Are Silicone-Gel Implants Safe?

Rarely does a day go by when I am in the office without a patient asking me this question.  As part of my continuing look at breast implants, I thought this would be a good opportunity to review this subject and hopefully settle some of the concerns patients may have about the safety of silicone-gel breast implants.

First, a little history.  Silicone-gel breast implants first were used in 1962 and over the next decades, numerous types and styles of silicone-gel filled implants were developed and used not only the United States but throughout the world.  In 1991, the Food and Drug Administration held an advisory panel looking at the safety of these medical devices-particularly concerns about the relationship of silicone-gel implants and a variety of human autoimmune diseases.  Despite the recommendation of the advisory panel that silicone-gel implants be left on the market, then FDA Commissioner David Kessler declared a voluntary moratorium on the use of silicone-gel implants for certain applications including cosmetic breast augmentation.  In October of 2005, the FDA held an advisory panel to re-examine the issue of silicone-gel breast implant safety and efficacy.  In 2006, the FDA reapproved the sale and use of silicone-gel implants from a number of manufacturers including using silicone-gel implants for cosmetic breast augmentation.

So what occurred between 1992 and 2005 to lead the FDA to reverse its earlier decision and reapprove silicone-gel breast implants?  First, dozens if not hundreds of studies were performed looking at the safety issues of silicone-gel implants.  Some of these studies were large-scale epidemiologic studies looking at thousands of women both with and without breast implants to determine if there was an elelvation of certain types of diseases called autoimmune diseases-these are the type of illness where your body’s own immune system attacks itself.  The end result of these studies was that no connection between silicone-gel implants and human autoimmune diseases could be identified.  Another series of studies looked at the possibility of an increase incidence of these types of diseases in patients who had experienced a failed silicone-gel breast implant.  A recent review of the findings of these studies was published in Plastic and Reconstructive Surgery.  To quote the authors, “There appears to be little scientific basis for any association between implant rupture and well-defined connective tissue disease or undefined or atypical connective tissue diseases.”
While no medical device is risk-free for complications including failure and breakage, silicone-gel breast implants have been examined, researched, and then re-examined more than almost any other type of medical device.  These studies have demonstrated silicone-gel implants to be safe and effective devices whose complication and failure rates equal or better those of other commonly used medical devices.  The manufactures of silicone-gel breast implants have also committed their companies to numerous long-term studies to follow patients with silicone-gel and saline-filled breast implants and to document and report their findings in open forums for all to see.  The plastic surgeons at St. Louis Cosmetic Surgery are participants in many of these studies and thank our patients for helping us learn more about how to help them and our future patients.

So then the question has to be asked; why is there so much “bad stuff” about silicone-gel breast implants on the internet?  To paraphrase my past mentor, Dr. Paul Weeks, “Anyone can have an internet site!”  The question really is; do they have the data and studies to back what they say?  Looking at all of the study results and the on-going research, I think we do have the answer about silicone-gel breast implants.  Are silicone-gel breast implants safe?  YES!

Herluf Lund MD

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