Dow Corning and the Silicone Breast Implant Controversy
posted by Handsome Devil on Wed, 01/04/2012 – 20:32
University of Wisconsin-Whitewater
1. What are some of the major factors that led to the Breast Implant Controversy?
Throughout the 1980s and 1990s, class-action lawsuits claimed that Dow Corning's silicone breast implants caused systemic health problems. The claims first centered around breast cancer, and then migrated to a range of autoimmune diseases including lupus, rheumatoid arthritis and various neurological problems. Ok
Even though Dow Corning has spotted the signs such as stakeholder complaints and various test reports in advance, they have not handled the problems ethically and have tried to manipulate information detrimental to themselves.
Here are a few issues we found in the article:
Ethically the company should have listened to the scores of questions from customers and their doctors about serious medical problems resulting from the use of its product; however, the company has not stopped producing the product or not done anything to improve the current situation for the stakeholder’s benefits – consumer health. Yes
Secondly, the company ignored the internal reports over lack of safety testing, as reported. The mammary task force raised a question that the product could cause “a bleed through” into surrounding tissue and the test result was still “inconclusive”, even in the new product tests the engineers didn’t make sure of the product safety. In spite of these facts, the company kept selling the product to the market.
Thirdly, the company has disregarded its social responsibility to lead its community. It seemed to limit its responsibility only within its legal responsibility in a case that its product breaks the rules. To make business ethics perfect in its community, it should take care about its full responsibility on its legal aspect and its moral ethics. The unbalanced ethics approach finally not only risked the stakeholder’s health but also increased social costs in its communities. Ok
Lastly, the top managers violated its fiduciary duty to its stakeholder even in facing the allegations that the company had hidden negative test results and lied to the public about the safety of its products. The board of the directors continued to manufacture and sell the product as well as to proceeded to fight customers who brought suit alleging injury. Ok
There are other key factors such as the competition etc that need to be discussed
2. What are the ethical issues and principals involved in this case? Who has acted the most and the least responsibility? Explain.
The main ethical issue of the article was whether or not breast implants, although potentially harmful to the body, should be on the market.
Since the 1960’s when Dow Corning used silicone to develop the first prototype of a breast implant, there have been ethical concerns that have not been resolved.
In the early 90’s, breast augmentation was the second most common cosmetic procedure performed by plastic surgeons, and the top money maker. Not only were breast implants important for reconstructive surgery, such as after an accident or cancer treatment, but the demand for the implants was growing more rapidly as an elective procedure. There is even a growing medical opinion that micromastia, known as flat-chestedness, is a disease which can result in a patient having a total lack of body image and low self esteem. Thus, the enlargement is necessary to insure an improved quality of life for the patient. Ok
However, as the number of breast implant patients increased, so did the number of complaints. There were allegations of the implants causing pain, scarring, and even debilitating autoimmune diseases in the patients. But how was a product that was clearing injuring patients allowed to be on the market? How ethical was it to allow these products to be so available, and yet, so potentially dangerous? Yes
First of all, breast implants were not governmentally regulated when first developed in the 1960’s. FDA could not require approval for safety and effectiveness before products were on the market.
Second, in accordance with “good manufacturing” practices, Dow Corning did attempt to determine safety of medical products before releasing them to the public. However, the determination of “safety” was vague and based on the company’s opinion. When tested on animals, silicone was injected into the body. There was clear evidence of chronic inflammation; however, because the silicone would not be injected into humans, the finding was ignored.
Third, the new and improved implants were brought into the market quickly without extensive medical testing. The reasoning for this was because similar substances had already been tested in other facilities. It was; however, brought to the attention of Dow Corning that “bleed throughs” were occurring. The company assigned a few employees to investigate (meanwhile still providing breast implant procedures). They found that the bleeding was “no greater than what we measure from old control gels”. However, it was stated that these tests were “inconclusive”, and were never researched again. Ok
Finally, in 1975, it was found that the reject rate at inspection was as high as 50% on some production lots. And yet, the implants were still available on the market.
