From: Subject: FDA APPROVES SILICONE GEL-FILLED BREAST IMPLANTS Date: Thu, 23 Aug 2007 13:03:43 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C7E586.08B49820" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3138 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C7E586.08B49820 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: file://\\server\Usuarios\EDASSY\Mis documentos\FDA APPROVES SILICONE GEL-FILLED BREAST IMPLANTS.htm FDA APPROVES = SILICONE GEL-FILLED BREAST IMPLANTS
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FDA News

FOR IMMEDIATE RELEASE
P06-189
November = 17, 2006=20

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Heidi=20 Valetkevitch, 301-827-6242
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888-INFO-FDA


FDA Approves Silicone = Gel-Filled=20 Breast Implants
After In-Depth Evaluation
Agency=20 Requiring 10 Years of Patient Follow-Up

After rigorous scientific review, the U.S. Food and Drug = Administration (FDA)=20 today approved the marketing of silicone gel-filled breast implants made = by two=20 companies for breast reconstruction in women of all ages and breast = augmentation=20 in women ages 22 and older.  The products are manufactured by = Allergan=20 Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa = Barbara,=20 Calif.

=93FDA has reviewed an extensive amount of data from clinical trials = of women=20 studied for up to four years, as well as a wealth of other information = to=20 determine the benefits and risks of these products,=94 said Daniel = Schultz, M.D.,=20 Director, Center for Devices and Radiological Health, FDA.  =93The = extensive=20 body of scientific evidence provides reasonable assurance of the = benefits and=20 risks of these devices.  This information is available in the = product=20 labeling and will enable women and their physicians to make informed = decisions.=94=20

Now that the products have been determined to be safe and effective, = FDA will=20 continue to monitor them by requiring each company to conduct a large=20 postapproval study following about 40,000 women for 10 years after = receiving=20 breast implants.  FDA often requires postmarket studies to answer = important=20 questions that can only be answered once a product is in broader use, = such as=20 the incidence of rare adverse events. 

FDA=92s decision to approve these implants was based on a thorough = review of=20 each company=92s clinical (core) and preclinical studies, a review of = studies by=20 independent scientific bodies and deliberations of advisory panels of = outside=20 experts that heard public comment from hundreds of stakeholders.  = In=20 addition, FDA conducted inspections of each company=92s manufacturing = facilities=20 to determine that they comply with FDA=92s Good Manufacturing = Practices. =20 Some of the complications reported in the core studies included = hardening of the=20 area around the implant, breast pain, change in nipple sensation, = implant=20 rupture and the need for additional surgery.  However, the majority = of=20 women in these studies reported being satisfied with their = implants. 

In the past decade, a number of independent studies have examined = whether=20 silicone gel-filled breast implants are associated with connective = tissue=20 disease or cancer.  The studies, including a report by the = Institute of=20 Medicine, have concluded there is no convincing evidence that breast = implants=20 are associated with either of these diseases.  However, these = issues will=20 be addressed further in the postapproval studies conducted by the = companies.

=93The silicone breast implant is one of the most extensively studied = medical=20 devices,=94 said Schultz.  =93We now have a good understanding of = what=20 complications can occur and at what rates.  We also know that women = who get=20 these devices will probably need to have additional breast implant = surgery at=20 least once.  This is valuable information for women who may be = considering=20 these products.=94

Full information about the risks and benefits of the devices can be = found in=20 the package and patient labeling mandated by FDA.  The patient = labeling=20 outlines some of the important factors women should consider when = deciding=20 whether to get silicone gel-filled breast implants.  Some of these = factors=20 are: breast implants are not lifetime devices and a woman will likely = need=20 additional surgeries on her breast at least once over her lifetime; many = of the=20 changes to a woman=92s breast following implantation are irreversible; = rupture of=20 a silicone gel-filled breast implant is most often silent, which means = that=20 usually neither the woman nor her surgeon will know that her implants = have=20 ruptured; and a woman will need regular screening MRI examinations over = her=20 lifetime to determine if silent rupture has occurred.  The device = labeling=20 states that a woman should have her first MRI three years after her = initial=20 implant surgery and then every two years thereafter.  The cost of = MRI=20 screening over a woman=92s lifetime may exceed the cost of her initial = surgery and=20 may not be covered by medical insurance.  The labeling also states = that if=20 implant rupture is noted on an MRI, the implant should be removed and = replaced,=20 if needed.

