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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

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