Although small, the US Food and Drug Administration (FDA) has identified an increased risk for developing anaplastic large cell lymphoma (ALCL) in the scar capsule adjacent to breast implants. Because the risk is small, pharmacists can help assure women that FDA-approved breast implants are safe when used correctly.
In an alert issued this week, the FDA details its review of 13 years of data published in the scientific literature. The review found 34 unique cases of ALCL in women with breast implant throughout the world. Although difficult to verify from the literature, contact with regulatory agencies leads the FDA to believe there are approximately 60 such cases worldwide. As part of its alert, the FDA asks providers to report confirmed cases.
Importantly, the FDA noted that it “believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.” The FDA does not recommend prophylactic implant removal in patients without symptoms or other abnormality.
Identified symptoms include pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. To date, most cases have occurred in patients undergoing implant revision operations for late-onset, persistent seroma. In addition, 24 of the 34 cases occurred in patients with silicone implants.
Providers should continue routine breast care for their patients with implants and educate them on appropriate home monitoring of their breasts.
Read the FDA alert: