People are used to take the resolutions of public services
for granted, however, sometimes they are guided not by scientific research
and citizens' safety.
The Food and Drug Administration (FDA) was turned to the question of breast implant for the
first time in 1976, tasked by Congress. From 1976 to 1991 silicone
and saline gel-filled breast implants were approved by the FDA and
quite available in the USA. The approval of a product is a two-step
process during which the company has to convince the FDA that its
novelty is safe. Once potential risks and side effects showed to be too
high, the FDA has the right to forbid further investigation of the
product. If the product was approved for investigation, the company
perform a thorough research which is presented to the commission of
experts. After this, experts can recommend the product to the FDA which
makes the final decision. Once the FDA approves the new device, it can
be distributed over-the-counter.
In 1991 the FDA declared that the manufactures of silicone breast
implants have to submit the results of their studies, after which the
implants were approved. But in 1992 already the FDA changed its mind,
because the provided data on silicone breast implants were
insufficient, and remove them from the market. According to the FDA,
silicone breast implants were not found unsafe, – that was
the
lack of information which was to blame.
While saline breast implants were growing more and more popular, their
silicone confreres sunk into oblivion in the USA – and just
the
opposite in Europe. However, the FDA allowed to perform studies on
silicone breast implants, and between 1992 and 2005 additional
experiments were run. Finally, in 2006 the FDA remove restrictions, and
using of silicone breast implants was allowed for women from 22 years
old.
However, some experts claim that the FDA sent the approvable letter
without considering the opinion of the scientists which criticized
breast implants and believe that actual studies are not enough. This
approach suggests unscientific base of the FDA's decisions and,
perhaps, some inner motives: “Once again, the FDA is ignoring
the
concerns of their own scientists, this time potentially endangering
breast cancer survivors.”
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