The term “gummy bear implants” is a popular nickname for a specific type of silicone breast implant known medically as a highly cohesive, form-stable silicone gel implant. The nickname was adopted because the internal material possesses a firmness and shape-retention quality similar to the candy, contrasting sharply with older, more fluid silicone gels. These devices are used for both breast augmentation and reconstruction, offering a distinct profile and feel. This newer technology was developed to address limitations of previous generations of silicone implants.
Defining the Cohesive Gel Implant
The fundamental difference between these implants and earlier versions lies in the material science of the filling agent. Older silicone implants contained a smooth, liquid-like silicone gel that flowed freely. In contrast, the highly cohesive implants are filled with a heavily cross-linked gel, meaning the silicone molecules are tightly bound together. This high degree of cross-linking gives the material a semi-solid, viscous texture, akin to a soft solid with a “memory.”
This unique consistency allows the implant to hold its specific shape, even if the outer shell is compromised. If an older, liquid silicone implant was cut, the gel would easily leak and migrate into the surrounding tissue. However, the cohesive gel resists flow and remains largely intact. This resistance to flow is the origin of the “gummy bear” moniker, as the material will not run or flatten.
The cohesive nature of the gel is directly related to its viscosity and density, making the implant feel firmer than traditional silicone while still offering a natural feel. Furthermore, these form-stable implants are often designed in an anatomical, teardrop shape rather than the traditional round profile. This anatomical shaping is intended to mimic the natural slope of the breast, with less volume at the top and more projection at the bottom.
The Timeline of Approval and Availability
While breast implants using silicone gel were first introduced in the 1960s, the “gummy bear” type did not become available in the United States until much later, following a lengthy regulatory process. The U.S. Food and Drug Administration (FDA) placed a moratorium on silicone implants for cosmetic use in 1992 due to safety concerns, allowing them only for reconstruction in clinical trials. This restriction drove manufacturers to develop safer, more advanced gel technology, which eventually led to the cohesive implants.
The FDA lifted the general restriction on modern silicone gel implants in 2006, approving two manufacturers’ products for cosmetic augmentation, but these initial approvals were for a less cohesive, round-shaped gel. The truly form-stable, highly cohesive implants that align with the “gummy bear” description required further, separate clinical trials. The first company to gain FDA approval for a portfolio of these cohesive, shaped implants in the U.S. was Sientra in March 2012.
Following this, another manufacturer, Allergan, received approval for its anatomically shaped, highly cohesive implant—often referred to as the “410” style—in February 2013. These approvals marked the official entry of the new generation of implants into the U.S. market for general augmentation and reconstruction. The FDA required extensive, long-term post-market surveillance studies as a condition of approval, tracking thousands of women for a decade to monitor safety and effectiveness data.
Current Status and Safety Profile
The highly cohesive gel structure offers an inherent safety advantage related to implant rupture, a potential complication with any implant device. If the outer shell of a cohesive gel implant breaks, the semi-solid material is much less likely to escape the surrounding scar capsule or migrate into the breast tissue. This tendency for the gel to remain contained is why a rupture in this type of implant is often referred to as a “silent rupture.”
Because a rupture may not be physically detectable by the patient or surgeon, the FDA recommends a specific long-term monitoring schedule. Women with silicone gel implants are currently advised to undergo an MRI screening three years after the initial implantation surgery. Following this first scan, subsequent MRI screenings are then recommended every two years for the life of the device.
This non-invasive imaging is necessary to detect silent ruptures, allowing for timely surgical intervention if required. Despite their advanced design, all breast implants are considered medical devices that are not designed to last a lifetime. They will eventually require removal or replacement, with the longevity varying greatly among patients.