Product is made of medical silicone which is ideal for long term implantations and is approved by the FDA and conforms with the ISO 14949. Already certified 10 years ago by G-MED, a notified body acclaimed for its excellent work in France, the implants are equipped with CE marking. It allows autogenous welding of the occlusion disc together with the envelope to minimize the lowest rupture rate possible. Its envelope comes with a barrier layer that prevents the silicone oils from diffusing inside the body. These implants are superior and complies with the regulations.