Why Are Polyurethane-covered Silicone Implants Not Legal in USA? Q & A...

Nov 22, 2011 by

I will try to avoid ranting and raving about one country not approving a drug/device while other major countries use the drug/device with great success. I will try. But, it still makes no sense to me that capsular contracture in the USA is shown in FDA studies to be up to 15% of implants with textured or smooth shells and the FDA doesn’t evaluate what 35 other countries are using- polyurethane foam covered silicone gel breast implants- to reduce capsular contracture. This might become a challenge for doctors in the USA as more and more patients know about capsular contracture and polyurethane foam covered silicone gel breast implants- will USA based doctors lose business to countries like England, Brazil and Mexico? I found this Q & A on the Real Self website (this is a great website for Q...

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Adjustable Breast Implants Gaining Popularity? No....

Oct 4, 2011 by

This is a really dumb article that pretty much leaves me looking for a larger soapbox to help people understand the facts. Here is the disappointing article that comes from what is usually a very good medical association: Here is the full article, please visit their website: http://www.surgery.org/consumers/plastic-surgery-news-briefs/adjustable-breast-implants-gaining-popularity-1035619  Adjustable breast implants gaining popularity October 3, 2011 Adjustable breast implants gaining popularity When it comes to breast augmentation surgery, deciding whether to opt for silicone or saline is not the only consideration patients must think about. Size is often the biggest consideration. Some doctors are now recommending adjustable breast implants for those who may not be sure just how big or small they want their breasts to be. “A woman comes in with one idea where she wants to be,” a Chicago-based plastic surgeon who is a proponent of the adjustable implants recently told...

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How Many Times Will Your Breast Implants Have to be Replaced?...

Sep 15, 2011 by

If you are 30 years old and live to be 80, it could be 4 or 5 times and would certainly be at least once. How do I determine that? I follow the USA FDA’s guidelines. The FDA recently published a patient booklet Titled Breast Implants Local Complications and Adverse Outcomes that stated the following: As many as 20 percent of women who receive breast implants for breast augmentation have to have their implant removed within 8-10 years. Over the course of your life, you may need to have your implant removed due to local complications. That is shocking news- 1 out of every 5 women that have breast implants will need to have them replaced every 8 to 10 years? If you are going to have breast implant surgery and expect to live for 40-50...

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Silicone Breast Implants- What will the USA FDA do?...

Aug 31, 2011 by

Ugh. Really? I cannot believe things have come all the way back around to the point where the USA FDA is being urged to instruct Johnson & Johnson to pull silicone gel breast implants from the market. The FDA had a hearing today (31 August 2011) to review the follow up studies on silicone breast implants, there was NOT any bad news regarding the safety of the silicone breast implants…but…Mentor (now owned by J & J) only has reporting from 21% of the woman that have had silicone implants since 2006 and this is well below the target (92%). Okay- quick background. Silicone gel breast implants were re-introduced in the USA in 2006- they were approved by the FDA. But, there was the requirement that Inamed (now part of Botox) and Mentor (J & J)...

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Capsular Contracture & Complication Rate Following Breast Reconstruction with Augmentation...

Aug 11, 2011 by

Breast implants help breast reconstruction patients attain a natural looking breast following the reconstruction. Note- the following will review the findings of one implant manufacturer, I am not attacking the quality of their implants, merely reviewing the findings of the study they submitted to the USA FDA and that lead to the approval of silicone gel breast implants in the USA. My intent is not to portray these implants as poor quality, but to point out the FDA approved implants do not solve the issue of capsular contracture following a breast reconstruction. I do not name this implant manufacturer, a link to their report is listed below. Note- I do not work for any implant manufacturing company or receive any compensation from any breast implant manufacturing company. I suggest you click on the link and read...

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