B-Lite Frequently Asked Questions

Frequently Asked Questions - Physicians

B-Lite lightweight implants are relatively new to the market so how can patients be assured that they are safe?

B-Lite implants were developed by a multidisciplinary team of physicians, scientists and engineers, then extensively tested over the course of 10 years before being offered to patients.
All materials used in the production of the CE marked B-Lite implants are well documented, safe, inert, biocompatible, and have a long history of use in medicine. B-Lite implants employ a premium shell, manufactured in Germany by a market leader with over 30 years of experience, hundreds of thousands of patients and an excellent safety record.
 

Is the surgical procedure for B-Lite different compared to traditional implants?

There is absolutely no change in the surgical procedure using B-Lite compared to traditional silicone implants, no special training is needed. Additionally, if a surgeon wishes to combine fat grafting or other complimentary techniques they would use the same technique.

Will a lightweight implant feel natural?

In a blinded, comparative trial, three leading Plastic surgeons evaluated the look and feel of 30 patients where half the patients underwent breast augmentation with traditional implants, while the other half underwent augmentation with B-Lite implants. The surgeons tried to identify which implant each patient had (without lifting the breast). Their guess was wrong in 35% of the cases, clearly showing that the augmented breast with B-Lite implants looks & feels like traditional implants. In a survey conducted, B-Lite’s natural look & feel was positively graded by over 95% of patients.

What is the B-Lite gel made of?

The B-Lite gel is a composite of traditional medical grade cohesive silicone gel enhanced with hollow borosilicate microspheres which are chemically bound within the silicone gel. The strength of these bonds significantly exceeds that of the cohesion forces within the gel, ensuring the gel and microspheres will not separate. This in turn, effectively creates gel-covered microspheres that do not separate even in the unlikely case of the implant rupturing.

What are the B-Lite microspheres?

The B-Lite microspheres are inert, high-purity hollow borosilicate microscopic spheres. The high-tech microspheres are very reliable and have been used by NASA to reduce weight of the Space Shuttle as well as in deep sea applications.
The microspheres undergo controlled placement and are spatially fixed within the implants ensuring no migration and a natural feel.
The microspheres are stable and will not change in size or shape under temperatures and pressures that humans can normally withstand. There is no concern with flying, recreational diving, mountain climbing, etc.
 

Are microspheres safe?

Yes. Microspheres are already widely used in a range of medical applications. They are biocompatible and can be found in medical devices and cosmetics. The microspheres are integrated within the cohesive gel and do not separate even in the unlikely case of the implant rupturing.
 

How are B-Lite implants different from other implants?

All breast implants are composed of a shell and a filler. The filler in traditional implants is either Silicone or Saline. B-Lite innovation is in the filler while using premium shells manufactured by a leading German manufacturer with over 30 years of experience. The B-Lite shell is composed of multiple layers of medical grade Silicone elastomer including a barrier layer. The barrier layer is implemented in all parts of the shell including the patch.
These same shells, filled with traditional Silicone gel, have been successfully used in hundreds of thousands of augmentation and reconstruction procedures with an excellent safety profile.  
B-Lite implants come in a matrix of options, including smooth, textured, round and anatomical.
 

Can the microspheres crush or break?

Crush strength tests, verified in every production cycle, ensure that the B-Lite microspheres can withstand pressures ranging from almost total vacuum to over 200 psi (>13 atm) without breaking or deforming. These pressures are far beyond the pressure ranges women are liable to be exposed to following implantation, including during flight and recreational diving.

Is borosilicate biocompatible?

Borosilicate is a standard biomaterial used in Orthopedic, Dental, Ophthalmic, Neurological and other implants and implantable materials. Borosilicate is also used as a reference material in biocompatibility studies, where it is used as the negative control since it is considered inert and completely biocompatible.