TK Portfolio_2

TK Portfolio_2 - Tyler Kreipke Bioethics Dr. Luegenbiehl In...

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Tyler Kreipke Bioethics Dr. Luegenbiehl In “Dangerous Devices” from Forbes Magazine’s November 2006 issue, Matthew Herper and Robert Langreth write about the dangers associated with implantable medical devices and the lax FDA regulations for the devices to make it to the market. Due to the inherent dangers involved with implanting medical devices in the body, ethical decision making and ethical action are imperative for all parties involved (i.e., the FDA, Biomedical Companies, and physicians). To guide this decision making, engineers, doctors, and FDA employees can look to their respective codes of ethics. The issues surrounding medical device implantation are best portrayed by two different, newly developed devices: the stent and spinal inserts. The stent is a metal frame inserted into vessels after an angioplasty to keep the vessel from reclogging (known as restenosis). Restenosis occurred in approximately 40% of patients after an angioplasty, stents reduced this to 15%. Later, drugs that prevented scar tissue from forming were placed on the stent, which further reduced restenosis cases down to 5%. However, there is new evidence to support that the drug coated stents may cause 4,500 heart attacks per year, 2,000 of them fatal. Also, although Guidant’s Ancure aortic stent had a malfunction in its delivery device, the company did not report this, and this led to 2,600 malfunctions in its 7,600 patients, 12 of the malfunctions were fatal. The other device in question, the spinal disc, has caused some controversy. Spinal inserts are placed into the vertebral column to help patients with chronic back aches. The advent of spinal inserts has caused a surge in back surgeries. According to Richard Deyo, as spinal surgeries increased, so did repeat operations on patients. He contends that if the devices functioned properly, repeat operations would have declined. Dr. Charles Rosen contends that Johnson and Johnson’s new Charite disc was able to be marketed because J&J skewed their test data to make the spinal insert to seem more effective than it really was. To add to this, 30 patients have sued J&J due to complications with their new Charite disc. However, J&J insists that their tests were not rigged. Only 8% of 688 patients needed repeat operations, and 300 of Dr. Richard Guyer’s patients say that they are happy with the Charite disc. Both the benefits and risks associated with the medical device industry bring some ethical issues to mind. The implementation of implantable medical devices brings up three distinct ethical issues, each dealing with a different facet of the medical device cycle. The first issue involves the companies that produce the medical devices. The issue surrounding the biomedical companies involves their devices reaching the market: Is it ethical for the medical device companies to market under-tested devices? This is the most important of the issues surrounding the dangers of medical devices. Since the production of the devices is the start of the medical device cycle, all other issues come into play after the
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This note was uploaded on 03/25/2010 for the course ABBE BE430 taught by Professor Weiner during the Spring '10 term at Rose-Hulman.

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TK Portfolio_2 - Tyler Kreipke Bioethics Dr. Luegenbiehl In...

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