“Gummy bear” implants are silicone gel implants with a thicker,more cohesive gel that has the consistency of a gummy bear candy. Initially, these implants were thought to be safer than other breast implants because the more cohesive gel made them less likely to break or leak.
However, research now shows that gummy bear implants are probably not safer than other breast implants. For example, one 5-year study by the implant company found the rupture rate of gummy bears in first-time augmentation patients was over 4%, and the percentage of women needing additional surgeries within 5 years ranged from 17% to 48%, depending on whether the patient was getting augmentation or reconstruction after mastectomy, and whether the gummy bear implants replaced previous implants.
Like other silicone gel implants, gummy bear implants may rupture without any obvious symptoms (called silent rupture). Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends that women have a breast MRI 3 years after getting breast implants. After that, a woman should have a breast MRI every other year to check for a rupture or leak.
When a medical device causes a problem in a patient, the doctor, nurse, or patient can voluntarily report it to the FDA. It can be reported online as an “adverse event report” here. From January 1, 2008, through June 30, 2017, 19% of all adverse event reports made to the FDA for silicone breast implants involved gummy bear implants. That is a very high percentage when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to 2012. In other words, gummy bear implants are causing problems after just a few years – perhaps even sooner than other breast implants.
NCHR’s President, Dr. Diana Zuckerman, along with colleagues Madris Tomes and Amelia Murphy, wrote a book chapter about breast implants. Read a summary of the book chapter here. Copies of the entire book chapter are available upon request at email@example.com.