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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. In fact, it has now been determined that these problems occur just as often in women who never had implants.

b. Further extensive research on this topic has shown no evidence of it having any relevance in humans with implants.

c. There is clear evidence that every implanted medical device, including implants, sheds microscopic particles which become trapped in the scar tissue capsule, and may even appear in lymph nodes. There has never been any evidence that this is harmful.

d. Silicone causes cancer in rats and mice, about 25% of them to be exact. In the same percentage of rats and mice, cancers are caused by pacemakers, artificial joints, heart valve materials, and in fact anything implanted in these animals. The cancers are of a type that is not seen in human beings. Breast cancer rates are lower in women who have implants than in women without them.

e. The National Institute of Medicine concluded in June 1999 that silicone implants do not cause birth defects.

f. Breast feeding ability would be reduced if the nerve to the nipple is damaged, which can happen.

g. It has been determined that cow's milk and formula contain more silicone than the mother's milk from a silicone-gel filled breast implant.

h. The insert also should have pointed out that people have died from the rare Toxic Shock Syndrome (TSS). But the insert also should have made clear that TSS has been reported after nearly every type of surgery, and even occurs in women who did not have any surgery.

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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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