Breast implant product summary
and package insert

Please read once: Cautions about reading these product summary and package insert pages
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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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. Crease fold failure is the way most implants fail. 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 of the implant surface. Eventually they wear out.

b. Usually deflation is fairly rapid, but not sudden. Typically the implant takes about two days to go down to about half size.

c. Implants do make mammography more difficult, and it possibly may make mammography less effective. It does require extra views. It must be kept in mind that small breasts make mammography more difficult and less effective as well. That is because the portion of the breast in the back against the muscle and ribs is not clearly seen on the mammogram, and in a small breast that may be a significant percentage of the breast tissue. It is important to be aware that self-examination of the breast is easier with an implant than without one. That is because the breast is spread out over a smooth round surface, and even very small lumps are easier to feel. It is worth noting that silicone does not cause breast cancer.

d. A properly done mammogram puts pressure on the breast, but does not put great pressure upon the implant itself.

e. The additional radiation required is approximately the same amount one gets travelling across the USA in a commercial airplane, and is considered not significant.

f. Capsular contracture is the greatest problem we have with implants, with something like 5% of patients requiring more surgery to correct it. There is no way to predict who will get it, and it can even occur on only one side. Some patients can never achieve soft breasts despite multiple operations for hardening. This is one of the reasons for taking antibiotic when having teeth cleaning.

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Summary insert:
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Product 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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