PIP Breast Implants in the United States

There has been a lot of news recently about PIP implants   and concerns that not only do they rupture at a rate higher than other implants but the silicone inside may not be medical quality.  Fortunately these implants  were never sold in the United States.  PIP did sell prefilled saline implants in the United States for a while (apparently about 35,000 were sold). However when  the FDA asked the three implant companies ( Inamed -now Allergan, Mentor , and PIP) in 2000 to submit a formal application (known as pre-market approval) only two of the companies received approval.  The two companies that received approval –  Inamed (Allergan) and Mentor-  are still the only two companies selling silicone implants in the United States.  PIP has stopped selling its prefilled saline implants in the U.S.A.