Breast Implant Safety
Since their introduction in the U.S. during the 1960s for cosmetic breast enhancement, breast implants have been a topic of significant debate. Over the years, both the filler materials—silicone gel or saline/sterile saltwater solution—and the outer shells—smooth or textured—have raised substantial safety concerns. In the 1990s, following reports of patient harm and high-profile lawsuits, the U.S. Food and Drug Administration (FDA) temporarily removed silicone implants from the market. After a 14-year hiatus, their reintroduction in late 2006 was met with ongoing issues. In October 2019, the FDA proposed draft guidelines suggesting manufacturers include detailed warnings on packaging about the risks and complications associated with breast implants. Earlier that year, several U.S. and international manufacturers recalled textured shell implants (both saline and silicone) due to studies linking them to a rare form of breast cancer known as breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL). Furthermore, many breast implant patients have reported experiencing symptoms such as brain fog, memory loss, anxiety, and fatigue months to years after implantation—a condition commonly referred to as breast implant illness (BII).
Despite these concerns, breast augmentation with implants continues to be one of the most sought-after plastic surgery procedures. According to Ruli, 96% of users consider it “Worth It,” and surgeons generally maintain that the procedure is safe. However, both silicone and saline implants come with their own sets of pros and cons. To help clear up confusion and address common misconceptions, we spoke with leading plastic surgeons to understand the key factors to consider when choosing between saline and silicone breast implants.
Related: Not Knowing This Before Getting Breast Implants Made the Procedure One of My Greatest Regrets
Breast Implant Safety
“No device has been studied more extensively than breast implants,” asserts Dr. Franklin Richards, a board-certified plastic surgeon in Bethesda, Maryland. “Both saline and silicone implants are equally secure.”
Recent data from the American Society of Aesthetic Plastic Surgeons (ASAPS) shows that 88% of breast implant surgeries currently use silicone implants, despite ongoing debates about their medical use. The FDA officially states that silicone breast implants are safe because “the shell prevents the silicone from moving within the body.” Additionally, studies have found no significant difference in the incidence of BIA-ALCL between the two types of breast implants.
However, detecting a leak in a silicone implant can pose additional challenges. “You will immediately know if a saline implant ruptures, as it will deflate visibly,” explains Dr. Robert M. Grenley, a board-certified plastic surgeon in Seattle. “With silicone gel implants, a rupture cannot be diagnosed through physical examination and often does not show up on mammograms. An ultrasound or MRI is usually required to detect a ruptured silicone gel implant.”
A ruptured silicone breast implant may eventually cause discomfort or changes in the breast's shape or contour. Women with silicone gel-filled implants are advised to undergo an MRI scan three years after the implant surgery and then approximately every two years thereafter.
The removal of ruptured silicone implants also carries its own health risks. A surgical technique called en bloc is necessary, which involves removing the implant and the surrounding scar tissue (capsule) as a single unit to contain the leaked silicone gel. This procedure requires the surgeon to operate blindly around the scar tissue behind the implant, increasing the risk of injury to healthy tissue, nerves, and lungs.
It's important to note that breast implants are not lifetime devices and will need replacement. On average, an implant lasts between 10 and 20 years, and 20% of women with saline or silicone implants have them removed (and often replaced) within eight to 10 years.
1. The Cost of Implants
“Silicone implants typically cost about $1,000 more than saline implants,” notes Dr. David Finkle, a board-certified plastic surgeon from Omaha, Nebraska, in a Ruli Q&A.
Beyond the initial cost of the implants, the lifetime cost of silicone implants can be slightly higher due to the ongoing need for MRI scans for monitoring.
According to Ruli data, the average cost of breast implants in the U.S. is $6,375. This cost can vary based on your location, the surgeon's expertise, and the complexity of your individual surgery.
2. How Breast Implants Feel
“A simple comparison of feeling a saline implant versus a silicone implant will usually lead 99% of patients to choose silicone,” says Dr. Frederic H. Corbin, a board-certified plastic surgeon in Los Angeles.
The reason? According to doctors on Ruli, silicone implants are made from a material that more closely mimics the weight and flexibility of natural breast tissue compared to the liquid saline solution.
3. How Breast Implants Look
The choice of implant material can also depend on the shape and size of your natural breasts. For patients with less natural breast tissue, there is a higher likelihood that “saline implants will appear less natural and have a greater risk of visible implant wrinkling,” warns Dr. Grenley.
However, some patients with asymmetrical breasts may prefer saline implants because the volume of each implant can be adjusted with additional saline solution to better balance the breasts.
4. Breast Implant Age Requirements
In 2006, the FDA reapproved the cosmetic use of silicone implants for women over 22 (and for reconstruction at any age). Dr. Daniel G. Schultz, then-director of the FDA's Center for Devices and Radiological Health, stated that the FDA “wanted to ensure that breast development was complete before these devices were implanted” and noted the lack of clinical data on younger women. Although it is still considered safe (and legal) for surgeons to use silicone implants in those under 22, manufacturers typically do not honor warranties when the implants are used off-label—i.e., in patients under 22—as it does not comply with FDA guidelines.
Conversely, the FDA approved saline implants for breast augmentation surgery in women over 18 and for breast reconstruction for post-mastectomy patients of any age in 2000. The age restriction disparity is due to the different risks associated with the two products. For example, silent ruptures are a risk for silicone breast implants but not for saline implants. The higher age restriction for silicone implants ensures that patients are mature enough to understand the additional risks and safety precautions (such as occasional MRI scans) they will need to follow throughout their lives.
Ultimately, each person is unique, and your needs may differ from others. Consulting a board-certified plastic surgeon is the best way to determine which type of implant is right for you.
When you're ready, make sure to familiarize yourself with the 21 essential questions to ask during a breast implant consultation.
