Complications and adverse outcomes

Most common local complications and adverse outcomes (FDA) >>

• Asymmetry—when breasts are uneven in appearance in terms of size, shape, or breast level

• Breast feeding difficulties

• Breast pain

• Breast sagging, also called “ptosis”

• Calcium build-up in breast tissue, also called “calcification”

• Capsular contracture—hardening of the breast area around the implant

• Chest wall deformity—when the chest wall or underlying rib cage appears deformed

• Deflation of the breast implant—when filler material leaks from the breast implant often due to a valve leak or a tear or cut in the implant shell

• Delayed wound healing

• Extrusion—when the skin breaks down and the implant appears through the skin

• Hematoma—collection of blood near the surgical site

• Iatrogenic injury or damage—when new injury or damage occurs to the tissue or implant as a result of implant surgery

• Implant displacement or malposition—when the implant is not in the correct position in the breast

• Implant palpability or visibility—when the implant can be felt through the skin

• Implant removal—with or without implant replacement

• Implant visibility—when the implant can be seen through the skin

• Implant wrinkling or rippling

• Infection, including Toxic Shock Syndrome— when during breast implant surgery, wounds are contaminated with micro- organisms, such as bacteria or fungi

• Inflammation or irritation

• Necrosis—when there is dead skin or tissue around the breast

• Nipple or breast changes, including change in or loss of nipple sensation

• Redness or bruising

• Reoperation—additional surgeries >>

• Rupture of the breast implant—when there is a tear or hole in the implant’s outer shell

• Scarring

• Seroma—the collection of fluid around the breast implant

• Skin rash

• Swollen or enlarged lymph nodes, also called “lymphedema or lymphadenopathy”

• Thinning and shrinking of the skin, also called “breast tissue atrophy”

• Unsatisfactory appearance due to implant style or size