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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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 is an understatement. Because implants wear out over time, every woman should assume that her implants will someday need replacement, which is an operation.

b. Infection is very rare, but more common if there is nicotine present during or after surgery.

c. Breast infection can occur years later after dental cleaning or infections elsewhere, which is the reason antibiotics are often prescribed for teeth cleaning visits. Dental cleaning pushes mouth bacteria into the bloodstream, which can then get to any part of the body including implants. That can cause late infection, or hardening. My patients are instructed to take antibiotics just before teeth-cleaning.

d. Bleeding or hematoma are rare. If there seems to be more bleeding than usual at the time of operation, drainage tubes can be put in. Bleeding is greater if there is nicotine present during or after surgery.

e. Delayed wound healing is more common if there is nicotine present during or after surgery.

f. Loss of sensibility of the nipples occurs in about 1% of patients (a little lower if through the navel) and depends upon incision site as well as implant size.

g. With many implants, what is felt is wrinkling. It is more common with textured surface implants. It is now known that some styles of implant should be filled to more than the manufacturer's maximum, ("Overfill") not only to reduce the annoyance of wrinkling, but also to prolong the life of the implant. The style featured in this insert is one of those that do not need to be filled beyond the maximum.

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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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