Date: Sat, 1 Apr 2000 12:05:08 -0700

To: Recipient List Suppressed:;

Informed Consent is a generic term , like caveat emptor (buyer beware), which usually refers to doing one’s homework. Surgeons use it as a form to sign which relieves them from liability. In the case of breast implants and Plastic Surgeons, informed consent laws are governed by each state. Thus a PS in FL can give you entirely different information from one in CA, since it is a legal document which protects them under State Law.

Most all of the Plastic Surgeon Associations issue guidelines regarding what information should be made available to a patient prior to surgery, but they have even been signed after a patient has been given a tranquilizer just prior to surgery. Thus, take some time to read and review yours if you are planning any surgery. And do your homework!

The FDA is currently studying recommendations on informed consent which they received at hearings on implants a month ago. The complete transcript of these hearings is at:

Informed Consent issues are at the end of this document. If you are considering implant surgery, the internet is a great wealth of information on informed consent. One of the best sites I can recommend is run by an Eye Surgeon, www.informedconsent.org. Please visit this site and review her document with your surgeon. After all who has more credibility to you, one who operates on your skin or your vision?

‘Informed Consent’ is also the title of a book written by John Byrne of Business Week. (McGraw-Hill, 1996, ISBN – 0-07-009625-2, catalogue 618.19 at most libraries). It describes in detail the background of the Dow Corning Implant lawsuit as described by Dow’s director of corporate ethics. Great Reading!

My suggestions, by all means insist on studying a copy of the package insert which accompanies the exact make and model of the implant you will receive. Consult with the manufacturer if you have any questions. I would also request a copy of the insert from the manufacturer whose fluid will be used in the implant. It is not all the same, ie. siliconegel or saline. (Who makes this fluid?) Some salines state that they are not to be used in any other container.

Lastly, breast feeding after implants. There just is not enough data or studies on this. Please refer to the above FDA site for the most current input on this , (approx. page 242). For more information by an unbiased third party regarding the FDA study, visit cpr4womenandfamilies.org).

Sincerely,

Dan Buck