Study: 300,000 U.S. Women With Silicone Gel Breast Implants May Have Rupture and Not Know It

by | Apr 1, 2022 | News

Just over 10½ percent of 584 women with current-issue silicone gel breast implants who participated in a recent study were found to have a silent rupture which they were unaware of.

The study, financially supported by Ideal Implant Incorporated, was completed in November 2020 and now appears in the latest January 2022 issue of Plastic and Reconstructive Surgery.

Its author, Louisville, KY board-certified plastic surgeon and past president of the Kentucky Society of Plastic Surgeons Dr. Marc J. Salzman, was one of the first U.S. plastic surgeons to use ultrasound scans to evaluate breast implants.

Silent Rupture Rate Directly Correlated to Length of Time Implanted

The women who participated in the study had undergone breast augmentation and received one or more silicone gel breast implants sometime between January 1, 2000, and December 31, 2015.

The longer women had the implants, the higher the prevalence of a silent rupture which they were unaware of.

“This study found a relatively high prevalence of silent rupture among women with silicone gel implants implanted for 3 to 20 years, with the rate of prevalence directly correlated to the length of time implanted.”

Salzman, Marc J. M.D. Silent Rupture of Silicone Gel Breast Implants: High-Resolution Ultrasound Scans and Surveys of 584 Women, Plastic and Reconstructive Surgery: January 2022 – Volume 149 – Issue 1 – p 7-14

In all, 10.6 percent of the women had a ruptured implant according to high-resolution ultrasound scans conducted between April 2019 and March 2020 at one of nine participating private plastic surgery practices.

Ninety-Five Percent of Patients Would Like Ruptured Implant(s) Removed

Dr. Salzman’s study was also the first-ever to look at women’s emotional attitudes and feelings surrounding a silent rupture of their implants.

Women had “significant concerns and anxiety about rupture.”

  • 95.2% of the women said that even if they were asymptomatic, if they learned that their implant was ruptured, they would want it removed.

Asked to check off all options they would consider after removal of the ruptured implant(s), 16.9 percent of the women said they would opt not to replace the implant at all.

1 in 10 U.S. Women With Silicone Gel Implants May Have Silent Rupture of Which They’re Unaware

According to a January 4, 2021 Blakeslee release, when the study’s information is correlated with publicly available statistics on the number of women with breast implants, the study data “indicates that over 300,000 women in the U.S. [or just over 1 in 10 of the more than three-million U.S. women with silicone gel breast implants] may have silent ruptures that they are unaware of.”

“These are not definitive rupture rates because this was not a controlled clinical trial and the sample sizes are small relative to the large number of implants implanted each year.”

Salzman, Marc J. M.D.

Blakeslee, whose clients include Ideal Implant Inc., also shares that women can avoid the risk of silent rupture and the need for frequent ultrasounds by choosing a saline-filled implant that allows for rupture detection merely by looking in the mirror.

Ideal Implant Inc. produces a smooth-surface, silicone-shell saline-filled implant with a unique internal baffle support structure that reduces rupture rates and the risk of capsular contracture, and which allows for instant rupture detection without an MRI.