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.

Breast implant brochure: GIF about 40K

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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. This does not ordinarily apply, because the implants are already sterile and do not need to go through the autoclave.

b. I am a firm believer in not inflating the implant until after it has been inserted into place. That way, it can be rolled up to a very small size, allowing it to be comfortably inserted through a small incision, for example inside the navel, without coming into contact with any instrument.

c. This seems to be a significant understatement, because given enough time, any medical device will fail eventually. The best estimates are that by 20 years after first being put in, between 20% and 50% will leak and require replacement.

d. Cleaning of the gloves with an antiseptic solution prior to handling the implants, and not touching the implants with any instruments, has been my standard procedure since 1977.

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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and up-to-date, the information of this website is only as current as the date of last update, and therefore may become out-of-date.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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