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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. Granulomas are hard lumps sometimes seen after failure of silicone gel filled implants. They do not turn into cancer, but can be confused for cancer, and generally require surgical removal. Granulomas are one of the factual (not imaginary) problems that can occur with silicone gel filled implants. They are a problem that is definitely related to having those types of implant, in contrast to the many problems that people have tried to connect to implants but for which the National Institute of Medicine found no evidence of a connection.

b. There is now very good data showing that a silicone implant in the mother does not cause birth defects in the baby. This was also concluded by the National Institute of Medicine in their 1999 report.

c. It was good that the manufacturer explained that the group of women unable to breast-feed included women who had undergone a mastectomy in the past and had implants for reconstruction, which means that there is no breast there. But they should have explained that inability to breast-feed among women who had never had a mastectomy is quite rare, and mostly related to decreased sense of touch on the nipple, which might slightly decrease milk production volume.

d. Capsular contracture is an extension of a normal process seen around every type of implanted medical device, and so is not properly termed a "complication".

e. 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.

f. Calcareous is just another word for calcification, and the insert should have defined it.

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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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