FDA Updates Breast Implant Safety Info

FDA has updated its “Risks and Complications of Breast Implants” Web page that clarifies information about implant removal and adds ultrasound as an acceptable alternative imaging device for screening for implant rupture for asymptomatic patients to the “Silicone Gel-Filled Implant Rupture” page.

The agency also added a new subsection entitled “Reports of Squamous Cell Carcinoma (SCC), Various Lymphomas other than BIA-ALCL, and Mesenchymal Tumors, including Sarcoma.” The agency notes that scientific literature and Medical Device Reports include SCC and various lymphomas reports in the scar tissue around breast implants. “The FDA has also become aware of reports of various mesenchymal tumors, including sarcomas of the breast, in patients with breast implants,” the agency update says. “The FDA will continue to gather and review all available data to evaluate the occurrence of various malignancies of the breast in patients with breast implants.”