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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. The National Institute of Medicine concluded in 1999 that there is no evidence connecting implants with any of the immunological disorders, lupus, arthritis, scleroderma, or neurological problems. These problems occur equally as often in women with implants as in women who never had them.

b. There are no known cases where this has ever occurred in any woman. 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.

c. The National Institute of Medicine concluded in 1999 that there is no evidence connecting implants with any of the immunological disorders, or connective tissue disorders, or neurological problems. These problems occur equally as often in women with implants as in women who never had them.

d. The National Institute of Medicine concluded in June 1999 that silicone implants do not cause birth defects. It has been determined that cow's milk and formula contain more silicone than the mother's milk from a breast that has a silicone-gel filled implant. Breast feeding ability would be reduced if the nerve to the nipple is damaged, which can happen.

Click on the page you would like to view next.
Summary insert:
A B C D E F __ __ __ __
Product insert:
_1 _2 _3 _4 _5 _6 _7 _8 _9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 __ __ __ __
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

Keywords: Breast implants; Breast enlargement; Breast Augmentation; Breast implants through the navel or underarm; Transumbilical breast implants; Belly-button breast implants; Breast enlargement via underarm incision; Underarm-scar breast augmentation; Breast enlargement via the breast-crease incision; Breast enlargement via incision around the nipple-areola; Through-the-navel breast enlargement; Through-the-navel breast augmentation; Trans-umbilical breast augmentation; Trans-umbilical breast enlargement; Belly-button breast enlargement; Belly-button breast augmentation; Breast enlargement through the navel; Breast augmentation through the navel; Navel breast enlargement; Navel breast augmentation; 'Scarless' breast enlargement; 'Scarless' breast augmentation; Mentor; McGhan