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Cautions about reading the package inserts

The pages presented were scanned from the printed inserts that are packaged with an implant. Although these are from one manufacturer and for one particular implant type, they are typical of the inserts for other manufacturers and styles. These inserts are not the most recent edition, but the information is left here for review because of the explanations and annotations that are present. 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. Most brochures are already out-of-date and inaccurate when they are printed because of the time it takes for research, writing, printing, and distribution.
All the information in these inserts is repeated and updated in the consent-for-operation forms which all my patients read and sign before surgery. There is nothing in this brochure that patients are not informed about. Because surgeons believe that patients should be given the most current and accurate information available, most surgeons believe it is wrong to give outdated and incorrect inserts to patients.

As you read these inserts, be aware of the following:

1. The manufacturers are duty-bound to list any and all negative possibilities whether or not they have ever actually occurred. In fact, they even have to mention problems that people have wondered about, even if they never have happened. For example, if someone has ever written they have an elderly patient with implants who has developed poor vision, then the manufacturer would have to put in the insert that there is a case report associating the two and that a relationship is being looked into.

2. These preprinted inserts cannot be kept totally up-to-date as new information emerges. For example, these two were written for release in late-1995 and mid-1998. That was before it was concluded that there is no evidence that implants are connected with immune system disorders, first by the court-appointed panel December 1, 1998 and then by the National Institute of Medicine in mid-1999.

As you read these inserts, you will want to be knowledgeable about the following:

The inserts may use scientific jargon, that usually has specific meaning, and which may be different from what the same words may mean in everyday life. Be knowledgeable about these scientific terms, so that as you read, you understand clearly the meaning of what is being said:

The phrases used and their meanings:

Very strong:
"...has been shown to..." means that something has been proven and established as true fact
"...has been proven..." means that something has been proven and established as true fact

Strong:
"...may result..." means that known instances have definitely happened and the cause is fairly well understood

Moderate:
"...may occur..." means that known instances have definitely happened but the cause may not be clearly understood

Weak:
"...is possible..." means that it could theoretically occur, but may or may not have actually happened, so no stronger term can be used

Very weak:
"...present possible risk..." means it is possible, but has not necessarily been seen, so no stronger term can be used
"...has been reported..." means that it occurs, but no connection has been established, so no stronger term can be used
"...suggests..." means it has been speculated as perhaps related, but that there has been no proof, so no stronger term can be used
"...reports have associated..." means that an event has occurred in whatever animal was used for testing, it may or may not occur in humans, and that there is not enough evidence to explain what caused it so no stronger term can be used
"...case reports associating..." means there have been medical reports of X, Y, or Z occurring in women with implants, but no connection has been established so no stronger term can be used
"...reports raised the possibility..." means there have been medical reports of X, Y, or Z occurring in women with implants, but no connection has been established so no stronger term can be used

Information learned after the inserts were written:

1. In December 1998 the court-appointed panel of scientists after a two-year study found no connection between silicone implants and any immune system disorders or diseases.

2. In June 1999 the National Institute of Medicine panel of scientists after a one-year study found no connection between silicone implants and any immune system disorders or diseases.

3. It has been proven that for certain implants, inflation beyond the maximum volume does not cause failure, but instead actually makes the implants last longer.

4. It has been proven that there is more silicone in baby formula and cow's milk than in the mother's milk from a breast containing a silicone gel implant.

5. It has been shown that there is no increased percentage of birth defects in children of mothers with silicone implants.

6. It has been shown that breast cancer occurs less often in women with breast implants than in women without breast implants.

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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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