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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. 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.

b. Crease fold failure is the way most implants leak. The implant is flexing and folding every time the woman breathes, some 15,000 times every day, 5 million times each year, and usually in exactly the same spot on the implant surface.

c. Women may participate in any normal physical activities without any more increased chance of leakage than occurs from breathing. The manufacturer's use of 'excessive' and 'normal' here in reference to the same activities is confusing and contradictory.

d. It has been known for years that underfilling an implant will definitely cause premature implant failure. It has recently been proven that many implant types need to be filled over the manufacturer's maximum in order to get to their optimum. That is, staying within the manufacturers recommended range will lead to premature failure also. But the implant styles featured in this insert do not need to be overfilled to get to the Optimum.

e. One reason why the failure rate is so low for implants inserted through the navel is that the implants never come into contact with any instrument whatsoever, only the patients tissues.

f. 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.

g. Since the time that this insert was written, it has been learned that some implants must be filled beyond the manufacturer's maximum to prolong the life of the implant and to decrease wrinkling or rippling. But the particular style featured in this brochure does not need that overfill to reach the Optimal fill.

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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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