B-lite implant in the USA?

Question

Hello, I'm looking to get breast implants and I've decided B-Lite is the one for me. The only issue is, I don't believe they are FDA approved yet and mainly used in Europe. If I wanted to get the specific B-Lite implant in the USA could I have the size I wanted shipped here for a doctor to surgically implant?

Caner Kacmaz, MD · Answer

Thank you for your questions. you have B-Lite in Turkey. you can have your procedure in Turkey we have B-Lite implants.

Breast implants are sized according to their volume in cubic centimeters (cc).

How do you know what size implant to choose? Looking at pictures and talking to friends who had a breast augmentation might help.

Off course the volume will depend on the shape and size of your actual breasts, your frame and the size you want to achieve.

Our plastic surgeon will advise you thoroughly. Bringing pictures of a desired restult to be shown to our surgeon, might be very helpful.

Wayne I. Yamahata, MD · Answer

Unless you are able to participate in a clinical trial, it is unlikely you will find a reputable plastic surgeon willing to use a non FDA approved device. Patient safety should always be paramount in aesthetic surgery and the use of such a product is contrary to this.

Nelson Castillo, MD · Answer

Thank you for sharing your question.  As they are not FDA approved you will not be able to order them or have them placed in the US.

Kenneth Hughes, MD · Answer

B-Lite breast implants are significantly more expensive than silicone implants as they represent a development time of around 10 years for the manufacturer. The implants are exclusively handmade in Germany and are CE certified. The average price in Germany is $10,346. Because they are not FDA approved in the US, I would recommend that you find a board certified plastic surgeon in the US to implant them before you purchase breast implants you cannot use.

Ronald J. Edelson, MD · Answer

I don’t know anything about the B lite implants but I would never be the first to jump in line for them. Every time something new comes out touted as the latest and greatest we later find problems.

Daniel Barrett, MD · Answer

Dear sparklejumpropekween,
most board-certified plastic surgeons use only FDA approved implants and I think that it would be hard for you to find a surgeon willing to use those implants. If you are considering a surgery, I would suggest you to consult a board-certified plastic surgeon. Only after a thorough examination you will get more information and recommendations.
Daniel Barrett, MD
Certified, American Board of Plastic Surgery
Member, American Society of Plastic Surgery
Member, American Society of Aesthetic Plastic Surgery

Connie Hiers, MD, FACS · Answer

Most, if not all, board certified plastic surgeon in the USA won't use implants that are not FDA approved. You would probably have to go a surgeon in Europe for these implants.

B-lite implant in the USA?

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