DiagonGel® 4Two prostheses, developed by Dr. Constantin Stan together with the German company Polytech, have either a round or oval base, with an anatomical or round profile.
Implant types in the DiagonGel 4Two range:
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AR = anatomical-round
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AO = anatomical-oval
The prostheses are available with two types of cover: POLYtxt® or Microthane®, and with two projections.
Due to the spherical nature of the design, the implant ensures optimal positioning of the nipple. The almost 90 degree angle at the tapered ends of the implant allows for no dead space, thus reducing seroma incidence, implant rotation and dislocation.
DiagonGel® 4Two with POLYtxt® or Microthane® coating are filled with two types of cohesive (non-flowing) and memory (shape-retaining) gel.
The softer Easy Fit Gel at the back makes the implant integrate gently into the rib cage and ensures natural breast movement. The firmer Sharpar Gel at the front facilitates optimal positioning of the nipple while serving as a push-up support for the breast tissue.
At the same time, Shapar gel offers a natural response in movement, consistency and increased shape stability, even in cases where there is little supporting tissue.
The elastic, chemically and mechanically resistant shell consists of multiple layers of silicone elastomer, including a peripheral diffusion layer.
Thanks to the soft gel at the back of the denture, the edges of the shell are almost imperceptible. Innovative techniques prevent delamination between the gels and between the shells.
The textured shell of the POLYtxt implant or Microthane® implant (micropolyurethane foam) is known for its reliability and has been scientifically proven to help reduce the risk of contractile capsule.
Implant production is based on ISO 9001 and ISO 13485 quality control certificates.
Directions:
- Breast reconstruction after mastectomy or ablatio mammae
- Augmentation and contour correction
- Adjustment of asymmetries, flattening or hypoplasia
- Combined breast and thorax deformities
- Breast ptosis or atrophy
- Changing implants
Polyurethane foam-coated implants were developed by Dr. Constantin Stan to minimize the rate of capsular contracture and to combat dislocation and rotation.
So, the main advantages of Polytech polyurethane foam covered dentures are:
- Extremely low rate of capsular contracture
- Absence of movement/ displacement/ rotation
- Reoperation period after an implant, much longer than for other types of prostheses
- Safety - FDA certification that polyurethane-coated prostheses are safe for breast cancer, with a risk rate of only 1 in 1,000,000
- Usage rate - this type of prosthesis is used daily, all over the world, with an increasing demand among patients worldwide.
Studies conducted over the last 20 years worldwide have shown that the formation of contractile capsule around prostheses was the most common problem after breast implant surgery. The incidence rate of capsular contracture for polyurethane foam-coated prostheses in virgin tissue is 0-9% compared to 9-50% for other types of prostheses.
A long-term study in the US, based on Kaplan-Meier analysis, confirms a significant reduction in the risk of capsular contracture for polyurethane-coated implants, even 10 years after implantation.
Statistics show that 8 years after implantation, the capsular contracture rate for polyurethane foam implants compared to textured shell implants is 15% or even 30% lower compared to smooth shell implants.
Compared to conventional prostheses, which do not have a polyurethane foam shell, around which a single large capsule forms, polyurethane foam shell prostheses (due to the microencapsulation of the polyurethane foam) encourage and allow the development of numerous microcapsules around the foam shell and therefore the contractile forces are neutralised.
The U.S. Food and Drug Administration has released a report showing that the risk of breast cancer from polyurethane foam-coated implants is less than one in one million over a woman's lifetime. In this respect, the Authority has concluded that there is thus no risk of breast cancer with polyurethane-coated prostheses.
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