Messages - plus Health Canada Grants Inamed & Mentor licenses

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Kathynye@... wrote: From: Kathynye@...Date: Fri, 20 Oct 2006 21:57:52 EDTSubject: POST:Note: & Health Canada Grants Inamed & Mentor licenses Kathynye@...To All,This news is very upsetting. We fight so hard but seem to take one step forward and three backwards.I will be away from my computer for a while. For reason to long to go into right now.I will be back online when I can.Kathy Nye=============================================================Subj: Sorry to bring bad news ... Health Canada Grants Inamed & Mentor licenses (with conditions) Date: 10/20/2006 1:35:31 PM Eastern Standard Time From: ilena.rose@... News

Releasehttp://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/2006/2006_103_e.htmlOctober 20, 2006For immediate releaseHealth Canada grants manufacturers Class IV licences with conditions to market silicone gel-filled breast implantsOTTAWA -Health Canada announced today that it will grant licences with conditions to Inamed Corporation and Mentor Medical Systems to market their silicone gel-filled breast implants in Canada. These Class IV licences are conditional on the manufacturers meeting several requirements to ensure their devices continue to meet the safety and effectiveness requirements of the Medical Devices Regulations.Health Canada's number one priority is to protect and promote the health and safety of Canadians. Decisions to grant licences for medical devices are strictly objective and based on evidence. Applications from Inamed and Mentor were evaluated

by Health Canada's scientific and medical staff to determine if the devices met safety and effectiveness requirements. Health Canada's decision followed a complete review of the manufacturers' evidence, independent evidence-based studies, public submissions and an Expert Advisory Panel's advice. The Expert Advisory Panel reviewed submissions from concerned Canadians and heard directly from the public at an open meeting before it provided its advice to Health Canada. In granting these licences, Health Canada has attached several conditions. The manufacturers are required to:Provide ongoing updates regarding long-term clinical trial results through to ten years. Conduct and report on at least two patient focus groups in Canada to determine the effectiveness of product labelling. Conduct a large, long term study involving tens of thousands of women. Manufacturers are required to start the study within one year. Survey Canadian plastic

surgeons on the effectiveness of the labelling and decision aids (brochures) provided with the implants. Continue implant retrieval and analysis studies - from all available sources - for further characterization of potential modes and causes of implant failure. In addition, the manufacturers have committed to the following:Provide updated sales and marketing histories - including a summary of any reported problems or recalls - in Canada and internationally. Provide implant registration cards with the device. (Patients receiving these cards from their surgeons can send them voluntarily to the manufacturer. This will allow the manufacturer, in addition to using general methods of dissemination, to distribute any new information directly to the persons affected.) Until now, only saline-filled breast implants have been licensed for sale in Canada. Silicone gel-filled implants have been available through the Department's Special Access Programme for Medical

Devices.In announcing this decision, Health Canada reminds Canadians that no medical device or drug is 100-per-cent safe, effective and without risks. Silicone gel-filled implants are considered a Class IV medical device, representing the highest degree of potential risk. A woman's decision to undergo breast reconstruction after a mastectomy or for breast augmentation should be made only after consultation with a health care provider and full consideration of the benefits versus any potential risks. Note: Summary Basis of Decision documents regarding the Inamed and Mentor applications are available at the Health Canada Web site - 30 - Media Inquiries:Carole SaindonHealth Canada(613) 957-1588 WaddellOffice of the Honourable Tony ClementFederal Minister of

Health(613) 957-0200Public Enquiries:(613) 957-29911-866 225-0709 ========================================================Subj: Dr. Zuckerman's comments on Canadian Decision Date: 10/20/2006 3:55:39 PM Eastern Standard Time From: ilena.rose@... Sent from the Internet (Details) Excerpt: The U.S.-based National Research Center for Women and Families, which has lobbied against the implants in the United States, said Canada also was making an ill-advised decision. "This shocking and unfortunate decision will jeopardize women's health for many years to come," the group's president, Zuckerman, said from Washington.She said possible silicone leaks could spread to other organs and could cost Canada's public health system millions of dollars.~~~~~~~~~~~~~~`http://ca.today.reuters.com/news/newsArticle.aspx?type=domesticNews & storyID=2006-10-20T191648Z_01_N20444142_RTRIDST_0_CANADA-CANADA-IMPLANTS-COL.XML & archived=False Canada allows silicone breast implants againFri Oct 20, 2006 3:16 PM EDT By Randall PalmerOTTAWA (Reuters) - The Canadian government licensed the sale of

