50 years of silicone gel breast implants

What are the important lessons and questions from half a century of clinical use?

October 1, 2012
American Society for Aesthetic Plastic Surgery (ASAPS)

Few medical devices are still in use nearly 50 years after introduction. Silicone gel breast implants, despite the controversies over the years, are one of the exceptions. Half a century after silicone gel breast implants were first introduced clinically, what are some of the lessons that plastic surgeons have learned about these devices, and what have they yet to uncover? These questions are discussed in a new editorial, "Silicone Gel Breast Implants at 50: The State of the Science," appearing in the November issue of Aesthetic Surgery Journal.

"In this piece, I wanted to point out specific highlights from the history of silicone gel breast implants and the implications for plastic surgeons," said author Mark Jewell, M.D., an Assistant Clinical Professor Plastic Surgery, Oregon Health Science University, Portland, Oregon, and former co-chair of the Joint American Society of Plastic Surgeons (ASPS)?American Society for Aesthetic Plastic Surgery (ASAPS) Breast Implant Task Force from 2005 to 2006. "One important lesson is that plastic surgeons cannot simply be end users of a device. Instead, we need to be clinician-scientists, collecting data on a daily basis. Not only will this help us better understand and deal with controversies, but it will also empower us to make data-driven decisions that improve the quality of our outcomes with all categories of breast implants."

The controversy regarding the safety of silicone gel breast implants was one of the major catalysts for both evidence- and quality-based movements within plastic surgery. After a 14-year Food and Drug Administration (FDA) moratorium on these devices beginning in 1992, silicone gel breast implants were reintroduced to the U.S. market in 2006. Plastic surgeons played a major role in bringing these devices back to market by collecting data, performing clinical research and advocating for patients based on science, safety, and choice to demonstrate that silicone gel implants were indeed safe and added to patient quality of life.

"Looking back, I find that there was a silver lining to the whole matter, which was the fact that scientific evidence trumped "junk science" and contrary opinion," said Dr. Jewell. "We should never forget the importance of data and scientific evidence, along with patient advocacy, when it comes to the politics of medical devices. These are lessons we can also apply now, in the current challenging regulatory environment, as investigators try to bring new, improved devices to market."

Breast augmentation with silicone gel breast implants, 50 years after its introduction, is a highly refined procedure that uses newer devices, made with better technology and a better understanding of how to minimize the risk of adverse events associated with this procedure. The latest generation of silicone gel breast implants will provide plastic surgeons an opportunity to improve patient outcomes. In particular, the peer-reviewed literature, recent articles published in ASJ and Plastic and Reconstructive Surgery suggests that the new form-stable, anatomically shaped silicone gel breast implants may produce better, more natural outcomes for patients compared to round, smooth implants. Future areas of research not only include new implant shapes and design, but also studies on the immunology of implanted biomaterials, new polymers to replace silicone elastomers and gel, and optimal management of patient expectations regarding size outcomes in breast augmentation.

"Given the challenges that silicone gel breast implants have faced, particularly the attempts to completely remove them from the marketplace,it is impressive to realize we are passing the 50-year milestone," said Foad Nahai, M.D., Editor-in-Chief of Aesthetic Surgery Journal. "As we move forward, it will be exciting to see the new innovations designed to improve outcomes with these devices."

According to the American Society for Aesthetic Plastic Surgery (ASAPS), breast augmentation was the most popular cosmetic surgery for women in 2011, with 316,848 breast augmentations performed, 69% of those procedures used silicone gel implants.