In November, 2006, silicone gel-filled breast implant devices were approved by the United States Food and Drug Administration (FDA) for use in breast augmentation and reconstruction.
Augmentation mammaplasty is a surgical operation performed to enlarge the female breasts for a number of reasons:
- To enhance the body contour of a woman, who for personal reasons feels that her breast size is too small.
- To correct a loss in breast volume after pregnancy.
- To balance breast size, when there exists a significant difference between the size of the breasts.
- To restore breast shape after partial or total loss of the breasts from various conditions.
- To correct a failure of breast development due to a severe breast abnormality.
- To correct or improve results of existing breast implants for cosmetic or reconstructive reasons.
Breast implant surgery is contraindicated in women with untreated breast cancer or pre-malignant breast disorders, active infection anywhere in the body, or individuals who are currently pregnant or nursing.
Individuals with a weakened immune system (currently receiving chemotherapy or drugs to suppress the immune system), conditions that interfere with blood clotting or wound healing, or have reduced blood supply to the breast tissue from prior surgery or radiation therapy treatments may be at greater risk for complications and poor surgical outcome.
Silicone breast implants are approved by the FDA for use in women who are at least 22 years of age. Women who meet this age criteria may utilize the silicone implants for cosmetic breast augmentation or for revision surgery to correct or improve results of earlier cosmetic breast augmentation. There is no age restriction on breast reconstruction procedures to restore breast shape after cancer, trauma, or severe breast abnormalities.