Modern breast augmentation utilizes cohesive silicone gel implants, often called “gummy bear” implants, which offer high form stability. A primary concern for individuals considering these devices is their long-term integrity and whether the internal material can escape the shell. The design specifically addresses material containment, aiming for a natural feel and a reliable safety profile. Understanding this unique structure helps explain how they manage the risk of material migration.
Defining the Gummy Bear Implant
These implants are distinguished by their highly cohesive silicone gel filling, which maintains its shape even if the outer shell is compromised. The gel’s unique properties stem from a high density of chemical cross-links between the silicone polymer chains. This structure makes the material behave more like a soft solid than a liquid, resisting free flow. This form-stable quality means that if the shell were cut, the material would remain together rather than running out. This design fundamentally shifts the focus of failure from a liquid “leak” to a shell “rupture.”
Understanding Rupture and Shell Integrity
While the cohesive gel resists flow, the outer shell of the implant is still susceptible to mechanical failure over time, correctly termed a rupture. Ruptures can be caused by physical trauma, surgical damage during placement, or the natural degradation of the shell material as it ages. Studies indicate that the risk of rupture increases over time, typically starting to rise after six to eight years post-implantation. For example, 10-year data suggests patient-level rupture rates can range from 9% to 16%, depending on the specific product.
A critical distinction is that even when the outer shell ruptures, the highly cohesive gel usually stays within the fibrous capsule the body naturally forms around the implant. This event is known as an intracapsular rupture, meaning the material is contained within the immediate pocket. The robust viscosity of the gel prevents the free migration of silicone into the surrounding breast tissue. Therefore, the cohesive nature of the filling prevents the fluid-like leakage associated with older devices.
Health Implications Following Rupture
When a cohesive silicone implant ruptures, the material is typically contained, which is why most ruptures are “silent” or asymptomatic. The FDA considers medical-grade silicone safe, and a contained rupture does not pose an immediate toxicity risk to the body. However, the presence of a ruptured implant still necessitates medical management, usually involving surgical removal or replacement of the device.
In some cases, the rupture can cause symptoms such as breast pain, changes in breast shape, or hardening of the breast tissue due to capsular contracture. If the cohesive gel moves beyond the immediate scar capsule—an extracapsular rupture—it could cause palpable lumps or nodules called siliconomas. This widespread migration is rare due to the gel’s texture. A confirmed rupture should always be addressed by a healthcare provider.
Long-Term Monitoring and Detection
Since most cohesive implant ruptures are silent, regular diagnostic imaging is a fundamental part of long-term patient care. The FDA recommends that individuals undergo their first screening for rupture five to six years after the initial surgery. Following the first screening, imaging should be repeated every two to three years thereafter.
The most sensitive and accurate method for detecting a silent rupture is a magnetic resonance imaging (MRI) scan. High-resolution ultrasound is also an acceptable and often more accessible screening option, especially for confirming a rupture. Patient awareness of potential symptoms is important; any noticeable change in breast size, shape, firmness, or the development of new pain should prompt an immediate evaluation. These monitoring protocols ensure the long-term safety and integrity of the cohesive silicone implants.