Case Study Of Dow Corning Corporation's Code Of Ethics
Dow Corning Corporation’s (DCC) lack of ethical framework lead to not fulfilling its obligation to society in a socially responsible manner. DCC’s unsatisfactory code of conduct resulted in insufficient disclosure of information to the public.
2.0 Situation Analysis
As the diagnosis for breast cancer and other traumas are rising the demand for breast reconstruction in women is essential. There is a need for health industries and companies to provide safe and efficacious options while restoring quality of life for women (Cordeiro 2008, p. 1590-1591).
The silicone gel breast controversy has generated much confusion, leading to informed decision making for physicians and patients increasingly difficult (Rohrich and Clark 1993, p. 52-53). The …show more content…
In the case of silicone breast implants safety studies should have been well designed prior to or during product development. There have been several studies and discussions associating silicone breast implants with connective tissue diseases (Wong 1995, p. 74-75) and silicone leakage with breast cancer (Winer et al 1993, p. 1407). DCC also reported rupturing silicone envelopes prompting second operation to remove or replace the implant but to perform further investigations. The case reports’ numerous litigation claims due to adverse events experienced by patients, yet fails to provide details of the safety assessments and regulatory interactions prior to or during product launch, questioning the existence, quality and safety of the product leading the public to question DCC’s integrity. Furthermore, no information in DCC’s code of conduct indicates the quality, safety and security of a …show more content…
The Declaration of Helsinki was first published in 1964 (Barrett & Whitty 2015, p. 2). DCCs implants were first introduced to the market in early 1960s at a time when regulation was not required. The FDA introduced regulation of medical devices in 1975 and DCC were able to avoid subsequent FDA review, raising two main questions; why did they avoid FDA review when regulated products would be useful for disclosing information to patients of the potential risks and could this absence of disclosure indicate lack of safety related studies and validity of research? At this point, DCC should have re-visited its breast implant entity and devised a strategy to implement regulations as required by the health authorities. Maintaining regular interactions with the FDA was imperative at this stage, yet evidently DCC chose to ignore this through its insufficient information disclosure of studies/data/documentation being submitted to the FDA.
DCC also claimed ‘assumption of risk approach’ (Emmons, Keller, Brand 1994, p. 7) suggesting inadequate validity of the research and unsatisfactory obligation to its consumers. If ensuring safety was a priority then this is not a feasible justification and does not demonstrate quality and integrity in their part.
2.3 Inappropriate informed
2.0 Situation Analysis
As the diagnosis for breast cancer and other traumas are rising the demand for breast reconstruction in women is essential. There is a need for health industries and companies to provide safe and efficacious options while restoring quality of life for women (Cordeiro 2008, p. 1590-1591).
The silicone gel breast controversy has generated much confusion, leading to informed decision making for physicians and patients increasingly difficult (Rohrich and Clark 1993, p. 52-53). The …show more content…
In the case of silicone breast implants safety studies should have been well designed prior to or during product development. There have been several studies and discussions associating silicone breast implants with connective tissue diseases (Wong 1995, p. 74-75) and silicone leakage with breast cancer (Winer et al 1993, p. 1407). DCC also reported rupturing silicone envelopes prompting second operation to remove or replace the implant but to perform further investigations. The case reports’ numerous litigation claims due to adverse events experienced by patients, yet fails to provide details of the safety assessments and regulatory interactions prior to or during product launch, questioning the existence, quality and safety of the product leading the public to question DCC’s integrity. Furthermore, no information in DCC’s code of conduct indicates the quality, safety and security of a …show more content…
The Declaration of Helsinki was first published in 1964 (Barrett & Whitty 2015, p. 2). DCCs implants were first introduced to the market in early 1960s at a time when regulation was not required. The FDA introduced regulation of medical devices in 1975 and DCC were able to avoid subsequent FDA review, raising two main questions; why did they avoid FDA review when regulated products would be useful for disclosing information to patients of the potential risks and could this absence of disclosure indicate lack of safety related studies and validity of research? At this point, DCC should have re-visited its breast implant entity and devised a strategy to implement regulations as required by the health authorities. Maintaining regular interactions with the FDA was imperative at this stage, yet evidently DCC chose to ignore this through its insufficient information disclosure of studies/data/documentation being submitted to the FDA.
DCC also claimed ‘assumption of risk approach’ (Emmons, Keller, Brand 1994, p. 7) suggesting inadequate validity of the research and unsatisfactory obligation to its consumers. If ensuring safety was a priority then this is not a feasible justification and does not demonstrate quality and integrity in their part.
2.3 Inappropriate informed