LAST FEW DECADES, SILICONE HAS
Some a crucial industrial produc, playing a roe i the
ulacture of thousands of products, fom lubricants to
sive labels to ily Putty. One of its medical uses, how-
mr has been controversal—namly, as the gel used fee
Best implants. Dow Corning, which was founded in 1943
produce sticones for commercial purposes, invented
mary prostheses inthe 1960s, Sinoe then a millon
atcan women have had bags of silcane ge implanted
‘elrbeeasts. For many of them, slcene implants are
of reconstructive surgery after breast cancer or other
ertions, However, by 1990 four aut of fve implants were
the cosmetic augmentation of normal, healthy beasts —
(precede that became increasingly popular inthe 1980s
celebrities suchas Cher and Jenny Jones spoke openly of
surgically entanood breasts,
Today, however, what used to be a common electie
eration i rarely performed. Tho reason dates from the
when women wih silcone breast implants fist began
ing certan paters of iness. There were stores of
piured or leaky bags, although the estimates ofthe propor-
br of women afeced ranged from 1-5 percent to 32 per-
And there were allegations that the sitoone implants
bre responsible fr various autoimmune dsorders—such
rheumatoid artis, lupus erythematosus, and scler-
Erma—invtich the body’ immune system tacks ts ov
eve tissue, Then, in 1991, a jury heard the case of
ann Hopkins, who claimed that her implants had rup-
fed and released silicone ge, causing severe joint and
Huse pain, weight hss, and fatigue, On the bass of docu-
ents suggesting that Dow Coming knew ofthe dangers of
oplants
leaty bags, a San Francisco jury found the company guity of
hnoglgence and fraud anc awarded Hopkins $7.3 milion.
‘When Dow Corning first sold breast implants in 1965,
‘hey were subject toro spactc government regulations. In
1978 he Food and Drug Acministaton (FDA) cased them
8 “Cis I" devices, meaning that they ld not need testing
to remain onthe market. in 1969, however, as worries about
‘he cangers of scone implants increased, the FDA reclass-
fied them as "Class i” deviees and in 1991 required all
manufactures to submit safely and eflecveness data
‘though some FDA sta members were seathingly rel of
‘the poor and ineonctusve documentation submited by the
‘manufacturers the FDA’ advisory paneled that te implants
‘Were not a major threat to heath. Based on public need, it
‘od to keep them on the markt.
‘Afi he Hopkins case, however, David A. Kessler the FDA'S
new chain, called for a mortorum on breast implants. He
‘sto! doctors to stop performing the opraicn, bat he tld
women who had aed ha the operation not to have the bags
Teroved. Sl the moratorium tetfied the worsen who had had
‘east implans, afew of whom tied in desperation to carve
‘hem cut hemsehes, andi ganized a polical movement ld
by women who were upset about having boon used, yet gain, a3
ea pigs for an uate medical procedure. For them, i as
[ust one mare episode in along history of the misveatment of
women by a mec, scientfig,andindustial establishment hat
‘efused to treat them as persons an tke thelr nee serous.
The FDA morta aso clvanized the legal frees marshaled
‘against the manufacturers of scone bags. By 1994, some
‘wont taser lawsuits had been fled against Dow Coming
one. Errepreneurl layers orgaized most ofthese ations