#breastimplantsafety

Breast Implants are the most investigated and regulated medical device in all of human history. As a Board Certified Plastic Surgeon who has participated in breast implant clinical research trials for all three FDA approved US based breast implant companies, it is reassuring that breast implant follow up research continues to be updated. Only through outcome studies can we glean the knowledge needed to continue to improve breast implants and breast surgery overall.

Breast Implant Safety

Breast implants are designated as a Class III medical device, which includes devices that support or sustain human life, are of substantial importance in preventing impairment of human health or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated, Class III devices require PMA approval before a manufacturer can legally market their device, which is the most stringent type of device marketing application required by the FDA.

Details to Come