Health Care ethics Discussion HW
Health Care ethics Discussion HW
Use of contraceptive is one of the fundamental pillars of global health care goals of maintaining sustainable families and population. One of the common contraceptive methods used by women to plan their families is the use of intrauterine devices. Over the past one year, the intrauterine devices known as the Essure has been associated with severe and chronic abdominal pains, heavy menses, and autoimmune disorders. More than 10000 women have petitioned the Food and Drug Administration (FDA) with evidence demonstrating that the use of the device has caused them significant damage which includes immense suffering due to chronic pain and hysterectomy. Even though the Bayer Company blames the adverse effects to health professional incompetence, the continued sale of the products raises a few ethical issues. For instance, who among the FDA, Bayer Company, and the physicians should be held responsible for the adverse effects caused by the device?
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The article states that FDA has refused to pull the product from the market and instead recommended the use of a checklist before implanting the device to determine the vulnerable population. Besides, the FDA has recommended that the package of the device should be labeled with warning signs illustrating that the device has the potential of causing chronic pain secondary to the punctured fallopian tube and traverse the uterus and the abdominal cavity thus necessitating the need for surgical removal and hysterectomy. The use of a checklist is not mandatory, and some Doctors argue that it address the anecdotes and fails to address scientific data. Others have claimed that the checklist is very long thus the probability of dissuading the Physicians from recommending the device. It has also emerged that the device approval process was fast tracked based on the fact that it was the first method of sterilization that does not require an incision. The failure of the FDA to champion for mandatory use of the checklist and more clinical trial begs the question “could the FDA be covering their incompetence in conducting thorough research before approving Essure?”
When choosing this article, I reflected on the ethical principle we discussed in class about beneficence and non-malfeasance. On beneficence, the development of the Essure contraceptive device by Bayer Company, its first tracked-approval by the FDA, and the prescription and insertion of the device by the physicians seems to be done in the best interest of the patient to prevent unwanted pregnancies and family planning. However, the adverse effects culminating from the method contravene the bioethical principle of non-malfeasance which requires the services to minimize the threshold of harm to the slightest levels possible. The article was very informative and shocking considering I know a few patients who are on Essure and have heard them complain about some issues raised. In my opinion, the FDA, the Bayer Company, and the health worker should stop the blame game and conduct clinical trials as soon as possible to eradicate this ethical dilemma. Do you support my opinion? How can such dilemmas be avoided in future?
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