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.
Breast Implant Regulation Updates
The updates center around patient information rather than changes in the breast implants or Breast Augmentation Surgery itself. The details will be specific to each manufacturer and they have been given 30 days to get their version of the checklist on their website.
The Patient Decision Checklist
The FDA Announcement centers around the “Patient Decision Checklist”. These will be specific to each manufacturer and will include the risks specific to each manufacturer’s devices.
Breast Implant Sales Restrictions
Restriction of the sale and distribution of breast implants will be to only health care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.” It will be the responsibility of the manufactures to make sure their customers comply with the requirements re: Use/review of patient checklist with both patient and surgeon signatures.
Details to Come
More details will become available as the manufacturers release their Patient Decision Checklists. Stay tuned to your San Francisco Plastic Surgery Blog for more details. If you are considering Breast Augmentation or Breast Implant Revision, be sure to seek an experienced, Board Certified Plastic Surgeon. In the San Francisco Bay Area call (925) 943-6353.Previous Post Next Post