FDA approved the silicone gel-filled breast implants with a number of = conditions, including requiring each company to: conduct a large = postapproval=20 study; continue its core study through 10 years; conduct a focus group = study of=20 the patient labeling; continue laboratory studies to further = characterize types=20 of device failure; and track each implant in the event, for example, = that health=20 professionals and patients need to be notified of updated product=20 information.

The postapproval studies will continue to gather information about = the safety=20 and effectiveness of the implants.  Information will be collected = about=20 rates of local complications, rates of connective tissue disease and its = signs=20 and symptoms, rates of neurological disease and its signs and symptoms,=20 potential effects on offspring of women with breast implants, potential = effects=20 on reproduction and lactation, rates of cancer, rates of suicide, = potential=20 interference of breast implants with mammography, and MRI compliance and = rupture=20 rates. 

The postapproval studies will be closely monitored by FDA.  FDA=20 anticipates that data from the studies will provide important = information for=20 patients and physicians, and may lead to improvements in device = labeling.

For more information, visit www.fda.gov/cdrh/breastim= plants.

Download video sound bites from FDA officials at http://media.= medialink.com/home.aspx?Story=3D32701.

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t+3223DHLffcdNdt991456333nz3F+3334AHLvjghBdu+OGIJ6744ow3LndAADs= ------=_NextPart_000_0000_01C7E586.08B49820 Content-Type: image/gif Content-Transfer-Encoding: base64 Content-Location: file://server/Usuarios/EDASSY/Mis%20documentos/FDA%20APPROVES%20SILICONE%20GEL-FILLED%20BREAST%20IMPLANTS_archivos/blkpixel.gif R0lGODlhAQABAIAAAAAAAP///yH5BAAAAAAALAAAAAABAAEAAAICRAEAOw== ------=_NextPart_000_0000_01C7E586.08B49820 Content-Type: application/octet-stream Content-Transfer-Encoding: quoted-printable Content-Location: file://server/Usuarios/EDASSY/Mis%20documentos/FDA APPROVES SILICONE GEL-FILLED BREAST IMPLANTS_archivos/triggerParams.js // Customer: U.S. Food and Drug Administration // Version : DHTML Trigger 3.0.1 function cppUrlPatch(s) { var translated =3D ""; var i;=20 var found =3D 0; for(i =3D 0; (found =3D s.indexOf(':', found)) !=3D -1; ) { translated +=3D s.substring(i, found) + "|"; i =3D found + 1; found++; } translated +=3D s.substring(i, s.length); return translated; } var triggerParms =3D new Array();=20 var excludeList =3D new Array(); triggerParms["dt"] =3D 0; // disable trigger if 1 triggerParms["mid"] =3D "oFU8oht9h8gMEgBp08oc5g=3D=3D"; // model = instance id triggerParms["cid"] =3D "5NElN0sYkQcFAAcgcYFYVA=3D=3D"; // customer id triggerParms["lf"] =3D 4; // loyalty factor triggerParms["sp"] =3D 0; // sample percentage triggerParms["npc"] =3D 1; // no persistent cookies if 1 triggerParms["rw"] =3D 129600; // resample wait (value in minutes) triggerParms["pu"] =3D 0; // pop-under control triggerParms["olpu"] =3D 1; // On Load pop-under control triggerParms["lfcookie"] =3D "ForeseeLoyalty_MID_oFU8oht9h8"; triggerParms["ascookie"] =3D "ForeseeSurveyShown_oFU8oht9h8"; triggerParms["width"] =3D 420; // survey width triggerParms["height"] =3D 500; // survey height triggerParms["domain"] =3D ".fda.gov"; // domain name triggerParms["omb"] =3D "1505-0186"; // OMB number //triggerParms["cmetrics"] =3D "90010257"; // coremetrics client id triggerParms["cpp_1"] =3D "userURL:" + cppUrlPatch = (window.location.href); triggerParms["capturePageView"] =3D 1; //excludeList[0] =3D "/exclude/"; //trigger script will not work under = this path //triggerParms["dcUniqueId"] =3D "TEST04JloZZN0k9cI1Ep5d"; // (22 chars = unique Id for double cookie I/II) //triggerParms["midexp"] =3D 129600; // model instance expiry value triggerParms["rso"]=3D 0; //user has chosen to use Retry Survey Option triggerParms["aro"]=3D 0; //user has chosen to use Auto Retry Option, = with SP=3D100 //triggerParms["rct"]=3D 1; //The maximum number of times allowed to = serve a survey to a user //triggerParms["rds"]=3D 1; //The minimum number of days to wait to = serve a survey repeatedly //triggerParms["mrd"]=3D 1; //The total number of days that a user can = be re-served a survey triggerParms["compliant508"] =3D 1; //508 compliant if 1 //DHTML Parameter triggerParms["dhtml"]=3D 1;// disable dhtml trigger if dhtml=3D0 triggerParms["dhtmlWidth"] =3D 400; // welcome page width triggerParms["dhtmlHeight"] =3D 290; // welcome page height triggerParms["dhtmlURL"]=3D "/fsrscripts/FSRInvite.html"; ------=_NextPart_000_0000_01C7E586.08B49820 Content-Type: application/octet-stream Content-Transfer-Encoding: quoted-printable Content-Location: file://server/Usuarios/EDASSY/Mis%20documentos/FDA APPROVES SILICONE GEL-FILLED BREAST IMPLANTS_archivos/stdLauncher.js // Customer:U.S. Food and Drug Administration // Version : DHTML Trigger 3.0.1 // ************ don't modify below this line ************* var popUpURL =3D "//www.foreseeresults.com/survey/display"; // base URL = to the survey=20 var FSRImgURL =3D "//www.foreseeresults.com/survey/FSRImg"; var OTCImgURL =3D "//controller.foreseeresults.com/fsrSurvey/OTCImg"; var ckAlreadyShown =3D triggerParms["ascookie"]; // name of the = persistent/session cookie var ckLoyaltyCount =3D triggerParms["lfcookie"]; // name of the loyalty = count cookie var fullURL=3Dnull; var oldURL=3Dnull; var myPopUp=3Dnull; var fsr_aol=3Dnull; var dcQString=3D""; var cpp_3 =3D ""; var winOptions =3D "width=3D 1,height=3D 1,top=3D 4000,left=3D = 4000,resizable=3Dyes,scrollbars=3Dyes"; var persistentExpires =3D new Date(); //persistent cookie expiration=20 persistentExpires.setTime(persistentExpires.getTime() + = (triggerParms["rw"]*60*1000)); function ForeCStdGetCookie (name) { var arg =3D name + "=3D"; var alen =3D arg.length; var clen =3D document.cookie.length; var i =3D 0; while (i < clen) { var j =3D i + alen; if (document.cookie.substring(i, j) =3D=3D arg) { return ForeCStdGetCookieVal (j); } i =3D document.cookie.indexOf(" ", i) + 1; if (i =3D=3D 0) { break; } } return null; } function fsr_showWindow() { =20 if(myPopUp !=3D null && !myPopUp.closed && fsr_aol=3D=3Dfalse) = {return;} =20 var cpp3Str =3D "";=20 cpp_3 =3D "Browser:"+ cppUrlPatch (navigator.userAgent)=20 cpp_3+=3D";dhtml";=09 var pos1 =3D fullURL.indexOf("&cpp_3=3D"); var pos2 =3D fullURL.indexOf("&",pos1+1); if (pos2=3D=3D-1){ fullURL =3D fullURL.substring(0,pos1); }else{ cpp3Str =3D fullURL.substring(pos2,fullURL.length); fullURL =3D fullURL.substring(0,pos1); } =20 fullURL+=3D"&cpp_3=3D"+cpp_3 + cpp3Str; =20 if(document.all && document.all.fsr_window.filters) { eval("document.all.fsr_window").filters.revealTrans.transition =3D 23 = ; eval("document.all.fsr_window").filters.revealTrans.Apply(); eval("document.all.fsr_window").style.visibility =3D 'visible'; eval("document.all.fsr_window").filters.revealTrans.Play(); } else if(document.all) {document.all.fsr_window.style.visibility =3D = 'visible';}=09 else if(document.getElementById) = {document.getElementById("fsr_window").style.visibility =3D 'visible';}=09 } function fsr_hideWindow() { if(document.all && document.all.fsr_window.filters) { eval("document.all.fsr_window").filters.revealTrans.transition =3D 23; eval("document.all.fsr_window").filters.revealTrans.Apply(); eval("document.all.fsr_window").style.visibility =3D 'hidden'; eval("document.all.fsr_window").filters.revealTrans.Play(); } else if(document.all) {document.all.fsr_window.style.visibility =3D = 'hidden';}=09 else if(document.getElementById) = {document.getElementById("fsr_window").style.visibility =3D 'hidden';} } function ForeCStdSetCookie (name, value) { var argv =3D ForeCStdSetCookie.arguments; var argc =3D ForeCStdSetCookie.arguments.length; var expires =3D (argc > 2) ? argv[2] : null; var path =3D (argc > 3) ? argv[3] : null; var domain =3D (argc > 4) ? argv[4] : null; var secure =3D (argc > 5) ? argv[5] : false; document.cookie =3D name + "=3D" + escape (value) + ((expires =3D=3D null) ? "" : ("; expires=3D" + expires.toGMTString())) = + ((path =3D=3D null) ? "" : ("; path=3D" + path)) + ((domain =3D=3D null) ? "" : ("; domain=3D" + domain)) + ((secure =3D=3D true) ? "; secure" : ""); } function ForeCStdGetCookieVal(offset) { var endstr =3D document.cookie.indexOf (";", offset); if (endstr =3D=3D -1) { endstr =3D document.cookie.length; } return unescape(document.cookie.substring(offset, endstr)); } function specialEscape(str) { var translated =3D ""; var i;=20 var found =3D 0; for(i =3D 0; (found =3D str.indexOf('+', found)) !=3D -1; ) { translated +=3D str.substring(i, found) + "%2B"; i =3D found + 1; found++; } translated +=3D str.substring(i, str.length); return translated; } function Pop(){ myPopUp =3D window.open(fullURL, 'survey',winOptions); if ( myPopUp!=3Dnull && !myPopUp.closed) { if (triggerParms["pu"] =3D=3D 1){ self.focus(); } else { myPopUp.focus(); =09 } } } function checkMAC(){ if(navigator.platform.indexOf("Win32") >=3D 0){ return false; } else { return true; }=09 } var detect =3D navigator.userAgent.toLowerCase(); function checkAOL(){ if (detect.indexOf("aol") >=3D0){ return true; } return false; } function currentLocationExcluded() {=09 var parentURLPath =3D window.location.pathname;//location path for(key in excludeList) { if(parentURLPath.indexOf(excludeList[key]) !=3D -1) { return true; } } return false; } var newDt; var currTime; // in millisecs var OTCImg; var FSRImg; var surveyProcessCont =3D 1; function stdImgProc() { if(triggerParms["compliant508"] =3D=3D 1) { fsr_showWindow();} else { setTimeout ( "fsr_showWindow();", 1000, "JavaScript" ); } } function fsrShowSurvey(){ if(dcQString =3D=3D "") { stdImgProc(); } else { newDt =3D new Date(); currTime=3D newDt.getTime(); // in millisecs FSRImg =3D new Image(); FSRImg.src =3D null; FSRImg.onerror =3D imgErrorProc; FSRImg.onload =3D imgOnloadProc; FSRImg.src =3D FSRImgURL + "?" + dcQString + "&uid=3D"+ currTime; = //for NE/FF Cache Fix } } function imgOnloadProc() { if(surveyProcessCont =3D=3D 1 && FSRImg.width =3D=3D 3) { stdImgProc(); = } return true; } function imgErrorProc() { surveyProcessCont =3D 0; return true; } function otcOnloadProc() { =20 if(surveyProcessCont =3D=3D 1 && OTCImg.width =3D=3D 3) { = fsrShowSurvey(); } else { surveyProcessCont =3D 0; } return true; } function otcErrorProc() { fsrShowSurvey(); return true; } function Poll() {=20 if(triggerParms["dt"] =3D=3D 1) { return; } if(currentLocationExcluded()) { return; } var stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount); // check = counter cookie var alreadyShown =3D ForeCStdGetCookie(ckAlreadyShown); // check if we = already have shown survey var pageCount; var randNum =3D Math.random(); randNum *=3D 100; if (stickyCounter =3D=3D null) { pageCount =3D 1;=20 ForeCStdSetCookie(ckLoyaltyCount, pageCount, = null,'/',triggerParms["domain"]); stickyCounter =3D ForeCStdGetCookie(ckLoyaltyCount); } if (stickyCounter !