Breast implant product summary
and package insert
Please read once: Cautions about reading these product summary and package insert pages
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This is not the most recent insert, but it is retained here because of the value of the annotations and explanations. Available on the Web are the most current version of the Mentor insert and the McGhan insert (The McGhan one requires Adobe Reader) both released June of 2000.
The large letters in the left margin refer to the updates below.
This is a photographically scanned copy, identical to the original; the only changes are the page numbers at the bottom for reference, and the large reference letters I put in the left margin that refer to the notes below.
Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate. Below you can read the updated current information about the text that has been annotated in the margin.
Updates and current information about the annotated text in the above insert:
a. The reason for not putting medical devices such as implants into people with a compromised immune system is because those people have a lower resistance to infection. It is not because of concerns that the implant might affect the immune system.
b. Because implants wear out over time, every woman should assume that her implants will someday need replacement, which is an operation.
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Summary insert:
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This page Copyright © R.V. Dowden, MD, 1999, 2000.
This information may not be reproduced or distributed electronically or in print without permission from Dr. Dowden.
Note that while the information given by Dr. Dowden during a consultation is completely current and up-to-date, the information of this website is only as current as the date of last update, and therefore may become out-of-date.
(The package insert bears no copyright notice and may be freely distributed.)
Note: the comments represent the result of current research or practice, but do not necessarily represent the opinion of the manufacturer.
Richard V. Dowden, MD
6770 Mayfield Road, Suite 410
Mayfield Heights, Ohio 44124
(440) 449-7470
Last Update: 6:29 PM on 7/14/2000
URL of Dr Dowden's home page:
http://dr-dowden.com/index.html
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