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11/17/2006 -- Allergan Announces FDA Approval of INAMED® Silicone-Filled Breast Implants for Breast Augmentation, Reconstruction and Revision Surgery
IRVINE, Calif., Nov 17, 2006 (Business Wire) -- Allergan, Inc. (NYSE:AGN) today announced that the United States Food and Drug Administration (FDA) has approved Allergan's INAMED® Silicone-Filled Breast Implants for use in breast augmentation, reconstruction and revision surgery. Until today, INAMED® Silicone-Filled Breast Implants were only available in the United States to women seeking breast reconstruction and revision surgery through clinical studies. The approval is a significant development for women in the United States who now have the same options that women in more than 60 countries have had for the last 25 years.
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11/17/2006 -- Mentor Receives FDA Approval To Sell Its MemoryGel™ Breast Implants
Announces Conference Call To Discuss Approval
Santa Barbara, California, November 17, 2006 – Mentor Corporation (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, announced today that the U.S. Food and Drug Administration (FDA) has approved for sale the Company’s MemoryGel™ silicone gel-filled breast implants with post-approval conditions. The products are indicated for women undergoing breast reconstruction and for women who are at least 22 years old undergoing breast augmentation.
“At this historic moment for Mentor, we would like to recognize with gratitude the dedication of the patients, nurses, and surgeons who have participated in the studies that provided the clinical and scientific support for this approval,” said Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. “Over the past 14 years we have remained devoted to returning MemoryGel™ implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options.”
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7/28/2005 -- Plastic Surgery Societies Applaud FDA “Approvable with Conditions” Letter to Mentor Corporation for Silicone Breast Implants
For Immediate Release: July 28, 2005
ARLINGTON HEIGHTS, ILL – The FDA’s “approvable letter” with conditions to Mentor Corporation regarding its silicone breast implants is applauded by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the two largest plastic surgery membership organizations. The approvable letter stipulates a number of conditions that Mentor must satisfy in order to receive FDA approval to market and sell silicone breast implants in the United States. This letter comes 13 years after the FDA restricted access to silicone implants because of safety concerns. Click here for more of this release
4/13/2005 -- FDA Advisory Panel Recommends Conditional Approval of Mentor Silicone Gel-Filled Breast Implants; Patient Advocates Hail Decision as Victory for Women Considering Breast Augmentation or Reconstruction
SANTA BARBARA, Calif.--(Business Wire)--April 13, 2005--Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that an advisory panel to the U.S. Food and Drug Administration (FDA) determined that the Company's silicone gel-filled breast implants are safe and effective for use in breast reconstruction and augmentation patients. The 7-2 recommendation for approval, with a series of conditions stipulated by the FDA's General and Plastic Surgery Advisory Panel, represents a significant step towards full approval of Mentor's silicone gel-filled breast implants in the United States. Click here for more of this release
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