Silicone gel implants have become the most commonly used implant in the world, including the United States. Their safety and efficacy are equal to or better than saline implants. I will discuss the differences between these implants in this article.
In the early nineties, there were not enough scientific studies showing the safety and efficacy of silicone gel implants to pass FDA protocol. This led to it being temporarily taken off the market due to the sole discretion of the head of the FDA at the time. The FDA Scientific Advisory Committee mandated American companies to start doing clinical studies, and this initiated a period of 14 years of intensive investigation involving 110,000 American women. During this time, silicone gel implants were not available for cosmetic purposes, but were for women willing to enter the study for reconstructive purposes. Saline implants helped fill the gap and became more popular for cosmetic breast augmentation procedures.
Since then, scientific studies from around the world have shown that silicone gel and saline implants are equally safe and there are no long-term or systemic diseases that are caused by them. In 2000, the FDA approved saline implants, and in 2006 they approved silicone gel implants. Most recently, ‘form stable’ implants, also silicone gel, have been approved. These are very high performing implants with some of the lowest risks for complications.
There is also a significant difference in the construction of silicone implants used back in 1992 and what we have now. Older silicone gel implants were not as highly cohesive and their shells were more prone to allow viscous oils to ooze through them. These silicone oils caused inflammation that could increase the risk of tight scar formation around the implants, known as capsular contracture.
Silicone gel implants have greatly improved since that time. Specifically, current silicone gel implants have very little viscous oil component, almost all of which is now bound into a solid gel. Additionally, the shell of the implant is now more impermeable to silicone oil; therefore there is significantly less risk of silicone oil ooze.
I do not recommend saline implants for breast augmentation anymore. They are inferior in how they feel and look, have a higher risk of rupture, and create an immediate cosmetic problem when they do rupture. Silicone gel implants feel better, last longer, and if they do rupture, it is not an immediate problem nor is it a health issue.
Silicone gel implants may rupture but the risk is lower than saline implants in any given time period. Unlike saline implants, a ruptured silicone gel implant is ‘silent’, there is no change in size, shape, or feel to the implant or the breast. Detection of rupture is performed with an MRI or high definition ultrasound. Recommendations by the FDA are that women have an MRI at 3 years after surgery, then every 2 years after that. New data suggests that high definition ultrasound may be more effective and that less frequent surveillance is necessary. FDA recommendations have remained unchanged as of yet.
There are two types of breast implants that are made of silicone, the standard cohesive gel implant which has been around since 2006, and the newest device known as the “gummy bear implants”. This is a highly cohesive, form stable cohesive gel implant. They are firmer and less apt to ripple, and their contents cannot potentially exit the shell of the implant, even if there is a crack in the shell. FDA studies show that these devices have the lowest risks and highest satisfaction rate than any other device.
Highly cohesive gel implants are roughly twice as expensive as regular silicone gel implants, which is usually a major factor for prospective patients.
In addition to these cost considerations, there is also a 1% risk of rotation with gummy bear implants that do not exist with other types of implants. Gummy bear implants are shaped and therefore have to be aligned properly unlike a round smooth implant that takes its shape from gravity and is not affected by rotation. A rotated gummy bear implant is a problem and needs an operation. Although this risk is very low, some patients prefer to have an operation without this risk at all.
Although both silicone and saline implants have both been proven safe in clinical trials, it is still my recommendation to go with silicone gel implants for their cosmetic benefits. Silicone looks and feels more natural, has a lower risk of rupture, and therefore has greater durability. If discovered to be ruptured, there is no urgency to replace immediately because there is no change to the appearance of the breasts.
Written by Cosmetic Town Editorial Team based on an exclusive interview provided by Dr. Gerald Minniti in Beverly Hills, CA.