Talk:Breast reconstruction
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I'm new and would like to flesh out this entry (pun intended). Do I just do it?--Islandtyger 21:03, 25 August 2006 (UTC)
Reply to last post:
As of July 2006, the FDA has never approved silicone gel breast implants. The last post stated that silicone gel breast implants are available to women under 18 with parental consent, but that is not accurate.
Silicone gel breast implants are availabe in the US under a "public health" exemption, only under certain circumstances, only for reconstruction.
For data on the safety and effectiveness of breast reconstruction with implants, go to www.fda.gov, click "medical devices", then click "breast implants" and then click FDA "Panel Information." That will take you to the April 2005, October 2003, and March 2000 meetings of the General and Plastic Surgery Advisory Committee. Each meeting includes a "Summary Panel Memorandum" which is a research summary written by FDA scientists, based on the companies' data.
Shouldn't this article have some footnotes? Drzuckerman 02:20, 12 July 2006 (UTC)Dr Zuckerman As of March 2006, the Food and Drug Administration(FDA) has not formally approved silicone-filled implant devices as safe and effective because the manufacturers have not provided to the FDA adequate scientific evidence to prove their safety and effectiveness. Although these implants have been in use for nearly 30 years, the number of women who, now or in the past, have had silicone-filled implants is not known. Estimates generally exceed two million women. The FDA is concerned that there is not enough information about possible health problems from the use of these devices. For this reason, the FDA has called for detailed scientific studies and will permit manufacturers to make these devices available while the data is being collected. Silicone-filled implants are being provided by certain manufacturers to patients who meet very specific criteria. To receive silicone-filled implants one must agree to participate in a clinical study, one must be a female of any age (under 18 must have parental consent), have a condition appropriate for breast reconstruction in which saline-filled implants are not suitable, have adequate tissue available to cover the implant(s), complete a screening by a surgeon and be willing to sign an "informed consent" document which gives information about the breast implant(s)- confirming a commitment to following the study requirements and acceptance of the potential risks involved. The study is designed to collect 5 year data about possible health problems associated with breast implants. These data will be used to help determine if these implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If the data from the studies does not show that they are safe and effective to the satisfaction of the FDA, they may not be available in the future.
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- Information obtained from the McGhan Medical Corporation Silicone-Filled Breast Implant Adjunct Clinical Study Patient Informed Consent document.
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Removed from text:
- Silicone gel implants have recently been re-approved for use in the USA after studies found little connection between the implants and auto-immune disorders.
I couldn't find any websites confirming this. Not even the FDA website. And at any rate it would not be a reapproval as they were never approved before. Saline ones weren't approved until 2000. If anyone can find that they have been reapproved please reinsert. --rmhermen
[edit] Image caption
So what exactly are those two images about? Before-after? Success-failure? Aroused-impotent? --Menchi 06:04 14 Jul 2003 (UTC)
- I don't really remember exactly, they were both breast implant failures. Two different kinds though. I may have put that information in the image description. Otherwise the information can be found by a simple search fda.gov. MB 13:58 14 Jul 2003 (UTC)
[edit] Article focus
This article doesn't discuss breast reconstruction. It seems to discuss the history of implants. We already have an article on breast implants. Shouldn't we actually discuss reconstruction in this article? —Frecklefoot 03:35, 24 Nov 2003 (UTC)
- I agree. I vote we merge the information from here into breast implant and then delete this article.... unless someone actually wants to write about reconstructive surgery. --Dante Alighieri | Talk 00:30, 6 Mar 2004 (UTC)
Okay, I (finally) took care of this. I merged the existing information into the breast implant article, as well as the images. The new content applies only to "breast reconstruction," as it should. Feel free to edit mercilessly. :-) —Frecklefoot 15:12, May 4, 2004 (UTC)
[edit] Surgery Images
Hi,
In my site I have images from a breast reconstruction procedure. I think the images are of great value especially for someone who has to undergo of such an operation. If you think so too feel free to add it in the external links section
http://surgery-images.com/plastic/breast%20reconstruction.html