Gummy bear implants, also referred to as the 410 cohesive silicone gel implants, anatomical, textured, Natrelle Allergan implants. These are highly cohesive silicone gel implants. They are known as gummy bears, because if sliced open, there is a very thick viscous silicone that is similar to that of a gummy bear candy. The internal material remains intact and maintains its shape even when cut. These properties together with a stronger outer shell reduces the incidence of gel bleed as well as leakage of the silicone from within the shell.
At this time, gummy bear implants are only available in the teardrop shape or anatomic, and they have textured coating. These can have a higher incidence of fracture of the shell, which can lead to rupture of these implants over time. They also can lead to malposition and rotational deformity because they are teardrop and not round implants. The textured shell will adhere and create a fibrous adherence to the breast tissue, later to be the capsule, around the implant. However, if the implant should rotate before this final adherence occurs, a rotational deformity could be significantly noticeable, leading to a serious deformed shaped breast. These implants are not FDA approved at this time. They are still undergoing clinical trials since 2004 by Allergan Pharmaceuticals.
The great advantage of the gummy bear implants is the consistency, being thicker internally, which is closer to breast tissue. They retain their form, and they will bounce back to its shape after the movement of the breast. Therefore, there is reduced visibility and rippling of the implants. It has been known that rippling of implants can increase cracks especially in textured implants, which could be a very significant cause for implant rupture. It has also been thought that capsular contracture, which is the primary number one complication after breast augmentation surgery both for cosmetic and reconstruction purposes, is significantly less with these cohesive gummy bear style 410 Natrelle implants. Obviously, leakage from the broken shell leads to less migration of the silicone material, and therefore less risk of migration extracapsular through the lymphatics and other parts of the body.
The major disadvantages of gummy bear implants are that these implants can have significant rotational deformity, especially if they are placed in an improper anatomical position. Some patients have felt the highly cohesive gel can feel thicker and stronger than the cohesive silicone gels, and therefore feel firmness to the breast, but it feels less natural. If a gummy bear implant should rupture, this could be determined by MRI. The implants should therefore be removed as soon as possible with a new implant replacement. Evidence is notable for MRI detecting rupture of this type of extra cohesive moulage of silicone gel. This silicone being more viscous could cause an even thicker capsule, which could cause stiffening or tightening affect around the implant, increasing risk for Baker IV capsular contracture. The leakage of the silicone material will form granulomas and calcifications. There is evidence that a risk can be slight incidence of infection as well as possible calcification with cancer. I do not use this implant in my practice as of 2012, because it is not FDA approved. There is too high an incidence of rotational deformity, and I do not at this time use textured implants, because of the increased risk of increased fracture cracking of the shell of the bag.