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WASHINGTON, April 12 (Xinhuanet) -- An
advisory panel to the US Food and Drug Administration (FDA) on Tuesday ruled
against lifting a 13-year ban on the silicone breast implants manufactured by
the Inamed Corp., saying the company failed to present convincing evidence to
show the devices are safe enough.
The panel of advisers voted 5 to 4 against
recommending approval of Inamed's implants on the second day of a three-day
scientific meeting held at Gaithersburg, Maryland, on whether to resume sales of
silicone implants in the United States. Health concerns that leaking silicone
could cause long term and disablingdiseases led to the imposition of a ban in
1992.
The panel reviewed new data provided by Inamed after
the FDA rejected a similar application from the company 15 months ago. The FDA,
which has the final say, usually follows the opinion of its advisers.
On Monday, the panel heard testimony both from women
who linkedthe silicone implants to chronic, disabling illnesses and from others
who said the devices were safe, and look and feel better than saline-filled ones
now available in the United States.
Silicone implants, which are widely available in
other countries, have not been in studies linked with lupus, rheumatoid
arthritis and other chronic diseases.
The implants can lead to complications including
breast pain. They can also break and require replacement operations.
Inamed officials said the risks from the implants
were "acceptably low" and more " related to the surgical procedure" thanthe
nature of the device.
Inamed's rival Mentor Corp. is also seeking to return
silicone implants to the US market. The FDA panel will review Mentor's studies
on Wednesday. Enditem |