FDA panel on post-approval studies of silicone breast implants

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FDA panel on post-approval studies of silicone breast implants

news-medical.net

A panel of expert advisors to the FDA has been asked to look into the matter of the thousands of women who enrolled in studies designed to evaluate rare complications that might arise years after they received silicone gel breast implants.

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Tags: Breast Surgery, Breast Augmentation, Women's Health, Pregnancy, FDA, News

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Most Recently Shared on September 1, 2011 at 7:32 am By:

Pregnancy_News News-Medical.Net

Pregnancy News: FDA panel on post-approval studies of silicone breast implants: A panel of expert advisors to th... http://t.co/gsMUP0C

8 months ago...

Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions

medicalnewstoday.com — “Sientra Inc's silicone gel-filled breast implant for breast reconstruction or augmentation has been approved by the FDA, as long as the company carries out post-approval studies to assess the deviView full resource at medicalnewstoday.com

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Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions http://t.co/XTDlDn7S #medicaldevices

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fda.gov — “Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.View full resource at fda.gov

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Most Recently Shared on March 9, 2012 at 7:33 pm By:

eyeonfda eyeonfda Health Lawyer and Pharma

#FDA approves new silicone gel-filled breast implant http://t.co/z2fCoyIf

2 months ago...

FDA panel reaffirms safety, efficacy of silicone implants -- and looks to the future - Related Stories - Plastic Surgery SmartBrief

smartbrief.com — “The FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee conducted a hearing on Aug. 30-31 in Gaithersburg, Md., to evaluate the progress of long-term postapproval studies mandated when silicone gel-filled breast implants were approved by the agency to return to…View full resource at smartbrief.com

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Most Recently Shared on September 16, 2011 at 6:56 pm By:

Dr_Kristen Kristen Rezak, MD Physician, Doctor, Surgeon, and Plastic Surgeon

FDA panel reaffirms safety, efficacy of silicone implants -- and looks to the future http://t.co/NlZ81Sxn

8 months ago...

FDA questions studies of breast implant safety - USATODAY.com

yourlife.usatoday.com — “A U.S. Food and Drug Administration advisory panel began a two-day meeting Tuesday on silicone breast implants to consider ways to improve the effectiveness of post-approval safety studies.View full resource at yourlife.usatoday.com

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Most Recently Shared on September 1, 2011 at 5:18 pm By:

HealthHive Health News Health News

FDA questions studies of breast implant safety http://t.co/IiJx0oa

8 months ago...

FDA questions studies of breast implant safety - USATODAY.com

yourlife.usatoday.com — “A U.S. Food and Drug Administration advisory panel began a two-day meeting Tuesday on silicone breast implants to consider ways to improve the effectiveness of post-approval safety studies.View full resource at yourlife.usatoday.com

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Most Recently Shared on August 31, 2011 at 3:55 pm By:

USATODAYhealth Maureen Linke Health News

FDA questions studies of breast implant safety http://t.co/vrx7a9s

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FDA Focuses on Silicone Breast Implant Safety Studies

health.yahoo.net — “TUESDAY, Aug. 30 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel began a two-day meeting Tuesday on silicone breast implants to consider ways to improve the effectiveness of post-approval safety studies.View full resource at health.yahoo.net

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Most Recently Shared on August 30, 2011 at 7:57 pm By:

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FDA Focuses on Silicone Breast Implant Safety Studies http://t.co/SkGwPNN

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Silicone Breast Implant Safety Studies Focus of FDA Review - Drugs.com MedNews

drugs.com — “A U.S. Food and Drug Administration advisory panel began a two-day meeting Tuesday on silicone breast implants to consider ways to improve the effectiveness ofView full resource at drugs.com

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Most Recently Shared on August 30, 2011 at 5:02 pm By:

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Silicone Breast Implant Safety Studies Focus of FDA Review: TUESDAY, Aug. 30 -- A U.S. Food and Drug Admin... http://t.co/UUOnmzg #drug

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online.wsj.com — “Women receiving silicone-gel breast implants experience frequent complications including needing additional surgery to fix or replace them, the FDA said, releasing preliminary data from post-approval studies.View full resource at online.wsj.com

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Most Recently Shared on June 22, 2011 at 4:28 pm By:

MedSavingsDoc Stephen Meyers, MD Doctor, Family Medicine Doctor, and Physician

Routine MRIs for silicone breast implants? That certainly adds to costs. http://t.co/aXGNe6g

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