Last month we had the long-awaited approval of gummy bear breast implants. Believed imminent since at least 2007, the FDA surprised many people by taking so long to approve the implants, then surprised others by approving them so suddenly. “Gummy bear” breast implants, more properly known as form-stable silicone breast implants, received their nickname because of their firm but yielding texture. Think of fresh gummy bears, not stale ones, and not ones squishy from being warmed in a pocket all day. Women considering breast augmentation and plastic surgeons have been eagerly awaiting gummy bear implants because they have developed a mystique about them as some sort of great leap forward in breast implant technology that is not only dramatically safer but provides significantly better results as well. But what do the clinical results show? In this blog, I’m going to compare the safety outcomes for the new Sientra breast implants with those of the older Mentor silicone gel breast implants. I’m using Mentor because their patient information pamphlet contains 3-year follow-up results, as opposed to Allergan’s Natrelle pamphlet, which contains 7-year follow-up results. One caveat is that the new Sientra studies report their results as Kaplan-Meier (KM) risk while the Mentor studies report pure numbers, a small statistical difference. Reoperation: Reoperation (also called breast augmentation revision) is the number one complication for both styles of breast implants. In the Mentor study, 15.4% of patients had a reoperation. In the Sientra study, KM risk of reoperation was 12.6%, with a 95% confidence interval (the range they believe is 95% likely to contain the actual risk) of 10.7-14.8%. A slight reduction, but if we had a CI from Mentor, the two intervals would overlap. Capsular contracture (Baker Grade III/IV): Capsular contracture (CC) is one of the more feared complications of breast augmentation, when the scar capsule around the breast implant begins to contract, eventually creating a hard, deformed, painful breast. Baker Grade is a rating of the degree of capsular contracture, and III is when it begins to look unnatural, while IV is when it becomes painful and hard as well. Mentor reported a CC incidence of 8.1% and Sientra a KM risk of 6.0% (CI 4.7-7.7%). Again, a slight reduction. Implant removal with or without replacement: The proportion of reoperations intended to remove the breast implant, with or without replacement by another breast implant, probably of a different size/style. Mentor reported removal rates with/without replacement of 2.8%/2.3%. Sientra reported KM risks of 4.6% (CI 3.5-6.1%)/1.2% (CI 0.7-2.2%). Slightly higher. Rupture: Rupture requires the removal of the implant. The rupture of silicone breast implants is of concern because some attribute systemic disorders that may or may not be associated with silicone breast implants to the migration of silicone throughout the body. Mentor reported a rupture rate of 0.5%, while Sientra’s rupture rate was 2.5% (CI 1.1%-5.5%). Possibly significantly higher. Nipple sensation changes: Short-term changes in nipple sensation, either a loss of sensation or increased sensitivity, are very common. It is only considered a complication when it persists. Nipple complications was the second most common complication in the Mentor studies, occurring in 10.4% of cases. This was significantly reduced in the Sientra studies, which reported only 3.2% risk of this complication (CI 2.3-4.6%). It's unknown whether this is due to the implant or due to improved surgical technique. So, overall the risk of most complications don’t seem to be dramatically different between Mentor breast implants and the new Sientra implants. Although any reduction is appreciated, it seems the hype surrounding the safety of gummy bear implants was unrealistic. To talk to a Philadelphia area plastic surgeon about all your breast implant options, please contact Dr. David A. Bottger today for a consultation.
Are Gummy Bear Breast Implants Better? Part 1: Safety
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