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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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 information was as correct as it could be at the time the insert was written. However, these inserts are outdated, and can no longer be considered correct.

b. It is precisely because of the surgeons responsibility to provide patients with the most up-to-date information, that most surgeons believe it is wrong to give patients these inserts.

c. "Reports associating these complications with implants" means that there have been patients who have these conditions who also have implants. It does not mean that implants cause these conditions.

d. Animals react differently to drugs and substances, and observations made in animals often do not hold true for humans.

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

f. Current evidence now is that there is no change in rheumatic disease if implants are removed. There is currently an unproven theory that some patients may have symptoms of low-grade infection if they are sensitive to bacteria that may exist on the surfaces of any medical device.

g. The National Institute of Medicine concluded in 1999 that there is no evidence connecting implants with any of the immunological disorders, lupus, arthritis, scleroderma, connective tissue disorders, or neurological problems. Current evidence now is that there is no change in connective tissue disorders if implants are removed. There is currently an unproven theory that some patients may have symptoms of low-grade infection if they are sensitive to bacteria that may exist on the surfaces of any medical device.

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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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