QUESTION: I am very concerned about my sister, who had breast surgery several years ago using breast implants.
She is now almost crazy about the reports that this could cause breast cancer to develop and wants the implants removed at once.
What information can you give me that will help me to talk with her and help her make the right decisions?
ANSWER: The recent flood of reports in newspapers and on television about these breast implants has caused many women the same distress your sister is now suffering, and to my thinking is a shame.
I am certainly for giving you all the information you need to make correct choices in medical care, but also believe that this advice must be based on substantial scientific evidence that helps bring us as close to the truth as possible.
That is not the situation in this case.
To start with, the reports were based on preliminary data in a Food and Drug Administration (FDA) study that was "leaked" to the press before even the FDA had a chance to examine the data completely.
Just who leaked the data or why is unknown, but even the FDA believes that some of the reports in the media "may have overstated the risk of cancer to woman who have these implants".
The source of the discussion is the polyurethane foam that is used as a coating for certain kinds of silicone gel-filled implants. It is possible that this material might break down into another substance that has been shown to cause cancer in laboratory animals.
The key word here is "might", as well as the fact that there is no evidence of cancer ever having been linked to the implants in humans. Despite this, the manufacturer of the implants, Surgitek, a subsidiary of Bristol-Myers Squibb, voluntarily stopped shipment of the implants and advised doctors to delay any surgery using these devices.
This responsible action will allow the FDA to complete its evaluation of the results of the study, and should publish its results in but a few weeks.
In a statement released by Bristol-Myers Squibb, it said that "it is confident in the safety of the product and that it deplored the uncertainty created by the anonymous reports of research results". The FDA, in a TALK PAPER issued about this question, stated "While still assessing the data, FDA believes that the statistical values expressed in some media accounts may have overstated the risk of cancer to woman who have these implants".
It also said, "It is unfortunate that preliminary FDA laboratory results reached the public before FDA's analysis of the data was complete. This has created an unnecessary climate of fear in patients who have been implanted with these products." In speaking with a spokesperson for the American Cancer Society, she too agreed that the sensationalism of press reports had been a disservice to the public and suggested the following advice.
Patients with these breast implants in place should not seek surgery to remove them.
This is not always a simple procedure and the risk of removal could outweigh the risk of keeping the implant.
In fact there may be no risk for cancer at all, or possibly one that is very small.
Women considering implant surgery should delay the operation until final analysis of the results of the FDA study. And that is my advice to you and your sister, as well as anyone else now facing this situation.
Once again, it is clear that you must carefully analyze anything you learn from the media, and I am here to help you.
The material contained here is "FOR INFORMATION ONLY" and should not replace the counsel and advice of your personal physician.
Promptly consulting your doctor is the best path to a quick and successful resolution of any medical problem.
