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Because of the time it takes the manufacturer to write, design, print, and distribute these inserts, they are always outdated and therefore often inaccurate.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. These particular implants are among the few that do not require exceeding the manufacturer's maximum fill volume to bring them to the Optimal Fill level. That is, Overfill is not needed for these, because the manufacturer's range already includes what would otherwise be the Overfill volume.

b. It is now also recommended that neither heating pads nor hot-water bottles ever be used on the breasts because implants store heat and reflect it back into the skin, which could burn the skin. But it is not dangerous in this regard to go into hot tubs, saunas, or tanning booths.

c. The manufacturers advise against trying to treat capsular contracture by forceful squeezing because it could possibly rupture the implant, requiring an operation, which would give some expense to the manufacturer through the reimbursement program. However, NOT attempting to treat capsule contracture by forcefully squeezing leaves no alternative but surgery, but in that case the manufacturer bears no expenses. Therefore, it is standard practice among plastic surgeons to offer the forceful squeezing to the patient as a possible way to avoid surgery. It is clear why the manufacturers don't recommend it.

d. Implants do make mammography more difficult, and it possibly may make mammography less effective. It does require extra views, which adds to the cost. It must be kept in mind that just having small breasts makes mammography more difficult and less effective. 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. After augmentation, that portion in the back of the breast that was hidden by the muscle or ribs preoperatively will remain hidden by the implant, or if the implant is behind the muscle, hidden by the muscle.

e. 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 in humans.

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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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