Fwd: Statement of Dr. Zuckerman, re FDA breast implant decision -- it's not as bad as you might think

[Guest guest]

Note: forwarded message attached.

The FDA's action (see below) regarding Mentor implants is very disappointing, but it's not a final decision. However, it is likely that some media outlets will report it that way. Rumor has it that this will be a long process with an uncertain outcome. We are trying to keep the reporting as accurate as possible, and trying to remind the FDA to listen to their scientists, not the industry flacks.

This is NOT the time to give up! We need you to speak out as effectively as possible. Let us know if you want to help.

Our statement and the FDA statement are below.

Best wishes,

Zuckerman, Ph.D.PresidentNational Research Center for Women & Families1701 K Street, NW, Suite 700Washington, DC 20006(202) 223-4000www.center4research.org

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Press Release Source: National Research Center for Women & Families

Statement of Dr. Zuckerman, President of National Research Center for Women & FamiliesThursday July 28, 8:48 pm ET

WASHINGTON, July 28 /PRNewswire/ -- The Food and Drug Administration (FDA) has issued an "approvable letter" to Mentor regarding their silicone gel breast implants. This does not mean that these implants have been approved, but it is a warning sign that corporate pressure on the FDA has once again put women's health at risk.

The FDA letter is a stumbling step in the wrong direction, amid mounting questions about FDA decision-making. Approval would be an embarrassment unless the Senate and the FDA give Mentor a "clean bill of health" after thoroughly investigating allegations that Mentor misrepresented the rupture rate of its implants.

A Senate investigation of the Mentor safety data and the FDA approval process is currently underway, and concerns are growing. Just before the FDA announcement today, key women members of the U.S. Senate sent a letter to the FDA Commissioner, expressing their strong concerns about the lack of safety data on silicone gel breast implants. And, as the public learns about defective pacemakers, recalls of defibrillators and the dangers of several other medical devices, questions still remain as to how safe these breast implants are.

Every week we hear from women with leaking breast implants, who can't afford the surgery to have them removed. FDA needs to make sure that they don't approve a product that adds to this frightening situation for so many women across the country.

The FDA needs to listen to its scientists and demand more long-term safety data before issuing any kind of decision. They also need to make sure that the data they are given are accurate. The credibility of the FDA is on the line, as is the health of millions of women.

Dr. Zuckerman is the president of the National Research Center for Women & Families, a nonprofit research and education organization that works to improve policies and programs that affect the health and safety of women, children, and families. Dr. Zuckerman is a nationally-recognized health policy expert with post-doctoral training in epidemiology from Yale Medical School. She was on the faculty of Vassar and Yale, and a researcher at Harvard, prior to becoming a Congressional investigator in the U.S. House of Representatives, where she initiated the first Congressional hearing on the lack of safety data on breast implants, held in 1990. She is widely quoted on a wide range of health issues, especially FDA and medical products. For more information about the Center's work, see http://www.center4research.org and http://www.breastimplantinfo.org.

--------------------------------------------------------------------------------Source: National Research Center for Women & Families

FDA Press Release

FOR IMMEDIATE RELEASEStatementJuly 28, 2005

FDA Statement on Approvable Letter to Mentor Corporation

The U.S. Food and Drug Administration (FDA) today issued an approvable letter to Mentor Corporation for their application for silicone gel-filled breast implants. Federal law and regulations prohibit the government from discussing the specific contents of the letter. However, an approvable letter is one of several intermediate steps in the FDA review process of new products. Previously at their April 2005 meeting, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor’s application was “approvable with conditions.” This letter does not mean that the device is approved for marketing in the United States at this time.

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