21 septembre, 2005 15:24
FDA OKs Silicone Breast Implants..Inamed's .. I am livid
In a message dated 9/21/2005 12:52:26 PM Central Standard Time, dz@center4research.org writes:They are not approved. It is an approvable letter. Reuters AlertNet - Inamed breast implants get conditional FDA OK
I see it's an approval letter, but Inamed and the, FDA can't be trusted to make the
Thank you warmly,
gigi/Karen
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Inamed breast implants get conditional FDA OK
21 Sep 2005 21:46:54 GMT
By Susan Heavey
WASHINGTON, Sept 21 (Reuters) - U.S. regulators granted conditional approval to a second maker of silicone gel-filled breast implants on Wednesday, allowing Inamed Corp. <IMDC.O> to sell its version if it meets certain requirements.
The move puts Inamed on par with rival Mentor Corp. <MNT.N>, which received similar approval in July, and signals the impending return of the controversial implants to the U.S. market after a 13-year restriction.
In 1992, the Food and Drug Administration limited sales to breast cancer survivors and others needing reconstruction or implant replacements amid concerns that leaking implants could cause long-term, disabling diseases such as lupus or rheumatoid arthritis.
Studies have shown the implants can cause scarring and other painful complications but most have not definitively linked them to any diseases.
Women's groups and other critics have called for more data on how often silicone implants break or leak and urged the FDA to postpone any final decision.
In April, an FDA advisory panel narrowly voted against recommending the lifting of sales restrictions on Inamed's implants but urged approval for similar implants from Mentor.
"Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel. Inamed has also said that it will no longer make available Style 153, which raised particular safety issues for the panel," the FDA said in a statement.
Diana Zuckerman, president of the National Research Center for Women & Families, said most patients Inamed studied had the 153 model and removing it from the data left little information to prove the devices are safe for breast cancer patients.
"There is no way to approve Inamed silicone gel breast implants based on scientific safety data," she said.
National Women's Health Network Policy Director Amy Allina said Inamed's revised data should be made public.
"Given the agency's track record over the last couple of years, I have to say I don't trust them to exercise the kind of judgment that is needed to protect women's health," she said.
FDA officials said federal law prevented disclosure of its conditions for Inamed, but the company said they were similar to those discussed at FDA advisory panel meetings in 2003 and last April. At those meetings, panelists said they wanted more safety information.
"We respect the thoroughness of the FDA review process and are pleased with this decision," said a statement by Nick Teti, Inamed chairman, president and chief executive.
Wednesday's news sent Inamed shares up $6.36, or nearly 9 percent, to close $77.42 on the Nasdaq stock market. Shares of Medicis Pharmaceutical Corp. <MRX.N>, which is buying Inamed, rose $1.69, or 5.18 percent, at $34.34 on the New York Stock Exchange (NYSE).
Analysts said final FDA approval could come by the end of 2005 or the first quarter of 2006.
Jayson Bedford of Adams Harkness Inc. said approval would add $70 million next year to the overall breast implant market, which is expected to top $400 million.
CIBC World Markets analyst John Calcagnini said Inamed's approval would boost its profits, but the pending merger could disrupt sales staff. "Mentor continues to gain market share," he added.
Mentor shares fell $1.86, or 3.54 percent, to close $50.70 on the NYSE.
