Breast implant product summary
and package insert

Please read once: Cautions about reading these product summary and package insert pages
(Opens in a new window that is the same for every page)

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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. It is no longer recommended to add any room air to the implant, because that air may not be sterile. The new implant already contains enough sterilized air to permit testing by immersion.

b. Addition of a small amount of saline and removal of all the air thereby before insertion has been my standard since 1992, and is highly recommended.

c. For maximum protection against the possibility of bacteria getting into the saline solution, it is adviseable to not permit the saline to come into contact with room air. Therefore it has been my practice since 1992 to transfer the saline directly from the original container into the implant using a closed sterile tubing system.

d. It is now known that some styles of implant should be filled to more than the manufacturer's maximum, not only to reduce the annoyance of wrinkling, but also to prolong the life of the implant. The style featured in this insert is one of those that do not need to be filled beyond the maximum.

e. Entrapped air inside the implant can make a sloshing noise for a few weeks until it is absorbed by the tissues. The implant shell has microscopic pores that allow air to diffuse out, but not salt or other large molecules. Water diffuses in and out constantly, continuously being refreshed and exchanged. But larger things such as salt molecules, or of course sugars, proteins or bacteria, cannot enter the implant.

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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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