The Dangerous of Breast Implant
...e Food and Drug Administration, also know as FDA, authority to regulate implants and other medical devices because of its widespread use (Bruning 7). At this point, the FDA started to ask the manufacturers to provide evidence that the implants were indeed safe and effective (7). Eventually, in 1978, the FDA found that there were many problems with silicone gel-filled breast implants such as leaking, rupturing, and hardening of the breasts (8). Bruning said, “By 1982, the FDA had received thousands of such complaints and finally moved the devices to a more stringent category which requires that the manufacturers supplied scientific evidence to prove that the products are safe”(8). At that time, because of the complaints of breast implant patients, the FDA started having concerns about more safety problems of implant surgery (8). In 1988, the FDA issued final regulations considering the reclassification of breast implants manufacturing and required manufactures to submit safety data within 30 months (8). Till today women and still facing the same health risks as women did more than two decades ago. This should be a sign to discourage those who seek “improvements” to their breasts. During 1990s, the controversial issue of breast implants and its surgery procedures expended. and enlarged during the 1990s. A patient, Sybil Goldrich, was a good example. “Sybil Goldrich, who told of body rashes, fever, pain, hardened breasts, and several surgeries to remove and replace her form-covered implants (Bruning 8). Goldrich’s case brought on much media attention and the case, along with other complaints. They had only 90 days to provide such data or else all silicone implants would be withdrawn from the market (8). In 1991, the FDA began to assemble a 22-member advisory panel to review and examine the material (8). In the same year, in November, the panel found that the data was not sufficient to establish the safety of implants and recommended that manufactures be given more time to collect and submit the data (8). Meanwhile, the largest manufacturer of silicone implants, Dow Corning Wright, was found guilty of fraud and forced to give internal memos to be used as evidence in the case (9). Wright was sentenced to pay $7.3 million to punitive damages because the memos implicated that Wright skimped on pre-market testing (9). Meanwhile, there were an increasing number of women suffering different conditions and they began to file lawsuits against implant manufactures. Therefore, in January 1992, FDA Commissioner, Kessler, declared a voluntary moratorium on the distribution of silicone gel implants (Bruning 10). Consequently, on April 16, the FDA made its official decision, and FDA severely restricted the use of silicone gel-filled sacs (11). Performing breast implants was to be implemented in three stages. First, women who had problems with their breast implant were allowed to receive implants (11). Secondly, women with mastectomies, congenital deformities, or other injuries needing to have reconstruction using silicone implants were qualified to be a part of the lawsuit (11). Thirdly, under the investigational status or conditions patients were also allowed to be eligible (12). Therefore, saline-filled implants replaced silicone gel-filled implants for breast implant surgeries. According to the report of FDA, “The manufactures of saline-filled breast implants were notified by FDA in January 1993 that the agency would require data on their products’ safety and effectiveness (US FDA). Afterward, on 19 August 1999, the FDA asked the manufacturers to submit evidence to Pharmaceutical Manufacturers Association, also know as PMA, that saline-filled breast implants were safe and effective (US FDA). In 2001, the FDA introduced a study on the health effects of ruptured silicone gel breast implants (US FDA). The results showed that there was an association between extra capsular silicone gel and fibromyalgia - a syndrome characterized by widespread pain and fatigue (Brown). Therefore, the FDA suggested that women should be informed the potential risk of developing of fibromyalgia if their breast implants ruptured (US FDA). Of course, not everyone agrees with my idea. My opponents point out that Breast Implants become a tendency to let women gain more confidences and better breast size. A 2001 Psychology Today survey found that two-third of American women were unhappy with the size of their breasts. For many women, personal body image and self-esteem are closely intertwined. Young women are bombarded with images of the "perfect" female body--often the sort of body they feel that men most admire and covet, and a standard that is nearly impossible to meet (Ventura 13). Many girls first become body-conscious during adolescence, when they notice changes in their breast sizes (13). Some women remain determined, often because of a lingering lack of self-esteem or confidence, to seek through breast augmentation what they consider perfection (13). My opponents also point out the risks of Breast Implants “In recent years, serious questions have been raised about the connection between silicone leakage and chronic ailments from mild fatigue to lupus (Iehance.com). While there is no medical evidence to support these claims, there is still a great deal of controversy surrounding silicone gel implants (IEnhance.com)”. Actually, after the saline-filled implant was created, saline-filled implants are believed to be safer than silicone because rupture or leakage will only release salt water—not silicone—into the body (The Facts.com). FDA has allowed these implants to remain on the market (The Facts.com). My opponents believe there is no known association of breast implants with breast cancer in human beings, and several large studies have shown a lower incidence of breast cancer in women with breast implants in fact (IEnhance.com). Yes, I agree women can gain more confidence by the Breast implant. In addition, I agree human’s body can absorb the solution of saline-filled gel and the doctors cannot proof women will get cancer after they receive the Breast Implants. However, I believe the women who want to take a breast implant need to consider the risks because FDA states “At least of three study radiologists agreed that 378 of the 687 implants were ruptured 55%. This means that 69% of the 344 women had at least one ruptured breast implant” (Brown, Middleton and Berg). The silicone gel leaking into the body could be harmful, and the patients usually need to do second or more surgeries to fix these problems (Brown, Middleton and Berg). Although b...