Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events
Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.
Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.
The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.
The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.
Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients. The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.
Copies of the entire book chapter are available upon request at info@center4research.org