{"id":1450,"date":"2026-11-01T11:26:05","date_gmt":"2026-11-01T11:26:05","guid":{"rendered":"https:\/\/healthdailyusa.com\/?page_id=1450"},"modified":"2026-11-01T17:45:10","modified_gmt":"2026-11-01T17:45:10","slug":"fda-move-on-breast-implants-draws-swift-reactions","status":"publish","type":"page","link":"https:\/\/healthdailyusa.com\/index.php?page_id=1450","title":{"rendered":"HealthDailyUSA.com &#8211; FDA Move on Breast Implants Draws Swift Reactions"},"content":{"rendered":"\n<div class=\"wp-block-group custom is-layout-flow wp-block-group-is-layout-flow\"><\/div>\n\n\n<div id=\"fb-root\" class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\"><\/div>\n\n\n<div style=\"display: none\">\n  <div id=\"inline1\" style=\"color: #004E98;text-align:center;font: 24px\/32px Calibri;margin-bottom: 10px;line-height:27px;overflow: hidden;width: 490px;height: 270px;padding-left: 8px;margin: auto\">\n    <h1 style=\"font: 48px Calibri\">Thank You!<\/h1>\n    <hr>    \n    You have made a smart decision! 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<div id=\"content\">      \n        \n\n<div id=\"k2ModuleBox143\" class=\"k2ArchivesBlock\">\n  <div id=\"title\" style=\"font-size: 20px;color: #333333;font-family: Verdana !important;padding-left:11px;padding-top:20px\"><strong>Archives<\/strong><\/div>\n    \n       \n<\/div>\n        \n         \n<div id=\"system-message-container\">\n<\/div>\n        \n<!-- Start K2 Item Layout -->\n<span id=\"startOfPageId293\"><\/span>\n\n<div id=\"k2Container\" class=\"itemView\">\n\n\t<!-- Plugins: BeforeDisplay -->\n\t\n\t<!-- K2 Plugins: K2BeforeDisplay -->\n\t\n\t<div class=\"itemHeader\">\n\n\t\t\t\t<!-- Date created -->\n\t\t<span class=\"itemDateCreated\">\n\t\t\tFriday, 02 September 2005 00:00\t\t<\/span>\n\t\t\n\t  \t  <!-- Item title -->\n\t  <h1 class=\"itemTitle\">\n\t\t\t\t\t\t\t\t\n\t\t\tFDA Move on Breast Implants Draws Swift Reactions\n\t\t\t\n\t  <\/h1>\n\t  \n\t\t\n  <\/div>\n\n  <!-- Plugins: AfterDisplayTitle -->\n  \n  <!-- K2 Plugins: K2AfterDisplayTitle -->\n  \n\t  <div 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-->\n\t  <div class=\"itemFullText\">\n\t  \t<p>FRIDAY, July 29 (HealthDay News) &#8212; After a 13-year moratorium, silicone gel-filled breast implants are making their way back to the U.S. market. <\/p>\n \n<p>Thursday night, the U.S. Food and Drug Administration moved one step closer to this end by issuing an &#8220;approvable letter&#8221; for Mentor Corp.&#8217;s application to reintroduce the product.  <\/p>\n \n<p>Reaction\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n was swift and urgent, with calls for caution coming even from a bipartisan group of female U.S. senators, including Dianne Feinstein (D-Calif.), Olympia Snowe (R-Maine) and Hillary Clinton (D-N.Y.). <\/p>\n \n<p>The nine senators sent a letter to FDA Commissioner Lester Crawford urging the agency to consider women&#8217;s health safety in its final decision on the implants. <\/p> \n \n<p>Because\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n of flaws in the basic research, CNN reported, the senators said they were &#8220;extremely concerned that the risks of this device are far disproportionate to the benefit that a woman undergoing breast augmentation would realize.&#8221; <\/p>\n \n<p>The letter also noted differences between saline and silicone implants, stating that silicone implants &#8220;bear greater risk.&#8221; The FDA was urged to note the additional distinction between using implants for reconstruction following cancer surgery and implants for augmentation. <\/p>\n \n<p>Post-marketing\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"> companies<\/span>\n\n conditions meant to address safety concerns &#8220;have proven to be ineffective or unenforceable,&#8221; the letter concluded. <\/p>\n \n<p>The other senators signing the letter were Kay Bailey Hutchison (R-Texas), Barbara Boxer (D-Calif.), Mary Landrieu (D-La.), Debbie Stabenow (D-Mich.), Blanche Lincoln (D-Ark.) and Barbara Mikulski (D-Md.). <\/p>\n \n<p>Other\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n reactions were mixed. <\/p>\n \n<p>Diane\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n Zuckerman, president of the National Research Center for Women &amp; Families, criticized the decision as &#8220;pathetic science&#8221; and &#8220;bad politics&#8221; while at the same time urging people &#8220;not too make a big deal of this.&#8221; <\/p>\n \n<p>&#8220;This\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n is a step in a process, not a final decision,&#8221; she said. &#8220;I would say a stumble in the wrong direction, because I think it&#8217;s illogical and really undermines the credibility of the FDA at a time when their credibility is not too high to start with. I think it&#8217;s politically an error for Dr. [Lester] Crawford [head of the FDA], who&#8217;s just been confirmed, to proceed, I think, recklessly in this direction.