Breast implant surgery, a form of augmentation mammoplasty, is a common surgery that may be performed for cosmetic purposes, for reconstruction after mastectomy, or as part of gender confirmation treatment. Breast implants consist of a smooth or textured silicone outer shell filled with either silicone gel or saline. Breast implants are not lifetime devices and will likely need to be surgically removed or replaced after approximately 7-12 years. The longer the implant has been in place, the greater the likelihood of complications.

According to statistics released by the International Society of Aesthetic Plastic Surgery, 1 777 182 breast augmentation procedures were performed worldwide in 2019. In the United States, breast implant surgery has been in the top-5 most common cosmetic procedures for over 10 years. More than 4 million Americans have undergone breast implantation surgery. In 2019, there were 287 085 breast augmentations, 135 996 breast reconstruction surgeries, and 3544 gender-confirming breast / chest surgeries performed in the United States, according to statistics released by the American Society of Plastic Surgeons (ASPS). Of the breast augmentations, 85% used silicone-gel-filled implants and 15% used saline-filled implants.

The US Food and Drug Administration (FDA) has updated its breast implant safety requirements to include a boxed warning on breast implant devices and a patient decision checklist to help individuals understand the risks. 

Local complications most commonly seen in patients with breast implants include:

• Capsular contracture – This is generally considered the most common complication of breast implant surgery. Some studies report the incidence rate as over 20%, although multiple other studies report much lower incidence rates. Capsular contracture is most commonly seen during the first 2 years following surgery, but it can occur thereafter. It occurs secondary to an excessive fibrotic reaction to the implant. The pathogenesis is unclear, but placement of the implant (increased incidence with subglandular as opposed to submuscular placement) and the use of smooth-surfaced rather than textured implants, are associated factors. Affected breasts are painful, feel hard, and may be contracted with skin puckering. The severity is classified using the Baker grading scale. Grades III and IV are clinically significant and may require reoperation:
  • Grade I – Breast feels soft and appears natural.
  • Grade II – Breast feels a little firm but appears normal.
  • Grade III – Breast feels firm and appears abnormal.
  • Grade IV – Breast feels hard, painful, and appears abnormal.
• Implant rupture or leak – Some implants have valves, and these valves can fail and leak, or the outer shell of the implant can tear. When these events occur with saline-filled implants, the condition is usually quickly identified because the breast will appear deflated as the leaked saline is absorbed. However, ruptures or leaks are difficult to identify with silicone-gel-filled implants as the silicone typically remains within the capsule and may not cause any symptoms (silent rupture). If the silicone does escape the capsule; however, it may cause inflammation and granuloma formation. These patients may have painful masses and visible or palpable abnormalities.
• Implant extrusion or exposure – Relatively rare. The skin of the breast becomes compromised, and the implant is externally exposed.
• Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) – A type of T-cell lymphoma that can develop in the scar capsule of an implant. The risk of developing this cancer is low, and it is more frequently seen in patients with textured breast implants. It occurs most commonly 7-10 years after implantation. Development of seroma more than 1 year after implantation may be a risk factor for BIA-ALCL development. The majority of cases remain localized and are treatable with implant removal. However, recurrences and systemic dissemination have been seen.

Other complications and conditions include:

• Nipple or breast sensation change – May be temporary or permanent. Can affect sexual sensation or breastfeeding.
• Persistent breast pain
• Hematoma – Occurs soon after implantation surgery.
• Wound seroma
• Infection
• Scarring
• Mondor syndrome

A relationship between silicone breast implants and connective tissue diseases has been debated in the literature. Currently, there is no definitive data to support a strong association. Further prospective studies are needed. A condition known as breast implant illness (BII) is now included in the FDA labeling recommendation for implant devices as a risk of breast implantation. The condition itself includes a constellation of signs and symptoms reported to begin after implant insertion, including fatigue, malaise, memory loss, cognitive impairment, arthralgia, myalgia, dry eyes, dry mouth, and alopecia.