“Gummy bear implants” is the common term for a specific type of highly cohesive, form-stable silicone gel breast implant. These devices retain their shape even if the outer shell is compromised, due to the unique material science of the silicone gel they contain. Knowing the manufacturer is important for patients and practitioners, as the choice dictates the specific styles, shapes, and long-term performance data available.
The Material Science of Cohesive Gel
The defining characteristic of a “gummy bear” implant is the density of cross-linking within its silicone gel filler. Standard silicone gels are composed of long chains of polydimethylsiloxane (PDMS) polymers, but in cohesive implants, these chains are linked together much more frequently. This cross-linking chemically bonds the polymer chains into a tight, three-dimensional network, increasing the material’s viscosity and elasticity.
This higher concentration of cross-links gives the gel a firm, rubbery consistency, similar to a gummy candy. This structure makes the gel “form-stable,” allowing the implant to maintain its pre-designed shape regardless of external force. Increased cohesivity also minimizes “gel bleed,” which is the migration of trace amounts of silicone from the implant shell. If the shell ruptures, the dense cross-linking ensures the gel remains intact and holds its shape, rather than flowing into the surrounding tissue.
Identifying the Approved Manufacturers
The market for highly cohesive, form-stable silicone breast implants in the United States is served by a small number of manufacturers that have successfully navigated the approval process. Currently, the three main companies producing FDA-approved, high-cohesivity implants are Mentor, Allergan (now part of AbbVie), and Sientra. Each company offers distinct product lines, providing surgeons and patients with a variety of shapes and sizes.
Mentor, a Johnson & Johnson company, offers high-strength cohesive gel implants under brand names such as MemoryShape. These products are characterized by a teardrop or anatomical shape designed to mimic the natural slope of the breast. Allergan, operating under the name Natrelle, produces highly cohesive, anatomically shaped implants, such as the Natrelle 410 series. This line was one of the first highly cohesive, shaped implants to receive FDA approval in the U.S. market.
Sientra is the third approved manufacturer, offering its own line of cohesive silicone gel implants. The availability of multiple manufacturers allows for greater customization in breast augmentation and reconstruction procedures. The choice of manufacturer determines the specific dimensions, projection profiles, and shell texturing available for the desired surgical outcome.
Regulatory Requirements for High-Cohesivity Implants
Silicone gel-filled breast implants, including the “gummy bear” variety, are classified by the U.S. Food and Drug Administration (FDA) as Class III medical devices. This classification is reserved for devices that support human life, are of substantial importance in preventing health impairment, or present an unreasonable risk of illness or injury. Because of this high-risk designation, manufacturers must obtain Pre-Market Approval (PMA) before the devices can be legally marketed in the United States.
The PMA pathway is the most demanding regulatory process for medical devices. It requires manufacturers to submit extensive scientific evidence demonstrating both the safety and effectiveness of the implant. This evidence includes results from multi-year clinical trials, non-clinical laboratory testing, and detailed manufacturing information. The FDA’s approval of a PMA application is a private license granted to the applicant for that specific device.
A mandatory component of PMA approval is the commitment to conduct long-term, post-market surveillance studies. These studies collect data on the device’s long-term performance, safety, and any rare adverse events over many years, often up to a decade or more. This ongoing data collection ensures that the safety profile of these implants is continually monitored throughout their use in the patient population.