&#8221; <\/p>\n \n<p>Zuckerman stressed that her organization is not against silicone implants or any other implants. &#8220;We&#8217;re a critic of unsafe medical implants,&#8221; she emphasized. &#8220;We just want some safe implants whatever they&#8217;re made of.&#8221; <\/p>\n \n<p>Dr. Richard A. D&#8217;Amico, chairman of the breast implant task force of the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery, said, &#8220;The FDA decision really follows as a logical outcome of the science on these devices. They&#8217;re the most studied medical device and the data supports their use.&#8221; <\/p>\n \n<p>D&#8217;Amico speculated that, depending on conditions requested of Mentor by the FDA, things could get going by the end of the year. &#8220;The plastic surgery societies are fully prepared to teach the educational component the FDA may require,&#8221; he said. &#8220;There will probably be other conditions, including a breast implant registry and we&#8217;re very supportive of that. That would really allow thorough postmarket surveillance. Plastic surgeons are ready to go now. We&#8217;re just waiting for FDA conditions.&#8221; <\/p>\n\n<p>Dr.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n Nolan Karp, associate professor of plastic surgery at New York University School of Medicine, said, &#8220;I think it&#8217;s about time. The companies, particularly Mentor, did what the FDA asked. What Mentor has is a more cohesive gel implant so if it ruptures, the gel is much less likely to come out.&#8221;<\/p>\n\n<p>The letter sent from the FDA to Mentor Corp. spells out certain conditions the company must meet to receive final FDA approval to market the implants\t  <\/p><\/div>\n\t  \n\t\t<div class=\"clr\"><\/div>\n\n\t  \n\t\t\n\t  <!-- Plugins: AfterDisplayContent -->\n\t  \n\t  <!-- K2 Plugins: K2AfterDisplayContent -->\n\t  \n\t  <div class=\"clr\"><\/div>\n  <\/div>\n\n\t\n  \n  \n  \n\t\t\t\n  \n\t<div class=\"clr\"><\/div>\n\n  \n  \n  \n  <!-- Plugins: AfterDisplay -->\n  \n  <!-- K2 Plugins: K2AfterDisplay -->\n  \n  \n \n\t\t<div class=\"itemBackToTop\">\n\t\t<a class=\"k2Anchor\" href=\"https:\/\/healthdailyusa.com\/index.php?page_id=1450#startOfPageId293\">\n\t\t\tback to top\t\t<\/a>\n\t<\/div>\n\t\n\t<div class=\"clr\"><\/div>\n<\/div>\n<!-- End K2 Item Layout -->\n\n<!-- JoomlaWorks \"K2\" (v2.5.4) | Learn more about K2 at http:\/\/getk2.org -->\n\n\n              \n                <div class=\"artBanner\">  \n            <div class=\"carouselbanner\">\n                <div id=\"wrap\">\n                    <ul id=\"mycarousel90\" class=\"jcarousel-skin-tango\">\n                        <li>\n                                                            <!-- Conversant Media 160x600 WIDE SKYSCRAPER CODE for AdRx - PD ROH -->\n                                \n                                \n                                \n                                <!-- Conversant Media 160x600 WIDE SKYSCRAPER CODE for AdRx - PD ROH -->\n                                                   \n                      <\/li>\n                    <\/ul>\n                <\/div>\n            <\/div>\n        <\/div>      \n          <\/div>\n        <div class=\"clr\"><\/div>    \n    \n       <div id=\"bottombar\">\n        <div class=\"panel\" style=\"float:none !important\">\n            <div class=\"bannergroup\">\n                <div class=\"banneritem\">\n                                        \t<!-- Conversant Media 300x250 Medium Rectangle CODE for AdRx - PD ROH -->\n\t\t\t\t\t\t\n                        \n                        \n                        <!-- Conversant Media 300x250 Medium Rectangle CODE for AdRx - PD ROH -->\n                                           \n                <\/div>\n            <\/div>\n        <\/div>                   \n        <div class=\"panel\" style=\"height:600px !important;margin-top:10px\">\n            <div class=\"bannergroup\">\n              <div class=\"banneritem\"> \n                                                               \n                                 \n                <\/div>\n            <\/div>\n        <\/div>\n  <\/div>\n        \n                     \n  <\/div>  \n  <div id=\"footer\">\n    <div class=\"copyright\">\t\n\n<div class=\"custom\">\n\t<p>\n\tCopyright \u00a9 \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uvjihtllwybcjaish\"><\/span>\n\n\n2012 Healthdailyusa.com. 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