July 29, 2005
Silicone breast implants get FDA OK
By Susan Heavey
WASHINGTON (Reuters) - Silicone gel-filled breast implants
won conditional approval to return to the broad U.S. market
after a 13-year ban when health officials on Thursday backed a
version made by Mentor Corp.
The U.S. Food and Drug Administration said the device maker
must satisfy a number of conditions before it receives final
approval to sell the implants. FDA officials said they were
legally prohibited from making the conditions public.
Mentor said the conditions were "generally consistent" with
recommendations from an FDA advisory panel earlier this year.
In April, the expert panelists voted 7-2 to recommend
approval of Mentor's silicone implants, but called for the
company to monitor some women for rupture over 10 years as well
as educate patients and doctors.
The FDA said its decision "does not mean that the device is
approved for marketing in the United States at this time."
Critics of the implants, banned for most women since 1992
amid allegations that leaking silicone caused disabling,
long-term illnesses, were hopeful the FDA would require more
safety information before making a final decision.
"FDA can still do the right thing," Sybil Goldrich, head of
the patient group the Command Trust Network.
The U.S. Senate health committee is investigating the FDA's
handling of the decision, citing complaints about a conflict of
interest among some FDA advisers. Other critics called for the
FDA to delay a final decision pending the probe's conclusion.
Studies have failed to find a connection between silicone
implants and chronic diseases. Researchers have linked the
devices to pain and other local complications, and
manufacturers admit the implants can break and require
Only U.S. women who need reconstruction surgery after
breast cancer, have a physical deformity, or need a replacement
after other implants ruptured have had access to silicone
implants as part of special clinical studies.
Many women and plastic surgeons say silicone implants,
which are available in Europe, look and feel more natural than
"I think women, with their physicians, can make informed
decisions," said Betsy Mullen of the Women's Information
Network Against Breast Cancer.