Breast Implant | Augmentation | US FDA Recommendations
US FDA Recommendations for Patients Who Have or Who Are Considering Breast Implants
Be aware that breast implants are associated with significant local complications, and the longer the devices remain implanted, the more likely you are to experience a complication. Local complications and adverse outcomes include capsular contracture, reoperation, removal, and implant rupture. Many women also experience breast pain, wrinkling, asymmetry, scarring, and infection.
Continue to receive routine follow-up with your physician. This includes having periodic MRI exams to detect “silent rupture” of the implant.
Notify your health care provider if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling.
Recognize that breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed.
If you have enrolled in an Allergan or Mentor post-approval study, continue to participate. These studies are the best way to collect information about the long-term rates of complications.
Continue routine screening mammography for breast cancer at intervals recommended by your health care provider based on your age and risk factors.