=3D null) { pageCount =3D stickyCounter; if(pageCount >=3D triggerParms["lf"]) { if(alreadyShown =3D=3D null) { if (triggerParms["rso"] =3D=3D 1 && triggerParms["aro"] =3D=3D 1) { triggerParms["sp"] =3D 100.0; // Update Ssample percentage } if(randNum <=3D triggerParms["sp"]) { fsr_aol=3D checkAOL(); var fsr_mac=3D checkMAC(); =09 var fsr_browser=3D"fsr_nn6"; if(document.all || document.getElementById){=20 fsr_browser =3D "fsr_ie"; } if(document.layers) { fsr_browser =3D "fsr_nn"; } fullURL =3D popUpURL + "?" + "width=3D" + triggerParms["width"] + "&height=3D" + triggerParms["height"] + "&cid=3D" + specialEscape(escape(triggerParms["cid"])) + "&mid=3D" = + specialEscape(escape(triggerParms["mid"])); if ((triggerParms["omb"] ) !=3D null) { fullURL +=3D "&omb=3D" + escape(triggerParms["omb"]); } if ((triggerParms["cmetrics"] ) !=3D null) { fullURL +=3D "&cmetrics=3D" + escape(triggerParms["cmetrics"]); } if (triggerParms["olpu"] =3D=3D 1) { fullURL +=3D "&olpu=3D1"; } if ((triggerParms["dcUniqueId"]) !=3D null) { fullURL +=3D "&dcUniqueId=3D" + = escape(triggerParms["dcUniqueId"]); } if (triggerParms["rso"] =3D=3D 1) { fullURL +=3D "&rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" + = triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + = triggerParms["rw"]; } if (triggerParms["capturePageView"] =3D=3D 1) { triggerParms["cpp_2"] =3D "PageView:"+ pageCount; // customer = parameter 2 - Page View } if ((triggerParms["midexp"] ) !=3D null) { fullURL +=3D "&ndc=3D1&fsexp=3D5256000&midexp=3D" + = triggerParms["midexp"]; } triggerParms["cpp_3"] =3D "Browser:"+ cppUrlPatch = (navigator.userAgent) + ";normal"; =09 var customerParams =3D ""; =09 for(paramKey in triggerParms) { if(paramKey.substring(0,3) =3D=3D "cpp"){ fullURL +=3D "&" + paramKey + "=3D" + = escape(triggerParms[paramKey]); } }=09 oldURL=3DfullURL; if (triggerParms["rso"] !=3D 1) { if(triggerParms["npc"] =3D=3D 1) { ForeCStdSetCookie(ckAlreadyShown, = 'true',null,'/',triggerParms["domain"]); } else { ForeCStdSetCookie(ckAlreadyShown, 'true', = persistentExpires,'/',triggerParms["domain"]); } } // for AOL users - show DHTML (by default) if (fsr_aol=3D=3Dfalse) { myPopUp =3D window.open(fullURL, 'survey',winOptions); } if (fsr_mac=3D=3Dfalse && (fsr_browser !=3D "fsr_nn") && = (triggerParms["dhtml"] =3D=3D 1)) { fullURL=3DoldURL; fsr_left =3D (screen.width - triggerParms["dhtmlWidth"])/2; fsr_top =3D Math.min((screen.height - = triggerParms["dhtmlHeight"])/2,150); =09 document.write("
" + "
"); =09 //DC I/II verification if (triggerParms["rso"] =3D=3D 1) { dcQString =3D "rso=3D1&rct=3D" + triggerParms["rct"] + "&rds=3D" = + triggerParms["rds"] + "&mrd=3D" + triggerParms["mrd"] + "&rws=3D" + = triggerParms["rw"]; if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D = "&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); } } if ((triggerParms["midexp"] ) !=3D null) { dcQString =3D "ndc=3D1&midexp=3D" + triggerParms["midexp"] + = "&mid=3D" + specialEscape(escape(triggerParms["mid"])); if(triggerParms["dcUniqueId"]!=3Dnull) { dcQString +=3D = "&dcUniqueId=3D" + specialEscape(escape(triggerParms["dcUniqueId"])); } } =09 =09 //Failover Check surveyProcessCont =3D 1; =09 newDt =3D new Date(); currTime=3D newDt.getTime(); // in millisecs OTCImg =3D new Image(); OTCImg.src =3D null; OTCImg.onerror =3D otcErrorProc; OTCImg.onload =3D otcOnloadProc; OTCImg.src =3D OTCImgURL + "?protocol=3D" + = window.location.protocol + "&uid=3D"+ currTime; //for NE/FF Cache Fix } =09 if(myPopUp !=3D null && !myPopUp.closed) { if (triggerParms["pu"] =3D=3D 1){ self.focus(); } else { myPopUp.focus(); } } } } } =09 pageCount++; ForeCStdSetCookie(ckLoyaltyCount, pageCount, = null,'/',triggerParms["domain"]); =09 } } ------=_NextPart_000_0000_01C7E586.08B49820--