Need to also integrate some theoretical perspective to assess Dow’s egoism + utilitarian principles
The responsibility for these ethical issues is a combination of both the Dow Corning company and the government. The Dow Corning company, although not held to any level of standards, was providing a potentially harmful product to the public. Yes Testing was done, but was not conclusive. The government (FDA) allowed companies, like Dow, to supply harmful products because they did not require extensive testing. It was not until 1989 when the FDA finally identified silicone implants as Class III devices, meaning riskiest. But still, after many hearings, breast implants were cited as a “public health need” and were left on the market.
Plastic surgeons and the public also hold some responsibility. Surgeons, although knowledgeable about the possible effects, still recommended and used the products on their patients. Many breast cancer advocacy organizations and satisfied recipients also supported Dow Corning and the use of breast implants. Ok
3. What was the role of the US Food and Drug Administration? Should they take some blame for the scandal? Should they have taken a more active role early in the controversy? Is the role government agencies can play in this respect limited?
In the early years of the product, the Food and Drug Administration (FDA) had very little oversight of silicone breast implants. The FDA did regulate products meant for ingestion (pharmaceutical drugs) since 1906 (Pure Food and Drug Act) but implants were considered medical devices and outside the FDA’s regulatory scope. The products could be removed from the market only if the manufacturer was proven to break the law. Despite the Medical Amendments Act to the Food and Drug Act (1976) the FDA didn’t label breast implants as dangerous until 1989 (after numerous lawsuits). Ok
The FDA should have taken an active role to regulate these products and can be considered somewhat responsible. Dow Corning was able to put a new product designed for internal human use into the market with little testing and no oversight. Their testing revealed health dangers that they ignored and kept from the public. If the product was regulated, the FDA would have seen the effects on laboratory animals – the Silicon causing inflammation as it sticks to various organs and lymph nodes. Despite intent to keep the silicon out of the body, ruptures or leaks would cause damage and users at least need to be aware of the risk before putting the product inside their bodies. Regulation would have revealed the numerous red flags (animal testing, plastic surgeons’ trade show) associated with Dow Corning’s implants and their FDA approval would have been delayed until the problems were solved. Yes
Dow Corning and other corporations have the goal of making profits and increasing their shareholders’ wealth. The FDA and other government agencies should realize this and put checks in place to ensure these companies offer safe products and services. Breast implants may not be a food or a drug but they are meant for internal use in the human body and they should have been added to the regulatory scope of the agency much earlier than they were. One of the roles of government is to protect its citizens (national defense, criminal justice, health care) and while it is often hesitant to regulate business (especially when that business makes significant contributions to political campaigns) when blatantly dangerous products are made available to consumers, the government does have and should use its authority to regulate and prohibit sales of these devices.
4. Why did Dow’s exemplary formal code of conduct fail in preventing the controversy? What can be done to make a Code of Ethics more effective?
Dow’s exemplary formal code of conduct failed because its implementation was flawed and didn’t address all ethical issues, most important being safety. With great diligence they fought to make all business transactions legit, thus denouncing scandals which was admirable, but to avoid addressing safety as an ethical issue is not above reproach. The first ethical question raised should be “is the product we are manufacturing safe to the parties we are soliciting?” If studies are performed findings should be disclosed on the label and not hidden. Safety not being on the ethics score card made the formal code of conduct vulnerable to controversy. Ok To make a product that may have safety issues without proper notification to the parties involved is highly unethical. The employee’s at Dow involved in the safety studies as well as the top level managers that made the decision to push the product were quite aware of the situation. The urge to generate profit and regain market share took precedent over any safety concerns.
In an effort to make the Code of Ethics more effective, a company such as Dow’s must address all ethical issue’s leaving nothing to chance. To the fullest extent any possible ethical dilemma the company could face should be analyzed and given a proper course of action. Yes Granted no society lives in utopia, thus no Code will be perfect, but at no point should major issues such as safety be brushed under the rug to obtain a profit. Companies must also be willing to be honest with themselves in addition to the parties that they serve. Doing so not only makes it easier to create an effective Code of Ethics but also implementing it will come with ease. In the Dow’s case they were not being honest about the product they were promoting and selling. Stemming from the early stages they knew the product had potential to be a safety hazard but elected to forgo the proper testing to ensure the product wasn’t detrimental to an individual’s health.
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