Late last month, the U.S. Food and Drug Administration issued a short announcement that set the wires buzzing briefly. The gist of the news was that while silicone breast implants are generally safe, they cannot be expected to last a lifetime.
Actually, neither of those two notions is exactly news. What the FDA was doing with its June announcement was updating the public with additional data on silicone breast implants, supplementing findings it announced in 2006 when silicone breast implants were re-approved for use here in the U.S. What were those findings from five years ago? You guessed it: silicone breast implants are generally safe but shouldn’t be expected to last a lifetime.
Many media organizations, including the New York Daily News, seized the more dramatic side of the announcement—the “don’t last a lifetime” part—and led with it (Goldwert 1). To be fair to journalists covering the announcement, the FDA did publish statistics showing that 20 percent of women with breast implants for 10 years will need them removed—and that is a data point worth publishing (FDA 1).
But in its own Consumer Update on the subject, the FDA actually led by reiterating the safety of these devices. The organization stated that since silicone breast implants had been re-approved in the U.S. in November of 2006, manufacturers have been required to conduct follow-up studies to gather more data on the devices. With this information in mind, the FDA “continues to support the safety and effectiveness of these implants…”(FDA 1).
This is good news for many plastic surgeons who prefer the newest generation of silicone gel-filled implants over saline implants for their superior look and feel. The silicone in these implants is termed “cohesive” as it holds together even if an implant shell is ruptured or the implant is cut. This quality, which prompts the nickname “gummy bear implants,” is quite a bit different than previous generations of silicone implants with liquid-like filling (Marina Plastic Surgery Associates 1).
In fact, if you look closely at the FDA’s Consumer Update, you’ll see that in some places the organization is talking about the risks of all breast implants, meaning silicone and saline. For instance, in the point about the devices not lasting a lifetime, the FDA stated that “women with breast implants will need to monitor their breasts for the rest of their lives.” Note the reference to “breast implants,” not silicone breast implants. The FDA further outlined the most frequent complications that occur, including, capsular contracture (tightening of scar tissue around the implant), rupture, wrinkling, asymmetry and others (FDA 1). These complications also occur with saline implants.
Does this mean there’s little cause for concern about the risks associated with silicone breast implants? Of course not. Women who have or who are considering implants of any type would do well to review the Consumer Update (reference below) and follow the suggestions of the FDA to monitor the integrity of their implants.
But this follow-up report by the Food and Drug Administration is good news for plastic surgeons and their breast augmentation. The devices the FDA described in 2006 as some of “the most extensively studied medical devices” (FDA 2) now have five more years of safety to report.
Goldwert, Lindsay. Silicone breast implants ‘not lifetime devices’: FDA; After 10 years complications likely to arise. New York Daily News. June 22, 2011. Web. July 10, 2011. http://articles.nydailynews.com/2011-06-22/entertainment/29710588_1_gel-implants-breast-implants-silicone
FDA Consumer Updates. Silicone Gel-Filled Breast Implants: Updated Safety Information. Food and Drug Administration. June 22, 2011. Web. July 10, 2011. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm259825.htm
Marina Plastic Surgery Associates. Silicone Implant Evolution. Gummy Bear Breast Implants. Web. July 10, 2011. http://www.gummybearbreastimplants.com/implant-evolution.cfm
FDA News and Events. FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation. November 17, 2006. Web. July 10, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108790.htm
Reviewed July 12, 2011
by Michele Blacksberg R.N.
Edited by Alison Stanton