Food and Drug Administration
- Pages: 3
- Word count: 578
- Category: Plastic Surgery
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FDA is the Food and Drug Administration which is a agency whose missions are to protect the health of the public by helping medical products that are safe and effective make it to the market. FDA research shows that breast implants have generated revenues of up to approximately five-hundred million dollars before the conflict occurred. The FDA studies show that two million women in the United States have received breast implants. Since their introduction in 1964 by Dow Corning, breast implants filled with silicone have gained popularity and slowly shifted from being predominantly reconstructive to being used for augmentation purposes. The FDA estimated that 80% of the procedures were performed for personal reasons and 20% for reconstructive purposes such as cancer. According to studies, breast implants formed the third most popular procedure in plastic surgery after nose reconstruction and liposuction. Between 100,000-150,000 implant procedures were performed each year. Surgeons’ fees accounted for the bulk of the implant industry’s $500 million revenues back in 1991.
When testing medical products they should first always go through FDA Medical products should be tested out using animals first so that data can be recorded to see how safety affective the medical product is. Because If the testing is not successful when tested on animals then testing cannot be moved forward to test on humans. It is important to test the medical products out on laboratory animals are very crucial when it comes to pointing out diseases and evaluating the safety of drugs, vaccinations, household products, workplace chemicals. The FDA oversees this process for drug, vaccine safety testing. Other agencies like the CPSC and the EPA regulate other types of testing. If the testing on animals of the medical products give accurate information on the effectiveness of the medical then the next step that should be taken should be clinical trials being ran on the medical products.
The medical products should not under any circumstance be given to people until after it has been tested on animals and put through clinical trials using animals as well. If then process up until clinical trials with the animals are successful then the product can be tested on humans using clinical trials. When FDA uses humans to test the medical products they use healthy patients during the trials because it allows to them to receive data on what the products side effects are and which ones are most effective. If the first clinical trials are do not give enough accurate information then the next steps that should be taken are to run a controlled group of clinical trials where two different groups receive different versions of medical products and both are compared to each other.
For products that were first marketed in a different regulatory environment they should disposed of in the most safest way possible and reconstructed using the most up to date regulatory environment because the products that may have worked for things years ago will not be able to work the same now due to time and things changing throughout society. Dow Corning was founded in 1943 as a joint venture between the American conglomerates as Dow chemical and Corning Glass. I feel as if Dow Corning Corp should have went back and ran more clinical trials on the medical products after the various episodes just so they could have more evidence that demonstrated the safety of the products because no matter what safety always comes first and should always be the main focus before anything.