silicone gel breast implants on Friday, reversing a partial ban that was in place for more than 13 years over health concerns. Health Canada granted licenses to two U.S. companies, Mentor Corp. and Inamed Corp., a unit of Allergan Inc. to market their implants in Canada.The two firms had already received conditional approval from the U.S. Food and Drug Administration, but are waiting for a final go-ahead to begin selling the devices in the United States. Canada had brought in a voluntary moratorium on the implants in 1992 and turned it into an effective ban in 1993 by saying they would not be allowed on the market without new clinical studies. The government did allow 24,000 silicone implants since then through a Special Access program, under which doctors had to certify that suitable alternative procedures were not available. Saline-filled breast implants were the only kind that had been generally available in Canada in the meantime."Health Canada's licensing of a medical device does not mean the device is risk-free," the Canadian agency said."Rather, it means the device has the potential to provide benefits, and the risks have been reduced as much as possible."The agency cited comprehensive reviews in Britain and the United States from 1995 to 2004 as concluding there was no evidence of silicone implants causing auto-immune diseases or other systemic illnesses. Two further studies showed that women undergoing cosmetic breast augmentation did not appear to have an increased long-term risk of cancer and that breast implants did not appear to directly increase mortality. The U.S.-based National Research Center for Women and Families, which has lobbied against the implants in the United States, said Canada also was making an ill-advised decision. "This shocking and unfortunate decision will jeopardize women's health for many years to come," the group's president, Zuckerman, said from Washington.She said possible silicone leaks could spread to other organs and could cost Canada's public health system millions of dollars. =============================================================The National - Wikipedia, the free encyclopediaGo to the National TV section on CBC., has told me; her interview against Breast Implants issupposed to air three times this evening. Starting at 7:00 PMCanadian Time. They are one hour behind me in, Texas. It's 4:40 PM my time right now. I'm sending you the whole TV page.Where those of, you that would like to listen to; 's interviewagainst Breast Implants can tune in and listen also. This article is about the Canadian television news show. For other meanings, see The National (disambiguation). The National The 2006 opening of CBC News: The National Genre News Running time 60 mins. Starring Mansbridge Country of origin Canada Language(s) English Original channel CBC Original run 1954–present No. of episodes N/A Official website The National, now officially known as CBC News: The National, is the CBC's flagship national television newscast. It reports on major Canadian and international news stories, airing on CBC Television weekday nights at 10:00 p.m. local time (10:30 p.m. NT).The program generally follows a format of news headlines for the first 20 minutes followed by a magazine segment that may include documentaries, feature reports and/or panel

discussions. The first commercial interruption usually comes about 40 minutes into the program. In exceptional news circumstances, the regular format may be waived.CBC owned and operated stations then repeat the news headline portion of The National at 11:00 p.m.; this practice ended in October 2006, when repeats of CBC News: The Hour began airing in that timeslot. Private affiliates of the CBC do not broadcast this airing. Additional airings, on CBC Newsworld, are at 9:00 p.m. (the initial version that airs live to Atlantic Canada on the main network), 12:00 midnight, and 5:00 a.m., all times ET.The National and other CBC newscasts (including its "supper hour" national and local newscast) are streamed on the CBC website. [1]In a controversial decision, the CBC announced in 2006 that for the summer months, The National would move up an hour to 11 p.m. on Tuesday nights in the Eastern Time Zone, in order to simulcast the American airing of The One: Making a Music Star over the summer. A Canadian version of the series may launch in the fall in another time slot, but a condition of the CBC's franchise deal for this production was to simulcast the ABC production. This also represented the first time in over a decade that

the CBC scheduled an American-produced series in prime time. However, The One quickly flopped in two weeks and four episodes, recieving record-low ratings on both ABC and CBC due to audience indifference, and The National returned to airing at 10 p.m. five nights a week as of July 31.On the affected nights, the newscast aired at both 9:00 and 10:00 ET on Newsworld. [2]===========================================================Subj: Please support Alecia ... implants since June 9, 2006 and wants them out Date: 10/19/2006 11:56:50 PM Eastern Standard

Time From: ilena.rose@... ---------- Forwarded message ----------From: Alecia Rothermund <ahr75@...>Date: Oct 19, 2006 8:55 PM ilena@...Please, tell me how to get these takin out? I have told so many people my story that I'll just give the abreviated version:I recently had implants put in on june 9,2006. One month later I began having breathing problems. I was in the ER for two days. I was diagnosed as having panic attacks. These attacks last for hours at a time,

sometimes it's all day long. I went from being perfectly healthy to something else. I've had pains in my breasts, they are uncomfortable, there is rippling when I bend over and I can feel the fill plugs. I hate them...I just want them out. Unfortunately I can't afford it. My husband paid for this with our tax return. After breastfeeding my two children for two years each- my breasts were not the same. At 30, I felt like I looked like an old lady. I was convinced I should get them, but then on my post-op appointment I changed my mind. I decided I didn't want the surgery. My husband was upset because we'd loose a $3000 deposit. So, not wanting

to put that burden on him, I went ahead with the surgery. Now I regret it every day of my life. I am perpetually nervous and afraid of the possible health problems in my future. But what can I do?...I am a stay at home/homeschooling mom. I told my husband I would try and find a way to pay for them to be removed, but how? I feel like I'm giving up and like everything is horribly wrong. I keep praying for help and healing- but I suppose the Lord is teaching me patience. Still, everyday is a struggle...and I don't know what it is doing to my body. Thank you and if you know of any good explanting doctors in So.Cal. that will do this for less, please let me know,Alecia