Lightweight Breast Implants
Surgeon & implants – the key to achieving a beautiful shape, natural feel and lasting results.
B-Lite Temporary Certificate Suspension 16th February 2021
Polytech Health and Aesthetics GmbH, a leading manufacturer of world-class breast implants recently stated that the presence of the B-Lite filling material was identified on the surface of the B-Lite implants. However, this was not due to any concern with the integrity of the shell of the implant but their analysis is that a droplet quantity of filling material containing the gel and microspheres touched the outer surface of the shell during manufacturing. They state the following: These findings do not pose a risk to patients’ safety but as a responsible manufacturer have voluntarily halted B-Lite shipments while they work with their notifiable body Medical Devices Certification GmbH (MDC) to address the issue. Microspheres are used throughout the body in many medical procedures….they do not pose a safety risk….the microspheres identified on the surface of B-Lite implants before and after are covered by a veil of cured silicone which further strengthens their adherence to the implant’s surface….B-Lite implants have gone though the most rigorous research, development and testing over 10 years prior to introduction….since then they have exceeded every required industry test prior to and post market….tens of thousands of implants have been used by surgeons in over 50 countries in the last 7 years.
This page will be updated with new information appearing here where it is relevant to the above.
Why have B-Lite implants been of interest to surgeons and patients?
The skills of the surgeon need to be combined with the quality of the implants and the right patient characteristics to achieve the desired results.
Over the last fifty years, surgical skills have come a long way but breast implants have evolved more slowly. The first generation implants were in the 1960s and had a high rupture rate. In the 1970s second generation implants failed with more ruptures, or silicone gel bleed where it leaked through the shell of the implant. The third generation devices in the 1980s were a great improvement with a barrier layer to reduce diffusion of silicone through the shell and better more cohesive silicone gels. In the 1990’s we saw the development of quality assurance into manufacturing techniques, more cohesive gels, form stable anatomical implants and the introduction of texturing. With the option of a lighter weight implant since 2014, the idea of having less weight dragging within the breast has been an attractive concept to consider.
B-Lite breast implants are the only lightweight option for augmentation and reconstruction.