1992:
The FDA bans silicone-gel breast implants, except for patients
with breast cancer and certain other conditions that could
get them through specially monitored research studies. Implants
filled with saline or salt water, were not restricted and
were the only option left for cosmetic enlargement in the
USA.
1999:
The Institute of Medicine, an advisory arm of the National
Academies, says there was no evidence linking breast implants
to serious illnesses, but that breaking, pain and other
local complications may occur.
2000:
The FDA re-evaluates saline-filled implants and declares
them safe enough to continue selling if women are warned
about high breakage and replacement rates.
2003:
Inamed Corp. asks the FDA to approve its silicone-gel implants
in the USA.
2003
October, a panel of FDA scientific advisers recommends
that the implants be allowed to return to the US market.
January
2004:
The FDA rejects Inamed's bid to bring silicone-gel implants
back to market and asks the company for more information
to ensure the implants are safe.
In keeping the implants off the market for the time being,
FDA took the highly unusual step of rejecting the recommendation
of its own scientific advisers, who in October
had reluctantly agreed the devices should return despite
some lingering questions about safety and durability.
Inamed
said the company would seek approval again after learning
exactly what additional information the government will
require as proof that silicone gel implants are safe enough
to sell.
Silicone
implants do not cause major disease
The
Institute of Medicine, an arm of the National Academy
of Sciences, recently concluded that women with silicone
breasts implants are no more likely than the rest of the
population to develop serious illnesses. The report said
new studies have led to, among others, the following conclusions: