Please read the Case Study #6.1, \"Breast Implants\" on page 297 of your text. D

Question

Please read the Case Study #6.1, "Breast Implants" on page 297 of your text.

Discuss the important ethical issues in this case. In your response examine the ethical issues in this case especially from the viewpoint of the consumer. In your response, please identify and evaluate the systems (if any) that were put into place to regulate the product, protect consumers, and ensure corporate compliance.

Please enter your response (minimum 200 words) for the case study.

When Dow Corning first sold breast implants in 1965, they IN THE LAST FEW DECADES, SILICONE HAS become a crucial industrial product, playing a role in the manu were subject to no specific government regulations. In 1978 the facture of thousands of products, from lubricants to adhesive FDA classified them as "Class lI" devices, meaning that they did labels to Silly Putty. One of its medical uses, however, has been not need testing to remain on the market. In 1989, however, controversial-namely, as the gel used for breast implants. Dow as worries about the dangers of silicone implants increased Corning, which was founded in 1943 to produce silicones for the FDA reclassified them as "Class ll" devices and in 1991 commercial purposes, invented mammary prostheses in the required all manufacturers to submit safety and effectiveness 1960s. Since then a million American women have had bags data. Although some FDA staff members were scathingly critical of silicone gel implanted in their breasts. For many of them, of the poor and inconclusive documentation submitted by the silicone implants are part of reconstructive surgery after breast manufacturers, the FDA's advisory panel ruled that the implants cancer or other operations. However, by 1990 four out of five were not a major threat to health. Based on public need, it voted implants were for the cosmetic augmentation of normal, healthy to keep them on the market. breasts -a procedure that became increasingly popular in the 1980s as celebrities such as Cher and Jenny Jones spoke new chairman, called for a moratorium on breast implants. He openly of their surgically enhanced breasts After the Hopkins case, however, David A. Kessler, the FDA's asked doctors to stop performing the operation, but he told Today, however, what used to be a common elective opera women who had already had the operation not to have the bags tion is rarely performed.06 The reason dates from the 1980s, removed. Still, the moratorium terrified the women who had had when women with silicone breast implants first began reporting breast implants, a few of whom tried in desperation to carve certain patterns of illness. There were stories of ruptured or them out themselves, and it galvanized a political movement led leaky bags, although the estimates of the proportion of women by women who were upset about having been used, yet again affected ranged from 1-5 percent to 32 percent. And there as guinea pigs for an unsafe medical procedure. For them, it were allegations that the silicone implants were responsible for was just one more episode in a long history of the mistreatment various autoimmune disorders-such as rheumatoid arthritis, of women by a medical, scientific, and industrial establishment lupus erythematosus, and scleroderma-in which the body's that refused to treat them as persons and take their needs immune system attacks its own connective tissue. Then, in seriously. The FDA moratorium also galvanized the legal forces 1991, a jury heard the case of Mariann Hopkins, who claimed marshaled against the manufacturers of silicone bags. By 1994 that her implants had ruptured and released silicone gel, caus- some 20,000 lawsuits had been filed against Dow Corning ing severe joint and muscle pain, weight loss, and fatigue. On alone. Entrepreneurial lawyers organized most of these actions the basis of documents suggesting that Dow Corning knew into a few large class-action suits so that their pooled legal of the dangers of leaky bags, a San Francisco jury found the resources would be more than a match for the manufacturers company guilty of negligence and fraud and awarded Hopkins $7.3 million. Meanwhile, Kessler instructed the FDA's advisory panel to re-study the breast implant question. Presented with a serie

Explanation / Answer

In spite of having the scientific evidence that later on emerged and that demonstrated no clear relationship between the breast implantation and the diseases, it must be noted that the women who first reported their illness in the 1980s must have suffered some kind of issues from which the procedure of rejection started. At that point in time, there was no scientific evidence to establish either in support or in against of implantation. Also, note that silicone implantation was never a new process and it had its use in medical cases of breast cancer surgery back in the 1960s. Thus it was completely ethical for FDA to first declare this as 'Class-III' device in 1989 and in 1991 it required all manufacturers to submit safety and effectiveness data. However, the moratorium held afterward was inappropriate in stopping the surgery or spreading the panic. Instead, the communication should be spread to aware the consumer that no such conclusive evidence so far does not exist and scientific evidence is yet to be gathered with the help of research institute.

The ethical position of the feminist groups and other groups was not correct because they were refuting the scientific evidence and were further advancing the panic in the public. In summary, the system of consumer protection turned out to be a prolonged chaos which resulted in deprivation of several groups - manufacturers for disrupting them with bankruptcy and consumer by terrifying them with the non-existent after effects of the surgery (which were proved later on by several scientific research studies) and keeping thousands away from fulfilling their needs and in some cases risks of injury when some of the women tried to carve out the silicone bags by themselves.

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