
Originally Posted by
Melonie
What actually happened was that the US FDA made a new ruling along with the 'legalization' of silicone implants. Since that new ruling, EVERY different model and size of breast implant must be fully tested to FDA standards in order to be legally 'used' in any US hospital, clinic, or private facility. Failure of those facilities to enforce FDA approval status puts the hospital, clinic, or private facility at risk of failing federal / state standards ( JACO ) as well as sending those facilities' medical malpractice insurance premiums into the stratosphere.
When the new FDA standards came down, the implant manufacturers had to make a decision in regard to which models and sizes of implants were 'worth the investment' of spending $100,000+ to conduct the FDA testing. The implant companies basically decided that there was insufficient potential future sales volume / demand for implants over 800cc rating to justify spending $100,000+ on the testing in order to obtain FDA approval to sell them in the USA. In other words, while tens of thousands of housewives might choose 500cc implants, and thousands of housewives might choose 800cc implants, only a comparative handful of girls would choose 1500 cc implants ( yet the $100,000+ investment would be the same ).
Bookmarks