How big can I get XL tissue expanders in the USA? And why can't I legally get XL implants?

Question

Xl tissue expanders are legal in usa, but not xl implants, why is that? thanks

Connie Hiers, MD, FACS · Answer

All implants used in the US are FDA approved.  Those approved implants only go up to a certain size, and each company determined what range of sizes they offer. Beyond that size, there are no approved implants in the US.

Barry L. Eppley, MD, DMD · Answer

The manufacturers simply don't make larger breast implants due to low market demand. There is nothing illegal about their manufacture. XL breast implants in the US means overfilled saline implants which is commonly done.

Adolfo Sesto, MD · Answer

Hello. They are not illegal but most manufacturers prefer not to mass produce them because their demand is not high, and most patients opt later to take them out for a lot of reasons. The manufacturers always produce in relation with the market demand and statistics evaluation of the product.But they can be costume make. Further discussion is needed to give you a recommendation.28 year experience
American Society of Plastic Surgeons
International Society of Aesthetic Plastic Surgery
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Tom J. Pousti, MD · Answer

There are no "legal" concerns with the use of larger breast implants;  I find most of my concerns regarding the use of larger breast implants have to do with safety considerations ( and avoidance of complications).  Patients who are looking for a certain "round, fake look" benefit from the use of overfilled saline implants.  This involves filling the saline implants past the range provided by the manufacturer.  I have found, through significant experience, that for the appropriately selected patient, very nice outcomes can be achieved safely.  Of course, the use of overfilled saline breast implants does have some potential drawbacks such as a firmer feel.Best wishes.

Jeffrey C. Hamm, MD - Account Suspended · Answer

Hi and welcome to our forum!Breast implants can be manufactured to any size. There is no legal size limit. However, the law of supply and demand makes it impractical to mass produce implants > ~ 800 cc. Larger implants can be custom made (they are quite expensive!). One can overfill saline implants but may void the implant warranty if significantly large volumes are chosen. Visit a board certified plastic surgeon for in-person evaluation and advice.Best wishes...

How big can I get XL tissue expanders in the USA? And why can't I legally get XL implants?

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